Kids With "H.E.A.R.T" News and Events
Our "H.E.A.R.T" online newsletter
Old Blood May Pose a Health Risk
Associated Press - Heart surgery patients were more likely to die or suffer problems if they received transfusions of blood that is more than two weeks old rather than fresher blood, according to a new study that adds to the debate about the shelf life of blood. (more)
Revolutionary Heart Procedure Gives Boy 2nd Chance
MIAMI (CBS4) ― Touted as a medical breakthrough by some and first in South Florida and the world by others, a new heart procedure for a 9-year old boy from Gainesville means a second chance at life. (more)
Special Events
Currently there are no special events planned.
Support Group Meetings
* Meeting are currently only held in the Green Bay area of Wisconsin. If you are interested in holding Kids With Heart Parent Support Group Meetings in your area, please contact Michelle for a list of families near you.
Parent Meetings are held the second Tuesday of the month for the months of January, March, April, and May. They are at 7:00 PM at one of the parents' homes and includes a variety of discussion topics.
We will update this information as it becomes available.
All families welcome Please RSVP
Please take the time to complete the survey below:
FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations
See below from the FDA home page. www.fda.gov
FDA News
FOR IMMEDIATE RELEASE
P07-69
April 17, 2007 Media Inquiries:
Heidi Rebello, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
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
Kids With Heart NACHD, Inc. Disclaimer:
The intention of this information is to give parents of children with congenital heart disorders a place to find information about specific disorders and other support resources. Kids with Heart National Association for Children's Heart Disorders, Inc. personnel are not doctors or medical personnel. In no way should any information found on this site be a substitute to professional medical care or attention from a qualified practitioner nor should it be inferred as such. ALWAYS check with your child's doctor if you have any questions or concerns about any diagnosis, symptoms, or treatments.
