If you belong to a biomed association, you have probably seen a notice going around that requests industry members, including students, to sign a petition regarding patient safety. As a way of sharing information, please see the notice below, as well as the link that will take you to the petition, if you choose to sign it.
Here’s the e-mail: We all have had ongoing problems with service literature, tools, instructions, AIAT, and other items that we need to maintain our medical devices in a safe and effective manner. Tom Quinn had created a petition, which you can access by the link below. We have several signatures so far, but need 25,000 by February 8, 2013. We need every BIOMED and every ENGINEER and every STUDENT to follow the link and sign the petition.
If you do decide to go to the link, when you reach the government site it says:
We petition the Obama administration to:
Protect patient’s safety from the inherent dangers of medical devices
“21USC gives the FDA authority over radiation emitting electronic devices. FDA has promulgated several performance standards for such devices as x-ray and lasers. These standards require manufacturers to provide instructions upon request to anyone to assure the safety of these devices. The FDA also has manufacturer’s requirements for instructions for the safe installation of all devices. Despite the guidance efforts of the FDA some manufacturers refuse to comply or create barriers to requests for instructions such as licensing or passwords. All efforts to resolve these issues with the FDA have failed. In order to protect patient safety we request a final, complete, lasting resolve of the issues reported to the FDA, including 21CFR instructions for 1020.30g,h, 1040.10h-11, and 820.170a,b.”
