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New FDA Reprocessing / Decontamination Guidelines: Comply or Die!

Times they are a-changin’.  Anyone who remembers the lyrics to this Bob Dylan song and is involved in the healthcare market may well recognize the connection made here.   The listener is, to paraphrase, reminded to embrace change or risk frustration and disappointment. Change is inevitable, and this is very evident when it comes to validation of reprocessing instructions for reusable medical devices.

I was personally reminded of this message when I received a phone call one morning from a person introducing themselves as, I’ll call him Dr. J – not of the basketball fame.  I could tell by the sound of his voice that he could be an older gentleman. This was confirmed when he stated that he was a surgeon with over 40 years experience.  He also said he had designed many surgical instruments over his career and he had a new instrument for which he needed to seek 510k approval. The new instrument, he claimed, was similar to another instrument that had been commonly used and reprocessed in hospitals for many years.

U S Food and Drug AdministrationHe desired to use the predicate instrument to validate cleaning and sterilization instructions for his new instrument. Up to this point, I had just listened – not that I was given much of a chance to do otherwise – but I was able to quickly comment that the FDA will not accept a predicate device to validate reprocessing instructions and informed him that an independent validation would be required. I suspect he knew this otherwise he would not have been seeking the validation services Life Science Outsourcing, my employer, provides.

He then said quite bluntly and with attitude, “You must have somebody behind you that allows you to exist.” His point was clear that he felt there was a conspiracy to make it more difficult to gain 510k approval for something that used to be simpler or, more to the point, for which he was familiar and comfortable.  I could have been offended but, in fact, I sympathized with his frustration over the increased requirements the FDA imposed for reprocessing instructions. At his request, I gave him an estimated cost range to perform the validations after which he directed an expletive at me and hung up in disgust.

Dr. J, if you happen to read this, I truly sympathize with your frustration.  However, while it is very difficult to thrive in a globally competitive and highly regulated market, there is no conspiracy.  The FDA is not without justification to require validation of reprocessing instructions.  As I’ll cover in my next blog, evidence is strong that reprocessing at healthcare facilities is simply inadequate much of the time. As a industry, we need to update and improve our methods and processes to ensure patient safety and raise the bar on healthcare quality, particularly in vital areas like infection control in healthcare facilities. Times, they are a-changin’. Dr. J, we need to you to embrace the change because the innovation and contribution you and others like you make is vital to meet the challenges we all face in the healthcare market.

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