Yesterday, Draeger announced that they had completed interoperability testing with WiFi infrastructure vendor Trapeze Networks. What they call a “Certification Notice” indicates that they’ve completed formal verification testing (and probably a “letter to file” for regulatory purposes) to ensure that their regulated medical devices, running on a Trapeze wireless LAN, operate within specifications. Aruba announced at HIMSS 08 their certification for use with Draeger’s Infinity patient monitoring system. Also, Aruba and Welch Allyn announced interoperability at HIMSS 07.
Here’s how Draeger describes their certification effort (emphasis mine):
In Drager’s notice of certification, Lars Roth of Drager’s Monitoring Systems and IT group, wrote, “Due to the critical nature of medical devices, Drager Medical tests and verifies network hardware components used for communication between medical system devices. These tests include proper IP Multicast handling, wireless roaming, wireless encryption and load testing. In addition, tests with competing traffic are run in order to understand and detect the proper Quality of Service settings. These are the key parameters that will ensure that in a shared Infinity OneNet installation, the data flow of the Drager patient monitors is being prioritized over non-patient monitor data.”
Most medical device vendors complete validation test for a new product supporting that one WiFi infrastructure vendor at market launch and beyond. Depending on the regulatory strategy of individual vendors’ products, completing the validation with additional wireless LAN vendors can be very time consuming and expensive. Compounding this is the fact that verification test is a common R&D bottleneck for many medical device vendors.
Back when most medical device systems were deployed in departments and electronic charting adoption was low, vendors could create”islands of information” running their systems on their own private networks. A large hospital can easily have over 200 of these unconnected systems installed on Cat 5 twisted pair, thinnet (10Base-T) and even thicknet (10Base5) coax cable. Such situations are going away as medical device connectivity and workflow automation adoption increases.
Over the years, patient monitoring has increasingly moved outside conventional high acuity units, as have ventilators. Most recently, networked smart pumps have burst onto the scene driving wireless medical devices throughout many hospital enterprises. Covering increasingly large physical spaces with private networks is time consuming and expensive. Besides, that’s what hospitals bought enterprise networks for – wired and wireless.
As medical devices have become enterprise-wide applications, networking issues have increasingly become an issue for hospitals. Medical device systems are not necessarily designed to operate in a shared enterprise environment – still. Infrastructure vendors vary in their helpfulness to medical device vendors in their pursuit of safe and effective products. These issues came to the attention of the FDA and other regulators a few years ago. The IEC 80001 risk management standard – which will impact infrastructure and medical device vendors and their customers – is one tangible result of their concern.
Once vendors have done the engineering work and succuessfully completed verification test for the initial product launch, just keeping up with changes in one wireless LAN vendor’s products can be daunting. This is a common problem with medical connectivity where you have vendors trying to support multiple versions of the same interface, API or IT hardware (computers and networks). Vendors frequently fall behind, puting customers in the position of using out of date software or a discontinued product. There has to be better way.