FDA Warns Endoscope Manufacturers
On August 12th, the FDA sent warning letters to the main manufacturers of the endoscopes that were responsible for the transmission of antibiotic resistant bacteria to patients cause serious illness, some fatally. As previously reported on this blog, the underlying problem is the inability to effectively clean all the intricate lumens and lacunas within the scopes.
In its letter to Olympus, the FDA cited the duodenoscope manufacturer for failing to timely report patients deaths due in part to their products and gave it 15 days to respond with corrective action. Olympus should be feeling humbled now, but at least the folks there can take some solace in that they do not work in the Quality Departments at Fujifilm or Hoya Corporation.
In a scathing letter to Fujifilm concerning its duodenoscopes, the FDA cited them for
- Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30
- failed to properly validate ethylene oxide sterilization (only ran 1 test)
- Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a)
- and a long list of other failures in their Quality system
Fuji Film was given 15 days to respond with corrective action.
Hoya Corporation (Pentax) also received a similar letter from the FDA, citing them for multiple failures in their Quality System too, including failure to properly validate EtO sterilization of their endoscopes – they tested a different model and assumed the same result and failure to notify the FDA when their product causes a patient death.
With the cross contamination of endoscopes having been in the news so much in the last few years, and patients being sickened and some dying; these companies should have expected FDA audits. If so, then why did Fuji Film and Hoya Corporation, large multinational medical device manufacturers, not fix their quality systems before the FDA came to visit; or better still, not need to fix them?