by William A. Rutala, MPH, PhD

bill-rutala2
William A. Rutala

In September 2015, the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) alerted healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices.1 Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety.  There are at least 8 outbreaks of duodenoscope-related infections of MDROs without reprocessing breaches.2   Additionally, there has been a Senate investigation that reported these outbreaks were not isolated incidents.  Between 2012 and spring 2015, closed-channel duodenoscopes were linked to at least 25 different incidents of antibiotic-resistant infections that sickened at least 250 patients worldwide.3  Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.1

In 2016, The Joint Commission (TJC) has concentrated on reprocessing instructions for semicritical items when they conduct their triennial review.  Below is a list of recommendations for a healthcare facility in North Carolina when TJC surveyors visited each of >30 areas reprocessing semicritical items.  The hospital requested clarification for four of the recommendations (i.e., temperature and potency check of the high-level disinfectant before each use; keep items moist in the transport container by using moistened towel, foam, spray or gel product; and track laryngoscope to an individual patient in the need to identify specific patients with the use of a specific scope). The recommendations for improvement marked with an asterisk are being clarified/challenged. SPICE will keep you informed regarding the disposition of these clarifications.

Issues: 

  • Place the open date and expiration date on products such as high-level disinfectants and chemical test strips (such as minimum effective concentration [MEC] test strips)
  • Transport all instruments to Central Processing (CP) in a container with a moistened towel, foam, spray or gel product*
  • Conduct quality control on the chemical test strips for MEC testing done as recommended by the manufacturer
  • Check and record the temperature of the high-level disinfectant prior to each use*
  • Check and record the potency of high-level disinfectant prior to each use*
  • Track laryngoscopes to an individual patient in case there is a need to identify specific patients with the use of a specific scope*
  • Measure enzymatic cleaner accurately and consistently with manufacturer’s instructions
  • Soak instruments in the enzymatic detergent for a minimum of 2-5 minutes per manufacturer’s instructions (use timer)
  • Transport instruments to CP in a covered  and labeled container with a biohazard sticker
  • Ensure pressure differentials are correct at soiled utility room and decontamination room (negative pressure to adjacent area)
  • Clean instrument shelves in CP regularly
  • Ensure equipment awaiting high-level disinfection in a sink remains moist
  • Transport instruments to CP equipment in a non-permeable container (rigid or non-rigid) that is marked with a biohazardous label
  • Store GI scopes without a “loop” or “circular pattern” that could allow for accumulation of moisture with the lumen
  • Ensure a line of demarcation or ability to differentiate clean equipment from dirty equipment in the reprocessing area.

Healthcare facilities should arrange for a healthcare professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assessment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer.

References

  1. Centers for Disease Control and Prevention. Immediate Need for healthcare facilities to review procedures for cleaning, disinfecting and sterilizing reusable medical devices.  http://emergency.cdc.gov/han/han00382.asp
  2. Rutala WA, Kanamori H, Sickbert-Bennett EE, Weber DJ. Carbapenem-resistant Enteriobacteriaceae and medical devices: Endoscopes and beyond. Virulence, In press.
  1. Murray P. Preventable Tragedies: Superbugs and how ineffective monitoring of medical device safety fails patients.  United States Senate. January 2016. ttps://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf
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