Putting an enterprisewide wireless technologies network in place, and then connecting to it every imaginable medical device, is an ambition of many hospital administrators these days. To them, Wi-Fi represents an economical, effective solution to support clinical equipment users in the hospital and at off-campus facilities on the other side of the city, region, or state.
“Wireless is attractive because it can help a hospital be safer, improve its quality of care, make its services more convenient, and operate more efficiently,” says Elliot B. Sloane, PhD, CCE, assistant professor of information systems at Villanova University, Villanova, Pa.
Sloane notes that there are many different types of applications for wireless—everything from RFID locator systems that aid in inventory loss prevention to systems that monitor the safe administration of medications via smart infusion pumps, and from medical information carts to always-in-use Bluetooth communication devices.
Adding to the Challenge
Of course, enterprise wireless environments do not spring into existence by themselves, with the full spectrum and complement of medical devices magically preconnected. These things come about only after meticulous, extensive planning. Rick Hampton, wireless communications manager for Partners HealthCare System in Boston, believes a hospital’s biomedical/clinical engineering department must be involved in that planning. Indeed, so essential is that department’s contribution to this process that it would not be unrealistic to think the department could help spearhead the effort.
“It would depend on biomed’s strength in wireless networking,” Hampton offers as a caveat. “The number of biomed departments that have sufficient strength in that area are few, but the good news is their ranks are growing.”
Don Witters, chairman of the Electromagnetic Compatibility and Wireless Group at the FDA’s Center for Devices and Radiological Health in Silver Spring, Md, takes Hampton’s view and notes that biomedical/clinical engineering could be a good choice as a planning-process leader by dint of its extensive familiarity with the medical devices that will transmit and receive signals over the wireless network.
“Biomed is the keeper of the knowledge and expertise for the medical equipment and medical functions of these systems,” he says. “Biomed knows the devices, knows the [hospital’s] environments, and knows how the devices may or may not be sensitive to some of those environments.”
According to Sloane, planning for a wireless implementation involves classical engineering steps “similar to most other implementations biomeds and clinical engineers have been involved with, except this time there will be vastly more stakeholders whose participation is crucial.”
Witters says an important part of the planning, therefore, is to engage the stakeholders in a dialogue about the wireless environment to come. This is an opportunity for all parties involved to air their concerns and spell out their ideas, he explains. “Stakeholders will not want to ignore any of the risks involved in implementing a conversion to wireless; however, they occasionally are not aware of some of these concerns, and that’s where the biomed community with its unique set of knowledge comes in,” he says.
Wireless planning is daunting enough as it is, but it becomes more so when the fast pace of technologic advancement is thrown into the mix of issues with which to grapple. Says Sloane, “Old products are improved and new ones enter the market so quickly that gearing up for an implementation requires much more flexibility on the part of the planners than would have been expected in a classical engineering process for a clinical application, such as the building of a new emergency room.”
Areas of Risk
Speaking of not ignoring risk, the need to identify potential threats to the wireless environment—in particular, the ability of the medical devices to function properly within it—is another important task for planners.
“The starting point is to carefully profile the intended applications and aggressively identify each one completely,” Sloane says. “Here’s why that is so important. Take a nursing home or ambulatory facility, for instance. Patients and other wireless equipment users move around quite a bit within that type of facility. Consequently, the distances they travel must be taken into consideration because that is going to affect where antennas or receivers are placed. Also, some buildings are inhospitable to wireless because they happen to be in very close proximity of radio and TV antennas, or of power-distribution towers and lines, or of electrically operated subways.”
Witters mentions that planners must examine as part of this risk-identification process those potential threats associated with the use of wireless technology in and around possibly susceptible medical devices. “The question must be asked: Are the wireless technologies to be introduced going to affect the medical devices? Also, are the wireless technologies adequate for the types of functions that they will be tasked with doing?” he proffers.
Witters adds that risk extends as well to system security, which is not always well addressed by wireless-capable laptop and desktop personal computers utilizing off-the-shelf communication protocols. Then there is bandwidth availability, another risk-related issue.
“The only place you can put high-bandwidth data networks is on an IEEE 802.11 wireless local area network,” Hampton says. “Unfortunately, with the currently dominant 802.11b and 802.11g WLAN standards, there is only limited spectrum to work with—basically, three available channels. Granted, on 802.11a, you have 20 channels, but because of the consumer-focused development of wireless technologies, most devices are built for 802.11b- and 802.11g-based networks.
“That is beginning to change with the slow addition of 802.11a capability into more products. When you add in the longer lead time required to develop medical devices, this problem is only exacerbated. We’re seeing the same lag in adoption of the latest wireless craze, 802.11n, which, incidentally, could have some detrimental side effects in the health care environment.”
Clash of the Titans
A fallacy associated with enterprise implementations purports that none but the IT department shall have total control over all aspects of the wireless environment—a fallacy encouraged by some hospital IT departments through the issuance of edicts declaring that the wireless network and the medical devices connected to it will come under IT’s domain and jurisdiction.
But even though IT does not in reality have an automatic right to so sweeping a grip, much bickering can ensue between that department and biomedical/clinical engineering in the event the latter chooses not to acquiesce to IT’s edict.
“There will be clashes over the network—who controls it, what can be added to it, and so forth,” Hampton warns. “However, biomedical and clinical engineering would do well to recognize that these clashes are also taking place at a level higher than just their hospital. Involved too are the IT industry and the medical device industry. This is important to understand because, on the one hand, medical device manufacturers must develop products with an eye toward obtaining FDA approval while, on the other hand, IT networking product makers are free of any such requirement. The result of which is the IT industry ends up being profoundly unknowledgeable about what constitutes a medical device and why it’s not OK to extensively modify them after they’ve been acquired and put into service.
“What’s needed is for the IT industry to understand that while health care is the last bastion where they are going to be able to make money, health care has unique and demanding requirements that set it apart from other business sectors. If we can convince them of that, we should hopefully be able to help them see that it is in their best interests to sit down with the medical device manufacturers and together begin addressing those unique challenges of wireless in the health care environment, which, by the way, will soon stretch from the hospital and the off-campus facility to the home and workplace. The IT industry and the medical device makers must be willing to jointly develop strategies for incorporating medical devices into the wireless network, and both parties must be willing to share data on risk analysis and risk mitigation with the hospital clinical engineering and IT departments.”
In that way, Hampton asserts, the hospital’s IT and biomedical/clinical engineering departments can come together and reach agreements on the details of the wireless environment that needs to be built. It might not lead to any sort of kumbaya everyone-hold-hands-and-hug dealings between the two players, but it could produce a fair amount of cooperation and, pivotally, a clear-eyed look at the monumental task set before them.
Rich Smith is a contributing writer for 24×7. For more information, contact .
Implementing the Answer
Planning and implementing a hospital wireless environment is more challenging than it need be, and that is owing to a lack of industry standards governing Wi-Fi in health care settings, experts argue.
“Most existing standards for wireless deal with business or entertainment applications, not life-critical applications,” says Elliot B. Sloane, PhD, CCE, assistant professor of information systems at Villanova University, Villanova, Pa.
The answer is to create a standard for health care enterprise wireless technologies. But the development of one has been hampered by a largely disinterested IT industry, says Rick Hampton, wireless communications manager for Partners HealthCare System, Boston.
“Members of the IT industry feel that since they aren’t medical device manufacturers, there’s no need for them to worry about standards specific to health care,” he says.
Standards for wireless in hospital settings would help in a number of ways. A particularly valuable assist would come in the form of easier mapping of the potential environments served by wireless so that manufacturers can begin to build more suitable products and appropriate configuration and testing tools.
“Until then, each medical wireless network is going to be just a one-off, customized implementation that, quite frankly, will be suspect as far as the ability to manage it safely goes,” Sloane says.
One thing standards should—and eventually no doubt will—address is the matter of data integrity. “Let’s say I’m allergic to a medication and this information is communicated via a wireless device to the clinicians who are providing care to me at that moment,” Sloane proposes. “If the wireless communications system loses or distorts this information, then my life could well be endangered as a result. This loss or distortion would be far less likely to occur were there to be in place a standard dealing with the safety and integrity of transmitted data.”
Despite the disinterest of the IT industry, efforts are ongoing to adopt health care wireless standards.
“We’re engaged in dialogue with the standards organizations,” Sloane says. “The discussion has at times been uncomfortable for the reason that they are not generally familiar with or comfortable in the medical-clinical environment. But we’re seeing more and more receptiveness and interest from these organizations.”
A bright spot is the progress being made toward improving existing standards by the IEEE, or the Institute of Electrical and Electronics Engineers. “We’re working diligently with the IEEE 802 standards community to build a crossover workgroup that will include representatives of biomed and clinical engineering,” Sloane says.
There also is headway to report for a health care networking risk-management standard by the International Electrotechnical Commission (IEC). “The IEC 80001 standard,” Hampton says, “addresses the risk management efforts required when connecting medical devices to the IT network and reinforces the relationship between the IT industry and medical device manufacturers. This will carry over into the relationship between the hospital IT and biomed departments.” Hampton, who serves as chairman of the wireless subcommittee on the 80001 workgroup, says the new standard is expected to be ratified in 2010.
For its part, the FDA is asking medical device and systems manufacturers—to the extent they come under the agency’s authority—to address risks and other issues surrounding wireless technology and electromagnetic compatibility.
“By and large, the manufacturers are doing a very rigorous and thorough job in this regard,” says Don Witters, chairman of the Electromagnetic Compatibility and Wireless Group at the FDA’s Center for Devices and Radiological Health in Silver Spring, Md. “However, it’s difficult for us to become involved with some of these hospital or clinical-area issues because we don’t directly deal with the manufacturers of information technology. Even so, there definitely needs to be more objective information and helpful tools placed into the public domain. The information and tools can be in the form of standards, guidance, or simply reference resources. The idea is that we need to have all parties clear about the pathways from conception, design, configuration, deployment, and maintenance.”
Toward that end, the FDA has joined with the Association for the Advancement of Medical Instrumentation, the IEC, the International Organization of Standards, the American Society for Testing and Materials, IEEE, and others, each of which has in one way or another sought to build consensus about the various issues touching upon wireless technology in clinical environments.
“Our own contribution has included posting at our Web site information about electromagnetic compatibility as well as our draft guidance document for wireless medical devices,” Witters says. “We also perform laboratory research and have an outreach to the manufacturers and the user community through the MedWatch adverse-events reporting system and through the MedSun interactive communications system.”