Devices & Diagnostics

Health equipment maker Midmark gets FDA warning letter on sterilizers

Healthcare equipment supplier Midmark has received a warning letter from the U.S. Food and Drug Administration relating to the company’s manufacturing of steam sterilizers. Most of the violations listed by the FDA focus on record-keeping issues and manufacturing procedures by Versailles, Ohio-based Midmark. For example, in one violation, the company was cited for failing to […]

Healthcare equipment supplier Midmark has received a warning letter from the U.S. Food and Drug Administration relating to the company’s manufacturing of steam sterilizers.

Most of the violations listed by the FDA focus on record-keeping issues and manufacturing procedures by Versailles, Ohio-based Midmark.

For example, in one violation, the company was cited for failing to monitor production processes to ensure that a device conforms to its specifications. In another violation, Midmark failed to maintain adequate records of acceptable suppliers, contractors and consultants for the sterilizers in question, according to the warning letter.

In a violation that the FDA labeled as “significant,” Midmark was cited for failing to file a report with the agency when the company became aware of a malfunctioning device. In this case, the malfunction involved a sterilizer’s door blowing open during use.

“Please note that it has been established that events involving a malfunction of your firm’s M11 sterilizer, resulting in the door blowing open, is likely to cause or contribute to a death or serious injury if the malfunction were to reoccur,” the FDA said.

In a statement, Midmark CEO Dr. Anne Eiting Klamar said the company takes the issues raised by the FDA “extremely seriously” and is committed to complying with applicable regulations.

“We will begin sending notification letters to customers next week,” she said. “Midmark will continue to work with FDA to ensure that all issues raised are resolved to their satisfaction.”

Midmark sells a wide variety of equipment to the medical, dental and animal health markets. Last year, Midmark signed a distribution deal for a sleep monitoring device developed by Cleveland Medical Devices.

Warning letters are considered by the FDA to be informal and advisory, and don’t necessarily indicate that the FDA intends to take any punitive action against recipients.