FDA investigators found “significant deficiencies. Earlier today, the U.S. Food and Drug Administration (FDA) seized all implantable medical devices from New Jersey-based Shelhigh Inc., saying that FDA investigators found “significant deficiencies in the company’s manufacturing processes” that “may compromise the safety and effectiveness of the products, particularly their sterility.”
Among the products in question are pediatric heart valves and conduits, surgical patches, dural patches (for tissue recovery after neurosurgery), annuloplasty rings (for repair of heart valves), and arterial grafts. These products are used in a range of settings, including open-heart surgery, neurosurgery, and abdominal, pelvic, and thoracic surgery. According to the FDA, “Critically ill patients, pediatric patients, and immuno-compromised patients may be at greatest risk from the use of these devices.”
Shelhigh’s numerous violations include poorly constructed and poorly maintained processing rooms
Shelhigh’s numerous violations include poorly constructed and poorly maintained processing rooms for sterilized devices; failure to adequately monitor critical manufacturing environments for possible microbial contamination; failure to conduct product tests for sterility and fever-causing contaminants; and failure to scientifically support product expiration dates.
The FDA is asking physicians to “monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device.” They are also telling patients who may have received a Shelhigh device during surgery to contact their physicians. In addition, the agency has asked medical professionals to consider alternate products in light of the findings.
FDA inspection of Shelhigh’s manufacturing facility last fall revealed a series of significant violations
An FDA inspection of Shelhigh’s manufacturing facility last fall revealed a series of significant violations. Yet, Shelhigh failed to correct these violations even after it engaged in a series of meetings with the FDA and after the FDA had sent two warning letters detailing the problems. The agency plans to release more information about the issue later this week.