I'd like to see technology, databasing, and associated identification
technologies become a greater part of the FDA's structured process for
manufacturers to use their devices in the US. A simple S/N and PID
(part ID) system with inventorying at hospitals will give them a greater
understanding of their inventory for these limited use items and ensure
that the standards are being upheld. From this simple low cost
implementation you will be able to find data such as how long parts are
kept in inventory, how many times they are used, and what is the
outcome of the procedure in which they are used. Certainly useful
information from everyone from the doctors to the manufactures.
Am I being unrealistic in thinking that we can optimize our system for
efficiency while providing valuable information for improving technique
and implementation?
FDA Commissioner Margaret Hamburg has asked for, and gotten, the resignation of Daniel Schultz (right) as head of its Center for Devices and Radiological Health (CDRH), the agency’s medical device regulator.
(Picture from the FDA.)
Schultz was a Bush holdover but was actually a career employee, having joined the agency in 1994. He is a surgeon by training.
The industry’s lobby, Advamed, issued a press statement that praised Schultz for pushing through a 2007 agreement reauthorizing medical device user fees to assure his agency’s funding.
For now Schultz will be replaced by Jeffrey Shuren, who also held major FDA positions throughout the Bush era.
Hamburg’s choice of a permanent replacement will deserve special scrutiny.
That’s because the Supreme Court last year, in the case of Riegel vs. Medtronic, essentially made the CDRH the final, ultimate arbiter on the safety of medical devices, saying plaintiffs could not sue in state courts if a device is FDA approved and used as directed.
The Bush-era aim may have been to give a green light to device makers, but the Obama counter is that if this agency is the final judge then its process needs to be highly rigorous.
Schultz did not do business that way.
- Schultz testified in 2006 that single use medical devices could readily be used multiple times.
- Schultz was accused earlier this year of halting enforcement of Good Laboratory Practice (GLP) regulations, the agency’s only way of seeing whether its decisions are being carried out after they’re made.
- The CDRH was also accused, by The Wall Street Journal, of making decisions under political pressure.
- Agency employees wrote Congress that devices were being approved even after they raised safety and efficacy concerns.
If you use the courts to guarantee that only one cop can be on the beat, and said cop is more Barney Fife than Joe Friday, then people are going to die with no recourse at all.
Hamburg’s choice is the only way we have of making certain the court’s Medtronic decision doesn’t give medical device makers a license to kill.
