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Improving medical devices through real-world testing

on June 26, 2013 Source:

When WiFi-enabled medical devices first came on the scene, there were relatively few of them. But as these devices have proven their worth, they have exploded in growth from hundreds to thousands in hospital environments. There are so many wireless devices competing on hospitals’ WiFi systems and its increasing the risk that the devices will malfunction.

As devices have increased in complexity with interoperability, they are sharing space on the wireless local area network ecosystems with nurse call systems, PACS images sent to laptops, guest access by patients, and the more and more healthcare professionals who bring in their own devices. Add to that wireless-enabled data devices, laptops, voice-over IP, wireless infusion devices, WLAN-enabled patient monitoring and pulse oximetry, and you create an environment that’s all too familiar to healthcare providers. It’s an atmosphere the author calls “the Wild West of wireless.”

That’s the pressing issue to which Integra Systems drew listeners’ attention in a recent webcast and outlined in a white paper by David Hoglund, the company’s founder and principal. They outlined some of the dilemmas medical device producers are facing and what they can do to help hospitals manage risk. Integra Systems advises companies in various industries, including healthcare, on WiFi and mobile device issues.

Companies looking at embedding 802.11a/b/g/n client radios into their devices need to test and validate performance in various environments, under varying traffic loads and for specific application environments, according to Hoglund.

One of the problems that comes from combining medical devices with WLANs is that manufacturers of access points and controllers roll out technology upgrades and modifications more frequently than medical devices are updated. And yet, these upgrades and modifications can alter the way medical devices perform compared with when they were originally tested and validated for U.S. Food and Drug Administration 510(k) clearance.

“Assess real-world performance and security by simulating live network conditions. Generating high traffic loads and interference allows the resilience, coexistence and security capabilities of devices to be realistically and thoroughly assessed,” the report recommended. “Testing should progress from simple setups using only two [access points] at a time to complex scenarios where the device sees multiple available access points broadcasting at different signal strengths.”

The ultimate goal in addition to helping hospitals mitigate risk is to improve patient safety. As the BYOD trend continues to rise and hospitals increasingly embrace technology innovations that rely on WiFi, the more vigilant device manufacturers need to be to ensure their WLAN enabled devices can work effectively in these environments. 

[Photo credit by - phil41dean]

Category:  Execution  Tags:  HealthIT, entrepreneurship, medical devices

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