The FDA has issued a warning letter to Conformis (NSDQ:CFMS) about the number of failures in the company’s Wilmington, Mass. vaporized hydrogen peroxide (VHP) system, the company said in a regulatory filing.
VHP is used in low-temperature sterilization and is compatible with a wide range of medical instruments and materials, including polypropylene, brass and polyethylene. Unlike ethylene oxide, a carcinogen also used in low-temperature medtech sterilization, VHP emits no toxic by-products.
Conformis said it uses VHP as a limited, alternative sterilization method for a small quantity of products and that the sterility of products leaving the Wilmington facility has not been compromised. The company said it does not expect any interruption in manufacturing or distribution or with its new product launch schedule. (The company won FDA clearance for its latest 3D-designed hip system last month.) Nor does it expect any material impact on its financial results, the filing said.
“The company takes seriously the matters identified in the letter, has worked diligently to address the identified issues, and will respond to the FDA in a timely manner,” Conformis said in the filing. The FDA has not posted the letter on its website.
Conformis said it had been planning to replace the VHP sterilizers and has already purchased and had validated a new onsite sterilizer. The company did not specify the type of sterilizer it had purchased, but said it has filed an application for FDA 510(k) clearance for it.
Neither Conformis nor the FDA immediately responded to requests for comment.