Defective Medical Device Lawyers
FDA Requests A Recall of Shelhigh Medical Devices
On April 17, 2007, U.S. Marshals seized all medical devices and components at Shelhigh, Inc.’s Union, New Jersey facility, and the U.S. Food and Drug Administration (FDA) requested that Shelhigh recall its products voluntarily after claiming to have found considerable deficiencies in its manufacturing processes.
Shelhigh, which is primarily known for its No-React tissues declined, arguing that the FDA allegations are unfounded. Shelhigh’s founder, Dr. Shlomo Gabbay, expounded, "I just hope that the FDA halts its public posturing and returns to discussions with Shelhigh ... so that [we] can return to the business of saving lives.”
Shelhigh’s No-React tissues have had a long-term proven ability to resist infection and calcification, even in cases of active heart valve infection. The company’s proprietary No-React tissues make use of a glutaraldehyde fixation process that avoids acknowledged problems associated with glutaraldehyde.
Shelhigh currently offers a variety of cardiothoracic surgical solutions that incorporate the No-React tissues, including those for valve replacement in open heart surgery, and for soft tissue structure repair in abdominal, brain, heart, lung, pelvic, shoulder and spine surgery.
With regard to the FDA recall request, the FDA claims that Shelhigh’s own records indicate that there were numerous sterility test failures of its products, and improperly performed retests. The FDA further contends that the substandard way in which the products were made increases the likelihood that they are not sterile and otherwise deficient.
In response to the FDA recall request, Dr. Gabbay stated that an independent International Organization for Standardization (ISO) certified laboratory was contracted to perform sterility testing of its products. He further asserted “our firm has implemented sterility testing procedures that have been in effect since prior to 2000 and have been reviewed through numerous FDA inspections of the Shelhigh facility... For the FDA to allege that these procedures are now in violation of regulations is inaccurate and misleading."
The FDA had based the “in place” seizure of Shelhigh products on allegations that the company failed to adhere to the Quality System (QS) regulation and that it failed to correct its violations despite several warnings. Seizing in place means that rather than physically removing the products, the manufacturer is not allowed to ship them without prior written permission of the U.S. Marshal. The alleged violations include:
- Failure to properly test products for fever-causing contaminants and sterility
- Poorly constructed and maintained “clean room” where sterilized devices are processed further
- Failure to adequately monitor critical manufacturing environments for potential microbial contamination
- Failure to adequately support product expiration dates
The FDA recommends that physicians consider using alternate devices and monitor patients with Shelhigh implants for infections and proper functioning over the devices’ expected lifetime. The FDA further recommends that patients who suspect that they may have received a Shelhigh device during surgery contact their physician.
A list of medical devices manufactured by Shelhigh can be found in an April 17 FDA press release at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01612.html.
If you believe you have been injured by a medical device manufactured by Shelhigh, please contact one of our defective medical device attorneys today.
