The use of contaminated medical instruments can lead to disabling or deadly patient infections or instrument malfunctions. Outbreaks associated with the use of contaminated duodenoscopes – such as those that caused headlines in recent years – illustrate that mistakes or oversights can be fatal. But duodenoscopes are not the only devices that warrant attention. ECRI Institute has received reports involving a variety of contaminated medical instruments that have been used, or almost used, on patients.
The severity of the consequences associated with instrument contamination and reprocessing failures, combined with the persistence of the problem, prompted ECRI Institute to once again include this issue on its annual list of the top health technology hazards. The topic appears as the number 2 hazard in the organization’s Top 10 Health Technology Hazards for 2017 report.
The Importance of Successful Reprocessing
Every day, health care facilities clean and disinfect (or sterilize) thousands of reusable surgical instruments and devices so that they can be used for subsequent procedures. When performed properly, this reprocessing removes residue and potentially infectious materials (e.g., tissue, body fluids, other organic material) and disinfects or sterilizes the instrument so that it can be safely used on the next patient.
When reprocessing is not performed properly or successfully, however, patient cross-contamination is possible, potentially leading to the transmission of infectious agents and the spread of disease. In 2014 and 2015, for example, attention focused on a series of fatal carbapenem-resistant Enterobacteriaceae (CRE) infections associated with the use of duodenoscopes that had not been successfully disinfected between uses. (CRE is a multidrug-resistant infectious agent, and thus can be extremely difficult to treat.) The duodenoscope example highlights a key point: The issue goes beyond the need for reprocessing staff to meticulously follow instructions, device manufacturers also must develop and communicate effective reprocessing procedures for their instruments. Duodenoscopes were found to be very difficult to clean even when hospital staff followed recommended procedures.
While deaths that can be directly attributed to inadequate reprocessing are rare, the highly publicized cases of CRE infections illustrate the significant harm that can result when contaminated devices are not cleaned effectively during reprocessing.
“Complex, reusable instruments – such as endoscopes, cannulated drills, and arthroscopic shavers – are of particular concern,” notes Chris Lavanchy, engineering director for ECRI Institute’s Health Devices Group. Components such as lumens, hinges, cannulated blades, stopcocks, and O-rings can make a device difficult to clean and then disinfect or sterilize between uses. Furthermore, the complex design can make the presence of any lingering contamination on, or in, such instruments difficult to detect.
ECRI Institute’s Investigations
As director of ECRI Institute’s Accident and Forensic Investigation group, Scott R. Lucas, Ph.D., has helped numerous hospitals identify – and correct – weaknesses in their reprocessing functions.
“Typically, a health care facility will contact our investigation group when there has been an incident, such as bioburden remaining on surgical instruments received in the OR,” Lucas states.
The causes, of course, may be unique to that incident or that facility. But Lucas identified a few problem areas that he and his colleagues commonly encounter over the course of their investigations. These include:
• Poor communication between OR staff and staff in the central sterile processing (CSP) department
• Insufficient reprocessing policies in the OR and CSP departments, or poor compliance with the policies that exist
• Insufficient staffing or scheduling to meet workload demands
• Insufficient reprocessing equipment
These challenges exist for all reusable surgical instruments, notes Lucas, but when nuances such as small diameter lumens and retractable, hinged, or otherwise moveable parts are added, “the difficulty of reprocessing increases dramatically.”
ECRI Institute’s Top 10 Health Technology Hazards for 2017 report includes detailed recommendations to help health care facilities institute more reliable processes for cleaning complex reusable instruments.
One critical step, as stressed in the report, is to preclean instruments immediately after use.
“Appropriate precleaning at the point of care makes the job of cleaning and disinfecting (or sterilizing) an instrument easier and more effective,” notes James Davis, senior infection prevention analyst at ECRI Institute. Without precleaning, instrument reprocessing can be compromised, sometimes irreversibly, by dried debris and biofilm formation.
“When contaminated instruments are presented for use,” adds Lavanchy, “the cause can often be traced to an operational failure involving the instrument cleaning steps, including precleaning at the point of use.”
In many instances, clinical staff should be responsible for precleaning because they have the most timely access to instruments immediately after a procedure.
Close coordination between the OR and CSP is likewise important for the successful reprocessing of surgical instruments.
“In our experience,” notes Lucas, “hospitals with the most successful reprocessing functions have CSP and OR departments that have a mutual respect for, and appreciation of, each other’s role in surgical equipment maintenance and reprocessing.” To achieve this, Lucas adds: “hospital leadership and staff must take ownership of this complex system issue.”
Continuing with the theme of communication and cooperation, Lavanchy describes the value of involving CSP staff before new types of surgical instruments are purchased.
“It makes sense to spend a few minutes up front, reviewing new instrument instructions with people who really know how reprocessing is done, rather than discovering after an instrument has been purchased that the cleaning process may prove to be exceptionally challenging,” Lavanchy says.
Additional recommendations described in the report include verifying that comprehensive reprocessing instructions are available to relevant staff and that all steps are consistently followed. Device manufacturers play an important role here: In addition to developing and validating effective cleaning procedures for the products they sell, manufacturers should familiarize hospital staff with the intricacies of their instruments, disclose any cleaning challenges, and detail the appropriate measures for addressing them.
Stay tuned, as more hazards from the list will be uncovered in the next issue of TechNation.
This article supplements ECRI Institute’s Top 10 Health Technology Hazards for 2017. 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/2017hazards, or contact ECRI Institute by telephone at 610-825-6000, ext. 5891, or by email at firstname.lastname@example.org
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