NICE Network Nurses Protecting Themselves

Reprocessing and Sterilizing Medical Devices: Regulations, Policies, and Legislations

Aaron McColpin, DNP, RN, FNP, RRT-NPSAssistant Professor of Nursing

CSU Channel Islands

November 10, 20181:45 – 2:15 p.m. PST

Hyatt Regency Newport Beach

Why Infection Control Project?

Overview of the CDC-ANA Project2-year initiative 25 national nurses organizationsANA\C and NJSNA only SNAsANA and CDC collaboration ANA\C contract w ANA (i.e. CDC)Peer-reviewed Webinar I (Live presentation on July 2017)Resources on ANA\C website

NICE Webinar I: July 12, 2017Easily accessed from our website under Resources for Infection Control

ANA\C CDC Task Force at Healthcare Con 2018 at SHC

Objectives• To highlight current cleaning and sterilization of medical equipment in

a variety of clinical settings.

• To emphasize the importance of current nursing programs to integrate knowledge of common errors of equipment reprocessing into their didactic and clinical teaching.

• To collaborate with CDC experts on helping nurses identify at least three government and non-government resources on best practices pertaining to infection control and prevention; injection safety; and cleaning, disinfecting, and sterilizing reusable medical devices.

Organizations that OfferGuidance

Association for the Advancement of the Medical Instrumentation (AAMI)

• ST 79 – steam sterilization and sterility assurance

Joint Commission

International Association Hospital Central Sterile Material Management (IAHCSMM)

Association of periOperative Registered Nurses (AORN)• Guidelines for Perioperative Practice book updated every five years

Food and Drug Administration (FDA)• Non-binding guidance document to assist manufacturers seeking 510(k) clearance

Goals of the Recommended Practices• Provide a framework for the safe

workflow to reprocess medical instruments

• Set standards for sterility assurance in the healthcare industry

• Offer evidence-based rationale for the practices

• Reduce possibility of HAI • Receive consistent quality patient

care

Single-Use Medical Device Reprocessing

• Goes against manufacturer’s guidelines for use

• Manufacturer no longer guarantees product after reprocessing

• Providers and frontline staff perceive product of inferior quality

• Produce less medical waste

• Provide cost-effective medical devices

• Have strict control in place by FDA on medical devicereprocessors

Common Issues with Policies• Challenges for effective disinfection

include • Confusion between nursing and

environmental services staff over the allocation of cleaning responsibilities

• Insufficient training

• Inadequate time to complete cleaning

• Difficulty ensuring disinfection of mobile equipment

• Contamination of reusable cleaning supplies with pathogenic bacteria

Shoemake & Stoessel, 2015

Evidenced-Based Practice (EBP) and Policy Recommendations

• Use appropriate PPE

• Advise schools to put greater emphasis on infection control in current curriculum

• Develop an institutional infection control policy based on local, state, federal, accrediting agencies, and professional organizations’ recommendations. • Get PAs, MAs, MDs, and others

involved

Spaulding Classification

• Noncritical Devices- come in contact with intact skin. Require low level disinfection or cleaning (i.e. blood pressure cuffs, stethoscopes)

• Semicritical Devices- come in contact with non-intact skin or mucous membranes. Require high level disinfection at a minimum (i.e. laryngoscope blades, vaginal or rectal probes)

• Critical Devices- penetrate skin and allow contact with the bloodstream or other sterile body areas. Require sterilization (i.e. surgical and dental equipment)

Sterilization vs. Disinfection

• Sterilization• Destroys or eliminates all forms of

microbial life

• Uses physical or chemical methods• Steam under pressure

• Dry heat

• EtO gas

• Hydrogen peroxide gas plasma

• Liquid chemicals

• Disinfection• Eliminates many or all pathogenic

microorganisms, except bacterial spores, on inanimate objects.

• Uses liquid chemicals or wet pasteurization

Source: CDC, 2016

Disinfectants and Contact Time

• Alcohol

• Hydrogen Peroxide

• Chlorine

• Iodophors

• Peracetic Acid

Sterilizing Agents and Contact Time

• Steam Sterilization

• Hydrogen Peroxide Gas Plasma

• Peracetic Acid

Reprocessing and Sterilizing Medical Devices: Case Study

Objectives• Participants will be able to demonstrate an understanding of current

cleaning and sterilization of medical equipment in a variety of clinical settings.

• Participants will be able to integrate knowledge of common errors of equipment reprocessing into their clinical practice.

• Participants will identify at least three government and non-government resources on best practices pertaining to infection control and prevention; injection safety; and cleaning, disinfecting, and sterilizing reusable medical devices.

Case Study

• A 26 y/o male brought into the ED as a tier 1 trauma with multiple gun shot wounds. Patient later found to have Hepatitis B.

• An open thoracotomy was performed in the ED due to penetrating descending aorta.

• ED staff used multiple instrument trays in the process.

Case Study: Observed Issues

Observed practices

• ED tech cleaned room after trauma & equipment was deposited in dry bin to be returned to sterile processing.

• Equipment not cleansed or soaked

• Equipment sat in dry bin for 4 days before taken to processing

• ED P & P in binder format• No specific policy for cleaning as

that policy is not owned by ED

• No electronic policy archives available to review current policy

• ED staff never formally trained in cleaning

What to Know: Key Points

• Cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products.

• Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.

• Utilization of a Web-based system for policies and procedures along with reference material is an excellent method to allow staff to have 24/7 access to all policies & procedures.

Don’t Forget, ANA\C and NICE!

http://www.anacalifornia.org/infection-control-resources-for-rns

ANA\C CDC Task Force Members:

Special thanks to the following contributors on this project:

Rachel Choudhury Thao Tran

Aaron McColpinBrian Harradine

Mary Ann McCarthy Christine Tarver Krista Greaves

Tanya Davis Marketa Houskova

Recommended Resources

https://www.cdc.gov/injectionsafety/index.html

Recommended Resources

https://www.cdc.gov/infectioncontrol/guidelines/Disinfection/index.html

Recommended Resources

https://www.jointcommission.org/topics/hai_portal_external_resources_disinfection_sterilization.aspx

Recommended Resources

https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf

Evidence-Based Practices

Best practices Rationales

1. Clean before disinfection and sterilization. Cleaning means manually clean the nail clipper or any instrument before disinfecting or sterilizing them.

This ensures residual and inorganic debris are removed. Organic material such as skin or dirt can block the effect of the disinfection or sterilization.

2. Any instrument that has been used on a patient is contaminated. This includes nail clippers.

Pathogen can remain visible on instruments even when not visibly contaminated. Hepatitis B is viable at least a week or longer.

3. Read instructions on chemical disinfectants. Many disinfectant solutions require at least 10-20 minutes of contact time. Chemical vary by manufacturer.

4. Syringes always are used on only 1 patient. Experimental studies have demonstrated that syringes become contaminated after use, even if the needle is changed.

Source: Wise et al., 2015

Evidence-Based Practices

Best Practices Rationales

5. Single-dose vials are used on only on 1 patient. Single-dose vials are considered contaminated after the first time they are used.

6. Dedicate multi-dose vials to single patients whenever possible.

This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients.

7. Gloves are necessary between patient even if they do not become visibly contaminated.

Pathogens can adhere to gloves even in absent of visible contamination. Disposable gloves are not impermeable.

Source: Wise et al., 2015

References• Association for the Advancement of Medical Instrumentation. (2014). Comprehensive guide to steam sterilization and sterility assurance in

health care facilities. www.aami.org

• Association of periOperative Registered Nurses. (2017). Guidelines for Perioperative Practice. Retrieved from www.aorn.org

• CDC. (2015). Prion diseases. Retrieved from https://www.cdc.gov/prions/index.html

• Destache, D. M. (2013, April 30). Hospital policies: Will they be a burden or a benefit to you in litigation? Midwest Legal Advisor. Lamson, Dugan and Murray, LLP. Retrieved from https://www.psqh.com/analysis/policies-and-procedures-f or-healthcare-organizations-a-risk-management-perspective/#sthash.ffUeAgAN.dpuf

• Eidt, J. F. (2017). Resuscitative thoracotomy: Technique. Retrieved from https://www-uptodate-com.proxy.library.maryville.edu/contents/resuscitative-thoracotomy-technique?search=thoracotomy&source

• Food and Drug Administration. (2015). Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

• Ontario Ministry of Health & Long-Term Care. Provincial Infectious Diseases Advisory Committee (PIDAC) Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings, 2010. Retrieved from http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/PIDAC_Documents.aspx

• Magill, S. S., Edwards, J. R., Bamberg, W., Beldavs, Z. G., Dumyati, G., Kainer, M. A., ... & Ray, S. M. (2014). Multistate point-prevalence survey of health care–associated infections. New England Journal of Medicine, 370(13), 1198-1208.

• Rutala, W. A., & Weber, D. J. (2013). Disinfection and sterilization: an overview. American journal of infection control, 41(5), S2-S5.

• S. B. 43 - Antimicrobial-resistant infection: reporting. (2017). Retrieved from http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201720180SB43

References• Schaeffer, J. (2013). The Essentials of Policy and Procedure Management . Retrieved from

http://www.fortherecordmag.com/archives/0713p18.shtm

• Shoemake, S. & Stoessel, K. (2015). Cleaning reusable medical devices: A critical first step. The Clinical Issue, 2. Retrieved from https://www.halyardhealth.com/media/1514/c14224-clinical-issue-two-cleaning-medical-devices.pdf

• Vaage, R. (2015). Secrecy increases risks of deadly hospital infections. Retrieved from http://www.vaagelaw.com/Blog/2015/May/Secrecy-Increases-Risks-of-Deadly-Hospital-Infec.aspx

• Wise, M. E., Bancroft, E., Clement, E. J., Hathaway, S., High, P., Kim, M.,…Montana, B. (2015). Infection prevention and control in the podiatric medical setting. Journal of the American Podiatric Medical Association, 105(3), 264-272.