Patients Not Informed When Hospitals Reuse Single Use Medical Devices
Debate continues over the safety of reusing surgical blades, forceps and other medical devices. The practice is called "reprocessing" single use devices. It cuts the cost of the device by half but is often done without the patient's knowledge or consent.
A federal law taking effect this fall requires companies that reprocess medical devices to put their name on the reprocessed devices. This could help determine who is at fault when a problem occurs.
There are also concerns about infections and whether these single use devices can be safely and completely cleaned for re-use. Reprocessed devices are soaked in sterilized solutions, disassembled and then reassembled, inspected and packaged and resealed. According to some reports, the devices originally marked as "single use" by the manufacturer, are reused on average three to six times.
Larry Spears, Compliance Chief for medical devices for the FDA asserts, "(I)t is as safe and effective as a new device if they meet our requirements."
In the past 18 months, the FDA has received reports of 13 deaths. Incident reports involving reprocessed medical devices include 421 other trouble reports, 130 involve serious patient harm.
The House Government Reform Committee is planning a hearing in the fall of 2006 on these issues.
Locally, Children's National Medical Center reports that it does not use reprocessed devices. Chief of Surgery, Dr. Kurt Newman reports, "(W)e want to use the safest and most sterile equipment."
Bioethicist Arthur Caplan, from the University of Pennsylvania, has concerns about the practice, particularly because patients are not told and are not given a choice. "I just think people ought to know what's going on," Caplan stated.