After a rash of reported illnesses and deaths that were linked to poorly-cleaned flexible endoscopes in the summer of 2015, the FDA has implicated manufacturers of endoscope washers as part of the problem.
As a result, the FDA has forced Custom Ultrasonics to recall 2,800 endoscope washers that have been in use in healthcare facilities across the United States. Prior concerns about the effectiveness of these devices in 2012 caused the company to stop manufacturing new washers, but they continued servicing washers that were already in the market.
According to the FDA, there have been ongoing concerns about Custom Ultrasonic's ability to thoroughly disinfect endoscopes with their units. The recall applies to all of the System 83 Plus, Plus 2 and Plus 9 devices that are currently in use.
These automated endoscope reprocessors (AERs) are used by healthcare facilities to reprocess flexible endoscopes in between patient procedures. Custom Ultrasonics is required to prove that their devices are working as advertised and, thus far, they have been unable to provide the required test data to justify their claims. In addition, an inspection of their facilities turned up numerous recurring violations by the FDA which the company failed to address in a timely manner.
Alternative cleaning procedures
As these endoscope washers are being recalled and tested for efficacy, healthcare facilities have been asked to use alternative methods for reprocessing their endoscopes. This means that they need to consult the manufacturer's instructions for use (IFU) to ensure compliance within the facility’s manual reprocessing practices.
Based upon past reprocessing failures leading to these recent infectious outbreaks, healthcare facilities will need to remain vigilant in ensuring best recommended practices are upheld.
The FDA is also asking that facilities who believe they have had infections caused by insufficient sanitization by Custom Ultrasonic's AERs to file an official report with the company to alert them of the issue.
Many people agree that the FDA failed to proactively prevent these infections from happening by allowing Custom Ultrasonics to continue servicing devices for several years before forcing the recall. In addition, very little information about the case was publicly released to the healthcare sites that were affected. This lack of action left care providers without enough information to make informed decisions about their scope cleaning and maintenance procedures that may have potentially prevented infections from spreading.
Going forward, Custom Ultrasonics plans to continue gathering test data and will present their case to the FDA in 2016 to prove that their devices meet minimum sterilization standards to remain in use.
For more information about flexible endoscope repair and maintenance, visit PREZIO Health today. Our experienced team can service and repair a wide range of endoscope devices from major manufacturers.
If your facility needs help with CSPD Optimization, PREZIO Health also offers consultation and training services to ensure that your team is fully informed and up to speed on how to care for and clean all endoscope devices.