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

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

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.”1

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

In order to reduce the risk of a newly designed instrument causing patient harm due to inadequate reprocessing instructions, the FDA now has stringent IFU validation requirements in place for all new 510(k) product approval submissions. Regretfully, these stringent IFU validation requirements for new products were not put in place until March, 2015.

When a manufacturer submits a new product 510(k) request to the FDA, as part of that submission package the manufacturer must comply with the following FDA requirement:

For class II and class III devices and select class I devices, manufacturers must establish and maintain procedures for validating the design of their device, which shall ensure that the device conforms to defined user needs and intended uses. 21 CFR 820.30(g).  Manufacturers must also establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, 21 CFR 820.75(b). Establishing procedures includes implementation.  21 CFR 820.3(k).  FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the device can be effectively reprocessed and safely reused over its use life, as intended.”2

As the preceding paragraph clearly demonstrates, the FDA now requires manufacturers to include the testing data that validated their reprocessing instructions with all new product submissions. Regretfully, the requirement for manufacturers to validate their reprocessing IFUs does not apply to the 20,000+ surgical instruments in daily use in healthcare facilities across the country. It is up to the healthcare facility’s staff to demand that their manufacturers provide them with validated IFUs to protect their patients.

When it comes to ‘validating the design of their device’ the FDA wants the manufacturer to design the product to conform to user needs and requirements. The FDA also wants the manufacturer to design the product with reprocessing challenges in mind.

“Manufacturers of reusable devices should consider device designs that facilitate easy and effective cleaning, as well as any necessary disinfection or sterilization by the users. Some complex device designs present particular challenges to cleaning and cleaning validation (e.g., shaft-within-lumen configurations, elevator channels, fine channels, seals and mated articulating surfaces).3


Photo of residual bioburden that remained trapped inside of conventional Kerrison Rongeurs after reprocessing following the manufacturer’s non-validated IFUs


1 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” March 17, 2015, page 29

2 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” March 17, 2015, page 22

3 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” March 17, 2015, page 4

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