E & EERGroup E & ER Group Phone 510-799-2551628 Second Street Fax 510-799-2572Rodeo, CA 94572 USA Tv2Q
Audit of Biomedical WasteManagement Practices
St. Kitts and Nevis E673
Prepared for:Natural Resources Management Unit (NRMU)
Organization of Eastern Caribbean States (OECS)
January 18, 2002
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Table of Contents
Executive Summary ................................................ i
Introduction ............................................... ii
Objectives ............................................... 1
Approach ............................................... 1
Inventory of Major Health-Care Facilities ............................................. 2
Assessment ................................................ 2St. Kitts and NevisLaws and Regulations ................................................ 2Existing Waste Treatment Technology ............................................... 3St. KittsPolicies and Procedures ................................................ 4Color Coding and Signage ................................................ 4Waste Collection, Storage, and Transport .......................................... 4Waste Treatment ................................................ 8Waste Disposal ................................................ 9Employee Training ............................................... 10NevisPolicies and Procedures ............................................... 11Color Coding and Signage ............................................... 11Waste Collection, Storage, and Transport ........................................ 11Waste Treatment ............................................... 12Waste Disposal ............................................... 13Employee Training ............................................... 14
Recommendations ............................................... 14Short-Term Recommendations for St. Kitts ...................................... 14Short-Term Recommendations for Nevis .......................................... 16Long-Term Recommendations for St. Kitts and Nevis
National Laws and Regulations ............................................... 16Institutional Policy, Administration, and Organization ................. 17Occupational Safety and Health ............................................... 19Waste Segregation and Classification ........................................ 19Waste Minimization ............................................... 22Labeling, Color Coding, and Signage ......................................... 22Waste Collection ............................................... 23Handling and Transport Within the Facility ................................. 24Transport Outside the Facility ............................................... 24Waste Treatment ............................................... 25Final Disposal ............................................... 27Summary of Biomedical Waste Management Procedures ......... 28
Contingency Planning ........................................ 28Employee Training and Public Education ................................... 33
AppendixrSources of Information ........................................ AlWaste Disposal Policy and Procedure - JNF Hospital ............. ....... A2Sample Institutional Policy ............ ............................ A3Waste Minimization ......................................... 4Sample Poster ........................................ A5Ideas for Hazardous Waste Minimization ........................................ A6
Executive Summary
This report presents the results of an audit of biomedical wastemanagement practices in St. Kitts and Nevis. The audit began withmeetings with various stakeholders and site visits to the main hospitals, arepresentative health center, a long-term care facility, dental office, andwaste disposal sites in St. Kitts and Nevis on November 13-15, 2001 Thefollowing assessment is based on the information received, observations,photo-documentation, review of relevant documents, and data obtainedafter the visit.
While there are some laws and a proposed bill dealing in a general waywith biomedical waste, there are no specific regulations or guidelines onthe national level. Recommendations are made on various elements thatcould be addressed in future regulations.
Incineration is the waste treatment technology in use at St. Kitts and NevisUnfortunately, the incinerators at JNF Hospital and Alexandra Hospital areof obsolete designs and do not meet the generally accepted criteria forgood combustion. Moreover, both incinerators are damaged. TheAlexandra Hospital incinerator, in particular, is almost completelydestroyed; it operates essentially as an open-burn platform and its useshould be halted immediately. On the ground around both incinerators,one finds partially burned residues, such as sharps, blood tubes and otherdebris, which pose a serious hazard to workers. Recommendations aremade to keep these areas clean. Because of the toxic air pollutantsassociated with these incinerators, recommendations are made to replacethe incinerators with treatment technologies that are more efficient,cleaner, and have much lower adverse impacts on public health and theenvironment.
The main hospital, JNF Hospital in St. Kitts, has a written waste disposalpolicy that has not been implemented. No color coding or signage is used.These problems need to be addressed in the short-term. At JNF Hospitaland Newtown Health Center, sharps are collected in cardboard sharpscontainers that are not puncture resistant. Recommendations are made touse rigid, puncture-resistant sharps containers. Newtown Dental Clinicuses rigid, puncture-resistant containers that meet international standards.At JNF Hospital, blood tubes are collected in empty bleach bottles; exceptfor the lack of biohazard markings, this is an acceptable practice. Fluidsfrom placenta waste are disposed in the sanitary sewer. This is also anacceptable practice as long as health-care workers are protected fromsplashes from body fluids. Except for the lack of color coding andbiohazard markings, the method of collection of cultures is also
acceptable. The numbers of regular garbage containers and biomedicalwaste containers are appropriate for the size of the facility. In-housetransport of waste is done using an open trolley. Recommendations aremade to use a dedicated, fully enclosed cart. Treated waste residues fromthe incinerator are sent to the Conaree disposal area. It is recommendedthat the treated waste be buried in areas not accessible to waste recyclersor pickers.
At Alexandra Hospital, there are no written policies, no color coding, norsignage. These need to be addressed in the short-term. Sharps waste iscollected in puncture-resistant containers that meet internationalstandards. Blood tubes are collected in plastic-lined corrugated cardboardcontainers. Surgical and pathological wastes, as well as placenta waste,are collected in plastic bags. Except for the lack of color coding and insome cases biohazard marking, these practices are acceptable. Untilsuch time as a new treatment technology is available, it is recommendedthat biomedical waste from Alexandra Hospital be buried in deep trenchesat the Low Ground disposal site; the trench areas should be fenced in withclear waming signs and pickers should not be allowed access to thoseareas.
Employee training is informal and infection control committees are eitherdormant or inexistent in all facilities visited. Recommendations are madeto include biomedical waste management in formal in-service training foremployees. Recommendations are also made to form or reactivateinfection control committees that would initially take responsibility forbiomedical waste management in the short-term. Long-termrecommendations are made to form Waste Management Teams to dealmore comprehensively with waste management in the near future.
Long-term recommendations are made for St. Kitts and Nevis on variouselements of biomedical waste management. They include administrativeand organizational recommendations outlining the responsibilities of staffmembers. Recommendations are also made on occupational safety andhealth practices, classifications of biomedical waste, waste minimization,color coding and labeling, specifications for collection containers, in-housetransport, transport outside the facility, recommended procedures for thetreatment of different categories of waste including expiredpharmaceuticals, and final disposal. These are summarized in five tablesin the report. Specific recommendations are also made on contingencyplanning, employee training, and public education.
In the appendix, resources are provided on general hospital wasteminimization as well as hazardous chemical waste minimization. A samplepolicy paper and educational poster are also presented.
INTRODUCTION
This project is a component of a larger World Bank-funded program toaddress the problem of solid and ship-generated wastes with the goal ofprotecting the environment and enforcing the MARPOL 73/78Convention. The program involves six members of the Organization ofEastem Caribbean States (OECS) and is coordinated by the NaturalResources Management Unit of OECS.
This particular component of the project deals with the management ofhealth-care waste and has four specific tasks: (1) an audit of medicalwaste management practices, (2) review of existing medical wastetreatment technologies, (3) development of a national biomedical wastemanagement plan, and (4) a training program/implementation andmonitoring.
This report corresponds to the first of the aforementioned four tasks. Itwas prepared by Dr. Jorge Emmanuel of the E & ER Group based inRodeo, California, USA. The author is grateful to Mr. Clifford Griffin of theMinistry of Health and Mr. Theodore Mills for their invaluable assistanceduring his first visit. He also acknowledges the support of PermanentSecretaries Mr. Elvis Newton and Mr. St Clair Wallace, as well as Ms.Nona Adams of JNF Hospital and all the personnel who providedinformation at facilities in St. Kitts and Nevis.
Jorge Emmanuel, PhD, CHMM, PE, REP, DESPresident, The E & ER Group
628 Second StreetRodeo, CA 94572
USAPh. 510-799-2551Fax 510-799-2572
E-mail: iemmanuelkcmindspring com
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AUDIT OF BIOMEDICAL WASTE MANAGEMENTPRACTICES
The objectives of this report are to review the current status of biomedical wastemanagement on St. Kitts and Nevis, and to present recommendations. Theconsultant's recommendations are based on:
a) The need to safeguard public health, enhance occupational safety of healthcare workers, and protect the environment without compromising patient care
b) The need to conform to generally accepted international practices andstandards related to the collection, transport, and disposal of potentiallyinfectious waste
c) The desirability of regional harmonization, where appropriate, of practices andstandards related to biomedical waste management.
Information for this report was obtained from meetings with stakeholders andvisits to various facilities conducted from November 13 to 15, 2001. Specificsources include:
a) Data gathered during meetings with govemment officials, health care facilitystaff, solid waste management personnel, and other stakeholders
b) Observations and photo-documentation of existing practices and technologiesduring site visits to the main hospitals, clinics, a long-term care facility, and adental office at St Kitts and Nevis
c) A review of relevant documents
d) Responses to follow-up requests for additional information
e) Consultations with personnel from the Natural Resource Management Unit ofthe Organization of Eastern Caribbean States.
Appendix Al gives a list of the facilities visited, personnel who providedinformation, and documents and photos obtained.
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Joseph N. France (JNF) General Hospital is the main hospital in Basseterre, St.Kitts. It was constructed in 1968 and currently has a 74-bed capacity.Completion of new construction sometime in 2002 will expand the bed size to150. JNF Hospital offers a range of medical services including general surgery,radiology, obstetrics and gynecology, emergency, and pharmacy. Two smallerhospitals offering a more limited range of services are Pogson Hospital in SandyPoint, St. Kitts, and Mary Charles Hospital in Molineux, St. Kitts. Of these, theconsultant visited JNF Hospital.
There are eleven health centers in St. Kitts: Basseterre, Newtown, St. Peter's,Cayon, Molineux, Tabemacle, Saddlers, Dieppe Bay, St. Paul's, Sandy Point,and Old Road. These health centers offer matemal health, male health, and childhealth clinics as well as communicable and non-communicable diseases, minortreatment, immunization, and other services. Of these, the consultant visitedNewtown Health Center.
Alexandra Hospital in Charlestown, Nevis has a 54-bed capacity and wasoriginally constructed in 1951. The hospital provides a range of services includinggeneral surgery, obstetrics and gynecology, emergency, and pharmacy. Thereare six health centers in Nevis: Chariestown, Combermore, Gingerland, BrownHill, Cotton Ground, and Butlers. They offer the same services as the healthcenters in St. Kitts. The consultant visited Alexandra Hospital in Nevis.
St. Kitts and Nevis
1. Laws and Regulations
A country's approach to managing biomedical waste is determined in the firstplace by the country's laws and regulations. The relevant legislation are: (1) ThePublic Health Act of 1969; (2) The Litter (Abatement) Act of 1989; and (3) TheSaint Christopher and Nevis Solid Waste Management Corporation Act of 1996.Directly related to biomedical waste is a section in the Solid Waste ManagementCorporation Act that includes, among the duties of the corporation, the provisionof facilities for the treatment and disposal of medical waste. However, none ofthese laws has any detailed provisions on biomedical waste.
There is a proposed Solid Waste Management Bill of 2000. The Solid WasteManagement Bill defines 'biomedical waste" as including 'any solid wastecontaining human or animal fluids, flesh, bones or other body parts except hair."Annex 1, Schedule 1 of the bill classifies the following waste streams, amongothers, as hazardous waste:
Y1 Clinical wastes from medical care in hospitals, medical centers and clinics
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Y2 Wastes from the production and preparation of pharmaceutical productsY3 Waste pharmaceuticals, drugs, and medicines
There are no classifications and formal definitions of the different types of medicalwaste.
Part II of the bill directs the Solid Waste Management Corporation to "identifymethods by which hazardous and bio-medical wastes and other specified classesof solid waste substances are to be managed". Except for these generalprovisions in the proposed bill, no specific regulations on biomedical wastemanagement exist.
Therefore, while there are some related laws and a proposed bill, there are reallyno regulations governing biomedical waste management in St. Kitts and Nevis. Itis recommended that future regulations incorporate various aspects of a nationalbiomedical waste management plan.
2. Existing Waste Treatment Technology
Incineration is the waste treatment technology used in St. Kitts and Nevis. Thehospitals use single-chamber, oven-style incinerators. The two incineratorsexamined by the consultant at the major hospitals (JNF Hospital in St. Kitts andAlexandra Hospital in Nevis) are damaged. Both incinerators do not meet thecriteria for good combustion and are a source of toxic pollution and hazardousresidues.
State-of-the-art incinerators generally involve a rotary kiln or dual-chamber designwith auxiliary burners and controllers to carefully control and maintain hightemperatures. The incinerator chambers must operate at about 1,500-3,000 OF(800-1,600 IC). In the 1960's, many of the new hospital incinerators then weredual-chamber controlled-air designs: medical waste bumed in a primary chamberoperating typically at 1,400 OF (760 OC) with controlled amounts of air, followed bya secondary chamber operating usually between 1,800-2,200 OF (980-1,200 OC).Controllers, auxiliary bumers in both chambers, and an air injection system wereused to maintain high temperatures. The incinerators examined by the consultantin St. Kitts and Nevis belong to an even older generation of incinerators.
Biomedical waste incinerators are a known source of highly toxic dioxins andfurans, particulate matter (fly ash), hydrogen chloride, hydrogen fluoride, sulfurdioxide, nitrogen oxides, carbon monoxide, lead, mercury, cadmium, and other airpollutants, as well as hazardous ash. Air pollution control devices, such asscrubbers and baghouse filters, lessen but do not eliminate these air pollutants.Dioxins and furans are considered among the most toxic substances because ofthe extremely low doses at which they can affect humans and animals.Particulate matter not only contribute to air pollution but can be dangerous inthemselves because of trace amounts of toxic chemicals that adsorb on thesurface of particulates which can then be inhaled into the lungs. Gases such ashydrogen chloride and sulfur dioxide contribute to air pollution, form acid rain, andcan damage plants directly or through their acidity. Heavy metals such as leadand mercury are toxic when taken into the body; they are released with the fly ashand deposited on soil or surface water thereby contaminating the environment.
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Single-chamber incinerators, which only operate at about 550 to 750 OF (about300-400 OC), emit black smoke and volatile organic compounds in addition to thepollutants listed above. Unfortunately, the temperatures at which single-chamberincinerators operate fall within the temperature range in which highly toxic dioxinsand furans are formed, i.e., 480-840 OF (250-450 IC). If proper operatingconditions are not met, incinerators also release pathogens through discharge airand residues. Specific comments and recommendations are made belowregarding the two incinerators examined.
St. Kitts: Biomedical Waste Management Practices
i. Policies and Procedures
JNF Hospital has a written "Waste Disposal Policy and Procedure" (no date). Acopy of the text is provided in Appendix A2. The policy was developed in the lastfew years. The policy requires color coding of bags or containers: red forpotentially infectious waste, yellow for any trace chemotherapeutic waste, clearbags for non-contaminated waste, and red or yellow puncture-resistant containersfor sharps. It also describes collection and treatment methods, e.g., use ofautoclavable red bags and on-site autoclaving for cultures. Some treatmentmethods are left unspecified, such as those for sharps waste. The written policyis a good start in standardizing color codes and categorizing waste components.However, the policy has not been implemented.
2. Color Coding and Signage
No color coding or signage is used in any of the health care facilities visited.Sources indicated that color coding had not been in place before and there hasnot been an impetus to change the current practices.
At JNF Hospital, health care staff reported that yellow bags have been used onrare occasions for highly infectious waste (described as waste from patients withHIV). However, this contradicts the written policy that yellow bags are to be usedfor trace chemotherapy waste.
Color coding and signage are important aspects of waste segregation for effectivewaste management, protection of public health, and occupational safety. Theyare the generally accepted standards for handling health-care waste. The lack ofcolor coding and signage is a serious problem that needs to be addressed in theimmediate term.
3. Waste Collection, Storage, and Transport
Sharps collection:At JNF Hospital, waste is segregated at the point of generation. Sharps waste iscollected in cardboard "UNIVEC Safety Box' containers (Garden City, New York,USA), shown in Figure 1. The sharps containers were found in the laboratory,surgical ward, and other areas. The UNIVEC containers are approximately 6.1liters (6.5 quarts) in volume and fill up approximately every two days. During the
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site visit, none of the containers were overfilled. Sources expressed difficulty inobtaining sharps containers. Rigid sharps containers take up much volumeduring shipment and consequently have higher shipping costs. In contrast, theUNIVEC boxes are collapsible and compact when shipped and are unfolded justbefore use.
Figure 1. UNIVEC Box
At the Newtown Health Center, sharps waste is also segregated at the point ofgeneration and collected in UNIVEC boxes. Collectors drive to the clinic twice aweek and transport the sharps boxes when full to JNF Hospital for incineration.Syringes are loaded vertically into the UNIVEC box The staff commented on theproblems getting needles to go down into the box, as needle points tend to stickto the sides and sometimes puncture the walls of the cardboard box. At least oneneedle-stick injury was related to the consultant: a needle sticking out of aUNIVEC box had punctured a nurse on the thigh as she was transporting the boxback to the clinic after conducting vaccinations at a school.
At the Newtown Dental Clinic, sharps waste is collected in Sage horizontal-loading, rigid plastic sharps containers (Sage has now sold its sharps containerdivision to Kendall in Crystal Lake, Illinois, USA). Each container (Figure 2) hasan approximate volume of 7.6 liters (2 gallons). The containers are eventuallysent to JNF Hospital for incineration. The Sage containers are rigid, puncture-resistant, durable, and meet intemational standards.
Figure 2. Sage Horizontal-Loading Sharps Container Behind Dental Chair
During the site visit, three large containers were lined with white plastic bags andcontained a large accumulation of sharps. Two of the containers were nearly fulland had no lids. Sharps containers should have lids to prevent accidentalspillage. They do not need plastic bags if they are incinerated. However, if therigid containers are reused, the plastic bags should not be removed from thecontainers (since needles can easily puncture the bags). Instead, the contents(sharps and bag) should be dumped directly into the incinerator chamber in a
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manner that would prevent needle-stick injury to the worker. The containersshould then be cleaned and disinfected.
The handling, collection, and disposal of contaminated sharps waste pose one ofthe greatest occupational hazards facing health care workers worldwide becauseof the frequency of needle-stick injuries and the potential transmission ofbloodbome pathogens. For this reason, the generally accepted performancecriteria for sharps containers include: puncture resistance, rigidity, durability, leakresistance on the sides and bottom, ability to be closed, and functionality under allnormal conditions during their use. Based on the anecdotal information providedand a visual examination of the UNIVEC boxes, the UNIVEC containers do notseem to meet basic performance criteria of puncture resistance during normalusage, whereas the Sage containers used in the Newtown Dental Clinic meet thecriteria.
Collection of other biomedical waste and regular garbage:At JNF Hospital, surgical and pathological wastes are collected in black bags.The "Waste Disposal Methods" table in the existing hospital policy does notspecify a color for the containers or bags to be used for pathological waste.However, the use of black bags is not in compliance with the general policystatement that requires all potentially infectious waste be placed in red bags.
Blood tubes and vials are collected in empty bleach bottles as shown in Figure 3.The containers seen by the consultant are rigid and impermeable but do not havebiohazard markings. The use of plastic bleach bottles for collecting blood tubes isan acceptable practice as long as containers are properly marked with theinternational biohazardous label.
Figure 3. Blood Tubes Inside Bleach Bottles Inside the Incinerator
Wet solid placenta waste is collected in covered white pails and the liquid portionis drained into the sewer. Disposing of fluids from placenta waste into thesanitary sewer is accepted practice as long as health-care workers are protectedfrom splashes. Collecting solid and semi-liquid placenta waste in pails isacceptable as an initial step but the wet solids should then be collected in redbags before being transported for treatment and disposal.
Cultures are collected in plastic bags. Except for the lack of color coding andbiohazard marking, this is acceptable as long as the cultures are in closed glasscontainers and are not broken. Any glassware that is broken, has sharp edges,or may easily get broken (e.g., test tubes, slides, cover slips, pipettes, etc.) shouldbe placed in puncture-resistant sharps containers.
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No chemotherapy waste is generated in any of the facilities.
Regular garbage is collected in garbage containers. Typically, one regulargarbage container is placed near each bed. The numbers of regular garbagecontainers and of containers for potentially infectious waste seem appropriate forthe size of the facility. Too many infectious waste containers have been shown toinflate unnecessarily the volume of waste as health care staff tend to discardregular garbage into infectious waste bins. However, sharps waste containersmust be readily accessible to the staff.
At Newtown Health Center, other types of waste such as bandages, cofton,gauze, etc. (except for sharps) are placed in trash containers and picked up anddisposed of along with regular garbage. Blood-stained gauze at the NewtownDental Clinic is segregated in separate containers and sent for disposal withregular garbage to the dumpsite. These are acceptable practices. A recent draftWHO report on biomedical waste health hazards notes that most blood-bornepathogens have a limited ability to multiple and remain viable longer than a fewhours to a few days in dried blood ("Review of Health Impacts fromMicrobiological Hazards in Health-Care Wastes" (draft), I.F. Salkin; edited by M.E.Kennedy, World Health Organization, Geneva, 2001). Therefore, concerns withthe handling of blood focus primarily on bulk liquid blood and the danger of bloodsplashes.
In-house storage and transport:Biomedical waste is transported via an open trolley and brought directly to theincinerator on a regular basis. Fortunately, due to the relatively small amounts ofwaste generated daily, there is no need for a storage area for biomedical waste.The use of a trolley (Figure 4) that is open on the top and sides is generally notacceptable for transport of biomedical waste. A fully enclosed cart, with a lid toprevent spillage and avoid offensive sights and smells, is recommended fortransporting biomedical waste. Until a fully enclosed cart is obtained, stepsshould be taken to minimize the possibility of spillage and the trolley should beregularly cleaned and disinfected.
Figure 4. Open Trolley for Transporting Waste
Regular garbage from the trash containers is dumped into a plastic bag twice aday and transported by trolley to a storage enclosure near the incinerator. It isrecommended that a separate trolley be used for regular garbage.
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Off-site transport:The Environmental Health Department schedules the removal of regular garbagefrom the hospital. A transport vehicle provides daily collection of garbage.Incinerator ash, treated sharps, and other waste are also collected andtransported to the dumpsite. It is recommended that treated biomedical waste bekept separate from regular garbage so that the latter can be disposed of in arestricted area where waste recyclers or pickers are not allowed.
.Waste Treatment
Sharps waste, surgical and pathological waste, placenta waste, and cultures aresent to the incinerator for burning. At JNF Hospital, waste is treated in an oldsingle-chamber oven-style incinerator (Figure 5) built around 1968 at the back ofthe hospital. The incinerator's stack was destroyed during Hurricane Georges in1998. (A new chimney has been purchased.) The purpose of the chimney orstack is to disperse the pollutants higher up in the atmosphere thereby reducingpollutant concentrations at ground level. Unfortunately, the residences behindJNF Hospital where the incinerator is located are at a higher elevation and hence,the advantageous dispersion and dilution effects provided by a chimney arelessened.
The incinerator is used approximately 4 days a week. Orderlies place the wasteinside the chamber and light up the incinerator. Buming is initiated by adding logsto the waste, pouring kerosene on the waste pile, and using matches to ignite thepile. The orderlies are instructed to check periodically while the waste is burning.However, if cultures or tissue waste is burned, orderlies are told to monitor theburning. The incinerator is adjacent to the storage area for regular garbage. Theash and other residues from the incinerator are collected in a garbage bin andsent to the landfill approximately once a week.
Figure 5. JNF Incinerator During Burning
During the site visit, it was observed that emissions from the incinerator weregenerally blown in the direction of nearby residences and commercial facilitiesbehind JNF Hospital. A single-chamber incinerator that is carefully maintainedand operated properly should produce ashes containing less than 3 percentunburned matter. Debris was scattered in the area around the incinerator andburned or partially burned sharps waste could be found on the ground near the
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incinerator (Figure 6). This creates an unsafe environment for orderlies and otherworkers dealing with biomedical waste and regular garbage that is storedadjacent to the incinerator.
Figure 6. Partially Bumed Residues
At one time, JNF Hospital had an autoclave but it malfunctioned. The hospitaldetermined that the autoclave was irreparable and it was subsequentlyabandoned.
Newtown Health Center has a small, unused single-chamber incinerator. Use ofthe incinerator was halted sometime in the mid-1990's due to the danger of fire orexplosion as the incinerator is in close proximity to a Shell gas plant locatedadjacent to the clinic. The incinerator was used for less than a week. The safetyconcerns related to the gas plant are valid ones and the incinerator should not beused.
Reportedly, Pogson Hospital and Mary Charles Hospital each have a small brickoven-type incinerator which one source described as "unapproved" designs.
The current incinerator at JNF Hospital, even with a chimney, does not meet thebasic criteria for good combustion and is a source of toxic air pollutants. Theappearance of the residues indicates very poor combustion which, unfortunately,is inherent in these types of single-chamber designs. Research has shown thatdestruction of test spores take place when the waste is exposed to a minimum of1,400 IF (760 IC) in a primary chamber and 1,600 IF (870 OC) in a secondarychamber with a 1.2 second residence time. Some regulatory authorities require aminimum temperature of 1,800 OF (980 IC) in the secondary chamber and aminimum 2-second residence time as a safety factor to assume total destructionof all pathogens. The single-chamber incinerator at St. Kitts does not meet thisbasic requirement. Steps should be taken to phase out the incinerator andreplace it with a new treatment technology.
5. Waste Disposal
The liquid portion of placenta waste is flushed down the sanitary sewer. As notedearlier, this is an acceptable method of disposal.
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The Multi-Purpose Lab is consulted on how to dispose of expired or condemnedpharmaceuticals; in general, they are bumed. The buming of pharmaceuticalsresults in the release of toxic air pollutants, as described above, andconsequently, in potential adverse impact to public health and the environment.
Spent solvents, such as xylenes and formaldehyde, are stored and disposed inthe drain. This is not an acceptable disposal method since these toxic organicsolvents could pollute the environment and possibly contaminate water sources.
Waste from radiology (developers and fixatives) are neutralized and disposed inthe sewer; there is no silver recovery system. This method of disposal into apublic sewer system is commonly done and is acceptable as long as it is inkeeping with any discharge permits or wastewater regulations. Since spent fixersolutions contain small amounts of silver (up to 1,400 parts per million), a silverrecovery system may be considered if large amounts of wastewater areprocessed through radiology.
The bumt sharps, ash, and other waste residues from the incinerator are broughtto the Conaree site, a solid waste disposal area or dumpsite that is over 40 yearsold. There the waste is dumped along with regular garbage. Individuals can walkin but vehicles are checked at the gate. Dumping is supervised. Regulargarbage is leveled and compacted by a bulldozer and an earth cover is added atthe end of the day. Unusual waste that the hospital wishes to dispose of in aspecial manner (as well as occasional abattoir waste from the slaughterhouse) isburied in trenches in specially designated areas on the northwest side of thedumpsite. Recyclers or pickers actively scavenge and collect salvageablematerial from the landfill.
Incinerator residues contain sharps and partially burned blood vials that poseneedle-stick and bloodborne pathogen hazards to pickers. Those types of wasteshould be kept separate from regular garbage and pickers should not be allowedaccess to treated biomedical waste. Around 2002, the Conaree area will be thesite of an engineered landfill to be constructed around the area where the currentmain entrance to the existing dumpsite is located. The development of anengineered landfill with restricted and marked areas for biomedical waste isrecommended.
6. Employee Training
At JNF Hospital, in-service training related to infection control was last conductedabout two years ago. A teaching manual had been completed, including lessonplans and handouts. The instructions covered disinfection among other topics Atpresent, little instruction on biomedical waste management is provided throughinformal, on-the-job training. In the future, some in-service training is planned toinclude waste handling.
A nosocomial or infection control committee exists but has been dormant. It usedto meet periodically. Unfortunately, staff attrition, in some cases due to studyleave, resulted in the committee becoming inactive. One source noted that thecommittee could easily be revived since the organizational structure remains inplace.
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Despite the inexistence of govemment regulations, lack of implementation ofhospital policies, and no formal employee training on waste management, manyhealth care personnel demonstrated some understanding of the need tosegregate at the point of generation and the importance of sharps wastemanagement. Nevertheless, biomedical waste management should be a part ofemployee in-service training and an infection control committee, which plays animportant role in biomedical waste management, should be fully reactivated. Thiswill be discussed further in the Recommendations.
Nevis: Biomedical Waste Management Practices
1. Policies and Procedures
There are no written policies or guidelines for biomedical waste management atAlexandra Hospital.
2. Color Coding and Signage
The following color coding had reportedly been used in the past: red bags forinfectious waste, black for regular garbage. However, color coding is currentlynot used. As noted above, color coding and signage are important aspects ofwaste segregation for effective waste management, protection of public health,and occupational safety. They are generally accepted standards for handlinghealth care waste. The lack of color coding and signage will be addressed in theRecommendations.
3. Waste Collection, Storage, and Transport
At Alexandra Hospital, waste is segregated at the point of generation. Sharpswaste is collected in two types of sharps containers: a small (tabletop) yellowplastic container (Vacutainer, volume of about 0.95 liters or 1 quart) and a largerred, horizontal-loading, rigid plastic container (Kendall, volume of about 7.6 litersor 2 gallons). These are shown in Figure 7. The use of rigid, puncture-resistant,and leak-proof containers for sharps is in keeping with generally recognizedstandards.
Figure 7. Small Vacutainer (background) andLarge Kendall (foreground) Sharps Containers
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Sharps containers were observed by the consultant in the medical/surgical ward,matemity, and laboratory. During the site visit, none of the sharps containersfound was overfilled. The number of sharps containers relative to the number ofregular garbage containers seems to be appropriate for this size of facility. Asnoted above, too many infectious waste containers tend to inflate unnecessarilythe volume of waste but there must be sufficient sharps waste containers to bereadily accessible to the staff. Details of infectious waste classification andsegregation are discussed in the Recommendations.
Blood collection tubes are collected in "Burn-up Bin" corrugated cardboardcontainers with translucent plastic liners (Figure 8). The cardboard bins have thebiohazard marking on the outside. Pathological waste, placenta, and surgicalwaste are collected in plastic bags; the consultant observed dark green plasticbags inside red plastic containers for this purpose. Cultures and chemotherapywaste are not generated at the hospital. Regular garbage is collected in blackbags inside garbage bins.
'CS'
Figure 8. Burn-up Bin
At Prospect Senior Citizen Home (long-term care facility), the staff noted thatinsulin needles were a concem in the past but not currently. At that time, theneedles were wrapped in paper and discarded in the trash. For generators ofvery small amounts of sharps waste, such as households of insulin-dependentindividuals or small long-term care facilities, it is recommended that the syringesbe placed in a puncture-resistant container such as a hard plastic or metal canwith a tightly secured lid and disposed with regular garbage.
Sources reported that sharps waste is collected from clinics, transported by theSanitation or Public Health Department, and disposed in trenches. Other sourcesindicated that animal carcasses from the two veterinary clinics (private and publicfacilities) are also buried in trenches.
Waste Treatment
At Alexandra Hospital, biomedical waste is burned in what had once been asingle-chamber incinerator, shown in Figure 9. The incinerator was severelydamaged by Hurricane Georges in 1998 so much so that less than half of thechamber remains standing. The incinerator essentially operates as an open-bumsite. Waste is bumed once or twice a week or as needed. The Public HealthDepartment picks up regular garbage and waste from the incinerator six days aweek. Approximately three drums of waste are collected a day.
12
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Figure 9. Nevis "Incinerator"
The "incinerator" at Alexandra Hospital cannot properly be classified as anincinerator. At the very least, an incinerator must have an enclosed combustionchamber. With this "incinerator," it is likely that not only toxic air pollutants butalso pathogens are discharged to the air and left in the residues Furthermore, apossible scenario is that when Burn-Up Bins are burned, the integrity of boxes isdestroyed by fire and blood collection tubes spill out to the ground with little or noexposure to high heat. The unburned or partially burned tubes break as they fallor are stepped on, thereby posing a serious risk of injury and spread ofbloodborne pathogens. As mentioned earlier, many regulatory authorities haverequired a minimum temperature of 1,800 IF and a minimum 2-second residencetime to assume total destruction of all pathogens. The single-chamber incineratorat Nevis falls far short of meeting this basic requirement. The 'incinerator" is ahazard and its use should be discontinued as soon as possible.
A new biomedical waste incinerator has reportedly been purchased and will beinstalled. However, no details about the incinerator could be obtained during andafter the consultant's site visit.
5. Waste Disposal
Ash and other residues from the incinerator are placed in boxes and taken by thePublic Health Department to the disposal site. The Low Ground dumpsite is inthe area of Long Point. It has about five monitoring wells in place for the testingof leachate in the future. Construction of a sanitary landfill is expected to becompleted in 2002.
During the site visit, the consultant examined a trench (about 4 feet deep)intended for sharps waste. At that time, it contained abattoir waste (Figure 10).Adjacent to it was a smaller trench containing asbestos materials. The idea of aseparate area for disposal of biomedical waste is a good plan. However, thatarea of the dumpsite must be separated by a fence or other barrier, marked witha warning sign to keep pickers out, and land disposal supervisors should beinstructed to restrict access to the area.
Note: Asbestos material, especially friable asbestos, is extremely hazardous.Microscopic asbestos fibers can be suspended in air and carried downwind.When inhaled, asbestos is known to cause lung cancer, mesothelioma, andasbestosis. The trench containing asbestos should be covered and markedpermanently to prevent anyone in the future digging up or accidentally disturbing
13
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the soil resulting in dangerous releases of asbestos. Anyone working onasbestos materials should wear personnel protection equipment includingrespirators designed for asbestos particles.
?
Figure 10. Trench for Sharps and Abattoir Waste
Expired pharmaceuticals in liquid form are discarded down the drain if thepharmacist deems them non-toxic. This is an acceptable procedure for smallamounts of non-toxic waste. Injectables are snapped off, placed in boxes, andincinerated. Solid waste, such as expired tablets, is sent to the dumpsite.Disposal of condemned drugs is addressed in the Recommendations.
6. Employee Training
There is no infection control committee and no employee training on biomedicalwaste management. Employee training is essential. An infection controlcommittee plays an important role in the management of biomedical waste. Thisis addressed further in the Recommendations.
0
Notes on RecommendationsShort-term recommendations are provided for immediate implementation toaddress imminent hazards and to protect health and the environment, andenhance worker safety. They may include some temporary measures as part ofa transition to the full implementation of best practices and a national biomedicalwaste management system.
Short-Term Recommendations:
SHORT-TERM RECOMMENDATIONS FOR ST. KITTS:
0 All containers intended for potentially infectious waste should be marked withthe intemational bio-hazard symbol in order to clearly distinguish betweeninfectious and non-infectious waste.
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* The UNIVEC Safety Boxes should be replaced as soon as possible withpuncture-resistant sharps containers. In the meantime, extreme care shouldbe taken when placing sharps into UNIVEC boxes and when manuallytransporting boxes containing sharps waste. As soon as possible, speciallydesigned sharps transport containers should be used by the health centerswhen transporting sharps waste from field immunizations.
* All sharps containers should have lids to prevent accidental spillage. If rigidsharps containers are reused, the contents should be dumped directly into theincinerator chamber in a manner that would prevent needle-stick injury to theworker. The containers should then be cleaned and disinfected.
* Any trolleys used to transport biomedical waste should not be used totransport regular garbage or other material. Orderlies should be instructed tominimize the risk of spillage. The trolley for biomedical waste should becleaned regularly with soap and water, and disinfected with a bleach (sodiumhypochlorite) solution. The open trolley should be replaced with a fullyenclosed cart.
* Steps should be taken to phase out the JNF Hospital incinerator as soon aspossible. However, as long as the incinerator remains in use, the areaaround the incinerator should be kept clean. The chimney should beinstalled. The hospital should consult with a local meteorologist to determinethe general time when the greatest air turbulence and dispersion happensduring the day. Burning during this time period will help disperse toxic airpollutants and minimize local pollutant concentrations. Only potentiallyinfectious waste should be incinerated. Sources of toxic metals (such aslead, mercury, cadmium, etc.) and chlorine (such as chlorinated plastics)should not be burned in the incinerator.
It is essential to remove ashes, soot, slag, and bumed residues regularly inorder to allow good air flow for combustion. The residues from the chamberand from the opening beneath the chamber should be collected directly intoash collection bins and not be allowed to scatter on the ground where theycould pose a hazard. Orderlies should continue to monitor the incinerator toensure as complete burning as possible.
* Land disposal supervisors should ensure that recyclers or pickers are keptaway from areas where treated waste from the incinerator is dumped. Thatsection should have a physical barrier such as a fence and signs clearlymarking the area as a restricted site.
* The nosocomial or infection control committee at JNF Hospital should bereactivated. In addition to its other usual tasks, the committee should initiallybe responsible for the management of biomedical waste at the hospital. Thatresponsibility can later be transitioned over to a Waste Management Team asexplained further in the Long-Term Recommendations.
15
SHORT-TERM RECOMMENDATIONS FOR NEVIS:
o All containers intended for infectious waste should be marked with theinternational biohazard symbol in order to clearly distinguish betweeninfectious and non-infectious waste.
o Use of the Alexandra Hospital incinerator should be halted immediately and anew treatment technology installed as soon as possible. Debris around thearea of the burn site should be cleaned and sharps, blood collection tubes,and other residues should be collected in rigid containers and buried in deeptrenches at the Low Ground dumpsite.
o Until such time as a new treatment technology is available, sharps and otherpotentially infectious waste should continue to be segregated and transportedregularly to the dumpsite where they should be buried in deep trenches andcovered with earth. The area should be fenced in and marked with warningsigns. They should remain segregated during transport and access to thetrench areas should be restricted especially from recyclers or pickers. Whilethis is not a preferred method of disposal, the consultant believes this methodposes less of a hazard than using the broken incinerator.
o The waste should be transported to a central collection point using a fullyenclosed cart with a lid to prevent spillage and avoid offensive sights andsmells. Orderlies should be instructed to minimize the risk of spillage. Thecart should be used only to transport biomedical waste and should becleaned regularly with soap and water, and disinfected with a bleach (sodiumhypochlorite) solution.
o An infection control committee should be formed at Alexandra Hospital. Inaddition to its usual role of developing and implementing policies, procedures,and programs to minimize the risk of spreading infection in the hospital, theinfection control committee should initially be responsible for the managementof biomedical waste. As explained in the Long-Term Recommendations,biomedical waste management should eventually be the responsibility of aWaste Management Team.
Long-Term Recommendations for St. Kitts and Nevis
1. National Laws and Regulations
Future legislation or regulations on biomedical waste management shouldconsider the following elements:
o Clear definitions of what constitutes biomedical waste and its categories
o Cradle-to-grave approach to biomedical waste management
o Coordination with hazardous (non-biomedical) waste management laws aswell as other laws dealing with health (including prevention of infectious
16
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diseases, hospital hygiene and infection control), sanitation, environment (airquality, water quality, land disposal), and occupational safety and health
* Delineation of responsible national and local govemment authorities forimplementation (usually the Ministry of Health has primary responsibility withthe Ministry of Environment involved in specific ways)
* Legal obligations of the biomedical waste generator
* Provisions related to record-keeping and reporting
* Provisions related to any fees for transport, treatment, and final disposal
* Provisions related to inspections for the purpose of enforcement, penalties fornon-compliance, and legal procedures for handling disputes related toenforcement.
2. Institutional Policy, Administration, and Organization
Every hospital or health care facility should have a written policy on biomedicalwaste management. The policy should state the facility's objective of providing asystem for management of biomedical waste in order to protect patients, staff,and the general public from hazards associated with biomedical waste. It shouldprovide an overview of responsibilities and outline major procedures forbiomedical waste management. A sample plan is provided in Appendix A3.
Proper management of biomedical waste depends on good administration andorganization. The waste management structure depends on the size andcomplexity of the facility. For JNF and Alexandra Hospitals, it is recommendedthat hospital waste management teams be established at both hospitals. Eachteam should be headed by the hospital administrator who is also the designatedcontact with the regulatory authority.
The administrator should appoint one member of the team as the WasteManagement Officer responsible for the day-to-day operation and monitoring ofthe waste management system. Because the Waste Management Officer musthave access to all members of the hospital staff, it is important that the teaminclude all department heads. Waste management will entail costs so thehospital's financial officer or accountant should also be part of the team.Therefore, the Waste Management Team should be comprised of:
* Hospital Administrator (Chair of the Team)* Department Heads* Matron or Senior Nursing Officer* Infection Control Officer and/or Hospital Hygienist* Hospital Engineer or Maintenance Supervisor* Financial Officer or Accountant* Other staff (with relevant training or responsibilities) as needed
The responsibilities of the Waste Management Team are:
1. To develop a written waste management policy, specific guidelines, and planfor implementation
17
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2. To review and revise (as needed) the policy, guidelines, and implementationplan on a periodic basis
3. To ensure adequate financial and human resources for efficient operation andmonitoring of the plan.
As mentioned, one of the above team members should be appointed the WasteManagement Officer (this could also be the Infection Control Officer, HospitalEngineer, or Matron). The Waste Management Officer reports directly to thehospital administrator and should have direct access to all staff members. Theresponsibilities of the Waste Management Officer are:
1. To facilitate communications among members of the Waste ManagementTeam to ensure that proper procedures are implemented, including timelyintemal collection, emergency procedures, and reporting
2. To monitor and evaluate waste handling and disposal operations with thehelp of the Infection Control Officer; this may entail a comprehensive riskassessment of all activities with the help of other members of the team
3. To ensure that adequate supplies are available
4. To maintain records of the amounts and types of waste generated, accidents,unusual operational events, and non-compliance
5. To ensure that all staff members are aware of their responsibilities regardingbiomedical waste and to work with the Infection Control Officer and other staffon the training programs
6. To identify items that need modification in the policy, guidelines, or plan.
Other team members have responsibilities regarding biomedical waste:
o The Department Heads and Matron should ensure that staff within theirdepartments are familiar with the policy, guidelines, and plan, and havereceived training; they should also make sure any incidents are reportedto the Waste Management Officer.
o The Infection Control Officer should act as a technical consultant to theWaste Management Officer, participate in evaluating waste handling anddisposal operations, and work with the Waste Management Officer andothers in ensuring that the training program is implemented
o The Hospital Engineer or Maintenance Supervisor should ensure that themaintenance or engineering staff receives training and should consultwith the Waste Management Officer on matters dealing with the treatmenttechnology.
o The Financial Officer should consult with the Waste Management Officeron matters dealing with supplies and budgetary needs, and shouldinvestigate options to minimize waste or reduce toxicity through product
* substitutions (e.g., using non-toxic substitutes for toxic solvents, replacinghalogenated plastic disposables with non-halogenated equivalents,finding vendors willing to take back expired pharmaceuticals, etc.).
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3. Occupational Safety and Health
Personal protective equipment should be made available to all personnel whohandle, transport, and treat biomedical waste. Orderlies and other staff who pickup and transport biomedical waste should be provided with heavy-duty gloves,boots or shoes with thick soles, and coveralls. Gloves are essential to preventlacerations, burns from hot surfaces (such as with a treatment technology), orcontact with any chemical or biological material. Boots or shoes with thick solesand good traction should also be provided to protect from spilled sharps,chemicals, and slippery surfaces. Plastic coveralls provide protection from bloodsplatter and splashes from body fluids or chemicals. Leg protectors may be usedin situations where the legs of waste workers may be in contact with waste bags.
Health-care workers that deal in situations where they may be splashed withblood, body fluids, solvents, corrosive chemicals, or other hazardous liquidsshould be provided with eye and face protection. They should be used by staffmembers when discarding free-flowing blood and body fluids in the sanitarysewer.
Immunization from viral hepatitis and tetanus is recommended for all wastehandlers. Basic personal hygiene is also important and should be emphasizedduring training. Convenient washing facilities with warm water and soap shouldbe available.
4. Waste Segregation and Classification
Segregation, or the separation of specific types of waste from other types ofwaste, is key to effective management of medical waste. It is the responsibility ofthe waste generator. Potentially infectious waste should be segregated fromregular garbage as close as possible to the point where the waste is generated.Segregation should be maintained during storage and transport up to the point oftreatment. To be effective, the same system of segregation should applythroughout the country.
There are many ways of classifying the different components of biomedicalwaste. In light of the types of waste produced in St. Kitts and Nevis, a simpleclassification is recommended in Table 1 focusing on the biomedical wastecategories that pose the greatest hazards, as explained below.
Sharps pose a potential disease transmission hazards because of their ability tocreate a portal of entry through the skin. In particular, needle-stick injuries are aknown cause of the spread of infectious diseases and a serious occupationalhazard.
Cultures and stocks may contain high concentrations of disease-causing agents.Laboratory workers must use extreme caution to avoid inadvertent exposure tothese pathogens and untreated cultures should be rendered noninfectious,preferably on site, prior to disposal. At present, there is no culture waste in Nevis.
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Table 1. Biornedical Waste Categories (CUassification I)
Waste Description Examples Where FoundCategory
Sharps Items that could cut Hypodermic needles, syringes, Nursing Stations,or puncture suture needles, scalpel and Laboratory,regardless of whether other blades, lancets, saws, Emergency Room,they are infected or knives, broken or unbroken Surgery, Matemitynot glass, vials, tubes, pipettes, etc. Ward, Clinics
Cultures and Cultures and stocks Human and animal cell cultures, Laboratory,Stocks of infectious agents stocks of etiologic agents, Microbiology
and associated discarded live and attenuatedbiologicals vaccine or serum, culture dishes
and other devices used totransfer, inoculate or mix cellcultures
Human Blood, Free-flowing blood, Free-flowing blood or blood Patient Wards,Blood Products, components or components, semen, vaginal Surgery,and Body Fluids products of blood, secretions, cerebrospinal fluid, Laboratory,
and specific body synovial fluid, pleural fluid, Emergency Roomfluids pericardial fluid, pertitoneal fluid,
amniotic fluid, saliva in dentalprocedures, and body fluidscontaminated with blood
Pathological Human pathological Tissues, organs, anatomical Surgery, Pathology,Waste waste waste (recognizable body parts Autopsy
except teeth) removed duringsurgery, autopsy or otherprocedures
Animal Waste Contaminated animal Animal carcasses, animal body Veterinary Hospitalswaste parts, blood, body fluids, and and Clinics,
bedding known to have been Researchexposed to infectious agents Laboratories
Selected Waste generated by Swabs, excreta, soiled Isolation WardIsolation Waste patients who are dressings, drainage sets, items
isolated to prevent saturated or dripping with humanthe spread of highly blood, etc. from patients infectedcommunicable with highly communicablediseases diseases (see below)
Inadvertent contact with blood through cuts or mucous membranes has beenassociated with the transmission of disease by blood-borne pathogens such asHIV and hepatitis B. The risk comes from contact with blood or body fluids inliquid form which is capable of splashing in the eyes or other mucousmembranes. Most blood-borne pathogens have a limited ability to multiply or
20
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remain viable longer than a few hours or a few days in dried blood. For thisreason, the focus of concem is liquid blood.
While pathological waste has not been generally implicated in diseasetransmission, it has potentially infective qualities. Moreover, there may beaesthetic, cultural, or religious factors that may determine how pathological wasteis treated and disposed. In general, they can be treated in a treatment technologyand buried in a sanitary landfill. Placentas and human fetuses can be interred inspecial burial sites.
The main concern relating to animal waste would be animal carcasses that havebeen inoculated with infectious agents or any animals exposed to pathogenssuch as those that cause transmissible spongiform encephalopathies ("mad cowdisease"). Regular abattoir waste is not included in this category.
In many countries, isolation waste is only limited to wastes generated frompatients infected with certain highly communicable diseases, specifically definedas Class 4 agents such as Ebola, Crimean hemorrhagic fever, Lassa fever,Marburg, etc. The hospital's infection control committee should determinewhether waste from specific isolation rooms should have special handling,treatment, and disposal.
Table 2. Additional Waste Categories (Classification II)
Waste Category Description Examples Where Found
Pharmaceutical Discarded items Expired, condemned, or PharmacyWaste containing contaminated pharmaceutical
pharmaceuticals products
Chemotherapeutic Waste containing Chiorambucil, Daunomycin, Cancer TherapyWaste cytotoxic, Melphalan, Mitomycin C,
genotoxic, or other Uracil mustard, Streptozotocin,hazardous Cyclophosphamide, etcantineoplastic drugs
Low-level Waste containing Pipettes, vials, syringes, Nuclear Medicine,Radioactive radioactive needles, gloves, absorbents, Clinical andWaste substances etc. contaminated with Research
radionuclides Laboratories
Other Hazardous Waste that exhibit Xylene, methanol, Formalin Nursing Stations,Chemical Waste hazardous (formaldehyde solution), Pathology,
characteristics trichloroethylene, sulfuric acid, Autopsy, Dialysis,(corrosive, ignitable, glutaraldehyde, mercury from Radiology,chemically reactive, broken thermometers, spent Laboratory,toxic) in addition to batteries, cleaning solvents, Facilitywastes already degreasers, potassium Engineering &classified above cyanide, asbestos, PCBs, etc. Maintenance,
Funeral Homes
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There are other classifications that either fall under the hazardous waste category(which in some countries is defined and regulated separately from infectiouswaste) and others that may not apply at this time but may describe biomedicalwaste streams in the future. The additional classifications are shown in Table 2.
At present, there are no chemotherapeutic and low-level radioactive wastes in St.Kitts and Nevis.
5. Waste Minimization
It is recommended that all health-care facilities institute a waste minimizationprogram. Waste minimization is the reduction, to the extent possible, of wastethat is destined for ultimate disposal. Potential benefits of minimization include:environmental protection, enhanced occupational safety and health, costreductions, reduced liability, and improved community relations.
The following are basic techniques of waste minimization: source reduction(including material substitution, process changes, and good practices), resourcerecovery and recycling, and composting. Some basic concepts of wasteminimization and recommended resources are provided in Appendix A4.
6. Labeling, Color Coding, and Signage
Every container for infectious medical waste must have the intemationalbiohazard symbol in a contrasting color painted or affixed to the container asshown in Figure 11. (Note: The dot in the middle is not part of the symbol; it isused to center the marking if needed.)
L~~.
Figure 11. International Biohazard Symbol
In addition to the symbol, one of the following warning signs should be painted ormarked on the container, whichever is appropriate:
o "Biohazard"o "Sharps" or "Biohazard" (for sharps containers)
22
The following color-coding is recommended:
Table 3. Color Coding
TYPE OF WASTE COLOR OF BAG OR CONTAINER
Potentially Infectious Waste REDSharps REDWashable Contaminated Linen YELLOWChemical, Pharmaceutical, or BROWNChemotherapeutic WasteRegular garbage TRANSLUCENT
Signage in the form of posters displayed in public areas is helpful, not just as areminder to health care staff, but also to inform patients and the public about thefacility's waste management system. A sample poster is shown in Appendix A5.
7. Waste Collection
Potentially infectious waste should be segregated in clearly marked containersthat are appropriate for the type of waste, as shown below.
Table 4. Collection Container SpecificationsTYPE OF WASTE SPECIFICATIONS FOR CONTAINER OR BAG
Sharps - Container should be puncture-resistant, leak-proof on the sidesand bottom, durable, and closable (closure should be secure)- Container should be labeled and color-coded- Container should be designed so that it is easily and safetydetermined when the container is nearly full
Non-sharps - Container should be leak-proof, rigid, durable, labeled, and colorinfectious waste coded(solid/semi-solid) - Plastic bag should be leak-proof, designed to prevent ripping,
tearing, or bursting under normal use, labeled; and color codedThe plastic bag should be placed inside a rigid container
Non-sharps - Container should be leak-proof and durableinfectious waste - Container should be designed such that it can be transported(liquid) without spillage
Appropriately sized sharps containers should be placed in locations easilyaccessible to personnel and as close as possible to the immediate area wheresharps are used. Examples include phlebotomy area, treatment and examinationrooms, nursing stations, operating rooms, emergency rooms, etc. To preventinjuries, needles should not be recapped nor removed from disposable syringes.Sharps containers should not be overfilled.
A ngid, puncture-resistant plastic sharps container specifically designed forneedles and syringes is recommended. A reusable container is acceptable aslong as the container and its contents can be disinfected in a treatmenttechnology and the sharps can be removed safely. A reusable container shouldbe cleaned on a routine basis. A bleach bottle with the biohazard symbol and"Caution: Sharps" marking in red is acceptable as a container for blood collectiontubes.
23
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The Waste Management Officer should regularly monitor sharps collectioncontainers to ensure that they are not overfilled, that full containers are promptlyremoved, that non-sharps waste are not placed in sharps container, that enoughsharps containers are available and located in appropriate locations, and that newstaff members are educated on sharps disposal practices. The WasteManagement and Infection Control Officers should document any needle-stickinjuries due to sharps collection, assess why the injury took place, and take stepsto prevent future injuries.
8. Handling and Transport Within the Facility
Personal protective equipment (PPE) should be worn dunng any operation wherethere is a potential for exposure. PPE included gloves, gowns, masks, faceshields, and/or safety goggles or glasses, depending on the operation.
Fully enclosed, wheeled carts should be used when transporting waste throughthe facility to a storage area or treatment technology. Carts used for potentiallyinfectious waste should be used only for that purpose. They should be cleanedand disinfected on a routine basis.
9. Transport Outside the Facility
Transport of untreated infectious waste outside any health-care facility should beregulated by the Ministry of Public Health and/or the Ministry of Environment.This should involve a cradle-to-grave approach to manage and account forbiomedical waste and entail a medical waste tracking system.
The waste generator (hospital or health-care facility) is always responsible forensuring that its medical waste reaches the off-site destination facility, such as awaste treatment center or sanitary landfill. Health centers and other smallfacilities should use special care when transporting sharps waste. Small amountsof sharps waste may be transported in fully enclosed transport pouchesspecifically designed for such purposes.
Infectious waste should be transported in leak-proof, fully enclosed containers orvehicle compartments that are secured when unattended and designed toprevent spillage or leakage during transport. If the vehicle is used for other waste,the infectious waste containers or vehicle compartments should be separated bybarriers from the other types of waste. The waste should be labeled with thebiohazard symbol.
The vehicle should have identification markings or placards on the sides andback. In keeping with intemational standards, the placard should be diamond-shaped with black inscription on a white background. The upper half of thediamond-shaped placard should have the intemational biohazard symbol, thelower half should have the words "INFECTIOUS WASTE" and "IN CASE OFACCIDENT IMMEDIATELY NOTIFY PUBLIC HEALTH AUTHORITY' and at thevery bottom, the number "6" which is the intemational hazard identificationnumber for toxic or infectious hazards.
24
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The transporter or hauler should have contingency plans in the event of spills oraccidents during transport.
10. Waste Treatment
The JNF Hospital incinerator should be replaced with a more effective andcleaner treatment technology with minimal impact on public health and theenvironment. Likewise, the Alexandra Hospital incinerator should be replaced atthe soonest possible with an effective and cleaner treatment technology withminimal impact on public health and the environment. Recommendations on awaste treatment technology for St. Kitts are presented in a separate reportentitled "Review and Recommendation on a Medical Waste TreatmentTechnology."
The waste categories listed under Classification II (expired pharmaceuticals,chemotherapy waste, low-level radioactive waste, and other hazardous chemicalwastes) are those that require special handling as hazardous waste. Some ofthose waste streams are currently not found at St. Kitts and Nevis but they maybe generated in the future. This section provides recommendations for thosewaste streams.
Four procedures are recommended for pharmaceutical waste: (1) Return ofexpired pharmaceuticals to supplier, (2) Inertization, (3) Encapsulation, and (4)Sewer discharge. Many healthcare facilities around the world now havearrangements with pharmaceutical companies to send back expired orcondemned drugs. This is the preferred method of handling this waste stream.
Another altemative is inertization: Solid pharmaceutical waste is removed frompackaging or containers, ground up and then mixed with cement, lime, andwater. The following ratio is recommended: 65% pharmaceutical waste, 15%lime, 15% cement, and 5% water. The homogeneous mixture is allowed toharden into cubes or pellets. The hardened mass should then be disposed in ahazardous waste landfill engineered to prevent groundwater contamination. Inthe absence of a hazardous waste landfill, the hardened mass may be disposedin a restricted portion of the sanitary landfill or buried in specially designedtrenches or burial pits within the health-care facility premises. In the latter case,the trenches or pits must be lined with clay or a membrane liner to preventleaching into groundwater, secured with a fence to restrict access, and eventuallycapped to prevent percolation of water. A waste minimization program should bein place so that only small amounts of pharmaceutical waste are disposed of inthis manner.
A third altemative is encapsulation: Solid, semi-liquid, or liquid pharmaceuticalwaste could be placed in drums which are filled to 3/4ths their capacity. Thedrums are then filled with cement mortar or clay, sealed, then buried in ahazardous waste landfill engineered to prevent groundwater contamination.Again, in the absence of a hazardous waste landfill, the sealed drums may beburied in a restricted area of the sanitary landfill. As with inertization, a wasteminimization program should be in place so that only small amounts ofpharmaceutical waste are disposed of in this manner.
25
A fourth alternative applies only to moderate quantities of relatively mild liquid orsemi-liquid pharmaceuticals such as vitamin solutions, cough syrups, eye drops,saline solutions, intravenous fluids, etc. It is acceptable to discharge these liquiddrugs into a sanitary sewer while diluting with large amounts of water. Antibioticsand chemotherapy drugs should not be discharged into the sanitary sewer.
Chemotherapeutic wastes are either bulk agents or materials, such as vials orgloves, contaminated with trace amounts of chemotherapy agents, also calledantineoplastic agents or cytotoxic drugs. Examples of these cancer therapydrugs are Chlorambucil, Cytoxin, Daunomycin, Mitomycin C, Streptozotocin,Melphalan, and Uracil Mustard. They require special handling proceduresbecause of their toxic characteristics. Many regulatory agencies allow thedisposal in a sanitary landfill of trace-contaminated waste. However, it isrecommended that trace-contaminated waste be encapsulated (placed in drumsfilled to 3/4ths their capacity, then filled with cement mortar or clay, and sealed)and buried in hazardous waste landfills or restricted sections of a sanitary landfillengineered to prevent groundwater contamination.
There are two recommended procedures for bulk chemotherapy waste: (1)Return to supplier and (2) Chemical degradation. Bulk quantities ofchemotherapy agents should be repackaged, marked 'outdated" or "not for use",and returned to the supplier. Chemical degradation methods exist forchemotherapy agents. These methods are relatively safe and simple. Theyinvolve oxidation by potassium permanganate or sulfuric acid, denitrosation byhydrobromic acid, reduction by nickel and aluminum, or hydrolysis using heatedalkali. The Unit of Gene-Environment Interactions of the Intemational Agency forResearch on Cancer (IARC, 150 Cours Albert-Thomas, 69372 Lyon Cedex 08,France) is a source of information for chemical degradation methods. Chemicaldegradation can also be used to clean up spills or contaminated urinals.Although incineration is a treatment method used for chemotherapeutic waste, itshould be noted that the destruction of chemotherapy drugs can only beaccomplished in specialized dual-chamber incinerators operating at very hightemperatures, typically above 2,200 OF (1,200 OC) with a minimum residence timeof 5 seconds.
Three disposal methods are recommended for low-level radioactive waste: (1)Decay in storage or "storage for decay", (2) Return to supplier, or (3) Long-termstorage at an authorized radioactive waste disposal site. Radionuclides with shorthalf-lives are generally stored for a period (typically ten times the half-life of thelongest lived radionuclide in a container) to allow decay to background levels asconfirmed by a radiation survey, then disposed as regular waste. Decayed butinfectious waste should be disinfected before disposal. Facilities shouldsegregate radioactive waste according to the length of time needed for storage:short-term storage (half-lives less than 30 days) and long-term storage (half-livesfrom 30 to 65 days). Storage facilities must be secure and designed to limithuman exposure. A radioactive waste management plan should include aprogram of waste minimization. Source reduction may be achieved by limitingthe quantity of radioactivity purchased, using non-radioactive materials or shorter-lived radionuclides where possible, and designing laboratory procedures toreduce the volume of mixed waste.
26
l / lu " )l'lto ('l( fl al(Mh' *} I /:l / I, ' PI; a( :i ''(
For large sealed sources or sources containing long-lived radionuclides, thewaste should be retumed to the producer or supplier of the original material. It isrecommended that any health-care facility planning to import a sealed source witha radioactivity greater than 100 MBq 10 years after receipt should require thesupplier to accept the source back after expiration of its useful lifetime and withina year after a return request is made. If this is not possible, the waste must bestored in an approved long-term storage facility in keeping with internationalguidelines. Whether the waste is returned or stored in a long-term facility, thewaste should first be conditioned to make it suitable for handling, transportation,and storage. Conditioning may involve immobilization in concrete, securing thewaste in suitable containers, and/or providing special packaging.
Other hazardous chemical waste includes spent organic solvents, degreasersand oils used by the engineering staff, mercury from broken thermometers, etc.Four disposal methods are recommended: (1) Return to supplier, (2) Chemicaldegradation, (3) Encapsulation and disposal in a hazardous waste landfill, or (4)Sewer discharge. Appropriate provisions may be included in the originalpurchase contract of chemicals to allow the return of spent or outdated chemicalsto the original supplier in a country with the expertise and facilities to dispose ofthe waste safely and in an environmentally sound manner. Shipment for thepurpose of returning the waste should comply with international agreementsincluding the Basel Convention. It may be possible to degrade or neutralize somechemical waste (e.g., acids or bases) at a special treatment facility. If neither ofthese altematives is possible, the chemical waste should be encapsulated insmall quantities in drums and buried in an approved hazardous waste landfillengineered to prevent groundwater contamination. Large amounts ofdisinfectants should not be encapsulated as they are corrosive and sometimesflammable. Hazardous chemical wastes of different compositions should bestored separately to avoid unwanted chemical reactions. Some mild chemicals,such as mild disinfecting or cleaning solutions, may be discharged in the sanitarysewer while diluting with large amounts of water.
Examples of ways to minimize hazardous chemical waste are provided inAppendix A6.
Final Disposal
Liquid blood and body fluids should be discharged directly and carefully into asanitary sewer using personal protective equipment (gown, goggles, face shieldor mask). Hands should be washed thoroughly after gloves are removed. Thefacility should check to make sure any effluents to the sanitary sewer are withinspecified regulatory limits, if any, for wastewater discharges.
In general, treated biomedical waste can be sent along with regular garbage forfinal disposal to a sanitary landfill constructed with a clay or geomembrane linersuch as high-density polyethylene to prevent groundwater contamination. If, forsome reason, untreated medical waste has to be disposed of in the landfill or iftreated sharps have not been destroyed to the point of eliminating needle-stickinjury hazards, a special trench or cell can be used for this purpose.Unauthorized entry to the area should be prevented by restricting access,constructing fences, and posting signs such as "BIOHAZARDOUS WASTE
27
4.1(h/ i!b P:li ca l C t 'I,t1.1 ,; ,ct,r t, i1 c 'S
AREA - UNAUTHORIZED PERSONS KEEP OUT'. However, the preferredmethod is treatment followed by final disposal.
12. Summary of Blomedical Waste Management Proceduires
The tables in the following pages outline in a simplified form the mainrecommended procedures for segregating, transporting, treating, and disposingof biomedical waste. Regular garbage is included for the purpose of comparison.A separate table is presented for waste categories under Classification 11.
13. Contingency Planniing
Health-care facilities should develop contingency plans in the event thatbiomedical waste is spilled, a worker is injured, or the treatment technology isdown for repairs.
For clearing up spillage of blood, body fluids, chemicals, or other potentiallyhazardous substances, personal protection equipment such as gloves andcoveralls are needed. If there is any risk of splashing, eye protectors and masksshould also be wom. The appropriate respirators may be needed if toxic vaporsor dust are involved. Solid residues should be recovered using hand tools suchas shovels. If potentially infectious waste is involved, the floor should be cleanedand disinfected after most of the waste has been recovered.
All health-care staff should be trained to deal with injuries and exposures. In theevent of an injury, first-aid measures should be applied followed by additionalmedical attention as needed. With needle-stick injuries, bleeding of the woundshould be encouraged and the area washed and cleaned thoroughly. Blood orother tests may be indicated, as well as prophylactic treatment.
Medical monitoring and incident reporting are important parts of contingencyplanning. Department heads and other members of the Waste ManagementTeam should encourage prompt and accurate reporting for the purpose ofensuring proper medical attention and prophylaxis, and to identify remedialactions to prevent injuries in the future. Incident reporting should not be seen aspunitive. Medical monitoring programs are specifically designed to evaluate theextent of workplace exposure or the effects of known exposures to workers'health.
If the treatment technology is shut down for repair or periodic maintenance,facilities should have altematives, such as long-term storage areas and/orarrangements with other facilities to transport and treat their biomedical waste atother sites.
28
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Table 5. Recommended Procedures for JNF Hospital, St. KittsFacility JNF Hospital
Waste Sharps Cultures & Blood & Pathological Waste Isolation (Contamin Regular
Type Stocks Body Waste ated Garbage
Fluids Linen)
Examples Needles, Culture Free- Tissues, Placentas, Swabs, Bedding Garbage
Syringes, dishes flovwng Body Parts Fetuses Soiled
Blood Blood Dressing
Tubes
Color Red Red Red Red Red Red Yellow Trans-
Code lucent
Marking Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard none
Symbol, Symbol, Symbol, Symbol, Symb. Symbol, Symbol,
"Sharps" 'Biohazard 'Biohazard" 'Biohazard" 'Biohazard" 'Biohazard" "Biohazard"
Packaging Puncture- Plasbc Bag Leak-proof Plastc Bag Plashc Bag Plasbc Bag Plastc or Plasbc
Resistant in a Rigid Container in a Rigid in a Rigid in a Rigid Linen Bag Bag or
Sharps Container Container Container Container Container
Container
In-House Covered Covered Covered Covered Covered Covered Covered Trolley or
Transport Cart Cart Cart Cart Cart Cart Cart cart not
for bio-medical
waste
Storage Protected Protected N/a Protected Protected Protected N/a Regular
Endosure Enclosure, Endosure, Endosure, Enclosure, storage
4°Cor39 4°Cor39 4°Cor39°F 4°Cor39 area
OF ' I °OF* . OF
Treatment Automabc Advanced Discharge Advanced Bunal or Advanced Wash in N/a
Needle Autoclave Into Autodave Advanced Autoclave Hot Water
Destroyer, Sanitary Autodave (160 OF or
Advanced Sewer 88 OC) for
Autodave 20 minutes
Off-Site Special Special N/a Special Specal Special N/a N/aTransport Vehicle Vehicle Vehicle Vehicle Vehilde
(untreated
waste) _
Off-Site Sanitabon Sanitabon N/a Sanitabon Sanitabon Sanitabon N/a Sanitabon
Transport Truck Truck Truck Truck Truck Truck
(treated
waste)
Disposal Sanitary Sanitary Sanitary Sanitary Interment in Sanitary N/a Recyding
Landfill Landfill Sewer Landfill Bunal Site or Landfill or
Sanitary Sanitary
Landfill Landill
N/a=not applicable, 'Recommended practce if storage bme is long enough to result in putnd smells from decaying organic waste
(e g , more than 48 hours)
29
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Table 6. Recommended Procedures for Pogson HospftW, Mary Charles Hospital, andHealth Centers, St. Kitts
Facility Pogson Hospital, Mary Charles Hospital, and Health CentersWaste Sharps Blood & Body Fluids Placenta or Fetuses Regular GarbageTypeExamples Needles, Syringes, Blood Free-flowing Blood Garbage
TubesColor Code Red Red Red TranslucentMarking Biohazard Symbol, Biohazard Symbol, Biohazard Symbol, none
'Sharps 'Biohazard" 'Biohazard"Packaging Puncture-Resistant Sharps Leak-proof Container Plastc Bag in a Rigid Plastc Bag or Container
Container ContainerIn-House Covered Cart Covered Cart Covered Cart Trolley or cart not forTransport biomedical wasteStorage Protected Enclosure N/a Protected Enclosure, 4 OC Regular Storage Area
or 39 OF *Treatment Automabc Needle Discharge Into Sanitary Bunal or Advanced N/a
Destroyer, Advanced Sewer AutoclaveAutodave
Off-Site Speaal Vehide or N/a Speaal Vehide Sanitabon TruckTransport Transport Pouch(untreatedwaste)
Disposal Sanitary Landfill Sanitary Sewer Interment in Bunal Site or Recycling or SanitarySanitary Landfill Landfill
N/a=not applicable, *Recommended practce if storage bme is long enough to result in putnd smells from decaying organic waste(e g , more than 48 hours)
30
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Table 7. Recommended Procedures for Alexandra Hospital, NevisFacility Alexandra HospitalWaste Sharps Blood & Pathological Waste Isolation (Contamina RegularType Body Fluids Waste ted Linen) GarbageExamples Needles, Free-flowing Tissues, Body Placentas, Swabs, Bedding Garbage
Synnges, Blood Parts Fetuses SoiledBlood Tubes Dressing
Color Red Red Red Red Red Yellow Trans-Code lucentMarking Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard none
Symbol, Symbol, Symbol, Symbol, Symbol, Symbol,'Sharps' 'Biohazard" "Biohazard" 'Biohazard' 'Biohazard" 'Biohazard"
Packaging Puncture- Leak-proof Plasbc Bag in Leak-proof Plastc Bag Plashc or Plasbc BagResistant Container a Rigid Container in a Rigid Linen Bag orSharps Container Container Container
ContainerIn-House Covered Cart Covered Cart Covered Cart Covered Cart Covered Covered Trolley orTransport Cart Cart cart not for
biomedicalwaste
Storage Protected N/a Protected Protected Protected N/a RegularEndosure Endosure, 4 Endosure, 4 Enclosure, 4 storage
°C or 39 OF * OC or 39 OF OC or 39 OF * areaTreatment Automabc Discharge Treatment Bunal or Treatment Wash in Hot N/a
Needle Into Sanitary Technology Treatment Technology Water (160Destroyer, Sewer Technology OF or 88 OC)Treatment for 20Technology minutes
Off-Site Special Vehide N/a Speaal Special Special N/a N/aTransport Vehide Vehicle Vehicle(untreatedwaste)Off-Site Sanitabon N/a Sanitabon Sanitabon Sanitabon N/a SanitabonTransport Truck Truck Truck Truck Truck(treatedwaste)Disposal Sanitary Sanitary Sanitary Interment in Sanitary N/a Recycling
Landfill Sewer Landfill Bunal Site or Landfill or SanitarySanitary LandfillLandfill
N/a=not applicable, 'Recommended practce if storage bme is long enough to result in putnd smells from decaying organic waste(e g, more than 48 hours) Note. Sinoe no informabon was obtained regarding the new incinerator to be able to evaluate itscapabilibes, the treatment technology for Nevis is not specified.
31
Table 8. Recommended Procedures for HeaDth Centers, Nevis
Facility Health CentersWaste Sharps Blood & Body Fluids Regular GarbageTypeExamples Needles, Synnges, Blood Tubes Free-flowing Blood Garbage
Color Code Red Red TranslucentMarking Biohazard Symbol, 'Sharps Biohazard SymbO, none
"Biohazard'Packaging Puncture-Resistant Sharps Container Leak-proof Container Plastc Bag or ContainerIn-House Covered Cart Covered Cart Trolley or cart not used forTransport biomedical waste
Treatment Automabc Needle Destroyer, Treabnent Disciarge Into Sanitary Sewer N/aTechnology
Storage Protected Endosure N/a Regular Storage Area
Off-Site Speaal Vehide or Transport Pouch N/a Sanitabon TruckTransportDisposal Sanitary Landfill Sanitary Sewer Recyding or Sanitary LandfillN/a=not applicable
Table 9. Recommended Procedures for Other Types of Waste (Classification 11)
Facility AllWaste Expired Chemotherapy Waste Low-Level Radioactive Other Hazardous ChemicalType Pharmaceutirals Waste WasteExamples Condemned drugs Chlorambucil, Cytoxin, tnbum, iodine-125, carbon- Formaldehyde,
Uracil Mustard 14, radium-226 tnchloroethylene, xylenes
Color Brown Brown Brown BrownCodeMarking "Hazardous Waste" Biohazard Symbol, Radiabon Symbol, "Hazardous Waste'
'Biohazard" 'Radioactve Waste"
Packaging Rigid, Leak-proof Rigid, Leak-proof Rigid, Leak-proof Rigid, Leak-proof ContainersContainers Containers Containers
In-House Covered Cart Covered Cart Covered Cart Covered Cart
Transport
Storage Protected Enclosure Protected Enclosure Conditioned Waste, Secure Protected EnclosureStorage Facility with
Radiological Protecton
Off-Site Special Vehide Speaal Vehide Speoal Vehide Speaal VehicleTransport
Treatment Retum to Supplier, Retum to Supplier or Decay in Storage, Retum to Retum to Supplier, Chemical& Disposal Inertzabon, Chemical Degradabon Supplier, or Long-Term Degradabon, EncapsulabonMethods Encapsulabon, or (for bulk agents), Storage (depending on half- and Disposal in Hazardous
Sewer Discharge Encapsulabon (for life of radionuclide) Waste Landfill, or Sewer(depending on type of trace-contaminated Discharge (depending on
I_________ drugs) waste) type of waste)
32
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14. Employee Training and Public Education
Employee training and public education are key components of biomedical wastemanagement. The objectives of training and education are:
1. To prevent occupational and public exposure to infectious waste andrelated health hazards
2. To foster responsibility among health care workers regarding medicalwaste management
3. To create awareness and educate patients and visitors about the risksrelated to medical waste and elicit their cooperation in preventingexposure.
It should be the responsibility of the Waste Management Officer and InfectionControl Officer to ensure that training programs and annual refresher courses orseminars take place.
Formal training of all health care personnel on biomedical waste management iscritical for a successful waste management program. Training can be in the formof staff workshops, seminars, in-service training, or classroom-type instruction.Separate training activities can be tailored and targeted to three different groupsin a health care facility:
* Administrative managers and clerical staff
* Medical doctors, nurses, lab technicians, and other health careprofessionals
* Cleaners, porters, waste handlers, and other auxiliary staff
General employee training programs should include the following:
* Overview and rationale of the health care facility's policy on wastemanagement and the objectives of the policy
* Roles and responsibilities of each staff member in implementing thepolicy
* Risks associated with medical waste, the basic elements of infection, andthe importance of safe practices
* Waste classification
* Procedures for waste minimization
* Procedures for waste segregation including labeling and color coding
* Overview of the fate of medical waste after collection: handling, storage,transport, treatment, and final disposal
* General cleaning, disinfection, and contingency procedures for spills andaccidents.
33
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o Reporting procedures for accidental exposures to infectious waste(needle-sticks, blood splashes, etc.) or improper collection, handling, ortreatment practices.
For health care providers, the following additional precautions should beemphasized:
o Special care has to be taken when dealing with sharps waste. Sharpscontainers should not be overfilled. Needles should not be manuallyremoved from syringes.
o No attempt should be made to remove items from an infectious wastebag or container. If an infectious waste item is accidentally placed in aregular garbage bag, the entire mixture should be treated as potentiallyinfectious waste.
o Hazardous chemicals, such as mercury and formaldehyde, andpressurized containers such as aerosol cans, should not be mixed withpotentially infectious waste.
Waste handlers and treatment technology operators should receive specializedinstruction. In addition to the above topics, training programs for them shouldalso include:
o Specific procedures for handling, including identifying the types of wastein bags and containers through their colors and labels; when to seal bags;how bags are sealed; how bags are picked up and deposited; how bagsshould be carried; procedures for handling sharps containers; andergonomic issues.
o Specific procedures for storage (if needed) and transport of medicalwaste, including how to keep waste segregated, loading and unloadingbags, and the proper use of carts
o Safe practices and use of protective equipment such as gloves andfootwear
o Emergency response to spills and other accidents
o General operating principles of the treatment technology
o Occupational safety, health, and environmental issues related to thetreatment technology
o Specific technical procedures for the operation and monitoring of thetreatment technology, including the loading and unloading of waste, start-up and shut-down procedures, understanding equipment monitoring data,and the use of controls
o Emergency response to equipment alarms and failures, including how todetect abnormal conditions and malfunctions
o Maintenance procedures related to the treatment technology
o Removal of residues from the treatment technology
34
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Public education may be done through the placement of posters (see for exampleAppendix A5), handouts, and/or verbal instruction to patients and visitorsexplaining the facility's color coding and labeling system. Importantly, patientsand visitors should be instructed: (1) not to place regular garbage into red, yellow,or brown bags or containers marked with the intemational biohazard symbol, (2)not to open or handle any biohazardous waste containers, (3) to keep childrenaway from any biohazardous waste containers, and (4) to report any spills oraccidents involving a biohazardous waste container immediately and to refrainfrom touching any of the spilled contents.
35
APPENDIX Al: Sources of Infonmnaton
The following facilities were visited between November 13 to 15, 2001:
2. Joseph N. France General Hospital, Basseterre, St. Kitts3. Newtown Health Center, St. Kitts4. Newtown Dental Clinic, St. Kitts5. Conaree Dumpsite, St. Kitts6. Alexandra Hospital, Charlestown, Nevis7. Low Ground Dumpsite, Nevis8. Prospect Senior Citizen Home, Nevis
The consultant met with the following individuals between November 13 to 15,2001:
1. Mr. Elvis Newton Permanent Secretary, Ministry of Health &Environment, St Kitts and Nevis
2. Mr. Clifford Griffin Senior Officer, Ministry of Health, St Kitts3. Ms. Launette Adams Operations Manager JNF Hospital, St.
Kitts4. Mrs. Jean Condor Director of Health Institutions5. Ms. Agnes Beachman Nursing Consultant, JNF Hospital, St Kitts6. Mr. Collin Mulley Biomedical Technician Engineer, JNF
Hospital, St. Kitts7. Mrs. Jasmin Hanley Manager, Laboratory, JNF Hospital, St.
Kitts8. Ms. Ena Sutton Infection Control and Quality Assurance
Manager, JNF Hospital, St. Kitts9. Mr. Robert Bowry Manager, Central Medical Supply10. Mr. Joel Patrick Radiographer, JNF Hospital, St Kitts11. Mr. Halvon Hendrickson Orderly, JNF Hospital, St Kitts12. Sr. Gannett Maternity, JNF Hospital, St. Kitts13. Mrs. Sylvia Isaac Co-coordinator, Community Health
Services, Ministry of Health, St Kitts14. Mr. Oliver Lawrence Chief Environmental Health Officer,
Ministry of Health, St. Kitts15. Mr. Carlton Frank Senior Environmental Health Officer,
Ministry of Health, St. Kitts16. Mr. Alphonso Bridgewater Manager, Solid Waste Management
Corporation, St. Kitts
17. Mr. Warrington Chapman Education Officer, Solid WasteManagement Corporation, St. Kitts
18. Mrs. Rhonda Lowry-Robinson Nurse-in-Charge, Newtown Health Center19. Dr. Nayan Bhandary Dentist, Newtown Dental Clinic20. Mr. Theodore Mills Manager, Solid Waste, Nevis21. Mr. St Clair Wallace Permanent Secretary of Health, Nevis22. Dr. Cuthwin Lake Superintendent and Health Advisor,
Alexandra Hospital, Nevis23. Mrs. Loraine Hanley-Browne Supervisor, Public Health Nurse, Ministry
of Health, Nevis24. Mr. George Meade Maintenance, Alexandra Hospital Nevis25. Mr. Bernard Liburd Maintenance, Alexandra Hospital Nevis26. Mrs. Veta A. Morton Laboratory Technician, Alexandra
Hospital, Nevis27. Mr. Adrian Douglas Student Laboratory Technician, Alexandra
Hospital, Nevis28. Mr. Earl Dowd Maintenance Technician, Alexandra
Hospital, Nevis29. Ms. Myma Webbe Avalon Medical Laboratory, Nevis30. Dr. Janardhan Vathada Dental Surgeon, Nevis31. Mr. Stedroy Williams Senior Public Health Inspector, Nevis32. Ms. Joselyn Liburd Administrator, Alexandra Hospital, Nevis33. Ms. Viola Martin Assistant Matron, Alexandra Hospital,
Nevis34. Mr. Loston Nisbett Pharmacist, Alexandra Hospital, Nevis35. Mrs. Adriene Stanley Nursing Sister, Alexandra Hospital, Nevis36. Ms. Simone Hill Nurse, Alexandra Hospital, Nevis37. Mr. Andie Jn.Panel OECS, St. Lucia
The following documents were obtained during and after the site visit:
1. Inventory of Health Centers St. Kitts and Nevis, prepared by Ms. SylviaIsaacs, 8 November 2001; provided by Mr. Clifford Griffin, Ministry ofHealth.
2. List of doctors and pharmacies in St. Kitts and Nevis, facsimile copy dated7 November 2001; provided by Mr. Clifford Griffin, Ministry of Health.
3. "Waste Disposal Policy and Procedure," JNF Hospital, St. Kitts(undated).
4. Lesson Plan #2, Infection Control Education and Annual Review; WeeklyUpdate form, Infection Control; Field Audit form, Infection Control; andPatient Audit form, Infection Control; forms and sample lesson planprovided by Ms. Agnes Beachman, Nursing Consultant, JNF Hospital, St.Kitts.
5. 'Bio-Medical Waste Management Plan: St. Christopher and Nevis," DraftReport, CBCL Limited Consulting Engineers, prepared for OECS,February 2000.
6. 'The Solid Waste Management Bill, 2000," Saint Christopher and Nevis.7. Electronic mail from Mr. Clifford Griffin, 23 November 2001.
A1-2
About a hundred digital photographs were taken during the site visits. Below arebrief descriptions and the number of photographs obtained:
1. Incinerator and storage area, JNF Hospital - 42. Various waste containers, JNF Hospital - 93. Large garbage collection bins, Long Point - 24. Long Point Dump Site - 125. Various waste containers, Alexandra Hospital - 86. Incinerator and surrounding area, Alexandra Hospital - 87. Waste containers in the Laboratory, Alexandra Hospital - 68. Waste containers in the medical/surgical ward, Alexandra Hospital - 29. Waste container, Prospect Center - 110. Waste containers, Microbiology, JNF Hospital - 311. Close-up of sharps container, JNF Hospital - 412. Waste trolley, JNF Hospital - 213. Conaree Dump Site - 2014. JNF Hospital entrance - 315. Incinerator and storage area, JNF Hospital - 816. Waste disposal, Radiology, JNF Hospital - 317. Regular garbage bin - 118. Waste containers and unused incinerator, Newtown Clinic - 819. Waste containers, Newtown Dental Clinic - 620. Abattoir facility - 1
A1-3
Audit of Medical Waste Management Pmctices
APPENDIX A2: Waste Disposal Policy andProcedure-JNF General Hospital
Purpose: To eliminate the potential hazard to patients, staff and the general public frompotentially infectious waste
Policy: All hospital waste matenal will be disposed of in one of three (3) different coloured bags-clear, red or yellow. In addition, all sharps will be disposed of in red or yellow sharps contamers
* Clear bags: for all non-contaminated waste* Red bags: for all potentially mfectious waste* Yellow bags: for all trace chemotherapeutic waste* Red puncture-resistant containers: for all discarded sharps, except trace chemo sharps
Patient areas ill require red bags only in soiled utility rooms, treatment/utlity rooms, medicationrooms and patient rooms with highly contagious conditions (NOT T.B., HIV) such as Ebola, LassaFever.
Responsibility
All patent contact staff: distinguish types of waste and place in proper containers/bags
Laboratory: Proper disposal of lab waste
Pathology: Prepare pathological waste for transfer m appropriate containers
Housekeepmg. Collection and transport of all waste matenals, prepare for delivery to on-sitetreatment and destruction (routine pick up or mcmeration)
Waste Disposal Methods
Categorn Material Disposal Method Bag/container
Pathological
All Areas All human tissue, carcasses and on-site incinerator hand-delivered inbedding exposed to pathogenic containers or bags toorganisms pathology
Laboratory
Clinical All matenals - solids and Autoclaved on site Red autoclave bagMicrobiology liquids (e.g., bactenal, viral or with indicator
fungal culture specimens Intightly lidded or stoppered non-glass contamers, petri dishes)
Culture in glass containers Autoclaved on site Red autoclave bage.g. blood culture bottles with indicator
discard in punctureresistant red contamers
A2-I
Audit ofMedical Waste Management Practices
All pasteur pipettes, blood vials, on site treatment and Puncture-resistant redTest tubes, slides, cover slips, destruction containersbroken or unbroken glassware incontact with infectious agents
Clinical, All specimens from patients on site treatment and Red bagsPathological and with highly comrnunicable destructionResearch (other diseases (clots, sera, etc.)than Cl. Micro)
All bactenal, viral or fungal autoclave on site autoclave red bag withculture matenal In non-glass indicator then discardcontainers in red bag
Culture in glass containers autoclave on site as above, thenpuncture-resistant redcontainers
Other glassware in contact with on site treatment and puncture resistant redmifectious agents destruction containers
Sharps That which will cause puncture on site treatment and puncture resistant redor cut, i.e., All needles, synnges, destruction containersblades, lancets, pasteur pipettes,blood vials, test tubes, slides,cover slips, broken or unbrokenglassware In contact withmfectous agents
Sharps Chemo as above used in chemotherapy on site incuineratnon Yellow puncture-resistant containers
Biological Liquids: excretion, exudates, Sewer - discard liquid discard container into(patient care Areas) secretions, suctionings m non- in utility sink, hopper, clear bag
sealed containers bedpan flushes orToilet (never disposein Handwashingsuiks)
Solids and disposable medical regular waste disposal Clear bagssupplies in contact with patient system(except tubing), e.g., disposabletowels, gown, apron, underpads,gloves, masks, clamps,electrodes
A2-2
Audit of Medical Waste Management Practices
APPENDIX A3: Sample Institutional PolicyPurpose: To provide a system for management of biomedical waste in order toprotect patients, staff, and the general public from hazards associated withbiomedical waste
Responsibilities: All staff must be familiar with the policy, guidelines, andimplementation plan and participate in training dealing with biomedical wastemanagement. Department Heads and Matron should ensure that staff within theirdepartments are familiar with the policy, guidelines, and plan, and have receivedtraining. The Waste Management Officer is responsible for day-to-dayimplementation and monitoring of biomedical waste management. The WasteManagement Team is responsible for the policy, guidelines and plan.
Policy:
Occupational Safety: Appropriate personal protective equipment must be usedwhen dealing with biomedical waste. Waste handlers will receive immunizationfrom viral hepatitis and tetanus.
Waste Minimization: The institution is committed to minimizing the impact of ourwaste on the environment. Staff members are responsible for participating inwaste reduction and recycling programs.
Classification: The following categories of waste are considered biomedicalwaste and must be handled cautiously as biohazardous or hazardous waste:sharps; cultures and stocks; human blood, blood products, and body fluids;pathological waste; animal waste; selected isolation waste; pharmaceuticalwaste; chemotherapy waste; low-level radioactive waste; and other hazardouschemical waste.
Segregation: Biomedical waste will be segregated throughout the facility.Segregation should take place at or as close as possible to the point where thewaste is generated, and segregation should be maintained during storage andtransport up to the point of treatment.
Labeling and Color Codinq: Every container for infectious biomedical waste musthave the international biohazard symbol in a contrasting color painted or affixed tothe container, along with the words "Biohazard" or "Sharps" whichever isappropriate. The following color coding will be used:
TYPE OF WASTE COLOR OF BAG OR CONTAINER
Potentially Infectious Waste REDSharps REDWashable Contaminated Linen YELLOWChemical, Pharmaceutical, or BROWNChemotherapeutic Waste I_IRegular garbage TRANSLUCENT
A3-1
Audit of Medical Waste Management Practices
Red bags will be available in treatment rooms, surgical suites, emergency room,nurses' stations, and isolation rooms. Sharps containers will be available inmedical and surgical wards, laboratory or phlebotomy stations, nurses' stations,treatment rooms, emergency rooms, and other areas easily accessible topersonnel near the area where sharps are used.
Collection, Storage, Transport, and Treatment: The procedures for biomedicalwaste management are summarized in the tables in the next two pages.
Training: Formal training will be provided to all health-care personnel onbiomedical waste management. Staff is required to attend the in-service trainingor workshops and refresher course.
Contingency Planning: Copies of the institution's contingency plans for wastespillage or other emergencies are found in . Staff should befamiliar with the contingency plan. Spills will be managed by the housekeepingstaff under the supervision of the Waste Management Officer.
Reporting: Any incidents such as biomedical waste spills, needle-stick punctures,or other injuries associated with biomedical waste should be reported immediatelyto the Waste Management Officer (name ).
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SUMMARY OF BIOMEDICAL WASTE MANAGEMENT PROCEDURESWaste Sharps Cultures & Blood & Pathological Waste Isolation (Contamin Regular
Type Stocks Body Waste ated Garbage
Fluids Linen)
Examples Needles, Culture Free- Tissues, Placentas, Swabs, Bedding Garbage
Synnges, dishes flowmng Body Parts Fetuses Soiled
Blood Blood Dressing
Tubes
Color Red Red Red Red Red Red Yellow Trans-
Code lucent
Marking Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard Biohazard none
Symbol, Symbol, Symbol, Symbol, Symbol, Symbol, Symbol,
"Sharps" 'Biohazard 'Biohazard" 'Biohazard' 'Biohazard' 'Biohazard' 'Biohazard'
Packaging Puncture- Plasbc Bag Leak-proof Plastc Bag Plastc Bag Plastc Bag Plasbc or Plastc
Resistant in a Rigid Container in a Rigid in a Rigid in a Rigid Linen Bag Bag or
Sharps Container Container Container Container Container
Container I
In-House Covered Covered Covered Covered Covered Covered Covered Trolley or
Transport Cart Cart Cart Cart Cart Cart Cart cart not
used for
biomed-
ical waste
Storage Protected Protected N/a Protected Protected Protected N/a Regular
Endosure Endosure, Endosure, Endosure, Enclosure, storage
4 IC or 39 4 OC or 39 4 OC or 39 OF 4 OC or 39 area
OF * OF * OF *_.
Treatment Automabc Advancod Discharge Advanced Bunal or Advanced Wash in N/a
Needle Autodave Into Autoclave Advanced Autodave Hot Water
Destroyer, Sanitary Autoclave (160 OF or
Advanced Sewer 88 °C) for
Autoclave 20 minutes
Off-Site Special Special N/a Speaal Speoal Special N/a N/a
Transport Vehicle Vehide Vehicle Vehicle Vehicle
(untreated
waste)
Off-Site Sanitaton Sanitabon N/a Sanitabon Sanitafion Sanitabon N/a Sanitaton
Transport Truck Truck Truck Truck Truck Truck
(treated
waste)
Disposal Sanitary Sanitary Sanitary Sanitary Interment in Sanitary N/a Recycling
Landfill Landfill Sewer Landfill Burial Site or Landfill or
Sanitary Sanitary
Landfill Landfill
*If storage bme is long enough to result in putnd smells from decaying organic waste
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SUMMARY OF BlOME=iICAL WASTE GANAGEMlEMT [PROCEDSIURES (Continued)Waste Expired Chemotherapy Waste Low-Level Radioactive Other Hazardous ChemicalType Pharmaceuticals Waste WasteExamples Condemned drugs Chlorambual, Cytoxin, tntium, iodine-125, carbon- Fomaldehyde,
Uradl Mustard 14, radium-226 trichlomethylene, xylenes
Color Brown Brown Brown BrownCode
Marking 'Hazardous Waste" Biohazard Symbol, Radiation Symbol, 'Hazardous Waste"'Biohazard" 'Radioactive Waste"
Packaging Rigid or Leak-proof Rigid or Leak-proof Rigid or Leak-proof Rigid or Leak-proofContainers Containers Containers Containers
In-House Covered Cart Covered Cart Covered Cart Covered CartTransportStorage Protected Enclosure Protected Endosure Condiboned Waste, Secure Protected Enclosure
Storage Facility withRadiological Protection
Off-Site Special Vehide Speaal Vehide Spedal Vehide Special VehideTransport
Treatment Retum to Supplier, Retum to Supplier or Decay in Storage, Retum to Retum to Supplier, Chemical& Disposal Inertzabon, Chemical Degradabon Supplier, or Long-Term Degradabon, EncapsulabonMethods Encapsulabon, or (for bulk agents), Storage (depending on half- and Disposal in Hazardous
Sewer Discharge Encapsulabon (for life of radionudide) Waste Landfill, or Sewer(depending on type of trace-contaminated DLscharge (depending on
drugs) waste) type of waste)
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Audit o/Medical Waste Management Pmclces
APPENDIXA4: Waste MinimizatonWaste minimization is the reduction, to the greatest extent possible, of waste thatis destined for ultimate disposal, by means of reuse, recycling, and otherprograms. The potential benefits of waste minimization are: environmentalprotection, enhanced occupational safety and health, cost reductions, reducedliability, regulatory compliance, and improved community relations. The followingis the recommended hierarchy of waste minimization techniques in order ofdecreasing preference:
1. Segregation - making sure waste items are in the appropriate container.Staff training is essential to keep regulated medical waste, hazardouswaste such as mercury, low-level radioactive waste, and regular trashseparated from each other.
2. Source reduction - minimizing or eliminating the generation of waste atthe source itself; source reduction should have a higher priority thanrecycling or reuse. Users, waste managers, and product standardizationcommittees should be aware of what waste is generated by the productsthey buy. Source reduction requires the involvement of purchasing staff.Steps should be taken to reduce at the source regulated medical waste,hazardous waste, low-level radioactive waste, as well as regular trash.Some specific source reduction techniques include:
a. Material elimination, change or product substitution, e.g.,substituting a non-toxic biodegradable cleaner for a cleaner thatgenerates hazardous waste; employing multiple-use instead ofsingle-use products; using short-lived radionuclides instead ofradium-226 needles in cancer treatment
b. Technology or process change, e.g., using non-mercury-containing devices instead of mercury thermometers or mercuryswitches; using ultrasonic or steam cleaning instead of chemical-based cleaners
c. Good operating practice, e.g., improving inventory control;covering disinfecting solution trays to prevent evaporative losses;using the minimum formulation recommended for an application
d. Preferential purchasing such as selecting vendors with reducedpackaging
3. Resource recovery and recycling - recovery and reuse of materialsfrom the waste stream. Some specific examples include:
a. Recycling newspapers, packaging material, office paper, glass,aluminum cans, construction debris, and other recyclables
b. Purchasing products made of post-consumer recycled materialc. Composting organic food waste
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Audit ofMed,cal Waste Management Practices
d. Recoverng silver from photographic chemicals
4. Treatment - treatment to remove and concentrate waste, preferably inprocess rather than end-of-pipe treatment. An example might be the useof filters and traps to remove mercury from wastewater.
5. Proper MDsposal - when all possible waste minimization options havebeen exhausted, the remaining waste should be disposed in the methodwith the least environmental impact.
The commitment of top management, active involvement of individuals fromdifferent departments, communication, and educational programs are essential toa successful waste minimization program.
APPROACHES TO WASTE MINIMIZATION
There are four basic stages in the development of a waste minimization program.These are: planning and organization, assessment, feasibility analysis, andimplementation.
The initial stage of planning and organization entails getting healthcaremanagement to be committed to waste minimization (reflected in a formal policystatement), setting overall goals, and staffing a task force to get key personnelfrom affected departments involved.
The assessment phase begins with the collection of data regarding wastestreams, processes and operations which are sources of these wastes, types ofpractices and process control, waste analysis, information on input materials, andeconomic information. A medical waste analysis (described below) is a valuabletool for the assessment phase. Flow diagrams and material balances are usefulin identifying sources and attempting to quantify losses or emissions. It may benecessary to prioritize waste streams based on quantity, toxicity, environmentalimpact, potential liability, regulations, cost, and other factors.
An assessment team of selected staff people with the assistance of outsideconsultants should review the data, inspect specific areas of waste generation,come up with waste minimization altematives, and screen and select options forstudy. With regards to municipal solid waste, the assessment team needs todetermine the recyclability of materials.
In the feasibility analysis phase, a technical and economic evaluation isconducted of the selected options. Among the criteria for technical evaluation areworker safety, maintaining quality of product or service, compatibility with existingoperating procedures and work schedules, minimal disruption to install a newsystem or process, space availability, etc. The economic evaluation usesstandard measures of comparative analysis such as payback period, retum oninvestment, and net present value.
The final phase is implementation. This entails obtaining funding, education andcommunications programs, installing new equipment or initiating new procedures,and evaluating the performance. A demonstration may be necessary to evaluate
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Audit of Afedical Wf/aste Management Practices
an option before final installation. Education and communications programs areessential. They must be designed to reach out to the entire staff, tap existingchannels of education, provide education on a continuing basis especially for newstaff, and respond to feedback from employees.
There are various measures to determine the effectiveness of wasteminimization. The initial method is to simply compare recorded quantities ofwaste generated before and after implementation. However, since wastegeneration may be dependent on rate of operation, the ratio of waste generationrate to some measure of rate of operation (such as number of occupied beds perday) is another way to analyze waste reduction. Another measure is to analyzethe waste minimization project's impact on the institution's cash flow which mayreflect reduced cost for waste management and raw materials. In someinstances, waste reduction may be expressed in terms of the ratio of inputmaterial consumption to rate of operation. These measurements are complicatedby processes or services that generate waste infrequently or intermittently, andsome evaluation methods may be more appropriate to specific units in the facilityrather than the entire facility.
MEDICAL WASTE ANALYSIS
A medical waste analysis or assessment can provide data on the sources ofwaste, compositions, generation rates, and waste flow within the facility. Medicalwaste analysis involves preparation, data collection, analysis, andrecommendations. Preparation entails defining goals, planning, enlisting thecooperation of key personnel and department heads, and a preliminary "walk-through" of the facility. Data can be collected in-house using self-audit forms andquestionnaires. Another approach is to employ an outside consultant. The needfor representative sampling determines the time period for data collection. Datacollected for a few days provides a snapshot of the waste flow. Collecting datafor two or more weeks requires greater staff effort but it may reveal importantvariations during different days of the week. A third approach is to install acomputerized waste tracking system for long-term data collection. A "waste sort"(separating and weighing components of waste collected during a time period)provides a more detailed analysis of waste composition and requires personalprotective equipment.
From the data, one establishes the flow of waste and generation rates of everyunit of the facility. Data on waste composition can be used to evaluateclassification and segregation practices. Over-classification (treating non-infectious waste as infectious waste) and lack of segregation (comminglingregular waste with infectious or hazardous waste) add significantly to treatmentand disposal costs. A waste analysis can uncover inefficiencies, estimate the truecosts of waste management, and establish the levels of compliance to policies.Waste analysis is essential in waste minimization as well as in related goals suchas developing recommendations for cost reduction, improving compliance, andreducing risk and liability.
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Audti ofMedical Waste Management Practices
SUGGESTED WASTE MINIMIZATION OPTIONS
Some suggested waste minimization methods for different types of waste aresummarized below. The table shows the areas in a hospital where recyclablesolid waste is generated and the types of common recyclables found. Thehealth-care facility may have to explore and negotiate with firms to acceptmaterials for reuse and recycling or to help develop markets for recyclables.
Sources and Types of Common Recyclable Waste in a Hospital
Sources OCC N MG WP C CPO AVIM G P P P P P otherP p 1 2 5 6 P
ShippinglRecvg x x x x x x 1Food Service x x x x x x 2Laboratory x x x x x x x xPabent Care x x x x x x x x x xAdmin Offioes x x x x x xRadiology, CT x x x x x x 3Surgery x x x x x x x xPharmacy x x x x x xDialysis x x x x x xDoctors Offices x x x x xMedical Records x x x x xHousekeeping x x x 4Faolity Mgt x x x x 5Public Areas x x x xHospital-wide 6
Legend. OCC - corrugated cardboard packaging; NP - newspaper, MG - magaanes; WP - white office paper, CP - coloredledger paper, CPO - computer pnntout paper (greenbar, bluebar); AV/M - aluminum and metal beverage, food, and other cans, G -glass including dear glass; P1 - PETE plastcs (soda bottles); P2 - HDPE (milk jugs, dialysis solubons, food stuffs, deaningsolubons), P5 - polypropylene (sterile irrigabon fluid bottes), P6 - polystyrene (food service and supply packaging); PP -polystyrene (Styrofoam) packaging peanuts; Other. 1 - stretchw rap; 2- grease, organic food waste, aerosol cans; 3-film, silverrecovery, 4 -aerosol cans, 5 -wood, aerosol cans, construction & demolibon debns, palettes. 6 -other recydables found hospital-wide indude durable goods such as fumishings, clipboards, old computer equipment, desks, drapes, mattresses, carpets,binders, dishware, phone directones, pnnter cartndges, etc. [Source An Ounce of Prevenion: Waste Reduction Strategies forHealth Care Facilities, C.L Bisson, G. McRae, and H.G. Shaner, Amencan Society for Healthcare Environmental Services(Amencan Hospital Assoaabon), Chicago, Illinois, 1993.]
An extra effort needs to be invested in segregating recyclable from non-recyclablewaste. The facility should develop an intemal system for collecting paper, glass,aluminum, and other recyclables. This may entail investing in recyclingequipment and collection containers. There may be recycling and waste-haulingcompanies who could provide recycling services.
In addition to paper, glass, and aluminum recycling, other ideas for recyclinginclude: identifying markets for plastic waste which comprise a significantpercentage of solid waste from hospitals; recycling or proper disposal of batteries;special recycling programs for bulky materials (old mattresses, furniture,stretchers, etc.); and recycling of construction and demolition waste. There maybe opportunities for recycling of scrap aluminum, wallboard, wood, metal piping,wiring, etc.
Another major potential for hospitals is composting to recycle organic wastessuch as food, yard, and wood fiber (low-grade paper and boxboard) scraps.
The purchasing departments of healthcare facilities play a major role in 'closingthe loop" by seeking out and purchasing products made mostly of postconsumerrecycled material. They can also reduce waste generation by purchasing goods
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Audit of Medical Waste Management Practices
for their durability and "reprocessability," selecting products with minimalpackaging, and working with supplier to support waste minimization. A productmanagement approach can identify opportunities for reducing waste throughpurchasing, inventory control, changes in packaging, and working with suppliers.
RESOURCES
Many resources are available to assist health care organizations develop aneffective waste minimization program in their facilities (see box insert). Bookssuch as Guidebook for Hospital Waste Reduction Planning and ProgramImplementation, An Ounce of Prevention: Waste Reduction Strategies for HealthCare Facilities, and The Waste Not Book provide valuable information andpractical suggestions.
RECONlMENDED READINGS ON WASTE MINIMIIZATION
Waste minimization model plans and guides including a chemical waste minimization plan, mercury-virtual elimination plan, and gulde toenvironmentally-preferable purchasing Hospitals for a Healthy Environment (an Amencan Hospital Association and U S EnvironmentalProtection Agency partnership) (available at wkvw h2e-online or,)
On-line resources on waste minimization for hospitals and laboratones, Minnesota Technical Assistance Program (MnTAP), University ofMinnesota, School of Public Health, Division of Environmental and Occupational Health (wv%'w mntap umn edu )
Waste Almuniziation in the HealtJhcare Industro A Resource Guide. J Emmanuel, EPRI, Palo Alto, CA 1999 TR-1 13841 (EPRJ, 3412Hillview Avenue, Palo Alto, CA 94303, 800-313-3774)
Environmental Managemnent in Healthicare Facilities, Edited by K D Wagner, C.D Rounds, and R Spurgin, W B Saunders Company,Philadelphia, Pennsylvania, 1998 (W B Saunders Company, The Curtis Center, Independence Square West, Philadelphia, PA 19106,800-545-2522, http llwww harcounhealth conv)
Guidebook for Hospital Waste Reduction Planning and Prograni Implementation, Glenn McRae and Holhie Gusky Shaner, RN, AmencanSociety for Healthcare Environmental Services (Amencan Hospital Association), Chicago, Illinois, 1996 (AHA Secvices, Inc, P O Box92683, Chicago, IL 60675-2683, 800-AHA-2626)
An OUaIce ofPrevention Waste Reduction Strategiesfor Health Care Facilities, C.L. Bisson, G McRae, and H G Shaner, Amencan Societyfor Healthcare Environmental Services (Amencan Hospital Association), Chicago, Illinois, 1993 (AHA Services, Inc, PO Box 92683,Chicago. IL 60675-2683, 800-AtHA-2626)
Tle 1Waste A'o Book, Public Affairs Division, Minnesota Hospital Association, Minneapolis, Minnesota, 1993 (Minnesota Hospital andHealthcare Partnership, 2550 W University Avenue, Suite 350-S, St Paul, MN 55114-1900, 800462-5393, www mhhp com)
"Facility Pollution Prevention Guide," EPA/600/R-92/088, U S Environmental Protection Agency, Risk Reduction Engineenng Laboratory,Off-ice of Research and Development, Cincinnati, Ohio, 1992 1
"Hospital Pollution Prevention Study," EPA/600/2-91/024, prepared by R Linen for DeparTment ofVeterans Affairs, Washington, DC, andRisk Reduction Engineenng Laboratory, Office of Research and Development, Cincinnati, Ohio, July 1991 *
"Guides to Pollution Prevention Selected Hospital Waste Streamns" (formerly titled "Guide to Waste Minimization in Selected HospitalWaste Streams"), EPA/625/7-901009, U S Environmental Protection Agency, Risk Reduction Engineenng Laboratory, Cincinnati, Ohio.June 1990 *
"Waste Minimization Opportunity Assessment Manual," EPA/625/7-88-003, U S Environmental Protection Agency, Hazardous WasteEngineenng Research Laboratory, Cincinnati, Ohio, 1988 *
( Contact EPA Publications at 800490-9198 or check out littp lvww epa gov/epahome/publicatioits htm for EPA reports)
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Audit ofMedical Waste Management Practtces
APPENDIXA5: Sample Poster
HOSPITAL WASTE IMANAGEMENT SYSTEM |
BIONMEDICAL WASTEailising from direct patient care
r~~ _
FOUL & INFECTED LINEN
4-
CHENMOTHERPAPY,_IW - ~ PHARMACEUTICAL &
CHEMICAL WrASTE
REGULAR TRASH
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Audit of Medical Waste Management Practices
APPENDIX A6: Ideas for Hazardous WasteMinimizationWASTE TYPES SOME HAZARDOUS WASTE MINIMIZATION IDEASSolvents Recover/reuse solvents through on-site or off-site distillation; e g., use fractional disbillation
to separate xylene from ethanol in histology wasteSubstitute less hazardous solvents, use non-halogenated for halogenated compounds, and
simple alcohols and ketones for petroleum hydrocarbons; use aqueous reagentswhenever possible.
Consider commercial xylene substitutes as histology solvents.Use pre-mixed kits for tests involving solvent fixabon.Use high-resolubon analytical equipment to reduce analyte test volumes.Use calibrated solvent dispensers for routine tests.Minimize sizes of cultures and specimens in pathology, histology and labs.
Formaldehyde Use reverse osmosis water treatment to reduce dialysis cleaning demands.wastes Minimize strength of formaldehyde solubons.
Develop standards for Formalin solutions based on microbial culture studies to determineminimum cleaning frequency and solubon concentrabons.
Investigate possible reuse of formaldehyde in pathology and autopsy.Use a chemical addibve that reacts with and cross-links waste formaldehyde solutions toform a non-hazardous end product.
Antneoplastic Substtute degradable drugs for environmentally persistent drugs.agents Optimize drug container sizes in purchasing and buy according to need.
Retum outdated drugs to manufacturers.Minimize the cleaning frequency and volume of gauze matenal used for the compounding
hood.Provide spill cleanup kits and employee training.
Photographic Recover silver using cabon exchange and electrolytic recovery instead of steel woolchemicals filtration units.
Ensure proper storage conditions to increase shelf life and test expired material forusefulness; retum off-spec developer to manufacturer.
Cover developer and fixer tanks to reduce evaporabon and oxidation; consider addingammonium thiosulfate to fixer or an acetic acid bath prior to fixing to extend life of fixingbath; use squeegees to reduce bath losses.
Recycle spoiled film and paper.Use countercurrent washing.Use a chemical additive that neutralizes spent fixer and developer waste and permanentlybinds silver to a solid matnx.
Mercury wastes Subsbtute electronic sensing devices and other non-mercury substitutes for mercury-containing devices
Provide mercury spill cleanup kits and train personnel.Completely drain residual mercury from medical devices and consider off-site recycling of
uncontaminated mercury.Disinfecting Use ultrasonic or steam cleaning instead of alcohol-based disinfectants.solubons Keep disinfecting solution trays and containers well covered to avoid loss by evaporation.
Use a chemical addibve that reacts with and cross-links glutaraldehyde wastewater to forma non-hazardous end product
Maintenance and Use ultrasonic or steam cleaning instead of aqueous or chemical-based cleaners, useutility wastes biodegradable cleaners instead of solvent-based cleaners.
Collect waste oil and solvents for recycling; segregate recyclable oils and solvents fromnon-recyclables.
Replace oil-based paints with water-based paints.Use only required pesticide quantties or use non-chemical pesticide control methods.
[Source: 'Guides to Pollution Prevenbon: Selected Hospital Waste Streams," EPA162517-90/009, U.S.Environmental Protection Agency, Risk Reducton Engineering Laboratory, Cincinnati, Ohio, June 1990.]
A6-1
IE & ER Group E & ER Group Phone 510-799-2551628 Second Street Fax 510-799-2572Rodeo, CA 94572 USA
MCOV I I adKe,U RIImmmetn d az~%t'H.1n ra- eicaiW Waste Treate
TachnoHogyAlwl
St. Kitts and Nevis
Prepared for:Natural Resources Management Unit (NRMU)
Organization of Eastern Caribbean States (OECS)
January 18, 2002
Table of Contents
Executive Summary .............. .......................... i
Introduction ...........................................
Objectives .. 1
Types of Biomedical Waste Treatment Processes ........ 1
Selection Criteria ............ ............................ 3
Screening of Treatment Technologies ............................ 7
Comparison of Advanced Autoclavesand Incinerators ......................................... 9
Summary: Tabulated Comparisons ............................... 20
Potential Impact of the Stockholm Convention ........... 21
Recommendation ............. .......................... 21
Cost Estimates for an Advanced Autoclave ................. 22
Appendix
Tender Specifications for an Advanced AutoclaveTreatment Technology ....................................... B1
Operating Procedures, Preventive Maintenance,Training Requirements, and Periodic VerificationTesting of Treatment Technology ............................ B2
EXECUTIVE SUMMARY
This report presents a review of available biomedical wastetreatment technologies and makes recommendations for St. Kitts.The possible location of the technology will be explored withstakeholders.
There are basically four processes involved in treating biomedicalwaste: thermal, chemical, irradiative, and biological processes.Screening criteria include size (throughput rate), level ofcommercialization, cost of the technology, and ability to meetinternational environmental standards. These criteria are used toinitially screen 49 specific technologies resulting in the selection oftwo commercially available advanced autoclaves. The finalselection considers a range of other factors including space, utility,and installation requirements, occupational safety, noise, odor,level of automation and ease of use, skill and training required tooperate the technology, reliability, maintenance, and availability oftechnical support.
A major portion of the report compares advanced autoclaves withincinerators. Comparisons focus on environmental issues, publicand occupational health impacts, pathogen destruction, and costs.The possible ramifications of the newly completed StockholmConvention on Persistent Organic Pollutants on medical wasteincineration are also discussed. Comparisons of an advancedautoclave and incinerator are summarized in tabular form.
Recommendations are made to replace the JNF Hospitalincinerator with an advanced autoclave, in particular, the San-l-Pak230-3P Auto-Clave system. Costs estimates are presented.Tender specifications can be found in the Appendix. Operatingprocedures, preventive maintenance, training requirements, andperiodic validation testing are discussed in the Appendix.
INTRODUCIION
This project is a component of a larger World Bank-funded program to address theproblem of solid and ship-generated wastes with the goal of protecting theenvironment and enforcing the MARPOL 73f78 Convention. The programinvolves six members of the Organization of Eastern Caribbean States (OECS)and is coordinated by the Natural Resources Management Unit of OECS.
This particular component of the project deals with the management of health-carewaste and has four specific tasks: (1) an audit of medical waste managementpractices, (2) review of existing medical waste treatment technologies, (3)development of a national biomedical waste management plan, and (4) a trainingprogram/implementation and monitoring.
This report corresponds to the second of the aforementioned four tasks. Thereport was prepared by Dr. Jorge Emmanuel of the E & ER Group based inRodeo, California, USA. The author is grateful to Mr. Clifford Griffin of the Ministryof Health and Mr. Theodore Mills for their invaluable assistance during his first visit.He also acknowledges the support of Permanent Secretaries Mr. Elvis Newtonand Mr. St Clair Wallace, as well as Ms. Nona Adams of JNF Hospital and all thepersonnel who provided information at facilities in St. Kitts and Nevis.
Jorge Emmanuel, PhD, CHMM, PE, REP, DESPresident, The E & ER Group
628 Second StreetRodeo, CA 94572
USAPh 510-799-2551Fax 510-799-2572
E-mail: iemmanuelC_mindsprinq com
RLi'c'(Iaelndl RcLommneandation on a . Ied(/I( *al F1 ,.t. 7; e(Itfl T itne Tt'cIh dg,Io,'
Review and Recommendation on a Medical WasteTreatment Technology
S. i"" -- - -
The objectives of this report are to review available waste treatment technologiesand to make recommendations. Only technologies that have been documentedas meeting intemationally accepted levels of microbiological inactivation efficacyare considered in this report.
This report is focused on St. Kitts alone. Although the consultant has conductedmany tests and technical evaluations of hospital incinerators around the world,no assessment could be made for Nevis since no information has been obtainedregarding the new incinerator despite follow-up requests for data.
Treatment technologies can be classified based on the fundamental processesused to decontaminate the waste. The four basic processes are:
1. Thermal processes
2. Chemical processes
3. Irradiative processes
4. Biological processes
The majority of technologies employ the first two processes listed above.Thermal processes are those that rely on heat (thermal energy) to destroypathogens in the waste. This category is further subdivided into low-heat,medium-heat, and high-heat thermal processes. This further subclassification isnecessary because physical and chemical mechanisms that take place in thermalprocesses change markedly at medium and high temperatures.
Low-heat thermal processes are those that use thermal energy to decontaminatethe waste at temperatures insufficient to cause chemical breakdown or to supportcombustion or pyrolysis. In general, low-heat thermal technologies operatebetween 200°F to about 350°F (930C -177°C). The two basic categories of low-heat thermal processes are wet heat (steam) and dry heat (hot air) disinfection.Wet heat treatment involves the use of steam to disinfect waste and is commonlydone in an autoclave. Microwave treatment is essentially a steam disinfectionprocess since water is added to the waste and disinfection occurs through theaction of moist heat and steam generated by microwave energy. In dry heatprocesses, no water or steam is added. Instead, the waste is heated by
1
Reicii and Rcoinniendaltion oni ai Wehial Pf/Paste Tl lat7wnt TfL hITl0h/o?JQ
conduction, natural or forced convection, and/or thermal radiation using infraredheaters.
Medium-heat thermal processes take place at temperatures between 350 to700°F (177°C-370 0C) and involve the chemical breakdown of organic material.These processes are the basis for relatively new technologies. They includereverse polymerization using high-intensity microwave energy and thermaldepolymerization using heat and high pressure.
High-heat thermal processes generally operate at temperatures ranging fromaround 1,0000F to 15,000°F (540°C-8,300°C) or higher. A significant change inthe mass and volume of the waste also occurs. Examples include incineration,plasma pyrolysis, and induction-heated furnaces.
Chemical processes employ disinfectants such as dissolved chlorine dioxide,bleach (sodium hypochlorite), peracetic acid, or dry inorganic chemicals. Toenhance exposure of the waste to the chemical agent, chemical processes ofteninvolve shredding, grinding, or mixing. In liquid systems, the waste may gothrough a dewatering section to remove and recycle the disinfectant. Besideschemical disinfectants, there are also encapsulating compounds that can solidifysharps, blood, or other body fluids within a solid matrix prior to disposal. Onedeveloping technology uses ozone to treat medical waste and others utilizecatalytic oxidation. Another system uses alkali to hydrolyze tissues in heatedstainless steel tanks. Solidification or inertization could be considered types ofchemical processes for treating biomedical waste.
Irradiation-based technologies involve electron beams, Cobalt-60, or UVirradiation. These technologies require shielding to prevent occupationalexposures. Electron beam irradiation uses a shower of high-energy electrons todestroy microorganisms in the waste by causing chemical dissociation andrupture of cell walls. The pathogen destruction efficacy depends on the doseabsorbed by the mass of waste, which in tum is related to waste density andelectron energy. Germicidal ultraviolet radiation (UV-C) has been used as asupplement to other treatment technologies. Irradiation does not alter the wastephysically and would require a grinder or shredder to render the wasteunrecognizable.
Biological processes employ enzymes to destroy organic matter. Only a fewtechnologies have been based on biological processes.
Mechanical processes--such as shredding, grinding, hammermill processing,mixing, agitation, liquid-solid separation, conveying (using augers, rams, orconveyor belts), and compaction - supplement treatment processes. Mechanicaldestruction can render the waste unrecognizable and is used to destroy needlesand syringes so as to minimize injuries or to render them unusable. In the case ofthermal- or chemical-based processes, mechanical devices such as shreddersand mixers can also improve the rate of heat transfer or expose more surfaces tochemical disinfectants. Mechanical processes can add significantly to the level ofmaintenance required. A mechanical process is supplementary and cannot beconsidered a treatment process per se.
2
Re1vici atl Raoinnnchitown /n a Aluizl oI"kthd TreCnnnt TecIuhulo(ov
The approach for selecting and recommending technologies is based on:
a) The appropriateness of the technology for St. Kitts in terms of size(throughput rate)
b) Level of commercialization
c) Cost of the technology
d) Ability of the technology to meet current international environmental standards
e) Others factors including space, utility and other installation requirements; feedopening size; reduction of volume and/or mass; occupational safety; noiseand odor; level of automation and ease of use; skills and training required tooperate; reliability and maintenance requirements; availability of technicalsupport; and vendor background.
The location of the new technology will be discussed with stakeholders andrecommendations will be made at a later time.
SIZE
To determine the appropriate size of a treatment technology, it is necessary toestimate the amount of medical waste generated at St. Kitts. One can calculatethe following generation rates for St. Kitts alone (assuming the island's populationis 3/4ths of the total population): 12,214 kg/yr of infectious in 2002. Projecting tothe year 2015 gives 12,901 kg/yr of infectious waste. These figures wereobtained based on CBCL data and the factor of 0.4 kg per capita. A secondestimate is provided below.
For purposes of comparison, a higher estimate can be obtained using the upperrange of estimates provided by the World Health Organization (WHO) for a districthospital (1.8 kg total waste per bed per day; infectious waste including sharps =16% of total waste) and for an urban health center (0.01 kg per day per patient).For JNF Hospital, the total beds after the new construction, 150 beds, will beused. For Pogson and Mary Charles Hospitals, 36 and 10 beds respectively willbe used. For the 11 health centers, the following assumptions will be used basedon information provided by Newtown Health Center: 60 patients per day forBasseterre, 30 for Newtown, and 20 for all the other health centers. Furthermore,calculations will be based on 7 days per week operation for the hospitals and 5days per week operation for the health centers. Using these parameters, onethen computes an upper range of 21,223 kg per year for St. Kitts (about twice theestimates computed above).
Therefore, estimates of waste generation range from 12,214 to 21,223 kg ofinfectious waste per year at St. Kitts. Treatment technologies are generally ratedon a per hour or per day basis. Assuming the treatment technology will be used 5days a week (261 weekdays per year), the following daily throughput rates are
3
R,oic'i1 and Recommendation ot tI A1fetihal "astL' 7r'abnnenlt Tech'iluokV
required: 47 to 81 kg per day (104-180 lbs/day). Assuming 2 hours of operationper day, the following hourly throughput rates are required: 24 to 41 kg per hour(53-90 lbs/hr). Hence, the treatment technology should be sized as close aspossible to this throughput rate.
In terms of volume, the daily rates range from 430 - 740 liters per day (15 - 26cu. ft per day).
LEVEL OF COMMERCIALIZATION
Some technologies, such autoclaves, have been in operation for decades, whileothers, such as plasma pyrolysis, are still in the development or demonstrationstage. For this report, technologies that are well established with a documentedtrack record will be selected.
COST
A treatment technology costing around $100,000 will be used in the selectioncritera.
ENVIRONMENTAL STANDARDS
For the purpose of selection, the U.S. Environmental Protection Agency'semission limits in the 'Hospital / Medical / Infectious Waste Incinerator Rule" andthe limits in the toxicity characteristic leachate procedure (TCLP) test will be usedas criteria for air emissions and solid residues respectively. These criteria arerelevant to thermal treatment technologies. U.S. Occupational Safety and HealthAdministration (OSHA) Permissible Exposure Limits (PELs) will be used ascriteria for ambient air concentrations in the workplace. Another criteria to beused will be whether the technology is an approved treatment technology in oneor more of the states of the United States.
Thermal treatment technologies should be able to show that their emissions meetthe EPA limits under the 1997 'Standards of Performance for New StationarySources and Emission Guidelines for Existing Sources: Hospital / Medical /Infectious Waste Incinerators." Table 1 below shows the emission limits set onnine criteria pollutants under the rule for new incinerators.
In addition, new incinerators are restricted to a 5% visible emission limit forfugitive emissions generated during ash handling and a 10% stack opacity limit.
If test results of the solid residue exceed the limits under EPA's toxicitycharacteristic leachate procedure (TCLP), the ash must be treated as hazardouswaste. TCLP is a testing procedure wherein an extract from a 100 gram sampleof the ash is tested for 40 toxic substances; if the analysis shows that one of thesubstances is present at a concentration higher than that specified in the TCLP,the ash is considered hazardous waste. This will be used as general criteriasince TCLP results can depend on the composition of waste treated.
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RLI'W1I azi Rcconintewnd/tui oi a.10/ aA1(11 ,a! ltre T,r-annent Ttchnol(%A
Table 1. Emission Limits for Biomedical Waste IncineratorsPollutant Emission Limits
Small Medium LargeParticulate Matter 69 mg/dscm 34 mg/dscm 34 mg/dscmCarbon Monoxide 40 ppmv 40 ppmv 40 ppmv
Dioxins/Furans 125 ng/dscm total 25 ng/dscm total 25 ng/dscm totalor 2.3 ng/dscm TEQ or 0.6 ng/dscm TEQ or 0.6 ng/dscm TEQ
Hydrogen Chloride 15 ppmv 15 ppmv 15 ppmvor 99% reduction or 99% reduction or 99% reduction
Sulfur Dioxide 55 ppmv 55 ppmv 55 ppmvNitrogen Oxides 250 ppmv 250 ppmv 250 ppmv
Lead 1.2 mg/dscm 0 07 mg/dscm 0.07 mg/dscmor 70% reduction or 98% reduction or 98% reduction
Cadmium 0.16 mg/dscm 0.04 mg/dscm 0 04 mg/dscmor 65% reduction or 90% reduction or 90% reduction
Mercury 0 55 mg/dscm 0.55 mg/dscm 0.55 mg/dscmor 85% reduction or 85% reduction or 85% reduction
Capacities: small=less than or equal to 200 lbs/hr, medium=greater than 200 lbs/hi to 500 lbs/hr;large=greater than 500 lbs/hr.
Wastewater discharges should be at a minimum while posing no problems tosanitary sewers or water treatment facilities.
OTHER FACTORS
Space is usually a premium at health care institutions. The space needed tooperate a technology should fit the available space in the facility. That space isnot only the footprint and height of the equipment but should also consideradditional space needed for opening waste entry doors, access to control panels,space for moving bins, storage areas, etc.
Some technologies only need an electrical outlet to operate, others requiresteam, compressed air, natural gas, drains, ventilation, etc. Not all these utilityservices and other infrastructure may available at the selected site. Concretepads, access paths, curb cuts, and other site preparations may be needed. Thelocation may or may not be on ground level.
In addition to proper throughput capacity, the technology should also have awaste feed entry area that is large enough to be able to introduce infectious wastebags or containers into the treatment chamber without any problems. Sometechnologies have large treatment chamber but are limited by small entry doors.
Volume and/or mass reduction is another important factor especially if facilitiespay by volume or mass for hauling the treated waste and disposing at a landfill. Ahigh reduction in waste volume can help minimize environmental impact.
Issues of occupational safety and health are important. Consideration should begiven to potential worker exposure to: hot surfaces, ionizing and non-ionizingradiation, chemicals released in the workspace, sharps that may fall out duringconveying, pathogens from the waste that are aerosolized during shredding,blood splatter, etc. Ergonomic issues should also be considered.
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Revicii a(wl Recoinniendatlon ont ai A'ludlcl PPaste 7i) ,jtfnent Te.mc/ lzoloc?
In the event of an equipment breakdown, the technology should have some wayof protecting workers who may need to access internal parts of the equipment.Some technologies have a way of injecting chemical disinfectants on untreatedwaste and intemal surfaces in these situations. Others have safety interlocks thatprevent workers from opening a treatment chamber door if the treatment cyclehas been interrupted.
An ideal technology is one that is noiseless and odor-free during operation. Thebest way to evaluate this is to observe the technology during actual operation atan installation in another health care facility if possible. Reducing noise andnoxious odors are important aspects of occupational health and communityrelations.
A technology should be automated to minimize operator errors while allowingefficient and easy control of the process, safety interlocks, diagnostics, remotemonitoring, alarms, and automatic documentation to meet record keepingrequirements. Most technologies are also designed for ease of use and minimaloperator time. Usually, the most labor-intensive task is introducing waste into theequipment. It is also a source of occupational injuries (e.g., back problems,needle-sticks). Many technologies now include automatic feed assemblies suchas cart lifters or bin dumpers to eliminate handling of red bags by workers.
When selecting a technology, the level of required skills and necessary training ofthe operator will be considered. Vendors generally offer operator training when anew system is installed; the facility may need to arrange for ongoing training andeducation. Operator training should include: a basic understanding of thesystems, standard operating procedures, occupational safety and personalprotection equipment, identifying waste that should not be treated in thetechnology, recognizing technical problems, dealing with unusual conditions,periodic maintenance schedules, emergency procedures, and contingency plans.Facilities should document operator training and qualification.
Reliability of equipment can be determined from past maintenance records (thesemay or may not be available for new technologies). Some vendors offer remotemonitoring and diagnostics capabilities. High maintenance items include majormoving parts such as mixing paddles, shredders, grinders, and feed systems,and parts that are subjected to high thermal stresses such as refractories.
It is useful to see if vendors are well stocked with spare parts and staffed withtechnical people who can respond quickly to queries or provide urgent repairservices. The availability of technical support is important especially for newlycommercialized technologies that may not have a long track record of operation.
It is important how long a technology manufacturer and/or vendor has been inbusiness, what their financial status is (i.e., are they financially stable), thebackgrounds of key officers of the company, whether or not they have been citedfor environmental or other violations, and any financial or legal liabilities.
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Revi'li a .nd. Rcco,ninendarion o), a. .'edua l lIl astu TrelCtment 7Technu1ocLi
In this section, 49 treatment technologies will be screened based on the first fourcrtera mentioned above. The table below summanzes the results.
Table 2. Treatment Technologies for Medical WasteType of Process Technology Vendors Size Cost Corn* Env*
LOW-HEAT THERMALPROCESSES _
Autoclave or Retort Bondtech (Somerset, KY) N y y yAutoclave or Retort Environmental Techtonics Corp N N y y
(Southampton, PA) IAutoclave or Retort Lajtos (France) y N y yAutoclave or Retort Mark Costello (Carson, CA) N y y yAutoclave or Retort Sierra Industnes (Santa Ana, CA) N y y yAutoclave or Retort StenTech (Bloomington, IN) y y N yAutoclave or Retort Tuttnauer (Ronkonkoma, NY) y y N yVacuum-Steam-Compaction San-l-Pak (Tracy, CA) y y y ySteam-Mixing- Tempico (Madisonville, LA) N N y yFragmenting/Drying/ ShreddingShredding/Steam-Mixing/Drying, Stenle Technologies Inc (West N N y yChemical Chester, PA)Shredding-Steam-Mixing/Drying Antaeus Group (Hunt Valley, y N N y
MD)Shredding-Steam-Mixing/Drying Ecolotec (Union Grove, AL) y N N ySteam-Mixing-Fragmenting/Drying Hydroclave Systems Corp y y y y
(Kingston, Ontano, Can )Pre-Shredding/Steam-Mixing Aegis Bio-Systems (Edmond, N N y y
OK)Shredding/Steam-Mixing- LogMed (Erdwich N N N YCompaction ZerkleinerungsSysteme GmbHMicrowave Treatment Sanitec (West Caldwell, NJ) N N y yMicrowave Treatment Sintion/CMB (Austna) Y Y N YElectro-Thermal Deactivation Stencycle (Lake Forest, IL) N _ __
Dry Heat Treatment KC MediWaste (Dallas, TX) N N y yDry Heat Treatment Demolizer N y y y
NMEDIUNI-HEAT THERMIALPROCESSESReverse Polymenzation Environmental Waste N N N
Intemational (Ajax, Ontano)Thermal Depolymenzation Changing World Technologies N N N
(West Hempstead, NY)
HIGH-HEAT THERMALPROCESSESStandard Incineration y N y **
Pyrolysis-Oxidation Oxidation Technologies N N y y(Annapolis, MD)
Plasma Pyrolysis DayStar/Prometron (Tokyo, N N N9Japan)
Plasma Pyrolysis Electro-Pyrolysis, Inc (Wayne, N N N ?
I _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___ PA )Plasma Pyrolysis HI Disposal Systems N N N ?
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ReL'eii aindl RecommL'nldaftion on 1i aILA(l . al R'astt- T tl(lnnenl Tec1hiuolocD
(Indianapolis, IN)Plasma Pyrolysis Integrated Environmental Systems N N N y
(Richland, WA)Plasma Pyrolysis MSE Technology Applications N N N?
(Butte, MT)Plasma Pyrolysis Plasma Pyrolysis Systems N N N
(Stuyvesant Falls, NY)Plasma Pyrolysis Startech Environmental Corp N N N
(Wilton, CT)Plasma Pyrolysis Unitel Technologies (Mt. N N N
Prospect, IL)Plasma Pyrolysis Vance IDS/Bio Arc (Largo, FL) N N N 9
Plasma Pyrolysis Vanguard Research Inc (Lorton, N N N?VA)
Induction-Based Pyrolysis Vanish Technologies/LFR N N N(Rantan, NJ)
Laser-Based Pyrolysis Anara Group (Las Vegas, NV) N N N?Superheated Steam Reforming Duratek (Columbia, MD) y N N yAdvanced Thermal Oxidation NCE Corporation (Carrollton, N N N
TX)
CHEMICAL PROCESSESSodium Hypochlonte-Hammenmill Circle Medical Products N N y y
(Indianapolis, IN)Sodium Hypochlonte-Shredding MedWaste Technologies Corp. N y y(mobile) (Houston, TX)Chlonne Dioxide- Encore/Medical Compliance (El N N y yShredding/Gnnding Paso, TX)Ozonation Lynntech (College Station, TX) y N yElectrocatalytic Wet Oxidation MeDETOX/Delphi Research N N y
(Albuquerque, NM)"Stencid"-Shredding-Mixing MCM Environmental y ? N y
Technologies (Gilboa, Israel)Dry Inorganic Chemical-Shredding Positive Impact Waste Solutions N N y
(Pearland, TX)Dry Inorganic Chemical-Shredding Premier Medical Technology N N y
(Houston, TX)Peracetic Acid-Gnnding Ecocycle 1O/STERIS Corp y y N y
(Mentor, OH)Alkaline Hydrolysis WR` (Indianapolis, IN) y N y y
IRRADIATION PROCESSESElectron Beam BioStenle Technology (Fort N N N y
Wayne, IN)Electron Beam-Shredding U Miami E-Beam (Coral Gables, N N N y
FL)
BIOLOGICAL PROCESSESEnzyme-Based Bio Conversion Technologies, N N NTreatment/Extrusion Inc (Norcross, GA) I
Legend Com = Level of Commercialization, Env = Environmental Standards, y = meets basic cntena, N = does not meetcntena, ? = no data available, technology has not been tested, or technology is still in development stage and cost figures are notyet established' ** = see discussion in the next section
A screening of available technologies using the first four criteria results in thefollowing potential options: San=4-pak and KfydrocDave.
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S * * g kg ~~* Di-1G IA *04
In this section, autoclaving and incineration are compared.
ADVANCED AUTOCLAVES
An autoclave consists of a metal chamber sealed by a charging door andsurrounded by a steam jacket. Steam is introduced into both the outside jacketand the inside chamber which is designed to withstand elevated pressures.Because air is an effective insulator, the removal of air from the chamber isessential to ensure penetration of heat into the waste. This is done in two generalways: gravity displacement or pre-vacuuming. In a gravity-displacement (ordownward-displacement) autoclave, steam is introduced under pressure into thechamber forcing the air downward into an outlet port or drain line in the lower partof the chamber. A more effective method is the use of a vacuum pump toevacuate air before introducing steam, as is done in pre-vacuum autoclaves.Pre-vacuum (or high-vacuum) autoclaves need less time for disinfection due totheir greater efficiency in taking out air. A retort is essentially an autoclave exceptthat a retort has no steam jacket.
Autoclaves and retorts require a minimum exposure time and temperature toachieve proper disinfection. Time-temperature recommendations for variousconditions are found in a number of references (See for example: J.L. Lauer, D.R.Battles, and D. Vesley, "Decontaminating infectious laboratory waste byautoclaving," Appl. Envron. Microbiol. 44 (3), 690-694, September 1982, W.A.Rutala, M.M. Stiegeland, and F.A. Sarubbi, Jr., "Decontamination of laboratorymicrobiological waste by steam sterilization," Appl. Environ. Microbiol. 43, 1311-1316, June 1982; E. Hanel, Jr., "Chemical Disinfection" in Control of Blohazardsin the Research Laboratory, Course Manual, School of Hygiene and PublicHealth, Johns Hopkins University, Baltimore, MD, 1981; Herman Koren,Environmental Health and Safety, Pergamon Press, NY, 1974). As shown in thetable below, the recommended exposure times are based on twice the minimumtime required to achieve a 6 logl0 kill of bacterial spores under ideal conditions;equivalent exposure times at different temperatures can be estimated. Acommon exposure temperature-time criterion is 121°C (250°F) for 30 minutes.
Table 3. Exposure Time-Temperature Criteria for DisinfectionTemperature Spore Kill Minimum
Time ExposureTime
Degrees F Degrees C Minutes Minutes240 116 30 60245 118 18 36250 121 12 24257 125 8 16270 132 2 4280 138 1 2
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Revl I"I(, and1f Rcolnnwndatlon on ti A'ludlLal Kast.' TLrannLent TL'chInloa.j
Color-changing chemical indicators or biological monitors (e.g., B.stearothernophilus or B. subtilis spore strips) placed at the center of test loadsshould be used to verify that sufficient steam penetration and exposure time haveoccurred.
Steam treatment is a proven technology with a long and successful track record.The technology is easily understood and readily accepted by hospital staff andcommunities. Autoclaves are an approved or accepted medical waste treatmenttechnology in all states of the United States. If proper precautions are taken toexclude hazardous materials, the emissions from autoclaves and retorts areminimal. Capital costs are relatively low compared to other technologies.
In the last few decades, a second generation of steam-based systems have beendeveloped for the purpose of improving the transfer of heat into the waste,achieving more uniform heating of the waste, rendering the wasteunrecognizable, and/or making the treatment system easier to use. These newsystems have sometimes been referred to as advanced autoclaves. Thesesystems basically function as autoclaves or retorts but they combine steamtreatment with pre-vacuuming and various kinds of mechanical processingbefore, during, and/or after steam disinfection.
San-D-Pak is one of the more established technologies among the advancedautoclaves. Since 1978, they have installed some 700 units in the United Statesand in about a dozen countries around the world. The technology basicallyintegrates high vacuum/autoclave with compaction and uses articulatingchambers to facilitate the introduction and removal of waste.
In the San-l-Pak systems, the autoclave cycle begins with a high vacuum toremove air, followed by exposure to 307°F (153°C) steam. The chamber isallowed to reach temperatures of 281-284°F (138-140C) or about 38 psig. Aftertreatment, the steam vents down through a diffuser to condense the steam andthe waste is automatically conveyed to a cart or compaction chamber.
In the mid-1990s, San-l-Pak developed a new line of articulating chambers, amodular design wherein each chamber has three basic positions. In the loadposition, the chamber is tilted with the door facing up making it easier for theoperator to insert an optional autoclavable liner and load the waste. The load tiltposition also prevents waste from falling out during loading. The chamber is thenrotated to a horizontal position to start the treatment cycle: air is evacuated usinga vacuum and 307°F (153 0C) steam is introduced (evacuated air is mixed withsteam to destroy pathogens and then reintroduced into the chamber). The wasteis exposed to steam for 30 minutes from the time the chamber temperaturereaches 270°F (132 0C) and a maximum of 284°F (140°C). After treatment, thesteam vents down through a diffuser. The operator opens the door and initiatesthe dump cycle in which the chamber rotates down allowing the waste to dropinto a waste bin or compactor. Units have digital displays and strip printers fordocumentation.
San-l-Pak offers a wide range of integrated custom designs based on dozens ofmodels. Multiple units can be lined up along a common load platform and wastecan be loaded from ground or dock level. Moreover, San-l-Pak offers cart
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Rewtic'l alnll Rc eonni'endation (i a Al dical l '1O(tL 7 cannen't 7Techno1lo(r
dumpers, conveyors, single- and two-stage shredders, compactors with 4-to-1and 6-to-1 compaction ratios, bailers, and auto-weighing systems. The modulardesign makes it easy to add units later to increase throughput capacities.
The Hydroclave is basically a double-walled (acketed) cylindrical vessel withmixing/fragmenting paddles inside. The waste is loaded through the loading dooron top of the vessel. After the door is closed, high temperature steam enters theoutside jacket to heat up the waste via the hot inner surface. During this time, ashaft and paddles rotate inside to fragment and tumble the waste. The moisturein the waste tums to steam and pressurizes the inner vessel; however, if there isnot enough moisture, a small amount of steam is added until the desired pressureis met.
In the Hydroclave, the temperature is maintained at 270°F (1 320C) for 15 minutes(or 250°F [1210C] for 30 minutes) while the mixing paddles continue to rotate.After treatment, the steam is vented through a condenser while maintaining heatinput, causing the waste to dry. The steam to the jacket is shut off, the dischargedoor is opened, and the shaft and paddles reverse rotation to scoop the waste outthrough the loading door onto a conveyor or waste container. A strip chartrecorder documents the process parameters.
INCINERATORS
Incineration is a high-temperature oxidation process wherein waste is burnedto produce combustion product gases, ash, and incombustible residues. Atypical incinerator has a waste loading system, refractory-lined primarychamber (hearth or furnace) and a secondary chamber, ash removal system,and flue gas stack. Incinerators also have air pollution control devices andcontrols.
In the past, single-chamber hearths with stationary grates were used to burnmedical waste. However, since these incinerators could not reach hightemperatures and their emissions did not meet environmental standards,these oven-type incinerators (such as the ones used in St. Kitts and Nevis)have not been in use in the United States and other developed countries fordecades.
In the last three decades, there have been three basic incinerator designsused for medical waste: (1) controlled air incinerators, also called starved air,two-stage, or modular incinerators; (2) multiple-chamber incinerators, alsocalled retort, pyrolitic, or excess air incinerators; and (3) rotary kilnincinerators. Controlled air incineration, the most common design used inthe last 25 years, uses a primary chamber with less than the full amount ofoxygen needed for complete combustion. Moisture and volatile fractions arevaporized while carbonaceous materials are burned to ash and incombustiblefractions accumulate in the residue. A secondary chamber is where volatilegases are combusted under turbulent and excess air conditions. In multiple-chamber incinerators, both primary and secondary chambers are usuallyoperated with excess air. The two basic designs are retort and in-line units.A rotary kiln incinerator also consists of a primary and secondary chamber
11
Re1vic1ii and Rccotnenudantlon on a. ILfu'lhaol V.lxl.f Il1sltrelamln Teclhnolog
but its primary chamber is a cylindrical, rotating kiln slightly inclined so wastematerial moves towards the discharge end as the kiln rotates.
Ash accumulates in the primary chamber, falls through grates into a pit belowthe chamber, or is pushed by transfer rams towards an ash container,discharge chute, or water pit at the end of the hearth. During combustion,hydrocarbons in the waste are converted to carbon dioxide and water. Alsoemitted are NOx, SOx, flyash (ash that is carried in the flue gas), andproducts of incomplete combustion such as carbon monoxide and soot (foundin particulate matter). Hydrogen chloride gas (HCI), polychlorinated dibenzo-p-dioxins, and polychlorinated dibenzofurans are formed due to chlorine inthe waste. Trace metals are also released as metal vapors or deposited infine particles entrained in the exhaust stream; they may play a role incatalyzing the formation of dioxins and furans on fly ash.
ENVIRONMENTAL ISSUES
Autoclaves: Odors can be a problem around autoclaves if there is insufficientventilation. If waste streams are not properly segregated to prevent hazardouschemicals from being fed into the treatment chamber, toxic contaminants will bereleased into the air, condensate, or in the treated waste. This is the case whenwaste loads contaminated with chemotherapeutic waste or heavy metals such asmercury are put in the autoclave. Thus, poorly segregated waste may emit lowlevels of alcohols, phenols, aldehydes, and other organic compounds in the air.
Decontaminated waste from an autoclave retains much of its physicalappearance. Some plastics such as low density polyethylene soften at autoclavetemperatures in a San-l-Pak and cause the resulting treated waste to form anamorphous mass but with recognizable waste. The Hydroclave breaks the wasteinside the treatment chamber and results in a somewhat unrecognizable mass.
In general, as long as organic compounds and leachable inorganic materialcontaining arsenic, barium, cadmium chromium, lead, mercury, silver or otherinorganic chemicals are kept out of the waste, the treated waste residue shouldpass the TCLP test.
Incinerators: Environmental emissions are the most serious problem facingincinerators. It is the reason why the number of hospital incinerators in the UnitedStates has dropped dramatically in the last decade. In 1988, US EPA estimatedthat there were 6,200 medical waste incinerators in the United States. In 2002,only 767 medical waste incinerators will be in operation and many of those arelarge commercial facilities using expensive pollution control devices to meetEPA's emission standards. Only four new medical waste incinerators have beenconstructed in the United States since June 1996 and one of the four had to beshut down recently.
A medical waste incinerator releases into the air a wide variety of pollutantsincluding highly toxic dioxins and furans, metals (such as lead, mercury, andcadmium), particulate matter, acid gases (hydrogen chloride and sulfur dioxide),carbon monoxide, and nitrogen oxides. These emissions have serious adverseconsequences on worker safety, public health and the environment. Dioxins, for
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RL'v1ic' an .Z/XRcLoiiinncwndauotnoi7 on Ic aludica/ Ifcast.c Treatmntn 7TechnolouI
example, have been linked to cancer, immune system disorders, diabetes, birthdefects, and other health effects. Mercury is associated with nervous systemdisorders particularly affecting developing fetuses and small children. Medicalwaste incinerators are a leading source of dioxins and mercury in theenvironment.
Incinerator ash remaining at the bottom of an incinerator after burndown oftencontains heavy metals that may leach out. Dioxins and furans may also be foundin the bottom ash. As noted earlier, if test results of the ash exceed the limitsunder EPA's TCLP, the ash must be treated as hazardous waste. Because ofhigh levels of leachable contaminants found in incinerator ash, some regulatoryauthorities have simply designated incinerator ash as hazardous waste.
Fly ash (ash that is carried by the air and exhaust gases up the incinerator stack)contains heavy metals, dioxins, furans, and other toxic chemicals that condenseon the surface of the ash. Even when the fly ash is removed from the exhauststream by pollution control devices such as baghouse filters, the toxic materialsremain concentrated on the filter cake and should be treated as hazardous waste.
To meet the 1997 EPA emission limits, medical waste incinerators will need airpollution control devices such as high efficiency wet or dry scrubbers andbaghouse filters with or without activated carbon. In older incinerators, secondarychambers may have to be retrofitted to insure at least a two-second retentiontime. Periodic stack tests must be performed to show compliance with the rules,and facilities must continuously monitor operating parameters such as secondarychamber temperature. The EPA regulations also require operator training andqualification, inspection, waste management plans, reporting, and record-keeping.
PUBLIC HEALTH AND OCCUPATIONAL SAFETY ISSUES
Autoclaves: If waste streams are not properly segregated to prevent hazardouschemicals from being fed into the treatment chamber, toxic contaminants will bereleased into the air, condensate, or in the treated waste. This is the case whenwaste loads contaminated with antineoplastic drugs or heavy metals such asmercury are put in the autoclave. Thus, poorly segregated waste may emit lowlevels of alcohols, phenols, aldehydes, and other organic compounds in the air.
A study of one autoclave facility by the U.S.-based National Institute forOccupational Safety and Health found no volatile organic compounds (VOCs) in aworker's personal air space and work area that exceeded permissible exposurelimits set by the Occupational Safety and Health Administration (K. Owen, K.Leese, L. Hodson, R. Uhorchak, D. Greenwood, D. VanOsdell, and E. Cole,"Control of Aerosol (Biological and Nonbiological) and Chemical Exposures andSafety Hazards in Medical Waste Treatment Facilities," National Institute ofOccupational Safety and Health, Cincinnati, OH, November 1997). The highestVOC level in the autoclave facility was 2-propanol, measured at 643 mg/m3,which is about three orders of magnitude lower than the permissible exposurelimit of 400,000 mg/m3. The data show that, compared to incinerators, autoclaveshave far lower emissions of pollutants with less adverse impacts on humanhealth.
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Rei'ic''10 4'nd Ra' onlfenl da'i1(1lonl oil a Al'It'th(1l I4aiste 7i etnntlLt Tetuchzo,(lo
Incinerators: In contract to autoclaves, many studies have been done on theemissions from incinerators showing adverse impact on human health. Thissection, while not intended to be an in-depth and comprehensive review, brieflysummarizes a number of epidemiological studies showing serious health effectsamong waste incineration workers and community residents living nearincinerators.
Epidemiological studies have shown significant associations between exposure toincinerator emissions and lung cancer, laryngeal cancer, ischemic heart disease,urinary mutagens and promutagens, as well as elevated blood levels of varioustoxic organic compounds and heavy metals. A summary of epidemiologicalstudies from 1988-1998, presented in chronological order, is given in Table 4.
PATHOGEN DESTRUCTION ISSUES
Autoclaves: With respect to pathogen inactivation, all states in the United Statesaccept or approve the use of autoclaves for medical waste treatment. Severalstudies appear in the literature on the effectiveness of steam autoclave treatmentof biomedical waste. They include the following:
Rutala et al. (Rutala WA, Stiegland MM, and Sarubbi FA Jr. Decontamination oflaboratory microbiological waste by steam sterilization. Appl EnvironmentalMicrobiology, 43:1311-1316. June 1982) reported on operating parameters forsterilization of microbiological waste. Standardized test loads of contaminatedpetri dishes and a biological indicator containing spores of Bacillusstearothermophilus were packaged and placed in a gravity displacementautoclave. The biological monitoring ampoules used were Kilit (BBL MicrobiologySystems, Cockeysville, Md.) standardized so that spores survive whenautoclaved for five minutes at 1210C and spores are killed when autoclaved for 15minutes at 1210C. Waste loads of five, 10, and 15 pounds of contaminated 100mm petri plates and biological monitoring ampoules were placed in commerciallyavailable plastic autoclave bags constructed of 1.5 mil polyethylene. Bags weretested in two modes: 1) in the open position, with the sides of the bag foldeddown to expose the top layer of petri plates, and 2) with the opening In the bagloosely constricted with a twist-tie and four holes punched in the top of the bag.Water (500 ml) was added to some of the closed bags that were placed either ina shallow stainless steel tray or a shallow polypropylene container. Thecontainers were placed in the steam autoclave and treated for periods of 15, 30,45, or 90 minutes. The load temperature was monitored by thermocouple at five-minute intervals during the test. At the conclusion of the test cycle the biologicalindicators were removed and incubated at 560C for seven days. Sterile swabswere dipped into the molten agar and swabbed onto blood agar plates whichwere incubated aerobically at 350C for 48 hours before growth evaluation. In 10percent of the experiments, plates were also incubated anaerobically at 350C for96 hours.
14
Rri'ut, izidI/ R (on7Inindion f on a Aluod(al f+1"Ist 71 catinL'nt Tiechnol1oe
Table 4. Summary of Epidemiological Studies on Adverse Health Effects Associatedwith IncinerationSTUDY SUBJECTS CONCLUSIONS REGARDING REFERENCE
ADVERSE HEALTH EFFECTS
Residents from 7 to 64 Levels of mercury in hair mcreased with P. Kurttio et al., Arch Environ.years old livmg within 5 km closer proximity to the incinerator dunng a 10 Health, 48, 243-245 (1998)of an incinerator and the year penodmcinerator workersResidents lving withim 10 Sigmficant increase mi laryngeal cancer In P. Michelozzi et al., Occupkm of an mcmerator, men living with closer proximity to the Environ. Med, 55, 611-615refinery, and waste disposal incinerator and other pollution sources (1998)site532 males working at two Significantly higher gastric cancer mortality E. Rapiti et al., Am. J Indmcinerators from 1962- Medicine, 31, 659-661 (1997)1992Residents living around an Significant increase in lung cancer related A. Biggen et al. Environ Healthuincmerator and other specifically to the incinerator Perspect, 104, 750-754 (1996)pollution sourcesPeople livmg withim 7.5 km Risks of all cancers and specifically of P Elliott et al., Br J Cancer,of 72 mcinerators stomach, colorectal, liver, and lung cancer 73, 702-710 (1996)
increased with closer proximruty toincmerators
10 workers at an old Significantly higher blood levels of dioxms A. Schecter et al , Occupincmerator, 11 workers at a and furans among workers at the old Environ Medicine, 52, 385-387new incinerator mcinerator (1995)122 workers at an mdustnal Higher levels of toluene, lead and cadmium in R. Wrbitzky et al., Int Arcliincmerator the blood, and hlgher levels of Occup Environ Health, 68, 13-
tetrachlorophenols and arsenic in urne 21 (1995)among incmerator workers
53 incnerator workers Significantly higher blood and urine levels of J Angerer et al., Int Archhexachlorobenzene, 2,4/2,5-dichlorophenols, Occup Environ Health, 64,2,4,5-trichlorophenols, and hydroxypyrene 266-273 (1992)
37 xvorkers at four Significantly higher prevalence of urnary X F. Ma et al., J Toxicolincinerator facilities mutagen/promutagen levels Environ Health, 37, 483-494
(1992)56 workers at three Significantly higher levels of lead and R. Malkin et al., Environz Res,incmerators erythrocyte protoporphyrn In the blood 59, 265-270 (1992)86 incinerator workers High prevalence of hypertension and related E.A Bresnitz et al, Am J Iid
protemuna Medicine, 22, 363-378 (1992)104 workers at seven Sigmficantly higher prevalence of unnary J.M. Scarlett et al., J Toxicolincinerator facilities mutagen and promutagen levels Environ Health, 31, 11-27
(1990)176 incmerator workers Excessive deaths from lung cancer and P. Gustavsson, Amn J Iidemployed for more than a ischemic heart disease among workers Medicine, 15, 129-137 (1989)year from 1920-1985 employed for at least I year, significant
mcrease in deaths from ischemic heart diseaseamong workers employed for more than 30years or followed up for more than 40 years
Residents exposed to an Reproductive effect. frequency of twinnmig O.L. Lloyd et al., Br J Indincinerator increased in areas at most nsk from Medicine, 45, 556-560 (1988)
incinerator emussions
15
Revc"'ic t'h a R o omlmenda1tion oil a AiCeh1 at aAl.: tl ' r,`(aturatineld iech lo)l(j
The study showed that the most Important factor with regard to treatmenteffectiveness were the types of containers holding the waste. The stainless steelcontainer enhanced heat transfer and the open bag allowed better steampenetration than the constricted bag. The addition of 500-ml water to the closedbag did not improve the heat up time in either container significantly. As expected,the smallest loads (five pounds) heated up faster than the larger loads. Nosignificant difference was found in results between the 10 and 15 pound loads.
The data for the 10 and 15 pound loads indicated that 90 minutes in the stainlesssteel container were required to inactivate the biological indicator spores. Thebiological indicators were viable at all test conditions in the polypropylenecontainer. All spore-forming and vegetative bacteria in the test loads (with orwithout water) demonstrated no growth after 45 minutes in stainless steelcontainers and after 60 minutes in polypropylene containers (without water). Thetest results demonstrated that for 10 to 15 pounds of waste placed in theautoclave the only conditions which insured complete kill of B. stearothermophilusand thus sterility of the load, were the use of a stainless steel container fortreatment duration of 90 minutes.
Lauer et al. (Lauer JL, Battles DR and Vesley D. Decontaminating infectiouslaboratory waste by autoclaving. Appl Environmental Microbiology, 44(3):690-694. September 1982) evaluated the addition of water to improve the treatment ofbiomedical waste loads in a gravity displacement steam autoclave. Test wasteloads of 1,750 or 3,500 grams of petri dishes containing agar were placed in apolypropylene autoclavable waste bag with or without the addition of water. Thespecific amounts of water added to the waste loads were either 100 or 1,000 ml.Biological indicators (Minnesota Mining and Manufacturing, Inc. Attest No. 1242,B. stearotherrmophilus in a steam penetrable package simulating a linen pack)and chemical Indicators (Biomedical Sciences, Inc., Thermalog S) were alsoadded to the waste loads. The autoclave bag containing the waste load was inturn placed in either a stainless steel or polypropylene container. The waste loadswere processed for 50 minutes in the autoclave at 1210C.
This evaluation demonstrated that a processing time of 50 minutes was adequatefor killing all biological indicator spores and converting the chemical indicator stripin the autoclave bag containing 1,000 ml of water that was placed in the stainlesssteel container. All other test conditions were inadequate to kill all spores.
Glick et al. (1961) evaluated steam autoclaving for the decontamination of nestingtype animal cages, animal carcasses, and laboratory equipment. A series ofexperiments were conducted on six stacked cages standing vertically or lying ontheir sides. Biological indicator organisms dried on filter paper discs (Bacillussubtilis var.- niger, 1 x 164 spores/disc) were placed in the litter of the usedcages. Thermocouples were also placed in the litter to record the temperature inthe waste load during the treatment cycle. The results of the first experimentshowed that when the cages were stacked vertically and autoclaved at 15 psi,2500F, indicator organisms remained viable after four hours. When the cageswere placed in a horizontal orientation and autoclaved at 20 psi, 2600F, atreatment cycle of 30 minutes was sufficient to kill all indicator organisms.
16
Rown san RC ( nn7 01danoi7 o)l a 'h11( (1 I"n/h' 1I a 'tItmeLn/1t Techml oi,,
The second experiment tested the ability of autoclave treatment to treat animalcarcasses. Twenty guinea pig carcasses were placed in a five-gallon fiberboardcontainer. A "Diack" sterilizer temperature indicator was inserted in the abdomenof the animal in the center of the load. The load was treated in the autoclave at250°F for time periods from one to 16 hours. It took over eight hours for the centerof the load to reach the desired temperature and the controls melted before 16hours of treatment was completed. These results indicate that the autoclave is notappropriate for the decontamination of animal carcasses.
The third experiment tested the steam autoclave for the treatment of metalequipment or equipment parts. The equipment parts were contaminated with aliquid spore suspension (B. subtilis var. niger, 1 x 109 spores/ml) and thenautoclaved both reassembled and disassembled. A treatment cycle of four hoursat 250°F was required to kill the indicator organisms on the reassembledequipment. One hour of treatment was sufficient to kill the indicator spores on thedisassembled equipment parts.
Cole et al. (E.C. Cole and K. Leese, "Evaluation of Medical Waste TreatmentTechnologies: Final Report," prepared for the Office of Solid Waste, U.S. EPA,RTI Report number 5400-005/01 F, Research Triangle Institute, ResearchTriangle Park, NC, January 1993) evaluated laboratory as well as largerautoclaves to determine their efficacy. The results of laboratory and field testsshowed steam autoclaving to be effective in treating biomedical waste.Laboratory data showed that high level challenges (with blood serum) of variousorganisms in surrogate waste loads were readily inactivated by relatively lowtemperature (1040C), short-term (5 min) exposure to the steam autoclavingprocess regardless of direct steam contact. Additionally, both laboratory and fielddata showed that high concentrations of bacterial spores were readily inactivatedat a setting of 1210C by exposure to the combined effects of steam, heat, andpressure.
The San-l-Pak system was one of the technologies evaluated by the U.S. EPA in1993 as background material for a report to Congress on medical wastemanagement. In that study (E.C. Cole and K. Leese, loc. cit.), all levels of B.stearothermophilus (up to 106) and B. subtilis (up to 108), both steam and non-steam exposed spore containers, were inactivated in every treatment cycletested.
Incinerators: Because of the relatively high temperatures achieved in anincinerator chamber, it has long been assumed that incinerators destroy allpathogens. Limited studies have confirmed that pathogens are not releasedin the stack under good operating conditions.
However, research has also shown that pathogens could be released in thestack and/or ash residue if incinerators are not operated under goodcombustion conditions. The destruction of test spores takes place when thewaste is exposed to a minimum of 1,400 OF in the primary chamber and 1,600OF in the secondary chamber with a 1.2-second residence time (M. Barbeitoand M. Shapiro, "Microbiological Safety Evaluation of a Solid and LiquidPathological Incinerator," Journal of Medical Primatology, 6:264-273, 1977).
17
Rewii aiul Rao onWldllCfl(1ti017 oln a AI A al PI ,I ate Tr .cainei 7i ( Techinloc
Below these conditions, test spores have been found to survive. Thus, somestates have required a minimum temperature of 1,800 OF in the secondarychamber and a minimum 2-second residence time as a safety factor toassume total destruction of all pathogens.
During poor operating conditions, pathogens have been shown to survive themunicipal waste incineration process in the ash residue (S. Klafka and M.Tierney, "Pathogen Survival at Hospital/infectious Waste Incinerators,"Proceedings: National Workshops on Hospital Waste Incineration andHospital Sterilization, EPA Office of Air Quality Planning and Standards, EPA-450/4-89-002, January 1989). Another US EPA report warned that if properoperating conditions are not met, incinerators could release pathogensthrough discharge air and residues (Hospital Medical Waste IncineratorOperation and Maintenance, U.S. Environmental Protection Agency, Office ofAir Quality Planning and Standards, March 1989).
COST ISSUES
Of all the non-incineration treatment technologies, autoclaves and advancedautoclaves have the lowest capital cost and among the lowest operatingcosts. The San-l-Pak 230-3P advanced autoclave, which has a capacity from87 to 106 lbs/hr, costs about $70,000.
In a review of data from medical waste incinerator vendors, the averagecapital cost of small, batch-fed incinerators with no automatic feeding, noautomatic ash removal, and no combustion control systems was found to bein the range of $150,000 (W.R. Seeker, "Medical Waste Incineration," inEnvironmental Management in Healthcare Facilities, edited by K.D. Wagneret al., W.B. Saunders Company, Philadelphia, 1998). Installation costs weretypically from 15 to 25% of base equipment cost for factory-assembled andskid-mounted incinerators, higher for incinerators with more complexinstallation requirements.
In 1995 and 1996, the US EPA conducted studies on what it would cost toadd air pollution control devices to medical waste incinerators to be able tomeet the EPA's emission limits. (These studies are presented in variousreports in Air Docket No. A-91-61, Air and Radiation Docket and InformationCenter, US EPA, Washington, DC.)
Using the EPA's equations, one obtains the following estimated costs (in1995 dollars, unadjusted for inflation) for a pollution control device (wetscrubber capable of achieving 69 mg/dscm) for a small 50-lb/hr biomedicalwaste incinerator without a heat recovery boiler:
Capital cost for wet scrubber = $194, 500Annual costs for wet scrubber = $48,700 per year
Using the EPA's equations, one also obtains the following estimated costs (in1995 dollars, unadjusted for inflation) for monitoring equipment, stack testing,and operator training based on estimated costs to upgrade existingincinerators:
18
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Capital cost for additional equipment for parametric monitoring,periodic stack testing, and operating training = $16,600
Annual operating cost for the air pollution control device, parametricmonitoring, stack testing, and training = $60,446 per year
The table below tabulates these and other costs for comparing incinerationand autoclaving. The cost of a small incinerator with a pollution controldevice and equipment for monitoring and testing costs almost four times thatof an advanced autoclave. This explains why incineration was eliminatedfrom the screening matrix above.
Table 5. Capital Cost ComparisonsCost Item Incinerator* Autoclave*
Base equipment cost 150,000 70,000Installation cost 22,500 6,500Cost of pollution control technology 194,500 0to meet EPA emission limits for a50 lb/hr incineratorCost of electric steam generator 0 16,000Cost for monitoring and testing 16,600 Monitoring - 2,000
Testing - 400TOTAL $383,600 $93,100
* Incinerator costs based on medical waste incinerabon review by Seeker (q v.) and EPA studies (q v.)Autoclave costs based on informaton from San-l-Pak.
19
Rei1 c nd Rc(o m)mlenida>ion (fli a *Vh:llica,l 11'aiste Treatmennt Techntlohir
The table below summarizes the comparison between incineration and advancedautoclaving.
Table 6. Overall ComparisonsParameter State-of-the-art Incinerator Advanced Autoclave
Capacity Appropnate size Appropriate sizeLevel of Fully commercialized Fully commercializedCommercializabonRange of Wastes All types of waste treated except No chemotherapeubc, phammaceubcal,Treated radioactve waste (chemotherapy, radioactive, or chemical waste; higher
pharmaceutical and chemical waste temperatures or longer times may berequire a special incinerator) needed for pathological waste or animal
carcassesLevel of Pathogen Stenlizabon if operated properly High level disinfecton if operatedDestructon properlyEnvironmental Significant air emissions; requires Minimal air emissions; does not requireEmissions costly pollubon control device pollution control deviceTreated Waste Unrecognizable ash; may contain Recognizable biomedical waste; sharpResidue leachable metals and organics needles may need to be destroyed
including dioxinReduction of Volume About 90-95% reducton in volume and No mass reduction -may increase weightor Mass mass due to steam condensabon; minimal
volume reducton - needs shredder orcompactor to reduce volume
Occupational Safety Significant concems over occupabonal Possible low levels of volatile organicand Health Impacts and public health impacts; potential compounds; minimal health impacts,
exposure to fire and hot surfaces potenbal exposure to steam and hotsurfaces
Space Requirements Larger footprint with pollution control More compact:device; stack height 33 sq ft footprint
8 5 ft height requirementMain Utilities Natural gas or diesel for bumers, Steam (may be produced using electnc
Water for scrubber or natural gas boiler)Installation Concrete pad, anchoring, electncal, Concrete pad, anchoring, electrical,Requirements natural gas or diesel, water supply, steam or water supply, drain
drain
Feed Opening Size Adequate AdequateNoise Low Low
Odor Minimal Significant odors if in an enclosed spacewith little ventilabon
Automation, Ease of Highly automated, easy to use Highly automated, easy to use
UseSkills Required Requires training in principles of Requires training in principles of steam
combuston, controls, operabng sterilization, types of waste treated,procedures, waste handling, periodic controls, operating procedures, wastemaintenance, contingencies, common handling, periodic maintenance,problems contngencies, validation testing
20
ReLicit and Rc oifl(lOldanon1n ai He(1hca/l Pl'sat: TI; atnlent T.chIi,olog
Major Maintenance Replacement of refractores is major Replacement of large gasket is majormaintenance item; significant cost maintenance item; minimal cost
Reliability Fairly reliable Fairiy reliableAvailability of Good availability Good availabilityTechnical SupportCost Higher capital and operabng costs Lower capital and operabng costs
In December 2000, international negotiations were completed on a global, legallybinding convention to reduce and eliminate the release of persistent organicpollutants (POPs) to the environment. The final version of the text of the"Stockholm Convention on Persistent Organic Pollutants" was adopted by theConference of Plenipotentiaries meeting in Stockholm last May 2001. It is now inthe process of being ratified by different countries.
Annex C of the Stockholm Convention deals with the unintended production ofPOPs. First in the list of three groups of POP chemicals are dioxins and furans.Once the Stockholm Convention becomes intemational law - something that isexpected in the next several years - countries will be required to develop andimplement an action plan within two years to address the release of dioxins andfurans, promote measures to reduce their levels of release, promote the use ofsubstitutes to prevent formation and release, and promote best availabletechniques and environmental practices.
The Convention specifically targets medical waste incinerators among processesthat have "the potential for comparatively high formation and release of thesechemicals to the environment."
Under the reduction measures proposed in the Convention, medical incineratoroperators might be required to use improved methods for flue-gas cleaning, treatresiduals to detoxify them, change processes, or modify designs to improvecombustion and prevent formation of POPs. A high priority will be given to the useof alternative processes. While it is yet unclear what specific effect the StockholmConvention will have on medical waste incineration, Article 5 of the Conventionmakes it clear that some measures will have to be taken to further reducereleases of dioxins and furans from medical waste incinerators with the goal oftheir "ultimate elimination."
Incinerators have the following advantages over advanced autoclaves: ability totreat a wider range of wastes; significant volume and mass reduction;unrecognizability of treated waste residues; and minimal odors.
Advanced autoclaves have the following advantages over incinerators: minimalair pollutant emissions and less impact on public health and environment;compact space requirements; lower maintenance costs; and lower capital and
21
RLn'iC1 and Rccommnnn(hation on a .1MethiLa/ fKaste' Trceatmnent Tehnoalor/gi
operating costs. Also, since dioxins and furans are not produced in a steamsterilizer, autoclaves are not affected by the Stockholm Convention.
The consultant recommends an advanced autoclave as the treatment technologyfor use in St. Kitts. In particular, the San-l-Pak 230-3P Auto-Clave isrecommended for the amount of waste generated.
S o;* -- A0 -"iA
The following costs are based on a price quotation from San-l-Pak, Inc. (Tracy,Califomia, USA) and McKesson Medical and Surgical Supply (Sacramento,Califomia, USA) for the 3M Attest kit.
Table 7. Cost Estimates for an Advanced Autoclave
Quantity Item Cost
BASIC EQUIPMENT:1 Sani-l-Pak 230-3P Auto-Clave 69,503.001 Electnc steam generator (480 VAC) with 15,701.00
water treatment1 Spare parts package Included in base cost1 Messaging system Included in base cost1 3M Attest validation test starter kit 340.25
OPTIONAL ITEMS:1 Mobile automatic cart dumper 8,984.002 90-gallon fully enclosed transport cart 712.002 3/4 cu. yd. dump cart for treated waste 1,4001 Deodorant system package 479.001 San-l-Pak weighing system 4,489.001 In-house monitoring software package 1,996.001 ICS-4 gas-fired steam boiler with water 26,906.00
treatment
22
APPENDIX B1: Tender Specificatons for anAdvanced Autoclave Treatment Technology
PART 1 - QUALIFICATIONS
1.1 Description:
The work includes fumishing and installing (optional), for interior or exterior service,complete and ready for operation one Auto-Clave 230-3P Sterilizer. The sterilizer shall bea unit designed to handle infectious hospital waste.
1.2 Qualifications:
A. Manufacturer regularly and presently manufactures sterilizers as one of its principalproducts.
B. Installer has technical qualifications, experience, trained personnel and facilities to installspecified products.
C. Manufacturer's product submitted has been in satisfactory and efficient operation atsimilar facilities.
D. There is a permanent service organization, maintained or trained by manufacturer whichwill render service no later than 24 hours after receipt of notification that service isneeded, and be capable of providing weekend monitoring and assistance. Submit nameand address of service organization.
1.3 Manufactured Products:
A. Materials, fixtures, and equipment fumished shall be of current production bymanufacturer regularly engaged in the manufacture of such items.
1.4 Submittals:
A Before delivery, manufacturer will supply the following
1) Certificates:
a. Manufacturer verifies it presently manufactures proposed equipment as aprincipal product.
b. Installer has technically qualified personnel and facilities to install equipmentspecified.
c. Name and address of service organization.
2) Manufacturer's literature and data:
a. Brochures showing name and address of manufacturer and the catalog ormodel number of each item incorporated into the work.
81 -1
b. Manufacturers illustration and detailed description.
c. List of deviations from contract specifications.
3) Test Report:
a. A.S.M.E. certified test report on the sterilizer model to be fumished.
4) Installation Drawings:
a. Show dimensions, method of assembly, installation and conditions relating toadjoining work which requires cutting or close fitting, reinforcement, anchorageand other work required for complete installation.
1.5 Safety Devices:
A. Exposed couplings, motor shafts, gears or other moving parts, shall be fully enclosed andguarded, in accordance with ANSI pamphlet B 15-1, irrespective of height above thefloor.
1.6 Electrical Equipment:
A. Electrical equipment shall be suitable for use with electrical system indicated on drawingsProvide electrical components including motors, disconnect switches, motor controllers,motor control devices and electrical circuits which conform to requirements of NFPA 70.
1.7 Name Plate:
A. Each piece of equipment shall bear a corrosion-resisting steel or anodized aluminumname plate located in a reasonably accessible position, permanently secured. Nameplate shall bear the name of the manufacturer, model number and serial number.
1.8 Applicable Publications:
A The publications listed below form a part of this specification to the extent referencedThe publications are referenced in the text by the basic designation only.
1) Federal Specifications (Fed. Spec ).
a. QQ-S-736D - Steel Bars, Wire, Shapes and Forgings, Corrosion Resistant
b. QQ-S-698(3) -- Steel, Sheet and Strip, Low Carbon
c QQ-S-766C(5) - Steel Plates, Sheets and Strip, Corrosion Resisting
2) American Society of Mechanical Engineers (ASME):
a. Boiler and Pressure Vessel Code, Section VIII - Pressure Vessels, Division I.
3) American National Standards Institute, Inc. (ANSI):
a. B1 5-1 - Safety Code for Power Transmission
b. Z245.1-1975 - Safety Standards
B1 -2
PART 2 - PRODUCTS
2.1 Auto-Clave 230-3P Sterilizer:
Auto-Clave 230-3P Sterilizer manufactured by San-l-Pak Pacific, Inc. or equal.(San-l-Pak Pacific, Inc. - 23535 South Bird Road - Tracy, CA 95376)
A. Sterilizer.
1) The sterilizer design shall utilize high vacuum combined with saturated steam. Thechamber shall be 17.5 cubic feet with a minimum opening of 32" (diameter).
2) The sterilizer chamber must be able to rotate into 3 positions; load, sterilize anddischarge positions.
3) Sterilizer chamber doors shall automatically lock once the sterilizer cycle begins.
4) Sterilization time to be initiated only after the preset operating temperature of 2700 Fis reached (customer and regulatory dependent; may be adjusted if requested)
5) The sterilizer shall be equipped with an automatic strip printer showing the date,time, operator, vacuum, pressure and temperature for each sterilization cycle. Thesterilizer shall also be equipped with a digital display which displays a machinefunction as it takes place This display shall also alert the operator if there is asystem interruption and provide instructions to correct the situation.
6) The sterilizer chamber will be constructed of stainless steel to ensure longer life ofthe system.
7) The sterilizer operation security shall be maintained by use of key locks and/orsecurity codes (operator identification) on the following functions:
a. Automatic sterilization cycle and discharge sequence
b. All pressure doors.
8) The sterilizer must have preprogrammed sterilization parameters to avoid humanerror resulting in improper treatment. The sterilization parameters must be tamperproof and are not to be left to the discretion of the operator.
9) The sterilizer shall be designed so the sterilized waste can be transferred to the cartwithout additional operator handling. The sterilizer discharge control to be initiatedby manual key switch or operator security code which may only be activated when"total kill" sterilization parameters have been achieved.
B Utility Requirements.
1) The electrical service of 120 volts, single phase shall be provided for the controlpanel from a 30 amp circuit breaker (If the cold weather package is used, the servicemust be a minimum of 40 amps). Foreign voltages are acceptable
2) The saturated steam flow rate shall not exceed 125 lbs. per hour at a minimum inletpressure of 65 psig.
a. Total steam usage shall not exceed .65 lbs. steam per pound of infectiouswaste (including reasonable system losses).
B1 -3
3) The domestic cold water service of approximately 3 gallons per minute (GPM)minimum shall be provided to the condensate tank and wash down hose.
C. Controls:
1) The sterilizer's automatic operations shall be controlled by a programmablecontroller located within the unit. The microprocessor shall be a solid state devicethat is fully programmable.
D. Materials:
1) Corrosion Resisting (Stainless) Steels:
a. Plate, sheet and strip: Unless otherwise specified, corrosion-resisting steel flatproducts shall conform to chemical composition requirements of any seriessteel specified in Fed. Spec. QQ-S-766.
b. Bars, shapes and forgings: Corrosion-resisting steel bars, shapes and forgingsshall be in accordance with Fed. Spec. QQ-S-763 and shall be of 300 series inannealed condition.
c. Corrosion-resisting steel tubes: Unless otherwise specified, corrosion-resistingsteel tubes shall be seamless or welded at manufacturer's option. Tubing shallbe in accordance with ASTMA 269.
d. Finish: Exposed surfaces shall have a standard polish equal to finish No. 4.
e. Corrosion-resisting (stainless) steel shall be hereinafter referred to as CRS.
2) Carbon steel:
a. Sheet Steel: Fed. Spec. QQ-S-698 cold rolled, commercial quality sheet steelwith No. 1 finish or better.
3) Fasteners
a. Rivets, bolts, nuts, stubs, spacers and metal used for welding shall be thesame kind of metal as the material joined. Where corrosion-resisting metalsare joined to each other or to other metals, rivets, bolts and materials used forwelding shall be corrosion-resisting metal.
4) Materials not definitely specified shall be of the quality normally used by themanufacturer in it's standard commercial sterilizers and be free of defects andimperfections which may effect serviceability or appearance of finished product.
2.2 Fabrication:
A. Welding: Joints in fabricated equipment shall be welded by an accepted method.Carbon arc welding is not acceptable, nor is any process permitting the pick-up of carbonacceptable. Welds shall be strong and ductile with exposed surfaces free ofimperfections such as pits, runs, spatter and cracks, and shall have the same color asadjoining surfaces. Welded joints shall be homogeneous with the sheet metal itself.Welding rods shall be of the same composition as the parts to be welded. Where sheetsize necessitates a joint, such joint shall be welded.
B1 -4
PART 3 - EXECUTION
3.1 Installation (Optional):
A. Equipment and materials shall be suitable for indoor or outdoor installation in theavailable space, arranged for safe and convenient operation and maintenance. If theinstallation will be indoors, the optional deodorant system package is recommended; it isalso suggested the unit be located in a non-odor sensitive area.
B. Furnish supervision of equipment installation at construction site by a qualified factorytrained technician(s) regularly employed by the equipment supplier.
3.2 Inspection:
A. Before shipment from manufacturer's plant and following installation at project site,finished articles shall be thoroughly inspected and tested for compliance withspecifications.
3.3 Tests:
A Perform tests under operational conditions in the presence of Resident Engineer, orhis/her representative.
B Evidence of malfunction in any tested system, piece of equipment or component partthereof that occurs during or as a result of test, shall be corrected, repaired or replacedand the test repeated.
3.4 Instruction of Personnel:
A. Provide services of a qualified technical person, at such time after installation is complete,for a period not less than 8 hours to instruct designated personnel in.
1 ) Operation and care of equipment.
2) Preventative maintenance procedures for individual items of equipment.
3) Techniques and procedures recommended by the manufacturer to achievemaximum dependable, efficient and economical utilization of the equipment.
3.5 Operating Instructions:
A. Provide printed instruction books and parts lists; to be delivered to the Resident Engineeror designee. These manuals shall contain the following
1 ) Instructions for the installation, operation and maintenance of the equipment
2) Wiring diagrams for electrical items and components.
3) List of replacement parts, with the name and part number of each, properlyidentified.
3.6 Protection to Fixtures, Material and Equipment:
Bi -5
A. Tightly cover and protect fixtures and equipment against dirt, water and chemical ormechanical injury. Thoroughly clean interior and exterior of fixtures, materials andequipment at the completion of all work.
3.7 Service:
A. Must have an organized service department, fully factory trained, capable of performingneeded repairs within 24 hours of notification.
Bi -6
APPENDIX B2: Operating Procedures, PreventiveMaintenance, Training Requirements, and PeriodicVerification Testing of Treatment Technology
1. Operating Procedures for the San-l-Pak Treatment Technology
Bagged biomedical waste is brought to the San-l-Pak Treatment System in collectioncarts. An autoclave liner, which has a time/temperature sensitive indicator affixed toit is inserted into the chamber. A clamp ring is then used to hold the liner in place.Next, the chamber is placed in the load position. The red bags are then loaded intothe lined chamber with the automatic cart dumper. After the chamber is loaded it iseither dog-eared or fastened with a tie strap. The door is closed and the unit's cycleis initiated. After the waste is autoclaved, the door is opened and the chamberdumps the treated waste either into a dump cart or into a compactor via a conveyor.
A. Loading and Operating
1. Load (with chamber liners, approximately 4 minutes)* Place chamber liner on chamber* Fold Chamber liner back over load door; place clamp ring over folded liner.. Load chamber, remove clamp ring, and fold excess liner into chamber.* Rotate chamber into the sterilization position.
2. Sterilization* Blue "Sterilize" button is activated.. San-l-Pak first pulls a vacuum with a minimum of 18 inches within the chamber.* Air removes during the vacuum stage is mixed with 3070 F. steam.• Steam is then injected into the sterilization chamber; chamber reaches a maximum
of 38 psig.* After a temperature of 2700 F. is achieved; a 30-minute timer is automatically
activated.* Chamber quickly reaches an ultimate temperature of 281° F - 2840 F.* Chamber is held in a high temperature, high-pressure environment for the full 30
minutes.* Upon completion of the sterilization cycle the chamber vents down.* Existing steam is piped to the condensate tank; it condenses and flows into the
sanitary sewer.
3. Discharge* Open load door.* Activate "Dump" button.* Sterilized waste falls into a dump cart or onto conveyor belt.* Return to load position.
4. Disposal or Compactiono Once filled, waste in the cart is transported for disposal to a sanitary landfill. If a
compactor is used, the cart is moved to the cart dumper/compactor and the cartdump/compactor button is activated.
Most operations of a San-l-Pak System require a minimum operator interface.Operators are needed to load the unit, (cart dumping systems are available), closethe sterilization chamber door, and to open the sterilization chamber door. Besidespressing a few buttons, no other operator interaction is required.
B. Process Monitoring
Each autoclave is equipped with recording devices, which automatically andcontinuously monitor and record performance and process parameters throughoutthe autoclave cycle. The autoclave's programmable logic controller is programmed toachieve the prescribed time, temperature and the process is reinitiated throughanother complete cycle. Through the telecommunication system, San-l-Pak, Inc. isalso able to monitor the system from the factory upon your request.
2. Preventive Maintenance
Maintenance of the autoclaves is performed consistent with the autoclavemanufacturer's recommendations, which include the following schedule ofmaintenance activities and planned frequency below.
Planned Frequency
Month | Maintenance Activity Description3 Examine door seals. Replace if necessary.6 Check door clearances and operations. Adjust/Lubricate.3 Check door safety operation.6 Check and adjust loading/unloading mechanisms and equipment.3 Check/calibrate temperature and pressure indicators3 Test safety valves.3 Check strainers and steam traps. Clean if necessary.3 Check filters. Clean or replace as required.3 Check all controls and indicator for proper operation.3 Check recording devices for proper pull-down.3 Test vacuum system for proper pull down.6 Perform vacuum leak test.3 Run all cycles while recording temperatures and pressures.3 Check piping for leaks and valves for proper operation.3 Check manual override for proper operations.6 Check Battery for memory backup.
The procedures are recorded on a data sheet, signed by the performing technicianand autoclave-operating supervisor, and maintained in a logbook.
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3. Training Requirements
No person is permitted to operate an autoclave used to treat biomedical wastewithout first receiving training. The manufacturer's representatives provide training toall hospital personnel who are required to implement portions of the Operation Plan.All such training is documented. Copies of the documentation are maintained in theindividual's personnel file at the hospital.
The training includes the following:
1. Classroom instructions on:a. The types of waste that may and may not be autoclaved.b. Waste segregation procedures.c. Procedures for containing, handling, storing and transporting RMW.d. Procedures for containing, handling, storing and transporting hazardous
waste, chemotherapeutic waste, antineoplactic waste and radioactive waste.e. Procedures for validation testing of the autoclaves.f. Procedures for the operation of the autoclaves.g. Procedures for handling spills.h. Procedures for dealing with emergency shutdowns.i. Challenge testing procedures.j. Maintenance procedures.k. Manifesting procedures.i. Certification procedures.m. Procedures for sealing the roll-off containers prior to transport to the facility.
2. Hands on Equipment Instruction for the staff responsible from the facility.a. Loading and unloading procedures.b. Validation testing.c. Operation of the equipment.d. Challenge testing.e. Emergency shutdown procedures, including unloading and decontamination
of the autoclave and adjacent areas.f. Procedures for sealing the roll-off container prior to transport.
3. Periodic Validation Testing
The San-l-Pak process should be monitored with a biological indicator. The use ofthe 3M 1276 Attest Steam Pack is recommended. This pack contains a biologicalindicator ampoule, indicator strips, and a record-keeping card. The indicator stripson the label and within the pack will change color to show the pack was indeedsteam processed. The biological indicator located within the pack will show theability of the San-l-Pak system to penetrate the barriers within the test pack, thusachieving sterilization.
This pack is a simple and effective method of challenging the sterilization abilities ofautoclave systems. Testing can be accomplished quickly and easily. During anormal waste processing cycle the 3M Test Pack should be placed in the chamberwith the waste to be processed. The 3M 1276 Attest Steam Pack is designed to be
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equivalent to a standard linen pack (12" x 12" x 20", 12 Ibs) which is recommendedby the Association for the Advancement of Medical Instrumentation (AAMI).
After removal from the San-l-Pak, the biological indicators contained within the 3MTest Pack are incubated at approximately 56 OC for 48 hours. After incubation, theampoule visually indicates growth or no growth of the indicator spore. No colorchange means no growth and a high level of disinfection.
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