ECRI Institute’s “Top 10 Health Technology Hazards” Part II

In Part I of this series (Elmed blog #30) we introduced ECRI Institute’s Health Devices GroupTop 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’sTop 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:

  1. Verify that staff has been trained to perform the reprocessing procedures correctly.
  2. a) Confirm (e.g., through periodic competency testing) that effective reprocessing can be achieved by the staff at your facility, including the steps to be performed by the clinical staff at the point of use (e.g., precleaning immediately after use) and those to be performed by the reprocessing staff.
  3. b) Consider having point-of-use and reprocessing staff observe how their counterparts prepare instruments for reprocessing (i.e., complete their precleaning or cleaning tasks). This cross-observation could help the two groups appreciate the importance of completing their tasks properly, and it may help build an effective team.
  4. Verify that the current inventory of instruments affords sufficient time for each cleaning step to be performed properly. According to the CDC, ‘flash sterilization’ is no substitute for having an adequate inventory of surgical instruments.1
  5. Before purchasing instruments that are new to the facility:
  6. a) Confirm that appropriate, validated reprocessing instructions (IFUs) are available.
  7. b) Review the cleaning requirements with reprocessing and clinical staff.
  8. c) Confirm that staff will be able to meet the requirements. To help with this process, consider using a checklist like the “Patient Safety Impact Assessment Tool” published by the Pennsylvania Patient Safety Authority. That tool provides a reminder to address reprocessing concerns before new types of instruments are introduced into the workflow.2
  9. 7. Consider purchasing only instruments for which the manufacturer has validated its cleaning instructions. Additionally, when applicable, request that the manufacturer provide written information explaining the validation process that was used.3
  10. Remind relevant clinical staff that precleaning immediately after use is critical.
  11. a) Without precleaning, instrument reprocessing can be compromised, sometimes irreversibly, by dried debris and biofilm formation.
  12. b) In many instances, clinical staff should be responsible for precleaning because they have the timeliest access to instruments immediately after use.

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 ( )

4 Op.cit.

5 Op.cit.

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