An Unwilling Conspiracy of Silence: Confronting the Industry Secret of Non-Compliance


Is every medical device in your hospital cleaned, inspected, and sterilized in compliance with the manufacturer's instructions for use (IFUs)?


No, seriously. Be honest:


Do you have the required sizes and types of every brush, listed on every IFU, for every instrument in your inventory?Is every suction, cannula, lumen, or ported device flushed at the proper PSI for the proper length of time with the proper solution and temperature of detergent?Is your detergent temperature, dilution ratio, and contact time hardwired and documented for each instrument tray?Anything being hand-washed that should go through an automated washer/disinfector cycle? Anything going through a washer/disinfector that should be hand-washed?Are your ultrasonic cycles the right length for device specific validations?What about your packaging systems? Is that set validated to be containerized? Can you sterilize that many instruments in a single peel pack?


The Access Myth


Notice that I'm not posing the question - "Do you have access to your device IFUs?" That's the wrong question to be asking for two reasons:


1) Access does not equal application

2) Most of what our industry calls "access" is really a myth


Having a department IFU binder or website somewhere on Jeff Bezos' mega-cloud with all the IFUs in the world is about as helpful as sleeping on the steps of the Library of Congress. Yes, there's a lot of information at your fingertips. But simply being in the presence of knowledge doesn't change anyone or any process. And in terms of IFUs, knowing where they are located is not what compliance requires. Actually applying those IFUs every instrument, every time is the true expectation.


But here's the second issue. A great many of us in the CS/SPD universe have been lulled into the false belief that particular websites or the ability to "integrate" IFUs with our instrument tracking systems solves the IFU access challenge. I'm quite confident in saying that every product or service I have seen to-date fails in this area, primarily because there is no single website or service that has every instrument IFU available. And we're not just talking about onesie-twosie instruments here, we're talking about entire swaths of vendor product categories not "linked" on these particular databases.


Begging the Question


So, that leaves you (the CS/SPD professional) with a conundrum.


If you rely on or subscribe to an IFU database, you need to know exactly which instruments you own that do not have processing IFUs on that particular database. And then you need to gather electronic or hardcopies of those individual IFUs on your own facility hardrive or filed in your binder system. If you don't have access to an online IFU database at all, everything obviously needs to be filed in some way (electronic or hard copy) in your department. Either way, you've got a massive job on your hands.


But remember, this just gets you to the access point.


What then? How do you confirm every variable on every device has it's required compliance counterpart built into your Sterile Processing workflow (correct supplies, chemicals, cycles, inspection tools, packaging methods, etc)? Where is the big-data conflict checking on your surgical inventory? Can you even prove that you could be compliant within your current workflow, even apart from proving you actually are?


Honestly, Help!


I get why we're not all raising our hands and admitting that most of our answers to these questions are "No." Too many attorneys read too many articles like this one, and explaining to your Infection Control department that you've "never" been processing a particular device compliantly is not an easy conversation to have. Jobs, liability, professional respect, PR firestorms are all on the line. But if we're not honest with ourselves, and especially with our CS/SPD vendors regarding the real compliance challenges still rampant in our industry -- we're no longer confronting the problem, we have become the problem.


So I want to issue a call to action today. If you're a vendor of medical devices, equipment, instrument tracking, sterility assurance or any other CS product/service -- WE NEED YOUR HELP! Get your CS customer behind closed doors and get some honesty from them. You may be surprised at what you hear.


The challenge is real.


The answers are few.


But the need is great.


Help us tackle this issue and #MakeCompliancePossible.

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