Single-Use Medical
Devices Commonly
Reused In US
(Note - This is a criminally-negligent practice which must be stopped. HIV, Hep-C, CJD and many other potentially fatal viral and bacterial diseases could be spread this way. Sterilization practices are NOT always applied properly. Furthermore, if CJD is indeed caused by prions, as is its bovine sibling, Mad Cow, it is important to note that temperatures in excess of 1,000 degrees F. are needed to destroy them. In other words, no normal sterilization procedure, even if done letter-perfectly, can inactivate CJD prions. And how many prions does it take to become infected? Also, keep in mind the long incubation periods of these diseases. If you have a procedure done with a non-sterile, contaminated and reused needle, catheter, or other internal medical device...and you become ill a year or several years later, who would know, or who could prove, that tainted medical device was responsible? As is the case with HIV, Hep-C, and CJD, the symptoms likely wouldn't show up for up to 10 years later. -ed)
NEW YORK (Reuters) - In hospitals and clinics around the United States, biopsy needles, catheters and other internal medical devices frequently are being reused despite labeling that stipulates ``single-use only,'' the New York Times reported Wednesday.
The practice of reusing such devices is not necessarily dangerous, experts told the Times, but it generally violates federal regulations.
So far, the federal government has not asked the companies that reprocess the devices to show evidence that they are safe and effective, but under pressure from device makers it is now reconsidering its approach, the Times said.
``We have used what we call enforcement discretion not to go after them,'' Larry Kessler, director of the office of surveillance and biometrics at the Food and Drug Administration, told the Times. One reason is that the agency has little evidence of a safety problem, Kessler said, although it is believed that research is urgently needed.
Some doctors and federal officials say the issue is more about economics than safety, as device makers make less money when single-use devices are cleaned, sterilized and reused, the Times said.
Doctors say the devices cost so much that they often cannot afford to use devices just once, but device makers contend that hospitals are putting patients at risk to save money, the Times said.
The FDA is considering requiring the device-reprocessing companies to show safety and effectiveness of the resold products, and requiring that device makers label their products with the risks from reprocessing. The agency is posting the proposal on its Web site, and will hold a satellite teleconference Wednesday in which the device makers, reprocessing companies, doctors, hospitals and ethicists can comment, the paper said.