Updated: Mar 10, 2022
With infections risks climbing endoscopes are going through significant changes.
The ANSI/AAMI ST91:2021 update is looming. It should be released at any time, and with it comes a change in the thought process to move away from high-level disinfection (HLD) to sterilization for the reprocessing of endoscopes. At this time, there is limited availability for sterilizers approved for reprocessing long multichannel endoscopes (e.g., colonoscopes, duodenoscopes). However, sterilization may not be the only option.
Essentially, the new recommendations for endoscope reprocessing follow previous recommendations for stainless steel instruments categorized for HLD, based on the Spaulding classifications, and are now recommended to be sterilized if acceptable, similar to laryngoscope blades. There is no doubt that sterilization is the preferred method of reprocessing. For endoscopes, reprocessing cycle time was always the issue. You can sterilize multichannel endoscopes with ETO, but because of cycle times, you only get one use for each scope a day. The cost of inventory is prohibitive. Manufacturers are now working on hybrid and disposable endoscopes.
Hybrid endoscopes are designed to replace the insertion tube after each use while the control head is disinfected. This design should significantly reduce the opportunity for cross-contamination. The term in healthcare for devices like this is reposable, part reusable and part disposable. There are already many examples of products like this in circulation. The advantage of utilizing reposables is in reducing landfill waste vs. disposable instruments. Another benefit would be lowering repair costs because most repairs on endoscopes are with the insertion scope.
Disposable endoscopes still have their place. Smaller Sterile Processing Departments (SPD) may not run 24 hours a day or even seven days a week. The opportunity to utilize a disposable scope after hours brings its advantages. Currently, disposable endoscopes are limited to smaller airway scopes. But, at the cost of around $400 per use, the price tag is significantly lower than a scope that goes unprocessed for hours or days and develops repair costs due to the increased difficulty of reprocessing. The repair cost can be in the thousands of dollars. Having disposable scopes as part of your inventory also eliminates the reduction of clean or sterilized endoscopes in your inventory, allowing for delayed on-time case start times, and turnover needs to be reduced.
The endoscopy world is undergoing significant changes, with infection control issues driving the change. Most recently, difficulty with reprocessed urological endoscopes has emerged. This acknowledgment is now coupled with the reprocessing issues already known about colonoscopes and duodenoscopes. The CDC predicts an increase in endoscope cases of 50% by 2050. A single approach to managing endoscopes may be short-sighted. ANSI/AMMI's new guideline ST91:2021 has numerous recommendations for change, including point-of-use treatment, enhanced visual inspection, endoscope drying, and others. For healthcare institutions to manage their endoscope inventory in the future, a risk assessment will be needed. A multifaceted approach in inventory, the design of the reprocessing areas, and the training of staff who reprocess the endoscopes will be required.
At Evolved Sterile Processing, our consultants have a greater focus on sterile processing. With our decades of experience, we will help you develop better processes and educational resources for your staff.