ECRI Institute’s annual list of the Top 10 Health Technology Hazards serves two key functions: It raises awareness about critical hazards associated with medical devices and systems, and it promotes solutions that can help prevent patient harm.
Each year, the nonprofit research organization identifies 10 health technology topics that warrant priority attention. Some are newly developing threats. The top hazard for 2018 – ransomware and related cybersecurity risks, which we described in last month’s issue – is one such example. Others can be classified as perennial concerns. This year’s Number 2 hazard – endoscope reprocessing failures – falls into that category.
ECRI Institute has addressed cross-contamination from flexible endoscopes and other reusable medical devices and instruments in eight of the 10 previous editions of its list. Continuing reports of patient exposures to contaminated scopes, along with studies highlighting the challenges of endoscope reprocessing, underscore why this topic remains a critical concern.
A Continuing Challenge
The failure to adequately reprocess contaminated flexible endoscopes – that is, the failure to clean and disinfect or sterilize the instruments before using them on subsequent patients – can have deadly consequences. Numerous reports in the clinical literature, as well as in the lay press, attribute the spread of fatal infections to scope reprocessing failures.
Even in the absence of known infections, however, the discovery of inadequate scope reprocessing requires critical action. All too often, health care facilities have had to contact hundreds of patients to let them know that they might have been exposed to a contaminated endoscope.
ECRI Institute and others have published extensively on this topic; yet incidents continue to occur.
One reason the problem persists is that reprocessing is a multi-step process, with several manual steps that must be performed consistently and correctly. Missed steps or poor technique caused by insufficient training, time pressures, the use of out-of-date instructions, or a host of other factors can compromise the process.
Recently, a study monitoring the quality of endoscope reprocessing raised an additional concern. In the February 2017 edition of the American Journal of Infection Control, Ofstead et al. reported the alarming finding that even when staff adhere to vendor instructions, the instruments sometimes remain contaminated after reprocessing. (See: Ofstead et al. Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures, Am J Infect Control 2017 Feb 1;45(2):e26-e33.)
Concerns also exist that it may not even be possible to reliably reprocess some types of scopes. Several models of duodenoscopes are being withdrawn from the market due to such concerns.
So what’s a health care facility to do?
Don’t Ignore These Steps
Effective endoscope reprocessing requires careful adherence to a multistep protocol. Typical steps include: precleaning in the room where the procedure was performed, transport to the reprocessing room, leak testing, manual cleaning, sterilization or high-level disinfection, rinsing and drying, and storage and handling
ECRI Institute’s 2018 report highlights two problematic areas in the reprocessing protocol that require particular attention:
1. The manual cleaning steps. Effective disinfection or sterilization requires that biologic debris and other foreign material be cleaned from the endoscope first. Because reprocessing efforts can be hindered by dried, hard-to-remove residues, flexible endoscopes and accessories should be precleaned at the point of use as soon as possible after the endoscope is removed from the patient. Additional cleaning should then be conducted in the reprocessing room.
Cleaning endoscopes effectively is challenging because it is a largely manual, technique-dependent process. Thus, access to complete and current reprocessing instructions, comprehensive staff training, the availability of appropriate cleaning agents and supplies, and the allotment of sufficient time to do the job right are keys to successful reprocessing.
Additionally, health care facilities should consider instituting quality control (QC) measures to verify the cleaning of reprocessed endoscopes. For instance: A lighted magnifier can be used to improve inspection of the instrument’s external surfaces before the final disinfecting step. The use of a borescope can be considered to inspect internal channel surfaces. A healthcare facility might even want to add biochemical testing to its QC program. Such testing can identify trace levels of adenosine triphosphate (ATP), protein, or blood that remain on, or in, an endoscope after inadequate cleaning.
2. Instrument storage after reprocessing. Moisture trapped in the channels of an endoscope can promote the proliferation of any microbes not eradicated by reprocessing. Thus, the instruments must be stored in a manner that facilitates the drying of channels.
The use of drying cabinets with filtered, forced air can help dry any moisture retained in the channels following reprocessing. ECRI Institute notes that the most efficacious solution might be to use drying cabinets with channel connectors that direct air through the channels.
Following are a few additional recommendations from ECRI Institute:
Stay tuned for the next issue of TechNation, where more hazards from the list are uncovered.
– This article supplements ECRI Institute’s “Top 10 Health Technology Hazards for 2018.” An Executive Brief of the report can be downloaded from ECRI Institute as a free public service. The full report, which includes detailed problem descriptions and recommendations for addressing the hazards, requires membership in certain ECRI Institute programs or separate purchase.
For more information, visit www.ecri.org/2018hazards, or contact ECRI Institute by telephone at (610) 825-6000, ext. 5891, or by e-mail at email@example.com.
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