FDA cites duodenoscope makers for safety violations

duodenoscope 210x210 FDA cites duodenoscope makers for safety violationsThe Food and Drug Administration (FDA) took a first step toward formal legal action against manufacturers of specialized endoscopes called duodenoscopes linked to outbreaks of deadly drug-resistant bacterial infections at some hospitals, issuing warning letters citing manufacturing safety violations.

The warning letters were sent to Olympus, Pentax and FujiFilm for various manufacturing and quality control violations. Olympus and Pentax were also cited for not properly notifying the FDA after learning their scopes were linked to infections. The agency also questioned whether Pentax and FujiFilm obtained proper clearance for their duodenoscopes before marketing them. Olympus was previously cited for this issue, the FDA notes.

Duodenoscpes are specialized endoscopes that are fed down a person’s throat to treat gallstones, tumors and other blockages of the bile and pancreatic ducts. More than a half million procedures using duodenoscopes are performed each year.

The surgical tools were linked to outbreaks of drug-resistant superbugs in hospitals in Pittsburgh, Chicago, Seattle, Los Angeles, Philadelphia, Milwaukee, and Massachusetts. In February, the FDA issued a warning that small crevasses in the scopes can harbor bacteria even after they have been cleaned and disinfected, which can spread the bacteria from patient to patient as the devices are reused. Despite this risk, the agency did not ban the tools, but instead recommended guidelines for hospitals to follow to better clean the tools.

The warning letters issued by the FDA were based on inspections at each of the manufacturers’ manufacturing plants, and serve as a first step toward formal legal action. The letters set strict timelines for duodenoscope makers to address issues cited, and failure to correct these problems can lead to administrative orders, fines and, potentially, federal lawsuits.

Source: USA Today