Re: LosAngeles Times Article - speedy FDA approvals & recalls
Nice to see a place to grouse about this. It would be just silly and frustrating to expect to discuss this in comments at LATimes, so another reason to be very grateful for Elsmar.
Not only does the study not standardize the recalls to the number of approvals, it makes no attempt to compare by volume of use. The most significant factors I see in the Cardiovascular category are the maturity of the technology and the conditions of use.
The Cardiovascular category is dominated by AEDs. I wonder what portion of AEDs are NEVER used? I looked up just one of the Welch Allyn recalls, (April 2005) and this is from the Reason for Recall:
"The malfunction occurs when impact to the exterior of the AED20 causes an internal electrical short resulting in the AED20 failing to analyze the patient’s heart function. When this malfunction occurs during clinical use, the AED20 displays a “Defib Comm” error message on the device display." (
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm063873.htm)
In simple terms... it was broken before they tried to use it, due to impact that caused a short. The device's fitness for use should mean that it can stand by in the intended environment... public, uncontrolled, and populated by [FONT="]monkeys [/FONT] untrained and enthusiastic bystanders. However, I don't think that a clinical study would have detected some of these issues. The AED device is not being held to the "without this, the patient would wait for the EMT or depend on CPR" standard, it is being held to the "a different AED might have worked" standard. The AED stands out because it is a complex device, still early in its product evolution, and deployed rapidly in the name of the public good.
If other recalls of AEDs have similar causes, I'd suggest that the devices were not subjected to sufficient "simulated use" conditions in the validation of the designs. Perhaps leaving each sample in a busy public place with a large and vibrantly colored "Don't touch" sticker might have resulted in the sort of impact and rude handling that was not encountered in transit simulation and thermal cycling.
Compare this to stunningly large numbers of diagnostic and therapeutic catheter and balloon products in this segment which are used by cardiologists, radiologists, and electrophysiologists. Virtually 100% of these devices will be used, for their intended use, and in an environment that is dependable about reporting any issues. Whether approved through the 510(k) or PMA route, these seem to have represented a small number of serious recalls. In part, these devices get a pass. A device that fails to work is promptly detected by the trained user and replaced.