Following the outbreak of several major infectious diseases linked to improperly cleaned and maintained endoscopes, major device manufacturers such as Olympus have redesigned problematic scopes and submitted them for approval by the FDA. Based on a recall of affected duodenoscopes and a clear plan for improvement in the future, the FDA has given approval to Olympus to move forward with their redesigned scopes.
After more than 250 reported infections were traced back to a possible bacteria problem in duodenoscopes used in over 500,000 procedures in the United States, the FDA issued warnings to manufacturers. Further investigation made it apparent that a poor seal at one end of the scope, along with improper cleaning procedures, were allowing bacteria to collect inside of the device and spread to other individuals.
Once the problem was discovered, Olympus issued updated instructions for endoscope cleaning to ensure that hospitals and other care facilities were doing everything they could to reduce the chances of infection. In addition, Olympus issued a recall on the nearly 4,400 affected scopes and plans to replace the seals in a four-day process that will prevent any further collection of fluids, bacteria and other tissue inside the device.
It is expected that all of the duodenoscopes will be repaired by August 2016.
New cleaning instructions
While Olympus works their way through the recall procedure, the FDA and the manufacturer have allowed older scopes to remain in use at facilities, but they must be sterilized using the new, specific cleaning instructions. As long as scopes are being properly cleaned and maintained, they are safe to use and should not slow down the roughly 500,000 annual procedures that use them.
Once all of the scopes have had their elevator mechanism seals replaced, Olympus will be conducting annual inspections on all scopes going forward to check for corrosion and issues with the new seals. This will provide an extra, proactive safety measure.
The Olympus endoscope issue has also put a spotlight on the FDA procedure for dealing with infectious outbreaks, as some officials note that they did not do enough to address the problem when it was first reported. The FDA is gathering further information about how to handle these types of situations in the future, including a change in the way infections are reported by hospitals.
Hospitals that regularly use duodenoscopes in their day-to-day operations should be paying close attention to the changing procedures for the proper cleaning of the Olympus endoscope. PREZIO Health offers endoscope repair services with full knowledge of all industry standards. For more information about endoscope repair and a consultation, please contact us today.