It’s a topic that never fails to fire up a heated debate on biomed Listserv sites: leakage current from computers and laptops introduced into the patient care area that are not medical grade. These devices are capable of emitting leakage current and potentially harming high-risk patients, such as those with compromised skin issues.

“In the past, most of the IT equipment was not directly in the patient care area,” says Dennis Minsent, MSBE, CCE, director of clinical technology services for Oregon Health & Science University in Portland. “Computers were kept at the nurses’ desk, were out in the hallway, or were in another centrally located area, so patient contact with it would be very unusual. Now that hospitals are moving toward electronic medical records and, for example, are putting PCs in the patient’s room to do the charting, it is becoming more of an issue. This is a very different way of deploying computers.”

Medical equipment is designed and regulated by the FDA and as a result, the manufacturers are very well aware of—and generally in conformity with—existing standards. In contrast, many of today’s software applications, while designed specifically for the medical community, do not require a special computer in order to operate. In addition to improved functionality, an off-the-shelf commercial business computer may bring with it some regulatory and safety issues.

It comes as no surprise, then, that some of the most common questions posted to online biomed communities hinge on determining exactly which pieces of equipment must be measured.

“Frankly, people need to stop guessing,” says Rick Hampton, wireless communications manager with Partners HealthCare System in Boston. “If they need to know an answer about what they should be testing, the first place for them to call is the state fire marshal’s office, because he is either the responsible person in that state for enforcing electrical safety code or he knows who it is. Once you find out who oversees that area, that is the person who will tell you which codes, rules, and regulations are enforced in that state. In many cases, they can also tell you when you need to test devices, how you need to test them, and in what areas you need to do different tests.”

Put to the Test

The National Fire Protection Association (NFPA), a worldwide fire safety organization, has addressed the leakage current issue with NFPA 99, the “Standard for Health Care Facilities.” This regulation is designed “to establish criteria to minimize the hazards of fire, explosion, and electricity in health care facilities providing services to human beings.” NFPA 99 governs testing methodology and limits for measuring the conductivity of objects within reach of the patient. Other regulations, set by the Association for the Advancement of Medical Instrumentation and the International Electrotechnical Commission, provide guidance on the same issue.

“You’re looking for systems that are within the patient vicinity, which is defined as being within 6 feet of the patient,” says John Gross, CBET, Saint Patrick Hospital and Health Sciences Center, Missoula, Mont. Beyond 6 feet is considered adequate to prevent a caregiver or other individual from becoming a conduit by touching the patient while simultaneously touching a charged item, causing electricity to travel to the patient. “So, for each instrument, you have to decide if it is really going to stay outside the patient vicinity or not.” For Gross, part of that decision comes from where the patient is being treated. “As far as I’m concerned, if something is in the OR suite, then there’s a chance it could be close enough to the patient to be out of compliance,” he says. “Unless it is mounted on a wall, I would rather just treat everything in the OR the same and test them all.”

Many organizations choose to err on the side of caution and test systems installed throughout the facility, even though the patient vicinity and the patient care area are defined by NFPA. “Those two very carefully defined areas are not necessarily where many biomedical teams believe they are,” Hampton says. For example, he notes that the patient care area does not include the hallway or ICU’s nursing station. “It seems pretty clear that the intent of the regulation is that these things be taken into consideration when you’re in a location where there’s a high degree of risk to an electrically sensitive patient.” This does not include any place where you may find a patient—including wandering the halls, he says.

Hampton adds, “If the patient is walking down the hallway, you have to ask yourself if he’s really at risk for macro or microshock. Even though he may have an IV inserted, because the pump is not plugged in, he’s likely not grounded.”

Addressing the Problem

Part of the challenge for biomeds is the lack of open communication that can sometimes exist between the hospital’s clinical and biomedical engineering and technology services departments. When a new PACS was installed at Saint Patrick Hospital and Health Sciences Center about 3 or 4 years ago, no one mentioned it to Gross.

“They just put computer stations in the operating room suites and started using them,” he says. “All of a sudden I saw these new devices in the OR, and the leakage for safety issue was the first thing that came to mind.”

After performing the required safety tests, Gross discovered that the hardware did not pass standard. At that point his team set about installing isolation transformers on each unit.

Laptops can also be hard to manage. Because of their inherent portability, they can easily move to within the determined patient vicinity. Facilities can deal with this mobility in multiple ways. One common solution is to restrict power cords to use in non-therapy areas.

“We have wireless laptops, about 95% of which are on carts, so the rule is that you charge them at the nurses’ station, which is not a patient treatment area,” Hampton says. “If you roll a cart into the patient’s room, it is not plugged in and just runs on batteries.”

For computers brought into the hospital by nonclinical staff, the Partners HealthCare System safety committee decided on a visual inspection policy. “We allow patients and their visitors to use their own laptops, and when people bring computers in, we visually inspect them,” Hampton says. “We are looking to make sure that cords aren’t frayed, the device isn’t falling apart, and that it’s not an obvious safety hazard.”

One solution to laptops in the patient vicinity is to charge them at the nurses’ station and restrict their use with power cords in patient rooms.

In addition to leakage, laptops bring with them other potential hazards that may not come under the biomed’s purview but may still involve the department’s input or action. Spilled fluids or body fluids in the bed, for instance, could easily enter the device through the keyboard or its many other openings. Laptops also create a warm environment for incubating bacteria or other unwanted agents, and are not easily sanitized. In addition, laptops are transmitters of digital noise and can be transmitters of coherent signals from Wi-Fi, cellular, or Bluetooth connections (think patient-owned devices).

“We have not been involved in infection control,” Gross says. “We have a department that takes care of that. Occasionally, we have had to implement what they have told us to do such as a containment device for when we have to move ceiling tiles in patient areas. As far as transmitters, we try to be involved so that we can make sure that the carrier frequencies that they operate on will not affect the telemetry units. We do recommend the continued ban on cell phones in patient care areas and the hospital has adopted that as the policy. We are used as a resource, but we don’t directly deal with these issues.”

Taking Control

The discussions facilities have over which items to monitor is usually accompanied by some conversation about who should be responsible for performing the tests. While traditionally computers and the associated networks and infrastructure have resided under the domain of IT departments, the press to put more and more technology at the patient’s bedside—from charting systems to PACS stations—has created a gray area in terms of exactly who should be ensuring compliance.

“It is a very different way of deploying computers and is not something IT professionals are intimately familiar with,” Minsent says. “Bringing in computers to these areas adds a whole different paradigm to the health care delivery. It’s something we need to be aware of and certainly need to address prior to deploying new hardware.”

Oregon Health and Science University determined the best path was for its biomeds to train the IT department on how to conduct the testing. “We are working very closely with IT to provide them the references and the respective regulations and standards, so they are aware of exactly what the requirements are,” Minsent says. “We are also collaborating with them to develop policies and procedures, and we are going to lead some training for their staff.”

The training will cover how to perform the actual testing and what will be required of the IT team in terms of documentation or repairs. This decision was made as a way of streamlining delivery of service to the hospital staff.

“From a support type of situation, ideally you want to have all of the responsibility for deploying or repairing computers to reside in a single department,” Minsent says. “That way, customers don’t have to call IT to fix a computer and then call clinical engineering to do the safety test, test the computer, and then get it back into service.”

This approach is not without its challenges. When seeking smaller, more affordable analyzers that comply with Oregon’s requirement for electrical devices to be tested and certified by a nationally recognized testing laboratory such as UL, CSA, or ETL, Minsent’s team has not had any success.

“OSHA [Occupational Safety and Health Administration] also has those requirements,” Minsent says. “So, if you’re a state that has adopted the OSHA laws, it is mandatory for any electrical device to be tested by one of these approved agencies. And we are really struggling with either having our IT department buy a safety analyzer that is way more than what they would ever need or want or buying the nontested analyzer and then having it tested at an additional expense.”

No Right Answer

Since testing the computers installed as part of Saint Patrick Hospital and Health Sciences Center’s PACS system, Gross has maintained ownership of the task. “It’s one of those things that once you do it once, it’s yours,” he says with a laugh. But it is not a duty he minds taking on. “I look at my departments and I watch for issues that need attention. Whether it is directly in my area or not, I take the initiative to contact the appropriate people and say, ‘This needs to be addressed.’ ”

Once ownership of who will do the testing has been assigned, these individuals need to determine whether or not to test pieces of equipment that are not directly addressed in the regulations. “When considering devices like drills that are used in the ears and in the eyes, phaco emulsifiers, for example, things that are actually invasive to the patient, there is not any standard as to what those kinds of devices should have in terms of electrical leakage,” Gross says. “Specifically, the equipment that has handpieces, like a burr, that actually come into contact with the patient, don’t fall under the definition of an electrode.”

At Partners HealthCare System, such large issues are resolved outside of the clinical and biomedical departments. “It’s the safety committee’s responsibility,” Hampton says. “They need to decide what is appropriate; it’s not the individual department’s decision.” Hampton stresses the importance of having a decision about compliance being overseen by a multidisciplinary group. “It is the safety committee, which includes input from biomedical engineering, that is ultimately responsible for this type of issue, because they can take into account the overall level of safety required in that particular facility.”

Read more about NFPA 99 in the September 2007 issue of 24×7.

Because of state and facility variations, there is not a set standard for how to manage, monitor, and maintain leakage current. And while it will not help to settle the debate on an Internet forum, health care organizations must essentially determine what works best for them and then stick to it.

“You cannot operate to the worst-case scenario, because there are diminishing returns to doing that,” Hampton says. “What it really comes down to is the level of risk-averseness present in that hospital.” He recalled an example of the threat of Y2K forcing one hospital to contemplate temporarily closing shop. “Is that paranoia?” he asks. “It depends. If you actually assess the risks and the hazards in a meaningful manner, and then talk with the safety committee, generally you can come up with something that works well and satisfies the regulations.”

Dana Hinesly is a contributing writer for 24×7. For more information, contact .