Medical software

Medical Software Logo, by Harry Gouvas

The terms medical software and medical device software are undefined terms that can designate any software, software item or system used within a medical context (e.g. medical devices that monitor or control patients are predominantly controlled by software), depending on its intended use / indication for use.

Overview

"Medical devices", as a broader term, refers to regulated products that must comply with local and regional laws.[1] In the United States (US), as of the mid-1980s, the Food and Drug Administration (FDA) has increased its involvement in reviewing the development of medical device software, due to patient overdoses caused by coding errors in a radiation therapy device (Therac-25).[2] The FDA is now focused on regulatory oversight in the medical device software development process and system-level testing.[3] Between 1995 and 2005, IEC 62304 became the benchmark standard for the development of medical software in both the EU and the US.[4]

Due to the broad scope covered by these terms, manifold classifications can be proposed for various medical software, based for instance on their technical nature (embedded in a device or standalone), on their level of safety (from the most trivial to the most safety-critical ones), or on their primarily function (treatment, education, diagnostics, data management).

Definition

The scope of the evolved regulatory definition of a medical device now explicitly includes the term "software" (and not simply software that is part of or within another product).[5] As such, the following would be considered to fall under its scope:

EU 2007/47/EEC that amended 93/42/EEC Directive introduces also the stand-alone software (Annex IX). This modifies the risk classification of the software because a stand-alone software is considered as an active medical device.

History

The generic term medical software has been around for almost three decades. The last decade then saw a vast new array of software programs entering the medical technology space. Dozens of examples now exist where the critical functions performed by medical devices are partly (or now sometimes entirely) directed by software, notably by software that is standalone. The interesting element is that, for the first time in the European MDD[ref 1], a medical device can now be 100% virtual (or invisible).

The dramatic increase in smartphone usage over the last five years or so is perhaps the most significant factor that has triggered the emergence of thousands of pure software programs and apps in this space, many falling into a ‘grey’ or borderline area in terms of regulation.

Medical Device Software

The term "Medical Device Software" [also: "Software Medical Device" or, less commonly, "Software-As-A-Medical-Device"], refers to a program or application (or a product itself) that is a standalone software system (not appended/integrated into a distinct product) AND meets the legal definition of a medical device (e.g. European medical devices directive MDD/93/42, updated in 2007 to explicitly include the term ‘software’).[5]

Regulatory changes

In the United States (US), starting three decades ago, the FDA increased its level of activity in reviewing the development of medical device software, due perhaps to coding errors causing patient overdoses in a radiation therapy device (Therac-25).[6] An increased regulatory oversight of the FDA on medical device software development processes and system testing has been described in safety research on infusion pump software.[7]

In the US, the FDA has published guidance (on the topic of medical devices) that specifically addresses medical device software.[8]

In July 2011 the FDA published a guidance on medical mobile applications, with the final regulations issued on September 2013.[9] These regulations only apply to "medical apps that transform a mobile device into a medical device or an accessory to a regulated medical device."[10] Examples include apps that regulate an installed pacemaker or those that analyze images for cancerous lesions, X-rays and MRI, graphic data such as EEG waveforms, bedside monitors, urine analysers, glucometer, stethoscopes, spirometers, BMI calculators, heart rate monitors and body fat calculators (see Mobile Medical Apps).[11]

International Standards

Over the last fifteen years, IEC 62304 has become the benchmark standard for the development of medical device software, whether standalone software or otherwise, in both the EU and the US.[12]

Leading industry innovation in software technologies has led key industry leaders and government regulators to recognise the emergence of numerous standalone medical software products that operates as medical devices. This has been reflected in regulatory changes. Example: European medical devices directive MDD/93/42, updated in 2007.[5]

In Europe, a guidance document has been published on this subject.[13]

The quality management system requirements for manufacturing a software medical device, as is the case with any medical device, are described in the QSR regulations[14] of the FDA and also in ISO 13485:2003.

Software technology manufacturers that operate within the software medical device space mandatorily develop their products in accordance with formal quality system requirements (cf. aforementioned FDA or EU requirements for this). Furthermore, though not mandatory, they frequently elect to obtain certification from a notified body, having implemented such quality system requirements as described within international standards, such as ISO 13485:2003.

See also

International Medical Device Regulators Forum: Software as a Medical Device(SaMD) [15][16]

References

  1. ↑ Category:Regulation of medical devices
  2. ↑ Jones, Paul (2010-02-09). "A Formal Methods-based verification approach to medical device software analysis". Embedded Systems Design. Retrieved 2010-09-09.
  3. ↑ FDA (2010-09-08). "Infusion Pump Software Safety Research at FDA". FDA. Retrieved 2010-09-09.
  4. ↑ U.S. Department Of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health and Center for Biologics Evaluation and Research (11 January 2002). "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". General Principles of Software Validation; Final Guidance for Industry and FDA Staff. Center for Devices and Radiological Health. Retrieved 2 June 2012.
  5. ↑ 5.0 5.1 5.2 European medical devices directive MDD/93/42, updated in 2007
  6. ↑ Jones, Paul (2010-02-09). "A Formal Methods-based verification approach to medical device software analysis". Embedded Systems Design. Retrieved 2010-09-09.
  7. ↑ FDA (2010-09-08). "Infusion Pump Software Safety Research at FDA". FDA. Retrieved 2010-09-09.
  8. ↑ FDA on Medical Device: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.
  9. ↑ Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications. Document Issued on: July 21, 2011. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
  10. ↑ Nursetogether.com. "FDA Now Regulating Mobile Medical & Nursing Apps" Retrieved: 9 January 2014. http://www.nursetogether.com/fda-regulation-of-mobile-medical-apps-may-e
  11. ↑ AK Yetisen, JL Martinez-Hurtado, FC Vasconcellos, MCE Simsekler, MS Akram and CR Lowe (2014). "The regulation of mobile medical applications.". Lab Chip. doi:10.1039/C3LC51235E.
  12. ↑ U.S. Department Of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health and Center for Biologics Evaluation and Research (11). "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". General Principles of Software Validation; Final Guidance for Industry and FDA Staff. Center for Devices and Radiological Health. Retrieved 2 June 2012.
  13. ↑ MEDDEV Guidelines: http://ec.europa.eu/enterprise/sectors/medical-devices/documents/guidelines/index_en.htm
  14. ↑ CFR 21 Part 820 http://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/default.htm
  15. ↑ http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions.pdf
  16. ↑ http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-smd-samd-140402.pdf

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External links

Media related to Medical Software at Wikimedia Commons