Medical devices are essential to the practice of modern medicine. Clinical measurements such as blood pressure and temperature, x-ray and ultrasound imaging, administration of intravenous medications, and support of critical life functions all require medical devices. However, despite our reliance on sophisticated medical equipment, most devices are not designed to interconnect with other devices. Therefore, it is difficult to connect individual devices into integrated medical systems to improve patient care, avoid unnecessary accidents, and obtain comprehensive data to personalize care delivery.

There are a number of challenges preventing the health care community from realizing the full potential of device interoperability. These challenges include technical issues (the mechanics of interoperability), systems engineering issues (repeatable processes for correctly and efficiently integrating devices into larger systems), and overarching reliability, safety, and security challenges. UL has been collaborating for almost a decade with the MDPnP team to develop sharable databases, open-source tools, and applications that will enable a broader community of researchers and manufacturers to implement secure medical device interoperability.

Regulatory Requirements

Additional technology-specific standards exist and serve to aid in the development of INTEROPERABLE devices including the Health Informatics, IEEE 11073 series, and other standards and supporting documents from HL7, IEEE, and IHE. Standards such as the Standard for 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, ASTM F2761-09 (2013) provide general requirements and a high-level architecture for an integration platform (Integrated Clinical Environment, or “ICE”).

A number of relevant international standards already successfully address segments of this technology space.

  • The Standard for Medical Devices – Application of Risk Management to Medical Devices ISO 14971
  • Standard for Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, IEC 60601-1
  • The Application of Risk Management for IT-Networks Incorporating Medical Devices, IEC 80001 series adds additional criteria for addressing technology-specific risk of integrating medical devices into hospital IT networks.

 

Services

InteroperabilityOur teams have taken a multi-faceted approach to reduce key barriers to achieving interoperability, including:

  • Support of suitable open standards (e.g. AAMI/UL 2800 leveraging principles from ASTM F2761, Integrated Clinical Environment, or “ICE”)
  • An OPEN SOURCE implementation of ICE being evolved now across many stakeholder groups
  • Elicitation, analysis, and modeling of clinical use cases and system engineering requirements for an open architecture instantiation of ICE as a platform and “ecosystem”
  • Alignment of clinical, manufacturer, and FDA regulatory expectations
  • Implementation of prototype use cases in an open “sandbox” environment in the MD PnP Lab
  • Diverse collaboration and engagement

 

WHY UL

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Knowledge of Global Standards and Regulatory Requirements

  • Covers many markets ie FDA (US), MFDS (Korean FDA), EU IVD, EU MDD
  • UL has helped to set more than 1,600 standards defining safety, security, quality and sustainability
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