The failure to adequately reprocess contaminated instruments – that is, to clean and disinfect or sterilize them – before using them on subsequent patients can lead to the spread of deadly pathogens. ECRI Institute has included this topic multiple times on its annual list of the Top 10 Health Technology Hazards. However, a series of fatal infections attributed to the use of contaminated endoscopes, combined with ECRI Institute’s own investigations into poor endoscope cleaning and disinfection practices, prompted the organization to elevate flexible endoscope reprocessing to the top of its 2016 list.
Problem
A key aspect of effective reprocessing is cleaning biologic debris and other foreign material from instruments before the disinfection or sterilization step. This entails initial cleaning of the instrument at the site of use, as soon as possible after the procedure, combined with more thorough cleaning at the reprocessing site. If this precleaning is not carried out properly, the disinfection or sterilization step may not be effective.
Flexible endoscopes in general, and duodenoscopes in particular, are of specific concern because their complex design and long, narrow channels can make effective cleaning difficult. A series of fatal carbapenem-resistant Enterobacteriaceae (CRE) infections that attracted a lot of attention in 2014 and 2015 illustrates this concern: The deaths were associated with the use of duodenoscopes that had not been successfully disinfected between uses.
Facilities need to emphasize to their reprocessing staff that inattention to the cleaning steps within the reprocessing protocol can lead to deadly infections.
Background
Cross-contamination of patients due to ineffective reprocessing of reusable medical devices is a recognized source of infection. For endoscopes, effective reprocessing requires careful adherence to a multistep protocol, typically encompassing the following:
• 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 (often, the channels are also flushed with alcohol)
• Storage and handling
The cleaning stages are mostly manual processes; thus, it’s possible that staff will not perform the required steps consistently. Concern also exists that staff will target these stages for shortcuts if they feel pressured to complete the reprocessing process quickly, as can occur if the demand for instruments is high.
Failure to preclean and keep instruments moist at the point of use before they are transported to the reprocessing area can result in the formation of biofilms that are exceedingly difficult to remove once they have been allowed to dry. In addition, bioburden and residual soil on the interior or exterior surfaces of the instrument can shield microbes from disinfection or sterilization. A key factor in the case of duodenoscope CRE infections is that the instrument’s complex design contributes to inadequate cleaning.
Our investigations have also shown that poor communication between reprocessing staff and clinical personnel can adversely affect the reprocessing function. For instance: An environment in which the needs of reprocessing staff are not considered can lead to unreasonable expectations and, ultimately, ineffective reprocessing. Health care facilities should instead promote a culture of teamwork between reprocessing and clinical staff, rather than allowing an “us and them” mentality to persist.
ECRI Institute Recommendations
Clinical managers should take the following steps:
1. Emphasize to all personnel involved in the reprocessing (cleaning and disinfection or sterilization) of reusable medical devices that inattention to the cleaning steps within the reprocessing protocol can lead to deadly infections.
2. Assess your reprocessing program to identify and rectify factors that could contribute to poor instrument cleaning. Such factors include:
a. Missing, incomplete, or inaccessible reprocessing instructions.
b. Inadequate training.
c. Inconsistent cleaning practices, possibly resulting from an underappreciation of the importance of these steps.
d. Insufficient work space, equipment, or supplies to perform the task effectively.
e. Time constraints, which can lead to demand-driven reprocessing shortcuts
f. Instrument designs that make cleaning difficult.
3. Verify that reprocessing procedures are:
a. Clearly documented (i.e., available in print or electronic form.)
b. Comprehensive, covering all steps including precleaning at the site of use.
c. Model-specific – reprocessing instructions can vary from one model of endoscope to another.
d. Readily accessible for review by personnel with reprocessing responsibility.
e. Up to date, reflecting the equipment, cleaning agents, and processes that are currently in use.
4. Review procedures periodically to confirm that they meet the above criteria.
5. Train appropriate personnel in the correct reprocessing methods. This should be done:
a. When individuals are first given reprocessing responsibility (e.g., when hired)
b. Before they are asked to reprocess any new device
c. When any changes are made to the process
6. Institute a method for assessing competency on an ongoing basis, and provide refresher training at regular intervals to help staff sustain competency. The U.S. Centers for Disease Control and Prevention (CDC) recommends that training be provided at least once a year (For details, see: http://emergency.cdc.gov/han/han00382.asp).
7. Monitor adherence to protocols and the quality of instrument cleaning.
Additional steps are described in the complete ECRI Institute report. Visit www.ecri.org/hazardsolutions to learn more.
Need Help? Check Out Our Solutions Kit
Awareness of critical health technology hazards is a key first step. The next steps involve taking action to prevent the problems from occurring. ECRI Institute now offers a 2016 Top 10 Health Technology Hazards Solutions Kit with comprehensive discussion of each topic, actionable recommendations for minimizing the risks of harm, and lists of useful resources for more information about each topic. For questions about the technology hazards or to purchase the comprehensive Solutions Kit, visit www.ecri.org/hazardsolutions, or contact ECRI Institute by telephone at 610-825-6000, ext. 5891, or by email at clientservices@ecri.org.