Medical Device Consent Decree - July 2, 2007

Shelhigh, Inc., of Union, N.J., agreed to stop distributing its implantable medical devices, used in heart surgery and other procedures, until the company brings its production processes in line with FDA standards.

Shelhigh manufactures 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.

Pediatric heart valves. Every parents' nightmare is to be told that your baby needs heart surgery and possibly an artificial valve to replace the defective valve they were born with. What would you do if your baby had a valve replacement three months ago and today you discover it was a Shelhigh valve?

On April 17, 2007, U.S. Marshals seized all finished devices and components of the devices at Shelhigh's manufacturing facility due to concerns of potential risk of nonsterility.

The consent order requires that the company hire independent expert consultants to inspect its facility and certify to FDA that corrections have been made. (How much do you think this will cost vs. the cost to prevent this from occuring in the first place?)

Read FDA's Press Release announcing this Consent Decree.
Go to: www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

Training Tip
During your GMP training sessions, discuss how nonsterile products could occur in your facility. Discuss the importance of following procedures. Discuss the consequences and cost that Shelhigh now faces and the potential impact on its employees.

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