Calls for Validated IFUs

The Continuing Call For Validated IFUs

In a new article in Healthcare Purchasing News, noted author and reprocessing expert Rose Seavey said that “Many reusable devices pose great risks of transmitting infections (e.g., endoscopes, arthroscopes, laparoscopic instrumentation) or pose a real challenge to adequate reprocessing (e.g., long narrow or multiple lumens, hinges, stopcocks etc.) therefore, it is imperative that the IFUs for instruments, equipment, chemicals etc. are followed.”1

Sending a laparoscopic instrument through a sterilizer after decontamination and cleaning does not automatically mean that it is safe to use, especially if it still contained residual bio-burden prior to sterilization. Medical device reprocessing personnel have always been told“If it’s not clean, it can’t be sterile.” The more accurate statement is that “If it’s not clean, it can’t be safe!” Dead, sterile bio-burden that gets deposited into the body from a ‘sterile’ instrument that was not completely free of organic debris prior to sterilization can still cause a surgical infection.

Over the past forty years, the FDA has taken an ever increasing interest in reusable device IFUs and their impact on patient safety. The FDA’s concern with the content and the validity of manufacturers’ IFUs was codified in March of 2015 when the FDA issued “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

In Section VII of the FDA report, Validation of Reprocessing Methods in Accordance with the Quality System Regulation, the report states:

“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.”

However, the FDA did not make the new requirement for manufacturers to validate their IFUs retroactive. Specifically, at present, the FDA’s IFU validation requirement only applies to new product 510(k) submissions to the FDA. Regretfully, almost all of the tens-of-thousands of surgical instruments that are used in patients every day have never had their cleaning and their sterilization IFUs validated.

“It’s the sad reality of what people in CS/SPD face — they are held accountable for returning clean, sterile, moisture-free instruments up to the OR and yet they are dealing with instruments whose cleaning IFUs have never been validated and they are having to rely on visual inspection, which is not an acceptable technique.”2

The primary reason that visual inspection is not an acceptable technique to ensure that an instrument is clean is because microscopic bio-burden and bio-film cannot be seen with the human eye. As pointed out in AAMI ST 79The use of methods that are able to measure organic residues that are not detectable using visual inspection should be considered in facility cleaning policy and procedures.”

Not only has the FDA has taken an ever increasing interest in reusable device IFUs and their impact on surgical infections, but many other organizations have as well. Research published in the JAMA Internal Medicine publication found that the cost of resolving surgical infections is a major cost to hospitals. According to the report "surgical infections contribute the most to overall costs, accounting for more than a third of the total costs caused by Never Events. Individual cases of surgical site infections added an average of $20,785 to a patient's medical bills."3

The first step in reducing the risk of a contaminated instrument being returned to surgery is to always follow the manufacturer’s IFU. If the manufacturer can’t, or won’t, provide you with an IFU for their product, look for a different manufacturer who can and will provide you with an IFU.

The second step in reducing the risk of a contaminated instrument being returned to surgery is to use instruments whose IFUs have been validated whenever possible. In order for the IFUs to have been validated, the validation testing must have been done by an independent testing laboratory using AAMI and FDA validation testing protocols.

 “It is essential to have access to the most current, validated manufacturers’ IFU documents for facilitating safe and effective reprocessing of medical devices and equipment. These items could pose a very real threat to the health and safety of both patients and staff if processes are not carried out in accordance with the procedures outlined in the manufacturer’s validated IFU.”4

If you are relying on manufacturer IFUs that have not been validated “to ensure that the device can be effectively reprocessed and safely reused,” then you cannot be sure that the instruments are clean, sterile and moisture-free on every reprocessing cycle.

Reducing your patients’ risk of a surgical infection caused by a contaminated instrument starts by only using instruments who’s IFUs have been validated using FDA validation testing protocols.

1.“Encouraging IFU compliance: Infection Preventionists are influencing change in sterilization and high-level disinfection” by Rose Seavey, HPN, February 2019

2. “Validated? It’s complicated” by Kara Nadeau, HPN, April 2017

3. Journal of the American Medical Association (JAMA), September, 2013

4.“Encouraging IFU compliance: Infection Preventionists are influencing change in sterilization and high-level disinfection” by Rose Seavey, HPN, February 2019