Recently the author received a forwarded email link to www.corporateresearchgroup.com regarding this seminar dated July 21, 2009.
This agenda outlines several important topics of discussion surrounding today's need to integrate medical devices on an enterprise wired or wireless network,from a medical device perspective. The following will provide some technology history and "author history" regarding and what is is believed to be the "best practices"in this regard.
How to successfully integrate medical devices into/onto an enterprise network?
The authors experience started in 1999 and 2000 while at Symbol Technologies (now Motorola) to help www.welchallyn.comdrive forward to the first ever non WMTS strategy of medical telemetry using 802.11FH. (This is not FH (frequency hopping) WMTS). This was pretty very forward technology wise at the the time, and paved the road for non proprietary network era, this while at same time 802.11b receiving ratification in 1999. Hence the explosion of WI-FI started.
Integra Systems then worked with www.draeger.com and saw the vision of where the medical device community would eventually move to. 
In 2005 the design of the first ever shared VLAN implementation of a "real time" patient monitoring system (network) over a converged data, voice, and medical network came forth. What was required at this timing was to ensure that the primary application (in this case patient alarms and real time physiological data was preserved across a shared network). As a needed requirement, we (along with www.gtri.com )
used a quality of service appliance from a company called Packeteer. www.gtri.com(former Anyware Wireless, became the go to integration partner.)
As of 2009, with technological innovations it is now not necessary to use such an external network appliance. IEEE 802.1Q or VLAN tagging is now used which will allow multiple bridged networks to transparently share the same physical network without the leakage of information between networks. IEEE 802.1Q defines the meaning of a virtual LAN (VLAN), with respect to the specific conceptual model underpinning bridging at the MAC layer and to the IEEE 802.1D spanning tree protocol. Together with the described VLAN strategy, this (OneNet) has proven itself in countless healthcare environments both domestically and across the globe. However the most important issue in all of this is to understand that most medical device companies have now moved from their solution core to a network modality (patient monitoring or infusion therapy) and may simply not have internal competency to one of a required wired and wireless network understanding. In doing so, they have to make the decision to go look at third party resources to gain this required new competency. In light of this major change, www.draeger.com was forward thinking (it seems the first in the industry) and turned to www.gtri.com the recognized expert in this area of wireless design and deployments. It is extremely important for the medical device area of wireless design and deployments to use this know how (or designated) to drive a total integrated solution to get to a first market competitive advantage. Also, these medical device companies simply have to seek out the right enterprise wireless integration talent to show value to the end user (that is the IDN or hospital). They have to demonstrate the competence..period. If you do, then you will get the sale and the network will be rock solid.
What is a converged network?
A converged network is simply a combination of services (wired or wireless) or latency sensitive applications. In this case it could be 802.11 b/g for data (for the EMR), voice over IP (802.11b/g), medical devices via 802.11b/g and forthcoming 802.11n that will allow spectrum convergence in both 2.4GHz and 5.0GHZ, while using the advantages of MIMO for high multi-path environments inherent in healthcare. It could also be said that a DAS (Distributed Antenna System), could be a part of this converged network, however there are significant caveats to this, i.e. WLAN with a DAS.
Why is convergence happening?
It was felt over five years ago, that this convergence made a lot of sense for patient monitoring. First the use of wired VLANS was already there. www.draeger.com had the first 802.11b WLAN NIC (FDA approved) and customers had already used "wired VLANS". Why is this convergence happening? Second data and voice convergence has already been integrated via the FMC model, (Fixed Mobile Convergence) . Voice is a very latency sensitive application and it requires at least a -65dBm signal strength and under 150msecs of latency. So, if you could design a network for voice requirements, have the quality of service via 802.1Q; hospitals could save "millions of $$ in infrastructure costs", versus installing stand-alone WIFI networks for specific medical applications, or costing WMTS antenna designs. Add to that no enterrprise real time management of these systems. Now you can use enterprise tools to manage the network properly. This significantly lowers risk, versus having stand-alone proprietary networks with no way of actually "managing" the network 24/7/365.
Potential pitfalls, FDA regulations, managing off open device use.
Issues remain with the medical device companies to engage third party organizations that have the correct wireless network competencies. The culture of the medical device company needs to fast forward to the dynamics of the IT product/or wireless product six month cycle or year driven model. It is simply not cost effective to try to grow this internal expertise to their organizations. Regarding any regulatory environment, it is important to understand the intent here. The technology inherent in enterprise wireless networks has now evolved to be used in the highest secure and quality of service environments, even for the DOD. Regarding off label use, it is the authors opinion that wireless management tools need to be used to identify those either rogue devices or other devices that do not conform to the approved policies and procedures of the respective institutions. In closing, each healthcare provider needs to implement a strategic wireless business plan. Bottom line, all the tools sets are there. Each enterprise customer and medical device customer just needs to use them.
Managing Vendors
Each medical device company needs to complete their own roaming, loading, and validation process to ensure how the primacy of how their application can co-exist both from a wired but also wireless medium on a shared network. All the current process and enterprise tools are present, however they just need to be used. (said before) The medical device vendors need to bring to the table their wireless integration partners that have demonstrated experience both on a wireless and wired side, but also under the unique attributes of the clinical application.
Provider side issues
Many times providers do not have the technical experience or understand how to integrate wired and wireless medical devices onto an enterprise network. This has not been their domain expertise and there is somewhat a concern for risk management. They need to look to those respective integrators that have demonstrative experience in this regard. Again, when the correct network design is implemented and managed, these applications will function correctly.
Solutions: IEC 8001 and WIreless Management
While IEC may be forthcoming; what is important is having the best of practices, using the current and projected enterprise tools, and providing the required process and documentation. When you have the appropriate test plans in in place that show the quality of service on a converged network, the correct security strategy, and enable the real time enterprise management, then it is felt that you will comply with the heart and intent of the perhaps pending IEC 8001.
