- FDA is pushing hospitals to switch to duodenoscopes that have disposable components or are fully disposable after seeing updated postmarket safety data.
- Postmarket surveillance studies on fixed endcap design duodenoscopes found 4.1% to 6.6% of samples tested positive with organisms such as E. coli that are more often associated with disease after contamination. Olympus and Pentax are withdrawing fixed endcap devices.
- FDA shared details of the transition on the same day that it wrote to healthcare providers about a Karl Storz recall that requires users of certain urological endoscopes to stop all high-level disinfection methods for affected devices in response to doubts about their effectiveness.
The contamination of reusable duodenoscopes has risen up FDA's list of concerns in recent years, as the agency has followed up a 2019 alert that advised healthcare providers to consider going disposable with 10 reports of device malfunctions the following year.
Third parties have recognized the risk, too. ECRI, a nonprofit that works to improve the safety of healthcare, listed poor duodenoscope reprocessing among its top 10 health technology hazards for 2022.
Now, FDA has strengthened its line against reusable duodenoscopes. The latest recommendations state that healthcare facilities should use duodenoscopes that have disposable components or are fully disposable. FDA wants facilities that still use fixed endcap duodenoscopes to transition to newer models with disposable features. Some manufacturers are offering no-cost upgrades, according to the agency.
FDA previously said hospitals should "consider using duodenoscopes that have disposable components." The strengthening of FDA's position, which includes the removal of a statement that "the risk of infection from inadequate reprocessing is relatively low," follows the competition of postmarket surveillance work.
The studies found between 4.1% and 6.6% of samples from Olympus and Pentax devices tested positive with high concern organisms that are often associated with disease after contamination. Olympus and Pentax are withdrawing the devices from the market. Fujifilm pulled its fixed endcap device before the completion of its study.
FDA has early data from a study of a Fujifilm device with a removable cap. After testing 417 samples, more than half of the targeted total, Fujifilm has seen two positive results for high concern organisms, resulting in a rate of 0.5%. None of the samples tested positive for enough low concern organisms to indicate a reprocessing failure.
Fujifilm, Olympus and Pentax now all market duodenoscopes with disposable components. Hospitals also have access to fully disposable duodenoscopes from Ambu and Boston Scientific.
The concerns about reprocessed duodenoscopes are echoed in other markets.
On April 1, Karl Storz began recalling reprocessed urological endoscopes after testing showed a manual high-level disinfection process failed to achieve the required efficacy. The manufacturer asked customers to immediately stop using the disinfection method and instead sterilize the devices after each use. Facilities that lack access to an appropriate sterilization method should stop using the devices.
Karl Storz's recall comes one year after FDA disclosed an investigation into 450 reports of contamination and patient infection linked to reprocessed urological endoscopes. The investigation covered devices sold by Karl Storz and Olympus.
Manufacturers have responded to mounting concerns about reprocessed devices by developing disposable alternatives. FDA cleared two disposable endoscopes in May 2021 and granted a 510(k) clearance to Boston Scientific's single-use bronchoscope later in the year.