IFUs & Patient Safety Pt. 1

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

According to the Centers for Disease Control and Prevention, hospital-acquired infections (HAIs) are one of the leading causes of morbidity and mortality among hospital patients in the United States.1 The website HealthyPeople.gov points out that among hospitalized patients, those HAIs are leading causes of preventable deaths in the U.S. The on-going battle against HAIs is a major focus for all healthcare personnel throughout the country. 2

There are just five categories of infections that account for the majority of HAIs in acute care hospitals. 3 Ranked in terms of their frequency of occurrence and their impact on patient morbidity and mortality, the five major infection categories are:

  1. Surgical site infections (SSIs)
  2. Ventilator-associated pneumonia
  3. Central line-associated bloodstream infections
  4. C difficile infections
  5. Catheter-associated urinary tract infections

Given that surgical site infections (SSIs) are the leading cause of HAIs and account for one-third of the overall costs of treating HAIs, any and all steps taken to reduce the risk of an SSI should be taken to reduce patient harm and improve patient outcomes. A major source of SSIs is contaminated reusable devices that are still contaminated with organic debris and biofilm after reprocessing and are then returned to surgery.

According to AAMI “Preventing reusable medical device contamination has become an essential public health issue. Since device contamination can occur at any time, infection prevention must be a shared responsibility—a collaborative, coordinated process in which all stakeholders participate. Such participation involves effective communication, education, proper usage, transportation and storage, cleaning and disinfection, and overall maintenance of often expensive and very delicate reusable equipment essential for proper care of the most important stakeholder: the patient.” 4

So what is the best way for you and your staff to help fight this “public health issue?” The first step in reducing your patients’ risk of contracting an SSI caused by a contaminated surgical instrument begins with an in-depth assessment of the various brands and options of surgical instruments that are available prior to making a purchase.

The purchasing decision process for surgical instruments must include an analysis of each instrument manufacturer’s product support capabilities including in-servicing, product IFUs, staff education, warranty service and field support. The instrument manufacturer’s support and input has the potential to reduce your patients’ risk of contracting an SSI from instruments that are difficult, if not impossible to thoroughly decontaminate, clean and sterilize.

When it comes time to analyze these various support items, the most important weapon in your fight to preventing contaminated instruments from being returned to the O.R. and causing patient harm is the manufacturer’s Instructions for Use (IFUs). When evaluating any manufacturer’s IFUs, AAMI recommends that you ensure the following components are part of the manufacturer’s IFU:

Document focuses on providing clear information for the end user (as opposed to simply meeting regulatory requirements)

Document includes all of the information needed (e.g., explicit steps to reprocess)

Document is organized so that information sought is easily found

Font size is large enough for easy reading

Document is written in plain language (i.e., at a reading level of an eighth-grade education) to ensure understanding of the information without need for interpretation by the customer

Revisions or updates will be provided by the manufacturer to all the facilities that carry the reusable medical device5

Failure to follow manufacturers’ cleaning IFUs can lead to instruments that are contaminated with microbial biomaterial being returned to the OR after reprocessing. According to a report from the CDC "Microbial contamination of the surgical site is a necessary precursor of a surgical infection.” 6 One of the more common sources of microbial contamination in a surgical case is a surgical instrument that is contaminated with dead, sterile bioburden following reprocessing.

Always remember that when you are evaluating an instrument manufacturer’s IFUs, the single most important thing to look for is whether or not the manufacturer had their IFUs ‘validated’ by an independent laboratory using AAMI/FDA testing protocols. Without validated IFUs, you have no assurance that you and your department are returning clean, sterile, moisture-free instruments to surgery on every reprocessing cycle.

  1. https://www.cdc.gov/
  2. https://www.healthypeople.gov/
  3. https://www.cdc.gov/
  4. AAMI 2017 publication “Checklists for Preventing Healthcare-Associated Infections (HAIs)”
  5. Cite.
  6. “Guideline For The Prevention Of Surgical Site Infection” Centers for Disease Control and Prevention