FDA List of “Greater Risk” Medical Devices and the Need for Validated IFUs for Laparoscopic Instruments (Part III)

In Part I of this blog (1/26/18) we began an analysis of the FDA’s list of “Greater Risk” medical devices and the need for validated IFUs to ensure clean, sterile, moisture-free instruments to protect patients from harm/death. 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 adequately reprocessed.1 In Part III of this blog we are going to analyze some of the FDA’s “Greater Risk” devices and what you can do to protect your patients from harm caused by these devices.

Most of the devices and instruments on the “Greater Risk” list are difficult, if not impossible, to thoroughly decontaminate and clean due to their design and/or construction. The FDA has long been aware of this manufacturer design/construction problem. As they point out “We recommend that all reusable medical devices be designed and constructed to allow adequate cleaning, because if a device cannot be adequately cleaned, any subsequent disinfection or sterilization process may not be effective.”2

When it comes to “Greater Risk” medical devices, over the past several years there have been far too many reports of patient harm or death that was caused by contaminated endoscopes. In the majority of those cases, the endoscope manufacturer had never validated their cleaning IFUs to ensure that you could, in fact, remove all of the bioburden and biofilm during reprocessing. You could follow the steps in their IFUs and still have a contaminated endoscope.

While endoscopes have received the majority of the headlines concerning contaminated medical devices causing patient harm, conventional laparoscopic instruments pose similar reprocessing challenges and a significantly ‘Greater Risk’ to patients. The FDA is concerned about the higher risk caused by laparoscopic instruments with their long internal lumen and operating rod. The FDA specifically mentions that risk in their report.

“Lumens (especially lumens of flexible design, multiple internal lumens, lumens that are not freely accessible, bifurcated lumens, lumens with internal surfaces that are not smooth, have internal ridges or sharp angles, or are too small to permit a brush to pass through);”3

Laparoscopic instrument manufacturers have long-known that it is impossible to thoroughly decontaminate and clean the internal lumen and operating rod of a conventional laparoscopic instrument. Instrument manufacturers attempted to solve this problem years ago by introducing ‘take-a-part’ or ‘modular’ laparoscopic instruments.

According to the manufacturers of take-a-part or modular laparoscopic instruments, their major benefit is that once they’ve been disassembled, you can ‘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 laparoscopic instrument 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 laparoscopic instruments 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 laparoscopic instrument because no two people can or will clean an instrument the same way on every reprocessing cycle.

The personnel at Joint Commission are also very concerned about the issues associated with reprocessing take-a-part laparoscopic instruments. They were so concerned that in January of 2011 they revised the guidelines for their inspection teams. Specifically, the new inspection guidelines from the Joint Commission read as follows:

Point-of-use preparation:

“Some typical point-of-use shortcuts that have been observed are: not unlocking instruments; not disassembling instruments; not wiping off gross material and body fluids during procedures; not moistening or pre-treating instruments before transporting them for sterile processing; and not returning instruments to their proper containers.”

Based on Joint Commission’s inspection guidelines, it is obvious that the failure of reprocessing personnel to disassemble, manually clean and then correctly reassemble take-a-part laparoscopic instruments is a major concern/problem.

Another major problem with all take-a-parts is that residual moisture can remain trapped inside of the instrument after the sterilization cycle. Trapped residual moisture greatly increases the risk of an instrument contaminated with waterborne pathogens being returned to surgery.

The only way to ensure clean, sterile, moisture-free laparoscopic instruments on every reprocessing cycle is to only use instruments whose cleaning IFUs have been validated to remove organic debris and moisture. Such validation must be done in accordance with FDA mandated validation testing protocols described in 21 CFR 820.3(k)Validation of Reprocessing Methods in Accordance with the Quality System Regulation.”4

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

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