F2761 and the Integrated Clinical Environment
A New Standard Addresses the Interconnectivity of Medical Devices in Hospitals and Beyond
The patient should have been fine.
While his procedure was serious — cardiopulmonary bypass — it wasn’t uncommon. In an operating room, physicians placed him under anesthesia and on a ventilator. They turned off the ventilator when they turned on a heart-lung bypass machine. Medical procedure completed, staff stopped the bypass pump and were supposed to turn the patient’s ventilator back on.
But no one did.
Amid juggling numerous tasks, awash in a sea of wires and machines, even with protocol in place to double-check all aspects of such a surgery, no one did. The patient suffered permanent brain damage.
“That could have been prevented in an integrated clinical environment,” says Julian M. Goldman, M.D., relaying the case. An anesthesiologist at Massachusetts General Hospital, Boston, Mass., Goldman is founding director of the Medical Device “Plug-and-Play” Interoperability program at the Center for Integration of Medicine and Innovative Technology and medical director of biomedical engineering for Partners HealthCare System, Boston, Mass. He also is chair of ASTM Subcommittee F29.21 on Devices in the Integrated Clinical Environment, part of Committee F29 on Anesthetic and Respiratory Equipment.
In an integrated clinical environment, known as ICE, all devices — from blood pressure cuffs to intravenous pumps to ventilators — could be interconnected in a so-called plug-and-play configuration that would enable health care to be better managed and patient data to be better shared. The plug-and-play terminology comes from the world of electronics, where various consumer devices are standardized to interoperate seamlessly. With such a system, if the patient’s condition changed, or if a device had a problem, equipment could adapt, compensate or use a proactive “smart alarm” to alert health care providers to life-threatening problems.
Life and Death
In the field of medicine, ICE is relatively new — only a handful of facilities now are planning to integrate equipment, though others are interested. Also new is ASTM standard F2761, which may help ICEs one day mean the difference between life and death.
STM F2761, Medical Devices and Medical Systems — Essential Safety Requirements for Equipment Comprising the Patient-Centric Integrated Clinical Environment (ICE), Part 1: General Requirements and Conceptual Model, will be published this fall.
The standard addresses safety requirements for equipment in an ICE, including operating rooms, intensive care units and even the home for those patients requiring higher acuity care. The standard specifies general requirements and a framework for integrating equipment with the goal of ensuring the safe integration of medical devices from various manufacturers in a world where proprietary devices often differ from one vendor to another, operate independently and generally cannot communicate with each other.
“This standard provides the missing framework to create ‘error-resistant’ patient care environments by enabling the integration of interoperable medical devices and other advanced technologies into smarter systems,” Goldman says.
Heart of the Standard
The standard addresses such topics as medical electrical equipment, medical device software and risk management. F2761 also describes:
“The purpose of doing this work is not to build a single device,” Goldman says. “It is to change the capabilities that we have in health care to facilitate innovation and empower the health care community to improve patient care.”
Goldman notes that interoperability has been supported by at least seven medical organizations, including the American Medical Association. Much of the foundation for the ICE standard is based on the contributions of working groups convened by the CIMIT Medical Device Interoperability program. Among others, the U.S. Department of Defense Telemedicine and Advanced Technology Research Center and National Science Foundation have contributed to the effort. The U.S. Food and Drug Administration Center for Devices and Radiological Health has collaborated on the foundational work that became the basis of the standard and has contributed its unique perspective on functional safety and effectiveness.
According to noted systems engineer Mike Robkin, president of Anakena Technology Solutions, “There’s nobody who operates a modern factory on the planet who doesn’t understand the value of control systems and good data, yet there are operating rooms across the country that are literally life and death (arenas) … (using) manual controls that have been here since 1950 in terms of connecting devices and sharing data.” Robkin, who through July worked for a large vertically integrated health care provider, has collaborated with Goldman on ICE-related projects.
Goldman and others note that such interconnectivity comes late to health care, but people expect it in everything from computers to televisions.
“Consumers have become accustomed to electronics and other equipment where we can just connect the devices together,” Goldman says. “Many people assume we have that capability in health care. The surprising thing is, we don’t. An educated patient might assume we have the ability to automatically stop an infusion of chemotherapy medication if blood pressure drops ... but we can’t do that.” As it stands now, Goldman says, to provide a similar level of care, a doctor or nurse would have to watch a patient’s equipment around the clock to observe every nuance of every device, a health care — and financial — impossibility.
With ICEs in place in the future, health care providers wouldn’t have to consider that type of observation. With the standard in place, medical professionals and patients will benefit from accurate electronic health records and well-informed guidelines that ultimately will improve patient safety and provider work flow.
“Part of the reason for developing the standard is to change expectations and give people a shared vision,” Goldman says. “We’re focusing on the safety aspect of integrating medical devices and systems to provide an extension of a caregiver’s ability. The standard is intended as the first in a series.”
Tracy Rausch, clinical engineer and co-founder of DocBox Inc., Waltham, Mass., is a member of Subcommittee F29.21, which started working on the standard in 2006. Fifteen subcommittee members in fields such health care, government and manufacturing contributed to the document.
Rausch, who has worked on developing ICE-related equipment, which she believes is critical to health care, says, “It allows the physicians and nurses to spend more time watching what the patients are doing and less time watching what the technology is doing.”
Patricia Quigley is an award-winning journalist and public relations practitioner who has written for local, regional, national and international publications. She resides in southern New Jersey, where she earned a B.A. in communication and an M.A. in writing from Rowan University.