The U.S. Food and Drug Administration (FDA) today issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns.
On April 17, 2007, U.S. Marshals, at FDA's request, seized all medical devices including components at Shelhigh's Union , N.J. facility after finding significant deficiencies in the company's manufacturing processes. During the seizure, Shelhigh was asked to perform a voluntary recall of its products, but the company declined.
FDA recommends that doctors and hospitals consider using alternative products.
"Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection," said Daniel Schultz, M.D., director, FDA's Center for Devices and Radiological Health. "FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter."
The company's deficiencies, described in a complaint filed with the U.S. District Court of New Jersey, may compromise the safety and effectiveness of the devices. Shelhigh's own records indicate a number of sterility test failures and that its testing and retesting procedures were not properly performed.
Shelhigh devices are used in infants, children and adults. The products include pediatric heart valves, tube-like devices for blood flow (conduits), surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.
FDA Preliminary Public Health Notification: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc.
Issued : April 19, 2007
Dear Healthcare Practitioner:
This is to notify you that all medical devices manufactured by Shelhigh, Inc. of Union, N.J. were manufactured under conditions that may have contaminated the devices and may result in devices that fail to function for the expected life of the products. We are also recommending actions that could help minimize risks to patients.
Background
FDA’s inspections of Shelhigh, Inc. revealed significant manufacturing problems that included improper sterilization and extension of expiration dates for the firm’s medical devices. The U.S. Marshals have seized at FDA’s request all the medical devices at the Union, N.J. manufacturing plant.
To identify a device manufactured by Shelhigh, Inc., we recommend that you first check for the company’s name and address, which we believe are consistently displayed on the device packaging. Below are some brand names known by FDA of medical devices manufactured by Shelhigh, Inc., including those made for another company and those that have not been cleared/approved by FDA:
Brand Name
* Endura No-React Dural Substitute
* Shelhigh BioRing™ (annuloplasty ring)
* Shelhigh Gold™ 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/UroPatch™
* Shelhigh Pericardial Patch
* Shelhigh Pre Curved Aortic Patch (Open)
* Shelhigh Pulmonic Valve Conduit No-React® Treated
* Shelhigh BioConduit™ stentless valve
* Shelhigh BioMitral™ tricuspid valve
* Shelhigh Injectable Pulmonic Valve System
* Shelhigh MitroFast® Mitral Valve Repair System
* Shelhigh NR2000 SemiStented™ aortic tricuspid valve
* Shelhigh NR900A tricuspid valve
Recommendations
1. Consider using alternative devices.
2. We recommend that you assess the overall health status of each patient implanted with a Shelhigh, Inc. device, and provide the testing, monitoring and care that is appropriate considering each patient’s individual case. The following information will help with your assessment:
* Shelhigh, Inc. received FDA’s clearance to market medical devices beginning in 1997.
* We are aware of published reports of premature (accelerated) failure associated with some Shelhigh devices.
* A Shelhigh device could potentially be contaminated with bacteria, fungi, or endotoxin.
3. You may wish to provide to your patients the FDA’s Preliminary Advice For Patients
4. If you note a failure or problem with a Shelhigh device, please follow the reporting instructions below.
Questions & Answers on Shelhigh Medical Devices (May 2, 2007)
FDA’s April 17 seizure of medical devices manufactured by Shelhigh Inc., Union, N.J., has generated interest from the medical community and the general public. The following will help answer questions.
Why did FDA seize Shelhigh’s medical devices?
Under order from U. S. District Court in New Jersey, FDA and U.S. Marshals seized all products and product components at the firm’s facility in Union, N.J., after FDA found significant deficiencies in the company’s manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.
At which locations were the devices seized?
The devices were seized at the firm’s manufacturing facility in Union, N.J. Products have also been embargoed by the state of New Jersey at a Shelhigh distributor.
Shelhigh claims that the seizure was unwarranted, that there is no evidence that their devices are not sterile, and that they are safe to use.
Shelhigh devices are intended for use in open-heart surgery for valve replacement; and repair of soft tissue structures during abdominal, pelvic, heart, lung, brain, shoulder, and spine surgery. These devices are permanently implanted into infants, children and adults during surgical procedures.
In the complaint filed in federal court, FDA has alleged that Shelhigh’s manufacturing processes are deficient in many respects. The company’s own records indicate a number of sterility test failures and that the tests and retests were not properly performed. The violative manner in which the products were made increases the likelihood that the products are not sterile and are deficient in other respects.
FDA has determined that use of these devices, if not sterile, poses a reasonable probability of serious adverse events or death. We recommend that hospitals and physicians consider using alternate products.
Is it true, as Shelhigh claims, that the seizure only prevents the company from shipping specific identified products from the facility?
All products at the Union, N.J. facility are affected by the seizure. None of the seized product may be shipped. The United States Marshal’s Service did not physically remove the products from the facility, but instead “seized them in place,” meaning Shelhigh cannot remove, attempt to remove or in any way interfere with the products at the facility without the prior written permission of the U.S. Marshal. The U.S. Marshal often seizes products in place when there are too many to move to another location or when removal would be impractical.
What was the basis for the seizure?
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.
Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained cleanroom 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.
More details on FDA’s concerns are described in the complaint for seizure filed in the U.S. District Court of New Jersey.
Please note that these are the government’s allegations that must be proven in court.
Is it true that Shelhigh was not aware of FDA's concerns with its manufacturing processes and that FDA was not willing to meet with Shelhigh officials?
No. At the end of each day during FDA’s inspection of the facility, FDA investigators told Shelhigh managers about their concerns. In addition, when the inspection was finished, FDA investigators left a 21-page list of observations with Shelhigh officials and further discussed those observations with them in two meetings, lasting about 12 hours. Many of FDA's concerns are detailed in the complaint filed with the court.
What products are involved?
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. Critically ill patients, pediatric patients and immuno-compromised patients may be at the greatest risk from the use of these devices. A list of products manufactured by Shelhigh is included in FDA’s April 17 press release.
Why does FDA believe use of these devices could pose a serious risk to patients?
FDA investigators found deficiencies in the firm’s manufacturing processes during inspections of the firm’s facility in 2000 and 2005. The inspections resulted in warning letters to the firm in 2000 and in 2005. An inspection again in December 2006 revealed ongoing deficiencies, which led to the seizure action.
What are FDA’s recommendations for physicians and patients who may have one of the Shelhigh devices?
In light of FDA’s inspectional findings and evaluation, physicians should carefully consider using alternate devices. 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.
Will Shelhigh recall the devices remaining in the marketplace now?
At the time of the seizure, Shelhigh was asked several times to voluntarily recall all products remaining on the market. The firm declined to do so. On May 2, because of continuing concern for patient safety, FDA issued a letter to Shelhigh formally requesting that the company recall all devices which remain on the market, including those currently in hospital inventories. Before FDA issued the letter requesting a recall, the agency warned physicians, hospitals, and consumers of the potential risks associated with use of Shelhigh products.
Why didn’t FDA request a recall sooner?
FDA’s recent inspection of Shelhigh was not completed until late December, 2006. FDA then evaluated the findings of its investigators to determine the seriousness of the violations and whether legal action was appropriate. FDA ultimately decided that seizure was appropriate and necessary to protect the public and took steps to seize the products. Shelhigh was asked several times while the seizure was being executed to recall the products and Shelhigh declined. When it became clear that Shelhigh would not honor the government's verbal requests, FDA issued a formal letter requesting the company to recall all products remaining in distribution, including those in hospital inventories.
If the firm doesn’t recall, what is FDA’s next step?
FDA is currently considering its options for further action with regards to Shelhigh, should they be necessary.
Preliminary Advice for Patients*: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Medical Devices Manufactured by Shelhigh, Inc.
Issued: April 19, 2007
The U.S. Marshals have seized at FDA’s request all implantable medical devices manufactured by Shelhigh, Inc., Union, NJ, because they were manufactured under conditions that may have contaminated the devices. Therefore, these devices may fail to properly function. FDA is providing the following information for patients and their families, so they will be better able to discuss the best course of action with their doctors. We will update this advice if necessary as more information becomes available.
Patients should understand that a seizure means that the existing devices at the company will not be introduced into the market, but it does not necessarily mean that the device needs to be removed from the patient. Seizure is meant to stop further distribution of a product.
Devices manufactured by Shelhigh, Inc. may have been implanted during various surgical procedures, including open-heart surgery for valve replacement; and repair of soft tissue structures during abdominal, pelvic, heart, lung, brain, shoulder, and spine surgery. Patients who are vulnerable to infection and are at greatest risk for unexpected complications from the use of these devices include: the critically ill, children, the elderly, and pregnant women.
The number of these devices that may be contaminated or experience problems isn’t known at this time. These devices have been available since 1997. Problems with the device could occur at anytime, and may become apparent to you and your physician during routine examination. Physicians have been notified of the problems associated with these medical devices.
Advice for Patients
* If you don’t know if you have one of the devices in question, contact the doctor who performed your surgery.
* If you know you have one of the devices in question, you should:
* Contact your doctor promptly
* Follow your doctor’s instructions on care after surgery
* Do not miss any follow-up appointments with your physician
* Contact your physician if you have ANY signs of infection, such as
o Fever
o Unusual pain, swelling, redness, and warmth in the area of your implant
o Drainage or discharge from the incision used during the procedure to implant the device
* Inform all your doctors about your surgery and that you may have a Shelhigh device implanted.
FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations
Issued: April 17, 2007
U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals today seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise 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. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.
All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. Shelhigh's 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.
Physicians should consider using alternative devices. 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. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients shortly with more information; those documents will be posted to FDA's Web site.
The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters.
Medical devices manufactured by Shelhigh include:
* Shelhigh Pericardial Patch
* Shelhigh No-React Pericardial Patch
* Shelhigh No-React PneumoPledgets
* Shelhigh No-React VascuPatch
* Shelhigh No-React Tissue Repair Patch/UroPatch
* Shelhigh Pulmonic Valve Conduit No-React Treated
* Shelhigh No-React Dura Shield
* Shelhigh BioRing (annuloplasty ring)
* Shelhigh No-React EnCuff Patch
* Shelhigh No-React Stentless Valve Conduit
* Shelhigh Internal Mammary Artery
* Shelhigh Gold perforated patches
* Shelhigh Pre Curved Aortic Patch (Open)
* Shelhigh NR2000 SemiStented aortic tricuspid valve
* Shelhigh BioConduit stentless valve
* Shelhigh NR900A tricuspid valve
* Shelhigh MitroFast Mitral Valve Repair System
* Shelhigh BioMitral tricuspid valve
* Shelhigh Injectable Pulmonic Valve System
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