Shelhigh Medical Device Manufacturer - Under the Gun - FDA Claims of Repeated Problems with Contamin

Many of us remember the TV Shows The Six Million Dollar Man and The Bionic Woman, but most of us had no idea how close we would come to rebuilding our human bodies in the 21st century. Inventions and advances in medical technology have given so many a second chance at life.

But, many times there may be a price to pay, as in the case of Shelhigh. Shelhigh is known for producing some of the best and most lauded medical devices available for the last ten years, but problems with repeated contamination at Shelhighs single facility in Union, NJ not only caused a recent FDA recall but these continued contaminations during the manufacturing process have potentially put at risk those patients who have been implanted with Shelhigh devices.

Shelhighs 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.

Shelhigh is well-known for its No-React tissue products which were developed for the express purpose of resisting infection. Unfortunately, even if the product was well-developed, the fact that it has been manufactured in a physical environment that itself was contaminated is not only counterproductive to Shelhigh, but dangerous to those who have trusted this company with their very lives.

Who is at risk? Because infection can best breed in those who are already compromised, critically ill patients, pediatric patients, and those with other diagnosed immuno-compromising illness are most at risk, because their bodies are unable to fight off the most innocuous infections.

Shelhighs medical devices include pediatric heart valves and conduits, which are tube-like devices used for blood flow; surgical patches; dural patches; annuloplasty rings and arterial grafts.

The following is a list of Shelhigh products:

Shelhigh BioRingT (annuloplasty ring)
Shelhigh GoldT perforated patches
Shelhigh Internal Mammary Artery
Shelhigh No-React Dura Shield
Shelhigh No-React EnCuff Patch
Shelhigh No-React Pericardial Patch
Shelhigh No-React Pneumopledgets
Shelhigh No-React VascuPatch
Shelhigh No-React Stentless Valve Conduit
Shelhigh No-React Tissue Repair Patch/UroPatchT
Shelhigh Pericardial Patch
Shelhigh Pre Curved Aortic Patch (Open)
Shelhigh Pulmonic Valve Conduit No-React Treated
Shelhigh BioConduitT stentless valve
Shelhigh BioMitralT Tricuspid valve
Shelhigh Injectable Pulmonic Valve System
Shelhigh MitroFast Mitral Valve Repair System
Shelhigh NR2000 SemiStentedT aortic tricuspid valve
If you are a patient who may have received one of these devices:

1. Contact the surgeon who performed your surgery and have your records checked to see if one of the affected devices was, in fact, implanted.

2. If you already know that you have one of the affected devices, then contact your doctor promptly.

3. If your doctor gave you after-care instructions when you left the hospital, be sure to strictly adhere to those instructions.

4. Be certain to contact your surgeon or family doctor if any signs of infection are present. Signs include, but are not limited to:

a. Fever

b. Unusual pain, swelling, redness, and warmth in the area of your implant

c. Drainage or discharge from the incision used during the procedure to implant the device

As a patient, please understand that the seizure of Shelhigh medical devices only means that the existing devices at the company will not be introduced into the market until and when the FDA determines that sanitary conditions within the manufacturing plant have been remedied. While some types of contamination may affect the life of the medical device, it does not necessarily mean that your device will need to be removed. Seizure is meant to stop further distribution of a product until safety standards are met.

Finally, be certain to notify all of your doctors that you might have a Shelhigh implant that falls within the recalled group.

As we see personal rights, individuals access to the courts and corporate accountability being eroded by pro-business and anti-consumer legislation and rule making by our present lawmakers, we are seeing corporate America becoming more and more brazen in dealing with federal agencies. Corporate America feels that they can get away with most things these days, that the federal regulatory agencies do not have much power and that those agencies certainly are not backed up by the White House. This feeling manifests itself in corporations like Shelhigh defying the FDA.

Article Source: http://www.articleviral.com

Please Rate this Article

5 out of 54 out of 53 out of 52 out of 51 out of 5 

Not yet Rated