New Resources on Medical Device Management and Interoperability

There is a host of new, free resources available—which I review here briefly—for improving the management of medical devices and interoperability of devices and information systems. Among these resources is the next issue of PSQH, which will be in the mail and posted online the week of Feb 11.

The issue includes an extended conversation with Julian M. Goldman, MD, medical director of biomedical engineering at Partners HealthCare System in Boston and director of the Program on Medical Device Interoperability at MGH and CIMIT. Goldman advocates a comprehensive view of interoperability, the “wicked IT problem” of our time, “in which there is little agreement about ‘the problem,’ no agreement on a solution, and problem solving is complex because of external constraints.” Despite these challenges, Goldman sees great promise for the future:

I’m suggesting that we should have a national dialog about the long-term vision of what we would change in healthcare if we had capabilities like this [interoperability]. In a sense, that vision of a completely different workflow using current sensors, actuators, and communication technologies in new ways, and lowering the barrier to introducing new technologies into the system of care, will generate a road map for the future.


For earlier articles on Goldman and the Medical Device Plug-and-Play interoperability lab, please see:

Connectivity to Improve Patient Safety: Making Medical Device “Plug-and-Play” Interoperability a Reality


MD FIRE: Hospitals Issue Call for Action on Medical Device Interoperability


The Association for the Advancement of Medical Instrumentation (AAMI) has released Medical Device Interoperability: A Safer Path Forward, which discusses issues identified at an Interoperability Summit AAMI convened with the FDA in October 2012. At the Summit, a professional facilitator lead more than 250 attendees through presentations, identification of key opportunities and barriers, and consensus on action items. Attendees represented diverse stakeholders in interoperability: “patient safety advocates, clinicians, healthcare technology managers, and other professionals in leading healthcare delivery organizations; systems safety experts; and representatives of manufacturers, standards setting organizations, regulatory bodies, research and academic institutions, and professional groups.” The report reflects this multifaceted group, with themes that range from establishing technical standards, to focusing on interoperability as a sociotechnical system, to streamlining clinical workflows.

The latest publication in the Safety Innovations series from the Healthcare Technology Safety Institute (HTSI) at the AAMI Foundation is Plan, Do, Check, Act: Using Action Research to Manage Alarm Systems, Signals, and Responses. This report describes Beth Israel Deaconess Medical Center’s (BIDMC) response to two serious adverse events that were caused by delayed responses to inpatient alarms. The report describes the events, background on alarm management, and two separate, successful improvement initiatives. Using FMEA and a rapid-cycle improvement process, BIDMC has made numerous short- and long-term improvements to alarm management throughout the hospital. BIDMC also improved safety in its emergency department by applying a Lean approach to improvement, in place throughout BIDMC since 2008, to observe, understand, and improve the complexity of its approach to alarm management. Preliminary results show the number of alarm signals in the ED dropped from 910,097 in March 2011 to 364,547 in March 2012.

The Joint Commission is seeking comments through Feb. 26, 2013, on a proposed National Patient Safety Goal on alarm management.