FDA investigators and U.S. Marshals announced Wednesday that all implantable medical devices were seized from Shelhigh, Inc. in New Jersey due to significant deficiencies in the manufacturing processes.
According to the FDA, those deficiencies can compromise safety and effectiveness of the products and their sterility.
The products seized include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts. These products are used in surgical settings, such as open heart surgery and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery.
The manufacturing violations include:
• Manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed
• Failing to adequately monitor critical manufacturing environments for possible microbial contamination
• Failing to properly test products for sterility and fever-causing contaminants and
• Failing to scientifically support product expiration dates.
The seizure was the result of inspections at Shelhigh last fall. The FDA warned the company and notified it that failure to correct the violations could result in enforcement action.
Physicians are being asked to consider using alternative devices and closely monitor patients that have had a Shelhigh implant.
FDA will issue a Preliminary Public Health Notification to physicians and a Preliminary Advice for Patients in the near future.