While outside of the United States I have been reading various content around this subject. Simply put over six years ago, while consulting with Draeger Medical the first enterprise networks both wired and wrieless came to fruition. It seems finally that the industry cannot ignore the market momentum of having medical devices on a wireless and wired network. If the network and design are correct in their performance requirements, there is absolutely no risk in my opinon for the application. This was somewhat my basis for discussion at the first Medical Connectivity conference while in Boston, MA earlier this month.  From the proven design of which reduces costs and in my opinion risk: this has evolved to even a better model. This is not the same with traditional medical device companies that want to hold on to legacy designs and private proprietary networks. It is suggested that the medical device community use the best of practices for wired and wireless networking as defined by www.bicsi.org.  In addition, each medical device company should use www.veriwave.com for their own internal QoS and security testing. Finally, www.verwiwave.com has a product coming out later this year, first part of 2010, called WaveDeploy.  This will allow installations of both wired and wireless to design a predictive model.  However, once this model is deployed, WaveAgent will allow proactive management of the medical device wired and wireless ecosystem. Note, while medical device manufactures will test and validate for a FDA 510K approval based upon specific software/firmware in the switches and controllers, once it is deployed the device manufactures may not have control of the actual changes in the enterprise wired/wireless model.  Using WaveDeploy will ensure that any changes to the network are noted and how they may or may not impact performance.  This in my opinion will ensure meeting the intended heart and intent of IEC 80001.  So what does this all mean?  Like John Chambers CEO of Cisco over five years ago at HIMSS, while present, stated "The days of proprietary networks are over".  It all about the best of industry practices and using commercially available tools in the industry.  This will utimately reduce costs in a huge way while decreasing risk for the wired and wireless medical device ecosystem.

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