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April 2007: FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations

On April 17, 2007, Food and Drug Administration (FDA) investigators and U.S. Marshals seized all implantable medical devices from Shelhigh, Inc., Union, N.J. The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall and two subsequent warning letters. The FDA considered deficiencies found in the company's manufacturing processes to be significant with respect to the safety and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery.

Physicians should consider using alternative devices and should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients.

If you have comments regarding this update, please contact Romil Rambhia at 516-482-9001 or email at romil@mdiconsultants.com

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