About the MD PnP Program

	Medical Device "Plug-and-Play" Interoperability Program The MD PnP program is leading the adoption of open standards and technology to interconnect medical devices for improving patient safety and healthcare efficiency

Medical System Interoperability --> Healthcare Provider Empowerment

"Interoperability can provide an infrastructure for innovation that will allow clinicians and biomedical engineers to leverage medical devices and IT systems to solve clinical problems, create error-resistant systems, and improve efficiency" J. Goldman, Sept 2007

The Massachusetts General Hospital (MGH) and CIMIT initiated a program in 2003 to lead the evaluation and adoption of open standards and technology for medical device interoperability. Four plenary conferences, working group meetings, and clinical focus groups have elicited input from a multi-institutional, multi-disciplinary MD PnP team to shape the mission and strategy and identify clinical requirements. Over 70 institutions and > 600 domain experts (including clinicians and engineers) have participated.

What is the scope of effective medical device interoperability?

There are two distinct – but closely related – requirements for interoperable medical device systems:

1. Data communication capability to support complete and accurate data acquisition by the EHR/EMR from vital signs monitors, infusion pumps, ventilators, portable imaging systems, and other hospital and home-based high-acuity medical devices. Comprehensive data acquisition will also enable the development of remote monitoring, advanced clinical decision support systems, intelligent alarms, and robust databases for Continuous Quality Improvement.

2. Medical device control capability to permit the integration of distributed medical devices to produce “error-resistant” systems with safety interlocks between medical devices to decrease “use errors”, closed-loop systems to regulate the delivery of medication and fluids, and remote patient management to support healthcare efficiency and safety.

What are the goals of the MD PnP Program?

Guide the development and adoption of open standards and technology to support medical device interoperability. The adoption of safe and effective networked medical device systems requires an ecosystem of ancillary devices and functions. An ecosystem standard for the Integrated Clinical Environment (ICE), is under development, and will address:
a.    A "network manager” function to support plug-and-play connections of medical devices
b.    Privacy/security/audit trail - to assure confidentiality and reliability of data
c.    Authorization - to prevent non-conforming devices from affecting the network
d.    Clinical/Business rules and rule engine - to support clinical algorithms
e.    “Black-box” recording - of network traffic and other data to support forensic analysis and to detect/prevent system problems.
Define a safe “least-burdensome” regulatory pathway for the proposed systems in partnership with regulatory agencies. (The FDA has been a key partner. See FDA letter.)
Elicit high-level user requirements for proposed interoperable systems to improve safety and efficiency.
Use the vendor-neutral MD PnP laboratory “sandbox” that opened in May 2006 to:

evaluate ability of candidate interoperability standards to meet clinical requirements

model clinical use cases (in simulation environment)

develop and test related network safety and security systems, especially to enhance the understanding of the technical issues at the intersection of Biomedical Engineering and Information Systems

support interoperability and conformance testing

serve as a resource for the medical device interoperability community

Application Areas for Networked Medical Device Systems

Networked medical device systems could support improvements in workflow and reductions in medical errors and healthcare costs to the benefit of patients throughout the continuum of care: from the home, to pre-hospital transport, and to clinical areas as diverse as the OR, ICU, and general hospital ward.

The integration of individual medical devices into patient-centric networked systems can provide real-time comprehensive data for the electronic medical record (EMR) and can support advances in patient safety and workflow improvements such as:
•    Clinical decision support
•    Medical device safety interlocks
•    Physiologic closed-loop control of medication, fluid delivery, and ventilation
•    Monitoring of device activity and performance
•    Automated system readiness assessment (prior to starting invasive clinical procedures)
•    Support of “e-ICU” implementations
•    Safeguarding of protected patient information through real-time encryption
•    “Plug-and-play” modularity to support “hot swapping” of “best of breed” devices
•    Facilitation of disaster preparedness: real-time inventory of hospital equipment in-use and national stockpiles, and rapid deployment of devices in makeshift emergency-care settings
•    Avoidance of unnecessary redundancy by using shared resources
•    Reduction of the cost and implementation barriers to technology dependent innovation

A long-term goal is to create a BME-IT infrastructure for healthcare innovation.

Please see the PUBLICATIONS page for more information including presentation slides.