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U.S. Department of Health and Human Services

Medical Devices

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Questions & Answers on Shelhigh Medical Devices (June 26, 2007)

FDA’s June 22, 2007 consent order with Shelhigh, Inc., Union, N.J., has generated interest from the medical community and the general public. The following will help answer questions.

Why did Shelhigh enter a consent order with FDA?

Shelhigh failed to adhere to the Quality System (QS) regulation (which describes current good manufacturing practice), required by law, and failed to correct its problems despite several warnings from the FDA. When a medical device manufacturer does not adhere to the QS regulation requirements, the manufacturer cannot assure the public that the finished products are safe and effective, or that products labeled as sterile are in fact sterile.

On June 22, 2007, Shelhigh, Inc. entered a consent order for condemnation and permanent injunction, under which the firm has agreed to stop manufacturing and distributing all components and devices until their methods, facilities, and controls used to manufacture their devices are in compliance with FDA law. This action follows the April 17, 2007, seizure of all implantable devices at Shelhigh’s Union, NJ manufacturing facility. The consent order can be found at: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/ucm056167.htm

Will Shelhigh be able to manufacture and distribute devices?

Shelhigh may resume manufacturing new devices in phases after FDA review and approval for each manufacturing phase. Shelhigh, however, will not be allowed to distribute devices until their manufacturing methods, facilities, and controls are in compliance with FDA law and the terms of the consent order.

Does the consent order address the seized devices?

The consent order also addresses the devices seized at Shelhigh’s Union, NJ facility on April 17, 2007. Under the terms of the consent order, Shelhigh may submit a plan for reconditioning seized devices. FDA will review this plan and if it is acceptable, FDA will approve it. Shelhigh will only be able to further process and distribute any seized devices or components that are successfully reconditioned in accordance with an approved plan and as long as Shelhigh’s manufacturing methods, facilities and controls are in compliance with FDA law and the terms of the consent order.

What products are involved?

Shelhigh’s devices 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. A list of products manufactured by Shelhigh is included in FDA’s April 17 press release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108893.htm.

What are FDA’s recommendations for physicians and patients who may have one of the Shelhigh devices?

FDA’s recommendations continue to remain the same. Physicians should carefully consider using alternate devices. The agency recognizes that each physician must make a risk-benefit decision based on the individual needs of each patient when considering use of a Shelhigh implant especially when no an alternate device is available.

Physicians 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.

Further recommendations for physicians are is available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062066.htm.

Advice for patients is at available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm064700.htm.