10/5/2012. Welcome! Topic: Device Manufacturers' IFUs: Why are they important? Facilitators: Diane Koch, 3M Susan Flynn, 3M

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1 3M Sterile U Network 3M Sterile U Web Meeting October 11, 2012 Device Manufacturers IFUs: Why are they important? Today s meeting times: 9:00 a.m., 11:00 a.m. and 1:00 p.m. CST 1 To hear audio, call and enter access code Phone lines are muted. Audio will commence when the webinar begins. Introducing the 3M Learning Connection: New Name, Same Great Courses It s an educational resource bringing you 3M Sterile U and other Infection Prevention courses. You ll soon see some exciting new benefits as our program evolves! Improved features: Add to my Calendar feature Other 3M courses will be more accessible as we expand our offerings. What do you need to do? Nothing. Your current registrations remain and our Sterile U offerings have not changed. 2 Welcome! Topic: Device Manufacturers' IFUs: Why are they important? Facilitators: Diane Koch, 3M Susan Flynn, 3M Housekeeping Questions Mute feature (*7 = unmute; *6 = mute) Chat feature Technical difficulties Post session follow-up For more information: 3 1

2 How do I get a CE Certificate? Next week, all of today s meeting participants will be sent an containing instructions for obtaining a CE Certificate for today s meeting. The will be sent to the address you provided when you logged-in to today s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate to them. 4 Disclosures David Jagrosse CSS Manager Middlesex Hospital Middletown, CT Webinar sponsored by 3M and onesource Document Site 5 Learning Objectives Discuss why it is necessary to have and follow current device manufacturers' IFUs Review methods accreditation bodies may use to assess compliance to device manufacturers' IFUs Describe methods of collecting device manufacturers' IFUs 6 2

3 Why are Manufacturers Instructions (IFU) Important? IFU provide instructions the device manufacturer states are needed to properly process their device Patient safety in surgery requires properly processed instruments Improperly processed instruments have been linked to patient injury* Not following IFU puts patients at risk 1.US Dep t of Veterans Affairs 2. Cutler Peck, et al. Journal of Cataract and Refractive Surgery 2010 Jul;36(7): TODAY Investigates: Dirty surgical instruments a problem in the OR 7 Why are the Manufacturers Instructions (IFU) Important? In accordance with FDA and AAMI Guidelines, the device manufacturer has validated the steps necessary to prepare a device that is safe for patient use, for example: Cleaning, testing for function, packaging, and sterilization Healthcare facilities are not equipped to validate Users must depend upon manufacturer for validated IFU 8 Why should you follow the IFU? Use of medical devices in accordance with manufacturers instructions is recommended by: The Association for Advancement of Medical Instrumentation (AAMI)* The Association of perioperative Registered Nurses (AORN) The Centers for Disease Control and Prevention (CDC) Following manufacturers IFU is necessary to deliver a safe product for surgery AAMI ST79:2010 & A1:2010 and A2:2011 Sec AORN 2012 Standards and Recommended Practices Care and Cleaning of Surgical Instruments CDC 2008 Guideline for Disinfection and Sterilization in Healthcare Facilities 9 3

4 Joint Commission and Centers for Medicare and Medicaid Requirements The Joint Commission now requires during surveys that Sterile Processing Departments show current manufacturers instruction for use documents and how they are used The Centers for Medicare and Medicaid Services (CMS) also requires the presence of manufacturers IFUs for audits on the Infection Control Surveyor Worksheet 10 The Joint Commission National Patient Safety Goal NPSG As of Jan 2010, the hospital implements policies and practices aimed at reducing the risk of surgical site infections that meet regulatory requirements, are aligned with evidence-based standards...and/or professional organization guidelines Joint Commission Manual on Hospital Accreditation National Patient Safety Goal, Element of performance E HOW DOES THE JOINT COMMISSION ENSURE YOUR COMPLIANCE? 12 3M All rights reserved. 4

5 TJC will observe instruments from when they leave one OR to when they are returned to the next Transport to OR room Put in storage Transport to OR Sterilize Load sterilizer Use in surgery wipe, moisten, irrigate during procedure Transport to decontamination Disassemble Soak if delay if tenacious debris 13 Assemble and package Inspect for cleanliness test for function Clean manual and/or automatic The Joint Commission May: Ask healthcare workers to provide the device, the packaging and the sterilizer IFU Ask healthcare workers to demonstrate cleaning and decontamination Observe that cleaning and decontamination matches the IFU Observe that sterilization matches the IFU Ask about the chemical and biological indicators 14 How Does CMS Ensure your Compliance? 15 3M All rights reserved. 5

6 CMS Infection Control Survey Worksheet Observations are to be made of staff who perform equipment reprocessing (e.g., surgical techs), unless these activities are performed under contract or arrangement offsite from the ASC Items pre-cleaned according to IFU High-level equipment maintained according to IFU Chemicals prepared, tested, replaced, documented according to IFU Instruments disinfected as specified in manufacturers IFU 16 CMS If manufacturers instructions are not followed, then the outcome of the sterilizer cycle is guesswork, and the ASC s practices should be cited as a violation of 42 CFR (b)(5). (CMS, 2009) Ref S&C (Revised Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) 7. Infection Prevention and Control and Safety E. The organization adheres to professionally accepted standards of practice, manufacturer s recommendations, and state and federal guidelines, including but not limited to the cleaning, disinfection, and sterilization of instruments, equipment, supplies, and implants

7 How Does Inadequate IFU Document Compliance Affect Patient Safety!!! If facilities don t follow Manufacturers IFUs, patient safety is threatened because medical devices may be Cleaned improperly Wrapped improperly Loaded into sterilizer improperly Sterilized using the incorrect type of sterilization process or cycle parameters for the device or load Disassembled and assembled improperly 19 How Can Following Proper IFU Documents Minimize Operator Errors? Not following IFU is a major contributor to sterilization process failures Being trained to follow up-to-date IFUs can reduce operator errors Staff responsible for instrument processing are responsible for having on hand current IFU that are available to staff at all times. 20 How Can You Obtain Current IFU Documents? IFUs are provided with new medical devices upon purchase and can also be received by calling the manufacturer of the medical device. You can build your own library of documents or You can subscribe to an online database to access a library of manufacturers IFU documents e.g

8 Middlesex Hospital Long journey of starting A-Z search obtaining library of IFU s. Paint analogy-start in one area and by the time we were done we had to make sure they were updated. 1 year process. 1 FTE Scanned to computer but then we still had to update and categorize. Available in all locations-went to online database 22 IFU Library? Accessible? 23 What Are The Requirements of Your Library of IFU Documents? The documents must be up-to-date and readily available to the operators. The documents must cover all of your instrumentation. The documents should be easy-to-use and communicate to others within the hospital. The documents should be in a credible condition to auditors and surveyors to be easily reviewed with them. 24 8

9 Have you ever experienced... Do not have Manufacturers Instructions for Use (IFU): Think you have IFU but cannot locate Not sure you have the most current IFU Have difficulty obtaining an IFU Not sure who to contact at medical device company Time constraints that make it difficult to track down IFUs and keep them current What does the future hold with respect to sterilization parameters specified in IFUs? 26 3M All rights reserved. So what does the future hold? FDA Draft Guidance Document issued May, 2011: Processing/Reprocessing Medical Devices in Health Care Settings: Vlidti Validation Mthd Methods and Lbli Labeling Draft Guidance for Industry and FDA Staff issued on May 2, 2011 Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 27 9

10 FDA Draft Guidance on Reprocessing FDA recommends: Sterilization parameters be technically feasible for end-users i.e., recommended sterilization parameters should be consistent with cycle parameters found on sterilizers commonly available in health care facilities Device manufacturers generate validation data in FDA-cleared sterilizers and with FDA-cleared accessories. Draft Guidance for Industry and FDA Staff issued on May 2, 2011 Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 28 FDA Draft Guidance on Reprocessing The FDA recognizes the challenge extended cycles pose to health care facilities FDA advises against including extended cycle recommendations in product labeling for a number of reasons. Draft Guidance for Industry and FDA Staff issued on: May 2, 2011 Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 29 FDA Draft Guidance on Reprocessing Appendix provides examples of cycles used in health care facilities Draft Guidance for Industry and FDA Staff issued on May 2, 2011 Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 30 10

11 QUESTIONS? 31 3M All rights reserved. Thank you! Next 3M Sterile U Web Meeting: When: Topic: Thursday, November 15 th When Steam is Too Extreme - Today's Options for Low Temperature Sterilization Register at