Instituting Manufacturing Changes Without 510(k) Draws Warning Letter

Devicemaker Steris made several significant changes to an FDA-cleared product — changes that warranted a new premarket submission, according to a recent warning letter.

However, it did not submit a new 510(k) for the changes to its System 1 Processor, including the Sterilant 20, a liquid chemical sterilizer for medical instruments. The device was cleared in 1989.

An FDA review of Steris’ records revealed modifications to design, components, intended use or method of manufacture, the letter said. Several of the changes could significantly affect the safety or effectiveness of the device, it added.

For example, Steris made a “large increase” to the cleared device’s chamber volume, and the Sterilant 20 formulation was altered to maintain peracetic acid concentration with the larger volume. The firm added five ingredients to the formulation of the Sterilant 20, the letter said.

In addition, the device’s high-pressure pump was changed to a model with a different flow rate in response to consumer complaints about leaks. This change altered the flow rate and characteristics of the pump.

The letter cited the firm for sending a notice to customers announcing changes to the connector design of its Quick Connect kits. The design alteration followed microbiological testing failures related to the older connectors.

The company said it has assembled a cross-functional team to address the latest letter and will continue to sell and service the System 1 Processor. The warning letter is available at www.fda.gov/foi/warning_letters/s6781c.pdf.