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FAQ’s about CEUs Understanding the difference between CEUs and Contact Hours What do you need to recertify? What is the difference between a CEU and a Contact Hour? Confusion is Common • Even CS professionals who have been in practice for many years are sometimes confused by the terms Continuing Education Unit, Contact Hour, CE Hour, CE Credits or CEU. • The confusion is understandable as many providers, some states, and marketing materials often use the terms interchangeably. A Continuing Education Unit (CEU) is a standardized method of recording participation in continuing education classes designed to improve occupational skills or knowledge. One CEU equals 10 actual classroom hours. No Contact Hours • Instructional (Contact)hours do not include time involved in: – Coffee Breaks – Meals – Social Activities – Vendor Exhibits(unless the vendor is providing specific approved education) – Business Meetings – Committee Meetings. How Many Contact Hours Do I Need to Maintain CRCST Status? • CRCST – 12 per year (or the equivalent of 1 per month) This is the baseline for all IAHCSMM Certification. What if I have additional certifications? You will need the baseline 12 contact hours plus additional contact hours. • CIS – an additional 6 per year • CHL - an additional 6 per year • FCS – an additional 6 per year Where can I get Contact Hours? • Conferences • Seminars • Workshops • Hospital In-Services • Printed Publication In-services • Online Educational Programs • Vendor Education Programs Contact Hour A contact hour is 60 minutes of instruction. The term continuing education is also allowed. Containerizing Pre-Configured Instrument Trays (Orthopaedic and Spine) What You Need to Know IAHCSMM 2015 - Edward Nuber, Group Product Director, Surgical Technologies In this presentation you will understand 1) Key Points of a Verification Process 2) How to Reconcile Multiple IFUs 3) How to Perform and Document a Verification Test 1. Key Points of a Verification Process Understand Key Terms and User Responsibility • Key Terms per AAMI ST79 1 – 2.136 user verification: “Documented procedures, performed in the user environment , for obtaining, recording, and interpreting the results required to establish that predetermined specifications have been met.” – 2.137 validation: “Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.” • “Validation is performed by the device manufacturer.” • “Pre-Purchase Evaluation” per AAMI ST79 1 10.10.3 User responsibilities – “Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material, including a rigid sterilization container system, is suitable for use in sterilization processing and sterility maintenance.” – “Before purchasing any packaging system, the user should gather information and perform testing to ensure that items to be packaged can be sterilized by the specific sterilizers and/or sterilization methods to be used within the facility.” 1. Key Points of a Verification Process Understand How Validated Parameters are Prepared Manufacturer of Pre-Configured Tray Selects Rigid Container Vendor and Performs Validation Study Manufacturer of Pre-Configured Tray is responsible for providing sterilization parameters (including sterile package information) to user 2 1. Key Points of a Verification Process Understand Sterile Packaging Weight Limits (PreVac Steam) Container vendors such as Aesculap, Case Medical, Medline and V. Mueller are typically FDA cleared for a total weight of 22 to 25 pounds. Blue Wrap is typically FDA cleared per model/product family for a maximum weight. Typical weight ranges from 3 to 25 pounds. 3,4 It is often assumed, correctly or not, that all wrapping materials are the same. ST77 2 2. How to Reconcile Multiple IFUs Pre-configured Set IFU Generically States Rigid Container User to compare and reconcile manufacturer parameters and rigid sterilization parameters Orthofix IFU 5 Aesculap Rigid Container IFU 6 Sterilization parameters are reconciled: •Exposure Time and Temperature 270F/4minutes are equal •Dry Time of Orthofix is longer than Aesculap minimum Therefore user performs verification test and documents results 2. How to Reconcile Multiple IFUs Pre-configured Set IFU States Specific Rigid Container System User to perform verification test in stated container system and document Biomet Orthopedics IFU 9 Smith and Nephew IFU 8 DePuy Synthes IFU 7 acumed IFU 10 3. How to Perform and Document a Verification Test Day of Verification Test 1. Ensure staff follows IFU for container system and pre-configured set 2. Confirm instrument set is not needed for surgical procedure 3. Conduct appropriate sterilizer testing to ensure proper function 4. Conduct verification test Refer to “Example Verification Test Documentation” on right as an example of how to document test results Criteria Documentation / Results Product/Set Tested Vendor X Hip Arthoplasty Model numbers of Sterile Package JK444, JK489 Weight of set (with container) 20lbs Sterilizer ID #1 Cycle Parameters Exposure: 270℉ / 4 minutes Dry time: 15 minutes Person preparing set John Example Person starting / releasing sterilizer Bob Example / Mary Example Load number 11010522014 Date of Test Feb 27 2015 BI Results OK CI Results OK Overall Result of Test Acceptable Example Verification Test Documentation References (1) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities (2) ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization (manufacturer’s document) (3) www.accessdata.fda.gov/cdrh_docs/pdf11/k112805.pdf (4) www.accessdata.fda.gov/cdrh_docs/pdf13/K132060.pdf (5) web.orthofix.com/Products/Products/SKYHAWK%c2%ae/SH-1403%20SkyHawk%20Plate%20IFU%207-15- 2014%5b3%5d.pdf (6) www.aesculapusa.com/assets/base/doc/instructions/aic/sterilcontainers/SterilContainer_System_and_SterilContainer_ S_System_in_Steam_Sterilization_SOP-AIC-5000238.pdf (7) www.depuysynthes.com/binary/org/DPY_SYN/About_DePuy_Synthes/IFU-0902-00-836%20Rev.%20D.pdf (8) www.smith-nephew.com/documents/resources/steam%20sterilization.pdf (9) www.biomet.com/orthopedics/getFile.cfm?id=2194&rt=inline (10) ifu.acumed.net/PKGI-76-B.pdf Internet references sited on February 16, 2015 Infection Prevention Sterile Processing OR Coordinator Internal / External Lab Materials Management 1. Key Points of a Verification Process Write a Pre-Purchase Evaluation Test Plan 1. Form a team 2. Identify most challenging set in product family - Ask manufacturer for support and document 3. Determine BI & CI placement - Typically in each corner and center of each tray 4. Determine how results will be recorded and stored ATTENTION TO DETAIL: ERGONOMIC AND SAFETY ISSUES IN THE WORK PLACE Melissa Polce, CRCST, CCC Tammy Walker, CRCST, CIS Linda Kincaid, CRCST, CIS ATTENTION TO DETAIL • Overhead “Operating Room Grade” lighting was installed at every work station to aid in the inspection/assembly of instrument trays. • Loupes are also available and are used during the inspection/assembly process. • Magnification lamps are also utilized at work stations. EVEN MORE DETAIL ERGONOMICS • Ergonomic chairs were purchased and placed at every work station. • A suitable chair is a critical step in preventing health problems in people who work in a sitting position for long periods of time. • Gel Wrist Rests provide extra comfort and support, ensuring a firm surface grip while using a mouse. OVER LOADED CARTS • Objects are more prone to fall off. • Can be more difficult to maneuver due to the excessive weight. TRAYS OVER-HEAD • No trays are to be placed on the top shelf of any shelving/cart. • Reduces the risk of Techs reaching overhead to remove objects on the top shelf, which could result in objects falling off or the cart tipping over. PERSONAL PROTECTIVE EQUIPMENT • Everyone is required to wear the proper PPE when in Decontamination. • Rubber mats are used to relieve fatigue and discomfort due to long periods of standing in one spot. ABSORBANT MATS • Mats are used in Decontam and can hold 14 times their weight in fluid. • Increase’s staff satisfaction by maintaining a dry environment. • Mats with properly applied tape, will stay in place and will not slide. • Heavier trays were removed from our shelving units, and placed into the “Motorized Rotating Unit”, • Heavier trays are now at waist level. •Weight of trays should be 25lbs and under(ANSI/AAMI ST79). HEAVY TRAYS
