News / August 27, 2020
In Part I of this series (Elmed blog #30) we introduced ECRI Institute’s Health Devices Group “Top 10 Health Technology Hazards for 2017.” This annual list identifies the greatest sources of danger to patients and offers practical, proven recommendations for reducing those risks and improving patient outcomes. The list details hazards that should receive a high priority.
The second biggest risk in ECRI Institute’s “Top 10 Health Technology Hazards for 2017” is Inadequate Cleaning of Complex Reusable Instruments Can Lead to Infections (this was #8 on the list just 2 years earlier). Any and all steps taken to reduce this hazard will have an immediate impact on reducing a patient’s risk of contracting a dangerous, painful and costly surgical infection.
Part II of this blog will complete the review of ECRI Institute’s recommendations to help reduce the risk of a contaminated instrument being returned to use after reprocessing and infecting a patient. We covered ECRI Institute’s first three recommendations in Part I and we now continue with the rest of their recommendations contained within the report:
“While process validation does not guarantee that a process will never fail, it does demonstrate that the provided cleaning procedures can be effective when completed properly. This additional level of assurance is important and was evidently lacking with the duodenoscopes associated with the recent Carbapenem-resistant Enterobacteriaceae (CRE) infections.”4
The FDA has become increasingly aware of the inconsistent quality of cleaning and reprocessing instructions. The agency now requires manufacturers of reusable instruments to validate their cleaning instructions as part of their 510(k) submission for approval to market a new instrument. This new FDA requirement is contained in their March, 2015 publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”
“Staff education should emphasize the importance of instrument cleaning, both at the point of use and during reprocessing, and how vital cleaning is to keeping patients safe.”5
To reduce a patient’s risk of a dangerous, painful and costly surgical infection, healthcare facilities must demand validated cleaning IFUs from ALL of their instrument suppliers, including take-apart/modular instrument suppliers. As documented in the ECRI Institute report, failure to demand validated cleaning IFUs from instrument manufacturers is a tremendous patient safety issue.
1 CDC publication “Guideline for Prevention of Surgical Site Infection”
2 Davis J., Equipment, environment, and ergonomics: an enigma of infection risk. Pa Patient Safety Advisory 2015 Mar; 12(1):37-40
3 ECRI website (https://www.ecri.org )
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