processing, perioperative nursing and medical devices. She has worked with sur- gical instrument manufacturers to review current validation methods and labeling/ IFU in connection with the 2015 FDA guidance and end user needs. As with LeClair, Spear too worked to categorize instruments and develop standardized cleaning protocols for each category. “One of the first things we did was look for common cleaning practices in the CS/SPD so we could validate the manu- facturer’s products against them,” said Spear. “So maybe it is effective to soak a prod- uct for 20 minutes, but will

Joan Spear

we get the same outcome by soaking for five minutes? In a user environment which would you choose?”

Where it all comes together: AAMI Workgroup 12

While they were working on their in- dependent IFU improvement projects, LeClair and Spear became members of the Association for the Advancement of Medical Instrumentation (AAMI) Steril- ization Workgroup 12, which has been tasked with developing standardized cleaning protocols for specific categories or “families” of instruments. A device manufacturer would select the protocol that best meets its device and use the protocol as the basis for the product’s IFU. The goal is to help standardize IFU format and cleaning steps across device catego- ries, thereby making it easier for CS/SPD professionals to understand and follow. LeClair and Spear discovered the simi- larities in their separate work, and found they were not the only ones who had been categorizing instruments and standard- izing protocols.

“There are three instrument manufac-

turers represented in Workgroup 12 and when we started talking we realized all three had established instrument group- ings that were quite similar,” said Spear. “What one manufacturer called “category one” another was calling “group 2” but they were essentially the same cleaning steps.” “What is terrific is that these manufac- turers are willing to share this informa- tion within the Workgroup,” said AAMI Workgroup 12 Co-Chair Ralph J. Basile, Vice Presi- dent of Healthmark. “The more manufacturers that do this, the greater the benefits down the road to healthcare facilities in that there will be less IFU variability and a

Ralph J. Basile

better chance that technicians can follow them. We also have involvement from end users, testing labs and members of the FDA.” The finished document will be an annex

to AAMI Technical Information Report (TIR) 12,: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. The AAMI TIR 12 is a support document to ISO 17664, Ster- ilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices. Basile notes that the annex is currently in a working draft form and will at some point be available for public comment. David Hill is a Glasgow-

based consultant engineer for medical device decontamina- tion, validation, sterilization and program management with 35 years experience in healthcare. He conducts gap analysis in relation to ISO 17664 require- ments, and evaluates process exposure re- quirements (manual cleaning, automated cleaning and sterilization) using a basic complexity analysis. He has completed this work for lethality exposure compari- son between US and UK sterilization. “Standardized format has been needed

David Hill

for a long time,” said Hill. “Sometimes I get the impression that manufacturers don’t really think enough about CSD capabilities and hide their uncertainty in the IFU. Another issue is the differences between EU and US times and tempera- tures. Manufacturers often just quote one or the other. I believe it would be a giant leap to develop a united IFU design tem- plate. These should already been provided within regulatory standards.”

The elephant in the room: validation

In the April 2017 edition of Health- care Purchasing News, we published an extensive article on the need for IFU validation, citing the FDA’s 2015 guid- ance ( validated-its-complicated/). For those manufacturers seeking 510(k) approval for new reusable medical devices, the FDA now requires manufacturers to in- clude the testing data that validated their reprocessing instructions. Regretfully, the requirement to validate IFUs does not apply to products already on the market.1 According to James Schneiter, Founder, America’s MedSource, since publication of that article, little has changed in the industry with regards to validated IFUs. He says while efforts to standardize IFUs


are beneficial, they are no substitute for independent laboratory validation of a manufacturer’s IFU. “Another year has gone by and we continue to harm patients because among other things, the FDA refuses to demand that manufactur- ers validate their IFUs for ALL of the reusable devices they are currently sell- ing,” said Schneiter. “If a manufacturer has validated its IFU, then you know what you can expect in terms of bioload re- duction, or elimination, after cleaning. Armed with this information, you can make an informed, quantitative decision as to whether or not that instrument is safe for your patients after reprocessing in your facility.

James Schneiter

‘But in the absence of validated IFUs, the manufacturer is simply saying ‘If you can’t see any bioload, then the instrument is clean.’ It is physically impossible for the human eye to see microscopic bioburden, much less biofilm,” he added. “Unless the manufacturer has validated that its clean- ing process removes at least 99.9 percent of the bioload, you have no assurance that you are sending a clean, safe instrument back to the OR. As recent lawsuits have shown, healthcare facilities have an ethi- cal, moral and legal obligation to demand validated IFUs from all of their device suppliers.”

A resource for CS/SPD professionals: ANSI/AAMI ST90 While the AAMI Technical Information Report (TIR) 12 is aimed at manufactur- ers, a new standard issued in June 2017 is geared toward IFU end users: ANSI/AAMI ST90 Processing of health care products— Quality management systems for reprocessing in health care facilities.2

Richard Schule, Director of Clinical Edu-

cation Services at STERIS Corporation and AAMI Quality Systems for Device Processing Working Group co-chair, notes how the standard speaks to the healthcare organization’s responsibility for not only obtaining and reviewing the manufacturer’s IFUs, but also demonstrating product acceptance crite- ria, including instructions for inspection of the set or device from cleaning through disinfection or sterilization. “The new ST90 document speaks to the importance of IFUs as part of the depart- ment’s quality management system and the hospitals’ responsibilities with re- gards to the manufacturers’ instructions,”

Richard Schule

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