FDA warns makers of superbug-prone devices over testing violations

Since 2013, there have been eight outbreaks of antibiotic-resistant bacteria linked to the devices at U.S. hospitals, according to government figures.

The agency last week sent letters to Olympus, Pentax and Fujifilm, saying the Japanese companies failed to report problems with scopes as they turned up and in some cases, did not make sure the devices could be properly cleaned, Bloomberg reports.

The Food and Drug Administration (FDA) posted a warning letter online on Monday in which the federal agency of the United States Department of Health and Human Services mentioned that Olympus Corp. didn’t inform regulators about 16 infections in patients who had undergone procedures with the Japan-based manufacturer’s scope about three years ago. The FDA has been grappling with the complex structure of the devices, which have proven to be extremely hard to sterilize before being reused.

As per the norms, any medical device manufacturer is supposed to report to the FDA about problems associated with their devices within 30 days of testing. Olympus didn’t report the issues to the FDA till 2015, when the corporate was already beneath scrutiny for a newer collection of outbreaks. And the company did not look into whether possible design or manufacturing problems caused its products to spread infections.

The companies have 15 business days from receipt of the August. 12 letters to respond to the violations that were found. The FDA didn’t disclose any potential penalties.

A spokesman for the Tokyo manufacturer said in a statement: “We are reviewing the FDA’s warning letter so that we can provide the required response in a timely manner”.

In addition, the agency told Fujifilm that its endoscope doesn’t have the necessary clearance from the FDA to be marketed in the U.S. The agency also is evaluating whether Pentax may be violating the same rule. Hospital staff at Cedars-Sinai and UCLA medical centers said the infections occurred despite following Olympus’ instructions for cleaning the devices, known as duodendoscopes.

Despite these problems the FDA has repeatedly said the devices should stay on the market because they fill an important need in a half-million procedures performed each year. And the risk of getting an infection from an inadequately cleaned device is “relatively low” given the number in use, FDA spokeswoman Jennifer Dooren told The Los Angeles Times earlier this month.