Activities
FDAAA Members Invited to Contribute to Joint FDA/NIH Exhibit on the History of Replacement Heart Valves
The Food and Drug Administration History Office and the National Institutes of Health History Office are collaborating on an exhibit documenting the history of replacement heart valves. Entitled "The Issue Was Patients: Developing Heart Valve Replacements," it opens with pioneers in the field from Charles Hufnagel to Alain Carpentier, Albert Starr and a host of other early cardiovascular surgeons and medical researchers. Central to the exhibit is the story of one of the earliest heart valve recipients. He is alive and well and will attend the exhibit's opening event.
One of the highlights of the exhibit will be the hand-sewn cloth valves made by Nina Braunwald, a physician and surgeon at the NIH, the first board certified female cardio-thoracic surgeon in the U.S., and a pioneer in heart valve replacements. The FDA portion of the exhibit will highlight the importance of emerging regulatory controls following passage of the 1976 Medical Device Amendment in helping to insure safe and effective replacement heart valves for patients. From an experimental medical "frontier" dominated by surgeons who invented and implanted dozens of new types of valves each year during the 1960s to the fruitful collaborations between surgeons and biomedical engineers which brought to market standardized and commercially viable valves by the mid-1970s, the exhibit will explore the scientific and regulatory advances which have shaped valve development from World War II to the present.
One important FDA panel in the exhibit contains a case study of the Shiley Convexo/Concave valve. This was the first heart valve which required pre-marketing approval from FDA following passage of the 1976 Medical Device Amendment. The Shiley valve suffered from both engineering and production defects and was eventually removed from the market in 1986. In numerous but rare cases, the welded struts on the valve gave way and, in a high percentage of patients, the rupture resulted in death or serious debilitation. Once the valve defects became known, the FDA and Pfizer contracted with the Medic Alert Foundation to locate and create a register of Shiley valve patients. Patients were notified by letter that they had a Shiley valve and were given a medical alert bracelet along with instructions on what to do if they suspected a valve failure. This valve's multiple level failures presented novel medical and regulatory challenges: elements of engineering and biomedical design research, advances in statistical analysis, device-specific compliance issues, as well as novel medical ethics and patient education issues. The Shiley affair shaped FDA's earliest actions in the field of medical devices as well as sharpening guidance documents and instituting new procedures to govern future prosthetic heart valve approvals.
The exhibit is slated to open in March 2010 at the Clinical Center at NIH. From there it will travel to the FDA's new campus in White Oak, Maryland. Eventually it will be made available to other museum and medical venues. There are also plans for a virtual online exhibit which will greatly expand the contents of the physical exhibit.
The designers and curators for the exhibit are still looking for interesting artifacts, photos, and documents to help tell the multi-faceted story of heart valve replacements. FDAAA members are invited to contact Suzanne Junod if you have any interesting physical objects or any interesting "stories" to tell, or if you would like to review and comment on the final text for the exhibit. She can be reached by email at Suzanne.Junod@fda.hhs.gov.
