New NJ Bill would Require Patient Consent for Reprocessed Devices
BY LAUREN UZDIENSKI, JANUARY 28, 2007
A new bill was introduced in the New Jersey state legislature earlier this month that would allow patients to decide if they want to receive a reprocessed medical device. A similar bill was introduced in Massachusetts last year, but it was never passed, and no further action is expected.
Still, the new bill speaks to ongoing concerns about the safety of reprocessed devices, as well as the responsibility of the surgeon to inform the patient of a product's status. FDA requirements, as of last October, require reprocessed devices to be marked, a change from the previous system where even the surgeon might be in the dark about a device's history of use. The NJ bill would require a surgeon to pass the information onto the patient receiving the device: written informed consent would have to be obtained before the device could be implanted.
