FDA List of “Greater Risk” Medical Devices and Validated IFUs Part IV

In Part I of this blog (Elmed blog 34) we discussed the fact that the FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission after reprocessing and represent a high risk of infection (subclinical or clinical) if they are not, or simply cannot be, adequately decontaminated, cleaned and sterilized.1

According to data from the Centers for Disease Control and Prevention (CDC), over 30,000 patients die annually from surgical infections. A significant number of those surgical infections are caused by instruments whose reprocessing instructions (IFUs) have never been validated to ensure the removal of bioburden and biofilm. This is why so many contaminated instruments continue to be returned to the OR after reprocessing and causing patient harm/death.

The FDA has long been aware of the problem caused by instruments whose IFUs have not been validated. As they pointed out in 2015 “However, reprocessing instructions for some older, legally-marketed, reusable devices may not be consistent with state-of-the-art science and therefore may not ensure that device is clean, disinfected, or sterile.  This may cause those devices to be adulterated under section 501(c) of the FDCA [Federal Food Drug and Cosmetics Act] because its purity or quality fall below that which it purports or is represented to possess, or to be misbranded under section 502(f) of the FDCA because its labeling does not bear adequate directions for use or under section 502(j) of the FDCA because it is dangerous to health, among other possible violations.”2

In the absence of validated IFUs from a surgical instrument manufacturer, reprocessing staff can be following every step of the manufacturer’s non-validated cleaning IFUs perfectly and yet they cannot ensure that the instruments are disinfected, clean, sterile and moisture-free. More to the point, reprocessing personnel can correctly perform every step of the non-validated IFU and still be sending dangerous, contaminated instruments back to the O.R that can cause serious patient harm or even death.

According to the FDA report, one of the design features which poses a greater risk to patient safety and thus requires validated reprocessing instructions is any instrument with:

Interior device channels (e.g., the “I” beam and channel inside of a Kerrison Rongeur) 3

The manufacturers of Kerrison Rongeurs have long-known that it is impossible to thoroughly decontaminate and clean the internal channel and “I” beam inside of a conventional Kerrison Rongeur instrument. Kerrison Rongeur manufacturers attempted to solve this decontamination and cleaning problem years ago by introducing ‘take-a-part’ or ‘modular’ Kerrison Rongeurs.

According to the manufacturers of take-a-part or modular Kerrison Rongeurs, their major benefit is that once they’ve been disassembled, you can supposedly ‘visualize’ the bioburden inside of the instrument and manually remove it. Regretfully, the human eye is NOT capable of seeing microscopic bacteria and biofilm on the surface of a surgical instrument.

Being able to ‘visualize’ the inside of a take-a-part Kerrison Rongeur does NOT ensure a clean, sterile, moisture-free instrument (assuming that reprocessing personnel know how or even remember to take the time to disassemble, thoroughly clean it and then properly reassemble the instrument). Regretfully, no manufacturer of take-a-part Kerrison Rongeurs has ever validated their cleaning IFUs. In point of fact, no manufacturer has ever even attempted to validate the cleaning IFUs on their take-a-part Kerrison Rongeur instrument because no two people can or will clean an instrument the same way on every reprocessing cycle.

This is a disassembled, conventional Kerrison Rongeur that remained contaminated with bioburden after reprocessing. Note how the bioburden collects in the channel and around the interior “I” beam of the instrument.

So how does the FDA list of “Greater Risk” medical devices (4) apply to a healthcare facility and to their patients? Unless a surgical instrument manufacturer has validated that its cleaning process removes the bioload from the instrument, healthcare facilities have no assurance that reprocessing personnel are sending a clean, sterile and safe instrument back to the OR. In light of this FDA report, and as recent lawsuits have shown, healthcare facilities have an ethical, moral, financial and legal responsibility to demand validated IFUs from all of their surgical instrument and reusable medical device suppliers.

1 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” June 9, 2017 Appendix E

2 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” March 17, 2015

3 Op Cite

4 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” June 9, 2017 Appendix E

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