Interoperability of Connected Medical Devices

An overview of medical device interoperability standards

Medical device interoperability is essential to the practice of modern medicine. We can help you navigate the relevant international standards that address segments of this technology space.

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.

Our teams take a multifaceted approach to reduce key barriers to achieving interoperability, including:

Supporting suitable open standards (e.g., AAMI/UL 2800, the series of Standards for Medical Device Interoperability) and leveraging principles from ISO 13485, Quality Management System, approaches to address complex risk management scenarios involving connected medical devices and their emergent (system) properties.
Open-source implementation of medical device interoperability approaches currently being evolved across many stakeholder groups.
Elicitation, analysis and modeling of clinical use cases and system engineering requirements for an open architecture instantiation of an integrated clinical environment (ICE) as a platform and ecosystem.

Alignment of clinical, manufacturer, and U.S. Food and Drug Administration (FDA) regulatory expectations.
Collaborating on the implementation of prototype-use cases in open cooperative environments such as the Massachusetts General Hospital Medical Device Plug-and-Play (MD PnP) Lab.
Working with consortia on standardized testing approaches through efforts such as Integrating the Healthcare Enterprise’s (IHE’s) and Health Level 7’s (HL7) Service-Oriented Device Point-of-Care interoperability (SDPi).
Diverse collaboration and engagement.

Additional technology-specific standards exist and serve to aid in the development of interoperable devices including the IEEE 11073 Health Informatics series, and other standards and supporting documents from HL7, IEEE and IHE. Standards such as ASTM F2761-09 (2013), 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. Others include the AAMI HIT 1000 series, such as AAMI HIT1000-1 (PS):2018 — Safety and Effectiveness of Health IT Software and Systems — Part 1: Fundamental Concepts, Principles, and Requirements. This identifies the core concepts and principles needed to maintain safe and effective health IT software and systems and provides general requirements and a high-level architecture for an integration platform.

A number of relevant international standards —including ISO 14971, the Standard for Medical Devices — Application of Risk Management to Medical Devices, and IEC 60601-1, the Standard for Medical Electrical Equipment — Part 1: General Requirements for Basic Safety and Essential Performance, already successfully address segments of this technology space. IEC 80001 series, The Application of Risk Management for IT-Networks Incorporating Medical Devices, adds additional criteria for addressing the technology-specific risk of integrating medical devices into hospital IT networks.

Enhance security and interoperability for connected medical devices

Several challenges prevent the healthcare 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. We have been collaborating for more than a decade with the MD PnP team and other such research organizations 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.

Bring connected medical devices to market efficiently with UL Solutions

Global market acceptance

Our business experience reaches back to 1894.
Our 15,000+ mission-driven employees work in 40+ countries around the world. Our diverse customers are based in 110+ countries.
Our reports and certifications are recognized and accepted around the world.
The UL Mark appears on billions of products globally.

Comprehensive testing and certification services

We offer field evaluations and on-site training and testing services
We offer full compliance testing/evaluation to prescans and other preliminary testing.
We have engineers that work with you from design through conception and production.
The UL Solutions company portfolio encompasses more than 11 industry business units.

Knowledge of global standards and regulatory requirements

We cover many markets, i.e., U.S. Food and Drug Administration, Korean Ministry of Food and Drug Safety, European Union (EU) In Vitro Diagnostic (IVD) Directive, EU Medical Devices Directive (MDD)/Medical Device Regulation (MDR).
We sit on 1,300+ standards panels and other technical committees.
Our engineers partner with standard committees, such as the Association for the Advancement of Medical Instrumentation (AAMI), American National Standards Institute (ANSI) and government bodies.
We have an FDA-recognized consensus standard for cybersecurity, UL 2900, the Standard for Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements.

State-of-the-art facilities

We have 140+ locations around the world, including 80+ with laboratories.
We offer tailored testing services, using software automation to enhance process efficiency, analyze results and reduce testing cycles.

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