Is IFU Validation New?

Is The Need For Validated IFUs A New Issue?

Over the past several years a recurring topic of these weekly blogs has been the need for all healthcare facilities to demand ‘validated’ cleaning and sterilization Instructions For Use (IFUs) from all of their reusable medical device manufacturers. If the manufacturer hasn’t validated their IFUs by an independent laboratory using AAMI and FDA approved testing protocols, you have no assurance of returning clean, sterile, moisture-free instruments back to surgery.

Until recently, the FDA did not require manufacturers to validate their IFUs to prove that their reprocessing instructions actually worked. This lack of a requirement for validation from the FDA has resulted in IFUs that are almost universally the same, and without any documented assurance that they actually work.

“Most companies create an IFU for a new product by plagiarism. They merely copy a competitor’s IFU and change the name. If the IFU is created by a regulatory expert, the IFU will be nearly identical to the competitor’s IFU. However, if the IFU is created by a marketing person, the IFU will explain how their product is totally different from the competitor’s product. Neither approach is effective.”1

The need for validated IFUs from reusable medical device manufacturers is not a new issue. The need for validated IFUs started to appear in various articles and publications almost 20 years ago.

Natalie Lind, CRCST, CCSMC, ACE, pointed out in her article “Reprocessing Specialty Instruments” that, “Improperly processed instruments pose a significant threat to patient outcomes. Failure to process instruments correctly can lead to nosocomial infections. Ideally, reprocessing considerations should be addressed before an instrument is selected and purchased. Part of the overall purchase decision should be the instrument’s cleaning and sterilization validation. 2

Ramona Conner noted in the April 2001 AORN Journal, "Decontamination is the first and most important step in the sterilization process. Inadequate cleaning of organic debris may result in retained organisms and make the sterilization process ineffective.” 3

She continued, "Proper decontamination and removal of all possible biomaterial is the most important step in the sterilization process. High bioburden inhibits the sterilization process, and sterility cannot be guaranteed.” 4

Instrument reprocessing is a significant risk factor that is under the control of the healthcare facility. It has the potential for a significant impact on the prevention of surgical site infections caused by instruments that remain contaminated after reprocessing.

“Do not allow a sales representative, delivery person, or your personnel to make any changes to a manufacturer’s original instrument/container set unless those are addressed in validated FDA-cleared IFU from that manufacturer. If changes are made, the medical devices may no longer be safe for patient use.” 5

As Linda Clement, a consultant in sterile processing for STERIS Corporation, stated back in 2002, "One of the most frustrating and challenging issues confronting sterile processing staff is the continuing struggle to clean and sterilize complicated medical devices, especially laparoscopic instruments. The simple fact of the matter is that if a device is difficult to clean or sterilize, sterile processing technicians are routinely placed in the position to do what they can and hope for the best. Unfortunately, this type of processing leap-of-faith can adversely affect patient care.

The ICP [Infection Control Personnel] should request data from all manufacturers of laparoscopic and endoscopic equipment in the facility (both flexible and rigid) verifying cleanability -- i.e., documentation that an independent laboratory has performed the testing that proves the device can actually be cleaned of bioburden, preparing it for sterilization.” 6

Dennis Maki, MD, head of the infectious diseases department at the University of Wisconsin Medical School, emphasizes, "When sales representatives makes claims about how well their product works, ask to see their documentation -- clinicals, independent laboratory testing, etc. If the manufacturer can't document its claims, why would you use that product with your patients?" 6

As these old articles point out, the need for validated IFUs to protect patients from contaminated instruments has been around for a long time. When reviewing IFUs, ensure that the manufacturer used an independent laboratory to validate their cleaning and sterilization IFUs.

When asking your instrument vendors for a copy of their validated IFUs, you need to follow Linda Clement’s advice, "Be sure the vendor understands you are asking for more than just cleaning instructions. You must have the independent verification that those instructions actually work for cleaning the instrument." 7

  1. Medical Device Academy blog, Rob Packard, April 12, 2017
  2. Reprocessing Specialty Instruments” Natalie Lind, CRCST, CCSMC, ACE, Infection Control Today, June 2000
  3. Washing and restringing instruments; bone debris; preparing setups; patient restraints; Group A Streptococcus.” Ramona L. Conner, AORN Journal, Volume 73, Issue 4, April, 2001, Pages 835, 837-838
  4. Cite.
  5. OR Manager, Vol. 27, Number 3, March, 2011
  6. “Laparoscopic Instruments: Handle With CareAnn Hewitt, RN, BSN, MM, Infection Control Today, November 2002
  7. Cite.