Posted on November 15, 2016 by Cogentix Medical

Inadequate Device Cleaning Remains a Top Issue: The 2017 ECRI Report

Colorful cleaning supplies“The use of contaminated medical instruments can lead to disabling or deadly patient infections or instrument malfunctions.” This summary statement explains why inadequate cleaning of complex reusable instruments claims the #2 spot of the Top 10 Health Technology Hazards for 2017 published by the ECRI Institute, a non-profit organization dedicated to helping healthcare facilities better manage patient safety risk.

The cleaning of reusable instruments has been highlighted as a major issue by ECRI since 2010. In fact, the top hazard in the 2016 ECRI report was inadequate cleaning of flexible endoscopes. While inadequate cleaning has dropped from the top hazard in 2016 to second-biggest hazard in 2017, the list of implicated products has grown, based on reports the ECRI Institute has received involving a variety of contaminated medical instruments that have been used, or almost used, on patients.

“Complex, reusable instruments—such as endoscopes, cannulated drills, and arthroscopic shavers—are of particular concern,” the ECRI report notes. “They can be difficult to clean and then disinfect or sterilize (i.e., reprocess) between uses, and the presence of any lingering contamination on, or in, the instrument can be difficult to detect.”

Another Top Hazard Related to Cleaning

While inadequate cleaning of reusable devices claims the #2 spot, it’s not the only top hazard related to cleaning. Claiming the 10th place on the top hazards list are device failures caused by cleaning products and practices. The crux of the matter, according the report, is that there is no single cleaner or cleaning process that will work with all devices. As a result, there is the need to stock multiple cleaning products and train staff on numerous device-specific cleaning methods. The report goes on to say that, "Failure to do so can lead to ineffective cleaning (a potentially deadly circumstance), as well as excessive component breakage and premature equipment failures (which can affect patient care and be a significant financial burden)." 

Updated Guidelines for Endoscope Reprocessing

One frustrating thing about the persistence of superbug outbreaks is that infections have occurred despite compliance with established guidelines. As a result, this year saw the emergence of new and updated recommendations, including an in-depth endoscope reprocessing guideline from AORN which focuses on all aspects of the process from room set-up, pre-cleaning, transporting, leak testing, manual cleaning, inspecting, high level disinfection or sterilization, storage, recording, quality management and even personnel.  

There is increased scrutiny on the certification and training of reprocessing staff.  According to the OR Special Report: Recent Guidelines Refine Endoscopy, legislators are even getting involved.  “Legislatures want to know what kind of infection prevention programs are being followed in endoscopy units and if qualified people are doing the appropriate jobs,” the report states. Currently, there are no certifications required for reprocessing.  As a result, unlicensed staff are only as good as the person who trains them.

All of this underscores the sentiment that that in order to ensure endoscope safety, a facility needs to assume stringent reprocessing practices and staff training which is both complicated and costly. Even then, some question whether these measures are enough. Sharon A. Van Wicklin, MSN, RN, CNOR, CRNFA, senior perioperative practice specialist for AORN, had this to say at the AORN Surgical Conference & Expo 2016. “We know that endoscopes are very complex in their design and that complexity increases the efficiency and effectiveness of endoscope procedures, but it also creates very significant challenges for reprocessing.”

Easier and Safer Reprocessing

What if something could make endoscope reprocessing easier and safer? That’s the goal of the EndoSheath® Protective Barrier which is designed to drastically reduce reprocessing time of the PrimeSight™ Endoscope between procedures. In addition, the use of the EndoSheath also eliminates the need for the caustic chemicals used in conventional scope reprocessing. 

How is this possible? The sterile, single-use EndoSheath Barrier covers the endoscope and completely isolates it from patient contact. The EndoSheath Barrier incorporates a sterile channel for suction, irrigation, and tool passage. At the completion of the procedure, the scope is removed from the sheath which contains the working channel and the associated contaminants.

Reprocessing between procedures involves a quick rinse and a rapid wipe-down routine involving enzymatic cleaner and 70% ethyl/isopropyl alcohol.  Then, the scope is ready for a new EndoSheath barrier. The process takes just three steps and ten minutes, compared with the lengthy steps and time required with conventional reprocessing. That’s fewer steps requiring training and fewer chemicals to keep track of.

But most importantly, these improvements to the reprocessing method translate to meaningful clinical outcomes. There have been no reported cases of patient cross-contamination after two decades and over five million procedures.

The Complete List: Top 10 Health Technology Hazards for 2017

  1. Infusion Errors Can Be Deadly If Simple Safety Steps Are Overlooked
  2. Inadequate Cleaning of Complex Reusable Instruments Can Lead to Infections
  3. Missed Ventilator Alarms Can Lead to Patient Harm
  4. Undetected Opioid-Induced Respiratory Depression
  5. Infection Risks with Heater-Cooler Devices Used in Cardiothoracic Surgery
  6. Software Management Gaps Put Patients, and Patient Data, at Risk
  7. Occupational Radiation Hazards in Hybrid ORs
  8. Automated Dispensing Cabinet Setup and Use Errors May Cause Medication Mishaps
  9. Surgical Stapler Misuse and Malfunctions
  10. Device Failures Caused by Cleaning Products and Practices

To develop the annual list, the ECRI Institute’s multidisciplinary staff of engineers, scientists, nurses, physicians, and safety analysts relies on resources from the Institute's nearly 50-year history, as well as expertise and insight gained through testing and analyzing healthcare technologies. Topics on the list include factors such as severity, frequency, breadth, insidiousness, profile, and preventability.

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