FDA, FCC Discuss Medical Device Network Testing Improvements

April 2, 2015 in News

At a public workshop on Tuesday, hospital and technology stakeholders called on FDA and the Federal Communications Commission to develop standards to improve network testing for medical devices, Modern Healthcare reports (Tahir, Modern Healthcare, 4/1).

Background

Specifically, FCC and FDA held the public workshop to discuss wireless test beds, which are used to test devices “across a range of interference scenarios” (Wicklund, mHealth News, 3/24).

Such testing focuses on how medical devices linked to the same wireless network in a hospital interact to ensure they do not pose a risk to patients by interfering with one another (Slabodkin, Health Data Management, 4/1).

Some providers and manufacturers have built their own test beds that allow them to see how the devices interact with each other in real-life environments.

However, no common protocols or standards exist for hospitals to conduct such testing (Modern Healthcare, 4/1).

Workshop Details

The workshop included four panel discussions and was open to various stakeholders, including:

  • Health care executives;
  • Device makers; and
  • Patient safety advocates (mHealth News, 3/24).

During the workshop, participants raised concerns about testing on crowded hospital wireless networks in which:

  • General Web searching is taking place;
  • Medical data are being managed; and
  • Voice calls are being made between doctors and clinicians.

For example, Shawn Jackman, the director of wireless product management and engineering at Kaiser Permanente, said one of its hospital networks could have 70 different devices connected to it, not including Wi-Fi-enabled computer and mobile devices used by patients and their families. Jackman said that Kaiser created its own test bed to ensure the networks could support the devices (Modern Healthcare, 4/1).

Recommendations

To address the issue, Phil Raymond, a wireless architect at Philips Healthcare, recommended the adoption of a test bed certification program to fill such a “gap between the medical device manufacturer and the hospital” (Health Data Management, 4/1).

Meanwhile, Robert Jarrin, senior director of government affairs at Qualcomm, suggested that FDA and FCC establish a private-public collaboration tasked with developing a protocol or shared environment to improve testing efficiency.

Rick Tevis, director of clinical engineering at Geisinger Medical Center in Pennsylvania, said such a protocol or shared testing environment is necessary because small and rural hospitals may lack the resources to create their own test beds. He said, “We need to get it down to a level in which everyone can use it” (Modern Healthcare, 4/1).

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