Device Approval Process Needs More Rigor

Billions are spent each year on medical equipment such as pacemakers, implantable defibrillators and cardiac stents. How thorough is the FDA’s review process for such devices?
Two major medical journals, the American Journal of Therapeutics and the Journal of the American Medical Association, take the FDA to task for lax standards. They point out that more stringent criteria are frequently applied to pharmaceuticals, even though drugs can be discontinued while removing devices like implants is extraordinarily complicated. If something goes wrong, the patient’s life is often at stake. Both journals call for enforcement of higher standards and the FDA is promising to improve the process.
[Journal of the American Medical Association, Dec. 23/30, 2009;
American Journal of Therapeutics, Nov/Dec. 2009]