The QMN Weekly Bulletin
Medical Devices / QSR / Inspections and Audits

Duodenoscope, Endoscope Makers Receive FDA Warning Letters

Sept. 25, 2015

Olympus is facing tough questions from the FDA following inspections conducted in April and May of four facilities that manufacture duodenoscopes. The company — along with Pentax and Fujifilm — is facing scrutiny after improper cleaning of its complex endoscopes was linked to patients becoming sick or dying.

In response, the FDA also issued new cleaning recommendations for duodenoscopes.

The FDA says Olympus failed to inform the agency within the required time period that its TJF Type Q-180V had caused patient injuries. That particular model has been linked to at least two deaths at UCLA Ronald Reagan Medical Center in Los Angeles.

The letter cites one complaint referencing 16 patients who contracted a Pseudomonas aeruginosa infection after being treated with one of the company’s duodenoscopes. Some of those treated experienced abscesses. According to the FDA, the company submitted one MDR to account for all of the patients — roughly three years after the events occurred.

“Your firm became aware of the event on May 16, 2012,” the agency says. “The referenced MDR and all additional MDRs associated with the event were received by FDA in 2015, which is beyond the 30 calendar day frame.”

The FDA received a response from an Olympus official addressing the concerns, but says its adequacy can’t be determined. Further, while the response described corrective actions, it didn’t provide evidence of implementation to the FDA.

Inadequate MDR Procedures

In addition, the agency found fault with the company’s MDR procedures, saying there is no internal system for the timely transmission of complete reports.

A company spokesman said that the company is reviewing the letter so it can respond in a timely manner. He adds that Olympus already has taken steps to make improvements, including working on its MDR system.

Regarding the multipatient MDR, he says Olympus submitted an MDR report on the incident on May 25, 2012, following up in 2015 with additional MDR reports to “unbundle” the 2012 report on the 16 patients and include additional information.

TJF Type Q-180V was launched in the U.S. market in 2010 and was based on an existing device, but it was never formally cleared by the FDA. The company says it thought it didn’t have to submit a 510(k), but did so in 2013.

Like Olympus, Pentax also was rebuked for not reporting patient injuries in the required timeframe. In this case, patients developed difficult-to-treat Carbapenem resistant enterobacteriaceae infections.

The FDA cites the company for failing to have adequate MDR procedures. Other issues include failure to establish and maintain design validation procedures to ensure devices conform to user needs and intended uses. According to the agency, the company failed to include testing of production units under actual or simulated use conditions or document the results of design validation in the device history file.

“The validation studies conducted to support the Ethylene Oxide (EtO) sterilization and cleaning and high level disinfection (HLD) instructions for use (IFUs) for the currently marketed device, ED-3670TK, were conducted using different model/series endoscopes. Your firm failed to document why design validation results for the different model/series endoscopes are valid and applicable to the ED-3670TK devices,” the warning letter says.

Pentax says it is reviewing the contents of the letter and will respond within the timeframe required by the agency. The company said it has been working with federal authorities, providers and industry leaders to address concerns related to the devices.

Fujifilm took heat for, among other problems, not having a proper reprocessing validation for the ED-530XT duodenoscope by not including an evaluation of the effects of reprocessing on the O-ring. Also, the company failed to verify that the LT-7F manual air leak tester could adequately perform the required task. The ED-530XT model also lacked FDA clearance.

Fujifilm said it is actively working with the FDA to ensure its products and processes meet FDA requirements. That includes filing a 510(k) application for the ED530-XT on Aug. 10, a FujiFilm spokeswoman said.

CAPA violations and failing to follow FDA protocols when dealing with and processing complaints are the two easiest ways to get a warning letter. Stay out of trouble by ordering our management report Medical Device Complaint Management: A Guide for Compliance, which spells the do’s and don’ts of effective device complaint management!