Posted July 8, 2020

Julian M. Goldman, M.D., Massachusetts General Hospital

When faced with an emergency response scenario, medical personnel may be challenged with managing dozens of patients simultaneously. The current COVID-19 pandemic adds an increased risk of exposure to an already challenging situation. While the use of technology to remotely monitor vital signs has become more common in healthcare settings, the technologies’ limited capabilities do not provide a comprehensive picture of the patient’s clinical status. Interoperability, or the capacity of multiple information systems and software applications to communicate and exchange data allows access to clinical patient data in real time from any location. With funding through the Fiscal Year 2016 Joint Warfighter Medical Research and Development Award, Dr. Julian Goldman and the Massachusetts General Hospital Medical Device Interoperability & Cybersecurity Program (MD PnP) are designing applications to enable interoperability and developing interoperability standards for the next generation of medical devices, real-time applications, and the platforms to deploy them.

Specifically, the applications will enable data from multiple devices to be combined, automatically detect clinically significant conditions, and provide peer-reviewed clinical guidance at any location to enable effective treatment strategies in theater or during public health emergencies when those with limited medical training may be faced with urgent, complex clinical challenges. The enhanced vigilance and Real-Time Caregiver Decision Support from a network of medical devices will be valuable for even the most experienced healthcare providers when faced with newly emerging or less-frequently seen conditions.

The MD PnP program’s efforts have informed the development of the Association for the Advancement of Medical Instrumentation’s (AAMI) standards for interoperability and cybersecurity to educate manufacturers of the necessary performance capabilities required for integrating medical devices and apps into Integrated Clinical Environments for remote monitoring, diagnosis, and closed-loop control. The MD PnP program is also developing a certification program to allow manufacturers to demonstrate and validate the performance of their products in accordance with applicable standards.

With the recent emergence of COVID-19, the need to leverage this technology has become evident. As co-chair of the AAMI COVID-19 Task Force, Dr. Goldman also recently led the development of several Consensus Reports¹ which serve as emergency guidance documents, providing the standards and criteria to enable the rapid development of ventilators and resuscitators to treat patients with COVID-19 respiratory failure. 

With the collaboration of manufacturers, the MD PnP program is working on the deployment of remotely controllable ventilators that will enable continuous monitoring and timely adjustment of ventilation while limiting the provider-patient contact. Controlling the frequency of required room entries not only decreases the chances of spreading the highly contagious virus, but also reduces the consumption of Personal Protective Equipment, which has been at critically low levels since the start of the pandemic. Remote control also enables health care providers to more rapidly respond to the patient’s clinical needs, thereby improving patient care.

The MD PnP program is setting the stage for the future of healthcare. Whether in a military or civilian setting, interoperability improves the safety and quality of care for patients, healthcare providers, Service Members, and Veterans.

Reference:

¹AAMI: COVID-19 Emergency Guidance

Link:

Public and Technical Abstracts: An Interoperable Platform for Real-Time In-Theater Caregiver Decision Support (RTCDS)

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