Creating Strong Sterilization Partnerships

Suppliers Explain How Their Business Model Has Changed as the Device Industry Evolves
by Jennifer Whitney

n early April, the FDA and US marshals dramatically seized products at Union, NJ-based Shelhigh, a manufacturer of implantable cardiothoracic surgical products. Prior to the seizure, which resulted in national headlines, the company received FDA warning letters citing concern with its sterilization (among other issues). For the device industry, there's a clear takeaway message from the Shelhigh debacle: Never forget the importance of ensuring product sterility.

The FDA seems to be on a roll, given additional warnings related to sterilization procedures that were sent in April. Clark Research and Development, Inc., a Folsom, LA-based manufacturer of Biocompatible Hyperfusion Cartridges, was another company recently cited for problems within its sterilization procedures. In April, the FDA sent a warning letter stating that the company’s validation studies for sterilization were inadequate. Specifically, the agency cited numerous problems with Clark's documented summary of an autoclaving process used for its devices