Aug 15, 2011: Eshoo, Markey Ask GAO to Study Safety, Reliability of Wireless Healthcare Tech

Washington, DC - Today, Reps. Anna G. Eshoo (D-CA) and Edward J. Markey (D-MA), senior members on the House Energy and Commerce Committee, sent a letter to the Government Accountability Office asking the agency to conduct a review of the Federal Communications Commission's (FCC) actions in regard to wireless medical devices. Specifically, the letter asks GAO to examine whether the FCC is identifying the challenges and risks posted by new medical devices and implants that make use of wireless technology to ensure that such wireless-enabled devices are safe, reliable, and secure, and do not cause harmful interference. An August 5 AFP article reported on a diabetic who was able to reprogram his insulin pump so it could respond to deliver insulin from a stranger’s remote control.  

"Innovation in broadband and wireless enabled medical devices holds significant promise for improving health and reducing the costs of healthcare for all Americans," wrote Reps. Eshoo and Markey in the letter. "In bringing forward innovative wireless technologies and devices for healthcare, it’s critical that these devices are able to operate together and with other hospital equipment, and not interfere with each other’s activities and data transmissions. It’s also important that such devices operate in a safe, reliable, and secure manner."

Eshoo serves as the Ranking Member on the Communications and Technology Subcommittee and Markey, a former Chairman of the telecommunications subcommittee, currently serves as a senior member of the Subcommittee.

The full letter to the GAO is below:

 
 
 
Mr. Gene L. Dodaro, Comptroller General
U.S. Government Accountability Office
441 G Street NW
Washington, DC 20548

Dear Mr. Dodaro,

Innovation in broadband and wireless enabled medical devices holds significant promise for enhancing health and reducing the costs of healthcare for all Americans. By incorporating wireless technologies into medical products, many products that were once tethered to patients, positioned next to hospital beds and located at a nurses’ station are now transportable. This can lead to healthcare improvements such as increasing patient mobility and enabling healthcare professionals to have real-time access to patient data throughout hospitals. In bringing forward innovative wireless technologies and devices for healthcare, it’s critical that these devices are able to operate together and with other hospital equipment, and not interfere with each other’s activities and data transmissions. It’s also important that such devices operate in a safe, reliable, and secure manner.

The federal government has a role in providing leadership and encouraging innovation and investment in new healthcare technologies that enable patients, doctors, and other health professionals to access the highest quality care. With respect to wireless enabled medical devices, the Federal Communications Commission (FCC) is responsible for governing radio devices so as to provide for effective operation and communication, including allocating spectrum and specifying technical requirements to avoid harmful interference between users. The Food and Drug Administration is responsible for protecting the public health and assuring patient safety and effectiveness by regulating medical devices.

As senior members of the Energy and Commerce Committee, we would like GAO to report on the extent to which FCC is:

1.      Identifying the challenges and risks posed by the proliferation of medical implants and other devices that make use of broadband and wireless technology.

2.      Taking steps to improve the efficiency of the regulatory processes applicable to broadband and wireless enabled medical devices.

3.      Ensuring wireless enabled medical devices will not cause harmful interference to other equipment.

4.      Overseeing such devices to ensure they are safe, reliable, and secure.

5.      Coordinating its activities with the Food and Drug Administration.

We request that GAO inform the Committee regarding any other issues of concern that it may uncover during its examination of issues related to wireless medical devices. Thank you in advance for your cooperation and attention to this request.  Should you have any questions about this request, your staff can contact Erin Katzelnick-Wise at 225-8104 (Eshoo) or Sara Schaumburg at 225-2836 (Markey).

Most gratefully,

Anna G. Eshoo                    Edward J. Markey
Member of Congress           Member of Congress 

 
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