Federal regulators have found safety violations in the manufacturing practices of all three companies producing a specialized type of medical scope that has been linked to a deadly series of superbug outbreaks at U.S. hospitals.
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As per the letter by FDA, the company did not tell the federal agency until this year when the Tokyo headquartered company was already under scrutiny for a number of outbreaks. Olympus and Pentax were specifically cited for failing to relay to FDA reports that their devices “may have caused or contributed to a death or serious injury” within 30 days of learning about the event.
The infections reported to Olympus involved Pseudomonas aeruginosa, a common strain typically found in people with weakened immune systems, such as hospital patients. Hospital staff at Cedars-Sinai and UCLA medical centers said the infections occurred despite following Olympus’ instructions for cleaning the devices, known as duodendoscopes. The FDA says the companies failed to report problems with the scopes as required by law and in some cases failed to ensure that the devices could be adequately cleaned.
The warning letters, based on inspections of all three manufacturers’ production facilities, are the first step toward formal legal action, setting strict timelines for the companies to address the problems cited.
The U.S. Department of Justice subpoenaed documents for all three manufacturers as part of an FDA investigation, according to the L.A. Times.
Duodenoscopes are reusable medical devices which inserted into the throat of a patient so as to help diagnose or treat any gastrointestinal tract disorders. The tip of the scope includes moveable instruments designed to remove tumors, gallstones and other blockages. Bodily fluids and other debris can stay in the device’s joints and crevices even after cleaning and disinfection. The FDA has been grappling with the complex structure of the devices, which have proven to be extremely difficult to sterilize before being reused.
The FDA cited numerous violations after officials inspected the facilities of Olympus, Pentax Medical and Fujifilm in Japan and the U.S. earlier this year, records show.
The companies have 15 business days from receipt of the Aug. 12 letters to respond to the violations that were found. The FDA didn’t disclose any potential penalties.
Olympus said it is reviewing the letter.
“Actions have been and will continue to be taken to ensure that our products and processes meet FDA requirements, and pose no risks to the health and safety of the public”, Fujifilm said in a statement.
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Fujifilm insists both its ED-530XT and ED-450XT5 devices are very similar and that since one had been cleared by the FDA, there was no need of clearance for the second one. Hospitals perform hundreds of thousands of procedures involving endoscopes every year, according to the L.A. Times.
