FDA Issues Guidance for Wireless Medical Devices

The U.S. Food and Drug Administration (FDA) has released final guidance for manufacturers of medical devices employing radio frequency (RF) wireless technology that acknowledges its increasing use and recommends steps that wireless medical devicesensure the devices’ safe and effective use.

“With the increasing use of RF wireless medical devices, continuing innovation and advancements in wireless technology, and an increasingly crowded RF environment, RF wireless technology considerations should be taken into account to help provide for the safe and effective use of these medical devices,” FDA said in the guidance. The recommendations were announced in the Aug. 14 Federal Register.

The FDA has an increasing concern about the use and deployment of RF wireless technology near medical devices because all of the electromagnetism may contain many sources of RF energy, reports the Health IT Law & Industry Report. RF wireless emissions could potentially affect the function of an RF medical device.

Pushing the expansion of RF technology is the National Broadcasting Plan, which Congress charged the Federal Communications Commission (FCC) to develop in 2009. The plan was meant to ensure that every American has access to wireless technology.

The FDA worked closely with the FCC to ensure that the mandate was met while ensuring that medical devices work effectively and safely. Bakul Patel, FDA’s senior policy advisor, says in an Aug. 13 blog post:

Our goal is to help industry develop a range of innovative, safe, and effective medical devices that incorporate wireless technology, which can, in turn, help reduce health care costs, enhance quality, and benefit patients and providers alike.

The danger with wireless technology is that a device could be overtaken by a deliberate signal to cause harm to the patient. To protect against cyber threats, the final guidance called for RF-specific safeguards.

“While most wireless technologies have encryption schemes available, wireless encryption might need to be enabled and assessed for adequacy for the medical device’s intended use,” FDA says in the final guidance. “In addition, the security measures should be well coordinated among the medical device components, accessories, and system, and as needed, with a host wireless network.”

Different wireless devices must be able to work near others. Designers and manufacturers of these devices “should consider the ability of their devices to function properly in the intended use environments where other RF wireless technologies will likely be located,” the guidance says. “In the design, testing, and use of wireless medical devices, the correct, timely, and secure transmission of medical data and information is important for the safe and effective use of both wired and wireless medical devices and device systems.”

An electromagnetic disturbance can affect medical device functions. There are other risks as well. Health IT Law & Industry Report explains further:

The guidance cautioned manufacturers to take into account other risks, such as:

  • poorly characterized or poorly utilized wireless systems (e.g., wireless networks);
  • poorly characterized or poorly utilized wireless systems (e.g., wireless networks);
  • lost, corrupted, or time-delayed transmissions, and degradations in wireless transmissions;
  • lack or compromise of wireless security;
  • and potential misuse of a wireless medical device because of lack of or inadequate instructions for use.
  • The guidance also discussed what needs to be done for a premarket approval application for these devices. Manufacturers will need to consider the quality of service necessary to ensure that the device functions properly, the security of the wireless signals, maintenance of the device, and whether the device will operate with other RF devices in a shared environment.

    Source: “FDA Finalizes Guidance on Radio Frequency in Wireless Medical Devices,” Health IT Law & Industry Report, 8/14/13
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