IFUs & Patient Safety Pt. 2

Why Are “Validated” IFUs So Important For Patient Safety? (Part II)

In Part I of this blog we described the magnitude of the problem caused by hospital acquired infections (HAIs).

A major source of SSIs are reusable instruments that remain contaminated with organic debris and biofilm after reprocessing and are then returned to surgery. The most important weapon in your fight to preventing contaminated instruments from being returned to the O.R. and causing patient harm is manufacturer’s Instructions for Use (IFUs) that have been validated. If the IFUs have not been validated, you have no assurance that you are returning clean, sterile, moisture-free instruments back into surgery.1

There has been a steady and growing awareness of the importance and need for validated IFUs over the past five years. In early 2014 there were news reports of patient deaths caused by endoscopes that remained contaminated with CRE after reprocessing. As a result of those patient deaths, in August of 2014 the FDA cited scope manufacturers for failing to validate their cleaning IFUs.

Recognizing the importance of validated IFUs, the FDA issued new guidelines in March of 2015 that specifically require medical device manufactures to "validate" their cleaning IFUs. On page 22 of the FDA publication, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff,” the third paragraph states, “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.”

Over the past few years, there has been a dramatic increase in the number of lawsuits being brought against hospitals who were using reusable medical devices whose IFUs had not been validated. The majority of these suits are being brought by a deceased patient’s family. These tragic patient deaths are just one of the many reasons why the FDA, AAMI, Joint Commission, AORN and the CDC are ALL pushing manufacturers to validate their cleaning IFUs.

When it is time to replace your current surgical instrumentation, the first step in reducing your patients’ risk of an SSI caused by a contaminated surgical instrument begins with an in-depth assessment of the various brands and options that are available prior to making the final purchasing decision. According to AAMI:

“A variety of stakeholders are accountable for each aspect in the life span of any reusable medical device: from its design, use, processing validation (cleaning, disinfection, and/or sterilization) to its maintenance, transportation, and storage. Every reusable medical device has the potential to be related to transmission of pathogenic agents due to contamination. Contamination of a reusable medical device with subsequent patient transmission is an important risk factor for healthcare-associated infections (HAIs) and continues to be a serious threat to patient safety. HAIs have increased morbidity and even mortality among patients, concurrently increasing healthcare delivery costs.” 2

For those of you who might not be familiar with the organization, the ECRI Institute is the largest independent, nonprofit organization that researches approaches to improving patient care. They specialize in providing scientific, evidence-based research and health technology assessments to over 5,000 healthcare organizations worldwide to help them deliver safer and more cost-effective patient care. 3

The ECRI Institute in their "Top Ten Technology Hazards for 2017" report states that the number two patient hazard is: "Inadequate Cleaning of Complex Reusable Instruments Can Lead to Infection." This growing patient hazard was number eight on the list just two years earlier. 4

In order to help solve this major patient hazard, the ECRI Institute recommends that healthcare facilities consider "Purchasing only instruments for which the manufacturer has validated its cleaning instructions.“ They go on to point out thatIf the manufacturer is unable to provide the validation information, consider purchasing alternative instruments when replacement is required.” They also recommend that “When applicable, request written information explaining the validation process." 5

To help reduce your patients’ risk of an SSI from an instrument that is difficult, if not impossible, to thoroughly decontaminate, clean and sterilize, your healthcare facility must be demanding validated cleaning IFUs from ALL of your instrument suppliers, including take-apart suppliers. According to the ECRI Institute report, failure to demand validated cleaning IFUs from your instrument manufacturers is a patient safety issue.

  1. AAMI 2017 publication “Checklists for Preventing Healthcare-Associated Infections (HAIs)”
  2. Cite. AAMI
  3. https://www.ecri.org/
  4. https://www.ecri.org/Pages/2017-Hazards.aspx
  5. Cite. ECRI