More than a decade ago, healthcare information technology leaders – concerned about electromagnetic interference (EMI) from mobile electronics – banned cellphones in patient care areas. While there was little empirical evidence documenting such interference with medical devices, apocryphal anecdotes and a precautionary attitude led to the bans.

Today, following studies by the Mayo Clinic and other researchers that showed almost no harmful effects from interference, those bans have largely disappeared. Cellphones have become ubiquitous, and they now share the patient room with a host of healthcare IT devices: Computers, monitors, peripherals, smartphones and tablets are all frequently operating within 6 feet of the bedside and exam table, according to a recent study by HIMSS Media¹.

As IT devices in the hands of patients and providers crowd the point of care, the question of EMI and its potential impacts on nearby medical devices – and patients – is being raised once again. There are new concerns about the impact of wireless technologies such as Wi-Fi and Bluetooth. And experts are also resurrecting worries about the risks of leakage currents when non-FDA-approved equipment is not properly grounded.

Consumer-grade concerns

Unlike medical devices that undergo rigorous electronics instrumentation testing to meet the International Electrotechnical Commission’s 60601 and, more specifically, 60601-1-2 standards, commercially produced desktops, laptops and tablets are not required to meet similar emissions standards.

“These products are designed for consumers and office environments, not clinical settings,” explained Raja Bhadury, head of HP’s care delivery portfolio. “The risk of electrical shock, burns and even cardiac arrhythmias due to leakage current from improperly grounded IT products is not fully understood.” As such, these IT devices are usually not rigorously tested for clinical environments. “Besides, considerable investment is needed to design products to meet these higher emissions standards, and it takes time to go through the certification testing.”

Juuso Leinonen, project engineer at the nonprofit ECRI Institute, said the patient safety-focused organization is aware of only isolated incidents in which high-powered radio transmitters (namely, two-way radios) interfered with the function of some fluid warmers operated in close proximity.

“Overall, most consumer-grade equipment is low-powered, which seems to mitigate the concern with EMI,” Leinonen said. “At least at present, we do not have reports to support this being a significant issue in the healthcare setting.”

But leakage current, on the other hand, poses a threat for certain types of patients, as it has for decades. In 2004, authors Leonard Eisner, Robert M. Brown and Dan Modi provided a primer on leakage current standards for Medical Device + Diagnostic Industry readers. “Leakage current is one of the most stringent, yet telling, parameters of possible danger to patients or caregivers,” they wrote more than a decade ago. “This is especially true for patients with weakened immune systems.”

Proactively weighing the risks

Good data on any negative impacts caused by leakage current have been hard to come by. One reason for the lack of empirical evidence is patients’ vulnerable state at the onset. It can be difficult to determine whether leakage current or an already weakened organ causes problems with immune-compromised or cardiac patients.

Despite the lack of firm research in this area, healthcare providers would be wise to proactively weigh the risks of EMI in their current IT equipment infrastructure, especially with a growing fleet of consumer IT equipment residing in patient rooms, edging ever closer to patient beds. That review includes assessing purchasing plans and guidelines, scrutinizing potential equipment and working with vendors to ensure patient safety at all times. 

Specifying a “minimum separation distance” (MSD) between IT devices with radio transmitters and sensitive medical devices can also help reduce risk. Researchers from Concordia University in Montreal found that when hospital staff comply fully with a MSD policy of even one meter, they can operate devices in the same room as the patient and medical equipment without posing a danger².                             

“The reality is, there’s always some risk,” Bhadury concluded. “PC vendors must work with their healthcare customers and regulatory agencies to assess the risk and make thoughtful design choices to address the risk.”

References

1. HIMSS Media, Creating a Patient-Safe Technology Environment: a HIMSS Custom Research Report. Prepared for HP. October 2017.
2. “Can personal devices interfere with hospital care?” Science Daily, June 16, 2015, https://www.sciencedaily.com/releases/2015/06/150616123921.htm