Words from a device manufacturer
July 12, 2009
I think the total focus of the FDA is wrong. FDA people are panicked over somehow being held responsible for any politically sensitive problem. Issues of real patient safety for the sake of patient safety is lost in the bureaucracy, no matter who runs it. In my humble experience since the device regs were installed in 1976, I have found the following:
1) The purpose of the device regulations is to form a framework where ANY political problem, such as a patient death or injury, can be pinned on some failure on the part of the company involved. The problem is NEVER lodged with the FDA over lack of regulations being promulgated. The way this is done is to write the regs so that the company has to include its own detailed procedures that the FDA then uses to inspect against. If the procedures provided by the company are not sufficient to have prevented the problem, its the company’s fault.
2) The acceptable OUT for the company in the regulations is always some failure of the EMPLOYEES after they have been trained. The company just reprimands the employee for not having followed the procedures as specified by the company and the FDA is satisfied. There can never be a problem about FDA enforcement of regulations then, since the FDA and the company did what they were supposed to do, but some lowly employee didnt listen and its THEIR fault.
3) The FDA is happiest with the large companies, since they are meticulous about closing the loop mentioned above. Therefore there is a paper trail which the FDA can rely on which shows the company set the proper procedures, but some lowly employee didn’t follow them after being “trained”.
This is why its easier for the FDA to go along with the large companies and do what they want!! The FDA is safe. The companies are safer because they can say they complied with government regs but some lowly employee just did a ‘human error’ thing.
The solution in my opinion is to redirect the focus of the FDA so it’s in an ADVISORY capacity and involved only in the scientific analysis of new things. It should beef up its scientific review and advertise to the hospitals and doctors that they should use FDA approved stuff BECAUSE THEY DO PROPER SCIENTIFIC ANALYSIS.
I just dont think that they can remain impartial when there is so much Industry-Government interaction.
