FDA Provides Wireless Devices Guidelines
By Katie Wike, contributing writer
The FDA has released guidelines for security, maintenance, and monitoring of wireless medical devices
Growing concern over the safety of mobile and wireless medical devices prompted the FDA to release a guide outlining their use. The publication, “Radio Frequency Wireless Technology in Medical Devices—Guidance for Industry and Food and Drug Administration Staff,” addresses devices that are implanted or worn on a patient’s body, as well as other wireless devices used in hospitals and clinics.
Security was the main issue as many worry these devices could be hacked or damaged remotely causing the patient harm. A previous Health IT Outcomes asked the question, “Are Providers Liable If Hacked Medical Device Harms A Patient?” Under the new FDA security guidelines, “Authentication and wireless encryption play vital roles in an effective wireless security scheme. Use of the latest up-to-date wireless encryption is encouraged. 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.” Higher levels of encryption and added security should ease providers’ worries about liability for the time being.
An FDA blog post by Bakul Patel, senior policy advisor for the FDA’s Center for Devices and Radiological Health, notes, “It is FDA’s role to assure that before such wireless medical devices are introduced into the marketplace, that they have been properly tested. It is essential that manufacturers first consider and test potential limitations of the wireless connectivity associated with their devices to prevent malfunctions that could harm patients.”
Patel continues, “For example, designers and manufacturers of wireless medical devices should consider whether these devices can function properly in the environments where they are intended to be used. Another consideration is wireless coexistence. Given the limited availability of the radio frequency spectrum, wireless technologies may compete for access to the same spectrum. As a result, coexistence issues may pose risks that could result in medical device signal loss or delay that can be life-threatening.”
In addition to security and functionality, maintenance and servicing of these devices was addressed. The guide indicates care should be taken to make sure devices are properly functioning and in good condition at all times. According to ModernHealthcare.com, environmental conditions such as electromagnetic interference (EMI) and the use of these devices with other wireless technology play a role in making sure it is properly functioning as well.