In the next few months, 24×7, as well as two regulatory bodies, will seek your expert opinions.
Through November 9, 2006, the FDA is asking for comments about the possible development and implementation of a unique device identifier (UDI) system for medical devices that could reduce medical errors, facilitate device recalls, and improve medical device adverse-event reporting.
Jay Crowley, FDA senior adviser for patient safety, says the agency hopes the survey will yield answers to such questions as: Is it a good idea? If so, why? What would you need from a unique identifier system? Are there certain kinds of information you would find useful? Would you like to associate accessories as a part of that system so that you would know which accessory would be appropriate, safe, and compatible with that equipment?
In addition, the agency is seeking information about various automatic identification technologies, such as bar code and radiofrequency that could be used with a UDI system.
The FDA recognizes that, as the number and complexity of medical devices grow, it must devise strategies to work with industry and device users to successfully manage the risks associated with this growth.
Crowley adds that the research applies to all medical devices used in a hospital, but the results may indicate that users believe that only a certain category of medical devices will benefit from a UDI system.
You can submit your comments about the feasibility of a UDI system by November 9 via the FDA’s Web site at www.fda.gov/dockets/ecomments. All comments must include the docket number 2006N-0292.
Through October 31, 2006, the Federal Communications Commission (FCC) is asking for input on the present and future needs for medical device radio communications, including wireless technology.
The FCC will coordinate the information it receives with the FDA to help address the wireless technology issues in and around medical devices and systems. The FDA is encouraging all health care facilities, medical device manufacturers, and designers to respond to this unique opportunity to provide information to the FCC to help formulate future telecommunications plans and actions. To participate, visit www.fcc.gov.
It’s also time once again for 24×7’s Annual Compensation Survey! This is your opportunity to candidly share your comments about your profession; and your views about compensation, your work environment, certification, and more. Your input is valuable, so if you have not already done so, I hope you will complete the survey today at www.24x7mag.com/survey. The deadline is September 29.