FDA: Big issues with maker of device linked to infections

FDA taking steps to prevent manufacturer from shipping device into United States, but no indication the administration has any plans to recall devices from existing facilities.

David Weissman
A heater-cooler device at York Hospital, Monday, Oct. 26, 2015, might have caused infections in 10 of York Hospital's open-heart surgery patients. Bill Kalina -

A U.S. Food and Drug Administration warning letter sent last week to the manufacturer of a device linked to infections and deaths in York Hospital patients highlights major issues with the company's tests for its cleaning procedures.

Late in 2015, WellSpan announced that it had identified eight open-heart surgery patients with a rare Nontuberculous mycobacteria, or NTM, infection, and five of those patients have died. Penn State Milton S. Hershey Medical Center found three similarly infected patients, two of whom have died.

What we know: NTM bacterial infection outbreak

The infections have been linked to a heater-cooler device manufactured by German-based Sorin Group, which recently merged with LivaNova.

While the device is not intended to have any direct contact with patients during surgery, there is the potential for contaminated water to enter other parts of the device or transmit airborne bacteria through the device's exhaust vent into the environment and to the patient, according to the FDA.

In June, Sorin sent a notice to its customers alerting them of the potential risks and updated cleaning and disinfection procedures after infections were reported in Europe.

The warning letter states that the FDA conducted inspections at the manufacturer's facilities in August and found, among other issues, that Sorin does not provide adequate information on how its new cleaning procedures prevent biofilm from growing in the devices or causing waterborne infection.

Despite the noted violations, FDA spokewoman Deborah Kotz wrote in an email that the administration is still referring users of the device to its Oct. 15 safety communication, which recommends strictly adhering to the manufacturer's cleaning and disinfection instructions.

"FDA has some concerns about these devices as described in the safety communication and FDA’s warning letter, however, these devices do serve a critical need for improving patient outcomes from many types of surgery," Kotz wrote.

The letter, sent Dec. 29, states that the FDA is "taking steps to refuse entry of these devices into the United States ... until these violations are corrected." The FDA requested that LivaNova respond within 15 business days of receiving the letter with specific steps to correct the violations.

LivaNova intends to respond "timely and fully" to the FDA's requests, according to a company press release.

Kotz wrote that she can't comment on whether the manufacturer has issued a response or any potential FDA follow-up measures. LivaNova did not respond to requests for comment.

When asked whether the FDA informed hospitals of the violations noted in the warning letter, Kotz wrote that it had made the letter available online.

WellSpan spokesman Brett Marcy could not immediately identify whether anyone in the organization had seen the letter.

Lawrence Muscarella, who independently advises and audits hospitals on infection-control practices at his Montgomery County business, said the letter reinforced his belief that the FDA is not doing enough to regulate medical devices.

"With this many problems, it clearly didn't happen overnight," Muscarella said. "(Sorin) is winging it because the FDA has (not proven that it will impose serious consequences)."

Another violation included in the letter is the lack of documentation proving that Sorin tested the updated cleaning instructions "under actual or simulated use conditions to ensure the usability of the cleaning (instructions)."

The original process — which York Hospital admittedly didn't follow — was about six steps, according to WellSpan spokesman Brett Marcy. The new process, posted in a video on Sorin's website, is 56 steps.

The FDA letter states that Sorin has received complaints of patient deaths potentially related to its devices since January 2014, and Sorin determined the users had not been following cleaning instructions, potentially contributing to patient infections.

Other violations included:

  • Cleaning instructions recommend U.S. users use Clorox as a substitute for Puristeril, which isn't available in America, but test report fails to demonstrate the two are equivalent.
  • No description for how the sampling locations, sampling methods and machine conditions used in tests represent worst-case conditions for finding bacteria.
  • Sorin's disinfection and drying procedure does not adequately validate to ensure that the process completely dries the device.
  • Failure to adequately develop, implement and maintain written Medical Device Reporting procedures. 
  • Distributed devices with modified instructions without notifying the FDA and submitting a new Premarket Notification application.

Federal law prohibits manufacturers from selling devices without successful Premarket Notification applications, according to Muscarella, who said that by allowing hospitals to continue using the devices, the FDA is violating policy and procedure.

"And what is the patient about to undergo a procedure (that utilizes that device) being told?" Muscarella asked.

Federal law requires hospitals to inform patients when a device without approved Premarket Notification is being used, but Muscarella doubts that will be the case.

"I think it can be reasonably argued that (these devices) need to be recalled immediately," he said.

— Reach David Weissman at