Author: C. Jason Rawlings, CRCST | Director of Clinical Services

All it took was two crashes in the span of five months for Boeing 747 Max jets to be grounded around the globe. As investigations have kicked off and Boeing attempts to handle the crisis, attention has been drawn to various government agencies that allow their respective industries to regulate themselves.

Not Just Airplanes” reads the title of an NPR article from early last month, which goes on to describe other federal agencies that similarly delegate regulation. “The Food and Drug Administration,” the article reads, “is another agency that relies on industry, in this case, drug manufacturers, to test new drugs, with the data then certified by FDA scientists.”

As sterile processing practitioners, drug testing doesn’t necessarily influence our daily work, but FDA regulations do—particularly with regards to surgical instruments’ instructions for use (or IFUs).

IFUs detail how to properly reprocess instruments. According to Nancy Chobin, writing for Infection Control Today, the FDA makes manufacturers responsible to “support product label claims of reusability by providing complete and comprehensive written instructions for the handling, cleaning, disinfection, testing, packaging, sterilization, and, if applicable, aeration of their products. Manufacturers also have the responsibility to conduct and document any testing necessary to validate the suitability of these instructions.”

Manufacturers know their instruments better than anyone else, so it makes sense that they would be responsible for outlining the proper reprocessing procedures. However, it seems that accountability is lacking for making sure that reprocessing procedures accomplish what they’re supposed to.

Additionally, the FDA provides a loophole that manufacturers can use to save time and resources when launching a new product: “Device manufacturers may forgo qualification studies if they can demonstrate that a device being considered represents no greater challenge to the cleaning process than another similar device that has been qualified.”

The manufacturer must still provide reprocessing instructions, but they don’t have to develop and test these instructions to make sure they are effective with the new device because it’s been declared similar enough to another device. Maybe the reprocessing instructions are suitable and successfully clean and sterilize the instruments, but it’s also possible that they don’t, and because no qualification studies have been done, we may not find out until a dire patient outcome points to a contaminated instrument—and our own 747 is stuck on the ground.

There are two major recommendations the sterile processing community might make to the FDA in terms of improving IFU regulation:

  1. Require Validation of IFU Procedures

It’s essential—first and foremost for patient safety and, on a related note, for institutional liability—that the manufacturer-recommended reprocessing procedures successfully clean and sterilize the instruments they are written for. If the SPD follows an IFU perfectly, step by step, but the instrument is still contaminated, the reprocessing procedure didn’t serve its essential function.

“In the absence of validated IFUs, the manufacturer is simply saying ‘If you can’t see any bioload, then the instrument is clean,’” James Schneiter, founder of America’s MedSource, told Healthcare Purchasing News. “It is physically impossible for the human eye to see microscopic bioburden, much less biofilm.”

In order to know that procedures accomplish what they’re supposed to, they need to be properly tested, so the natural progression would be to regulate that testing—and not just the testing of new devices, but also the testing of devices that have been on the market for years and have been grandfathered into the existing regulations.

  1. Standardize the IFU Format

Right now, manufacturers are not required to follow any particular format when writing their IFUs. Every new instrument requires SPDs to step away from everything else and decode the directions for reprocessing. While slow onboarding of new instruments is one thing, but putting patients at risk is completely unacceptable and ultimately defeats the purpose of having a sterile processing department in the first place. If we’re not cleaning and sterilizing instruments properly, we’re not doing our jobs.

To address this problem, the FDA could regulate how IFUs are written so that every IFU follows a specific format and is easy to navigate. When a new instrument enters the SPD, you’d know exactly where to find the proper sterilization process—no need to dissect the IFU.

Standardized IFUs could have a major impact on SPD compliance with manufacturer reprocessing instructions, as well as how quickly a new instrument’s process is understood and carried out—all while improving patient outcomes.

Patient safety requires properly processed instruments. SPDs exist to process instruments properly. If implemented, these two recommendations could improve SPD processes while providing greater assurance that manufacturers are doing their part to make sure IFUs are appropriate for their instruments.

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