FDA Recognizes Medical Device Interoperability Standards

Medical device interoperability is an important aspect of clinical practice that has historically been difficult to regulate. It’s clear that medical devices that are used within the same treatment setting must work together as flawlessly as possible in order to ensure the best possible patient outcomes, but achieving a set of standards at the federal level to help cement this goal was only recently accomplished in the summer of 2013.

In August 2013, the FDA elected to recognize a set of standards gathered from IEC, ANSI, ASTM, and ISO sources concerning medical device interoperability. The news came as part of the Agency’s yearly standards update, but the groundwork was laid earlier in 2012 when both the FDA and the Association for the Advancement of Medical Instrumentation (AAMI) held a summit discussing the need for a set of interoperability standards that could handle the wave of data sharing and transmission sweeping through the medical device industry.

On the surface, it seems obvious: the growing number of mobile devices running medical software means a greater need for the ability to make sense of the information being gathered and analyzed by these products. Standards related not just to software apps but also the firmware and software being run on hardware devices are crucial to ensuring end-to-end communication between medical devices in a clinical setting.

The voluntary standards included under the FDA’s blanket recognition are as follows:

  • 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)
  • Systems and software engineering – Systems and software assurance – Part 4: Assurance in the life cycle (ISO/IEC 15026–4 First edition 2012–10–01)
  • Industrial communication networks—Network and system security – Part 3–1: Security technologies for industrial automation and control systems (IEC/TR 62443–3–1 Edition 1.0 2009 – 07)
  • Application of risk management for IT networks incorporating medical devices – Part 1: Roles, responsibilities and activities (IEC 80001 – 1 Edition 1.0 2010 –10)
  • Application of risk management for IT networks incorporating medical devices – Part 2–3: Guidance for wireless networks (ANSI/AAMI/IEC TIR80001–2–3:2012)

The ultimate goal of painless data interfacing between all aspects of medical IT is still on the horizon. The introduction of these standards, however – in addition to being a step towards universal data transferability – is also important for medical device companies looking for yet another advantage when making a 510(k) submission. Products which follow standards are looked upon more favorably by the FDA, which is an incentive to adhere to the newly-listed guidelines during the device design phase.

Next Steps

Benjamin Hunting
Aptiv Solutions Blogging Team

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  1. FDA on Diabetes Innovation: Tackling Accuracy & Interoperability Challenges : DiabetesMine: the all things diabetes blog - January 28, 2014

    […] While we are encouraged by the successes of 2013, several outstanding challenges for both artificial pancreas systems as well as daily management of diabetes with traditional devices remain. The inability of different devices to communicate with each other, also known as interoperability, can lead to a lot of frustration for users. Many groups are working on several fronts including consolidation of software so that information from all of the devices can be viewed at once, remote data uploading, mobile medical applications for diabetes, and standardization of data formats so that users can easily interpret the data and use it effectively to manage their diabetes. The guidance on mobile medical applications that was finalized in 2013 provides more information and clarity about FDA’s thinking on this topic and we look forward to working together to address interoperability challenges. […]

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