Dr. Jose Nazari reused safely more than 1,500 cardiac catheters at Chicago-area hospitals during the past four years. In contrast, an appeals courts recently affirmed a $15 million Cook County jury award against Baxter Healthcare for defective "new" medical tubing that killed a patient.
Oddly enough, Baxter belongs to a group of medical device manufacturers -- including Tyco International, Johnson & Johnson, Boston Scientific, and Mallinckrodt -- using "scare" tactics and lobbying to force restrictive regulation of reprocessed medical devices, including catheters, biopsy needles and angioplasty balloons.
If imitation is the sincerest flattery, credit goes to more traditional activists -- fearmongers in the environmental movement. Large corporations have now adopted terrorist tactics typically used to impose regulations on business.
At a recent congressional hearing, a Johnson & Johnson executive testified "I cannot understand why anyone would believe it is acceptable to clean and reuse a delicate complex medical device that was designed for use in a single patient and approved by FDA for only one use." Despite widespread use, the executive could only dubiously describe a few problems only allegedly linked to reprocessed devices.
In contrast, a 1997 Journal of the American College of Cardiologists study concluded, "Restoration of disposable coronary angioplasty catheters using a highly controlled process appears to be safe and effective."
While one might expect Sen. Richard Durbin (D-Ill.) to introduce legislation imposing burdensome regulation on business -- his bill would require reprocessors to prove their products safe and effective -- congressional Republicans have been co-opted into pushing for tough regulations on about 20 small reprocessors.
This will harm consumers, hospitals, small businesses and the health care system. Reprocessors save hospitals money by refurbishing medical devices labeled "single use" by giant manufacturers. Each device is tested to ensure sterility and functionality before reuse.
Device manufacturers lose sales when hospitals use reprocessed devices instead of buying costly new ones. Competition forces device manufacturers to hold down prices.
Learning from the activists, the device manufacturers have launched an intensive public relations campaign creating unfounded alarm about reprocessed devices. They want reprocessors out of business. Reminiscent of other now debunked health scares --including Alar on apples, and cancer from power lines -- the device manufacturers raise the specter of "possible" health threats to patients.
The sensationalist media plays cooperates by raising "questions" about safety issues. A recent USA Today article was headlined "FDA exposes patients to risks of medical recycling." Never mind facts or science, you can’t beat a good scare story.
The FDA "has been unable to find clear evidence of adverse patient outcomes associated with the reuse of a single use device from any source." A CDC staffer recently stated he "would be just absolutely amazed if [reprocessing] is a major health problem and the [leading hospitals] have failed to realize it." Peer-reviewed scientific studies confirmed "single use" devices can be safely reprocessed. Hospitals, which have been reprocessing for 20 years, view reuse as safe.
That should be enough for anti-big government, free-market lawmakers.
But in response to the health scare campaign, the Republican Congress has jumped head first into more regulation. The powerful House Commerce Committee is promising action this year on what is really a nonissue for the public. This is the same Committee that, when led by Democrats, was chastised by Republicans for interfering in the marketplace.
The Republicans’ willingness to reject their core principles -- less federal government, more reliance on state government, free market competition -- in pursuit of shortterm political gain is disappointing. Illinois already has a new law governing reprocessed devices. What is the point of pre-emptive federal legislation?
Republicans are heading down a treacherous road by buying into phony health scares. They simply validate the tricks of the antibusiness environmentalists, who know sensational media reports count more than hard science and facts.
Steven J. Milloy is a lawyer, biostatistician, publisher of Junkscience.com and adjunct scholar at the Cato Institute.
Comments on this posting?
Click here to post a public comment on the Trash Talk Bulletin Board.
Click here to send a private comment to the Junkman.