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Following Olympus email scandal, US representative to push for stringent guidelines for medical device warnings: 7 notes


 United States Rep. Ted Lieu (D-Torrance) is urging Congress to tighten requirements governing medical device warnings, in light of the discovery that Olympus told U.S. executives not to issue a warning to hospitals regarding a possible deadly infection from tainted scopes, according an L.A. Times report.

Here are seven notes:

1. Internal emails from Olympus have surfaced showing that in 2013 the company told executives in the United States that it was not necessary communicate scope-related infection outbreaks in French and Dutch hospitals to U.S. hospitals.

2. Since 2013, almost 35 U.S. patients have died from infections due to contaminated gastrointestinal scopes that Olympus manufactured. Major hospitals across the United States, such as Los Angeles-based Cedars-Sinai and Seattle-based Virginia Mason Medical Center, were the site of severe outbreaks.

3. Rep. Lieu called Olympus’ decision not to issue a warning “despicable,” according to the report.

4. Rep. Lieu filed the Device Act in April, which would require medical device companies to issue safety warnings more broadly. Additionally, companies would have to tell the FDA when they issue safety alerts regarding their devices’ design and cleaning protocols in other countries.

5. Rep. Lieu said he would urge Congress to take up the bill in September.

6. Rep. Lieu has also filed another bill that would require companies to scientifically validate cleaning instructions for their devices.

7. In a statement, the company has said that “patient safety is our top priority. The duodenoscope issue continues to receive the highest level of attention at Olympus.”