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Software as a Device The application of the EU-Medical Device Directive and the US-Medical Device Data Systems regulation ...
Introduction <ul><li>Frank Maxwell </li></ul><ul><li>Project Manager,  </li></ul><ul><li>Professional Services EMEA,  Acqu...
Relevant Experience <ul><li>14 years Professional Services Delivery (Enterprise Software) </li></ul><ul><li>Industries:  <...
Research Focus <ul><ul><ul><li>“ How can software be classified as a medical device?” </li></ul></ul></ul><ul><ul><ul><li>...
Research Focus <ul><li>To apply the two regulations against the software catalogue in use by private European hospital. </...
Point of Change - US FDA Centre for Devices and Radiological Health made the clear statement ; “ Under the Federal Food an...
Point of Change - EU In May 2010 the UK agency Medical and Health related Regulatory Agency (MHRA) reviewed all incidents ...
USFDA - Medical Device Data Systems (MDDS)  21 CFR 880.6310 <ul><li>15 th  February 2011:  The new rule was announced  </l...
USFDA - Medical Device Data Systems (MDDS)  21 CFR 880.6310 <ul><li>The electronic transfer of medical device data </li></...
Medical Devices Directive 93/42/EEC (EU-MDD) <ul><li>2005:  EU Commission introduced amendment M5 2007/47/EC  </li></ul><u...
Medical Devices Directive 93/42/EEC (EU-MDD) “ medical device’ means any instrument, apparatus, appliance,  software , mat...
Medical Devices Directive 93/42/EEC (EU-MDD) <ul><li>Diagnosis, prevention, monitoring, treatment or alleviation of diseas...
Application: EU-MDD Decision diagram.  (COCIR, 2010)
Application:  EU-MDD Audit Decision Matrix
Application: US-MDDS  Decision diagram for qualification of software  (HIMSS Analytics, 2010)
Application :  US-MDDS Audit Decision Matrix
Software Catalogue
Results Summary
Results Summary <ul><ul><li>Will the outcome be different for each regulation?  </li></ul></ul><ul><ul><li>Significant  Ye...
Results Summary <ul><ul><li>What further research could be developed on the findings? </li></ul></ul><ul><ul><li>The evalu...
Results US-MDDS
Harmonised Standards
Thank you <ul><li>Email:  [email_address] </li></ul><ul><li> frank.maxwell@gmail.com </li></ul><ul><li>Linkedin: http://ie...
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Software As Device - Frank Maxwell

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Transcript of "Software As Device - Frank Maxwell"

  1. 1. Software as a Device The application of the EU-Medical Device Directive and the US-Medical Device Data Systems regulation to a private hospitals software catalog.
  2. 2. Introduction <ul><li>Frank Maxwell </li></ul><ul><li>Project Manager, </li></ul><ul><li>Professional Services EMEA,  Acquia </li></ul>
  3. 3. Relevant Experience <ul><li>14 years Professional Services Delivery (Enterprise Software) </li></ul><ul><li>Industries: </li></ul><ul><li>Pharmaceutical Clinical Applications (R&D) </li></ul><ul><li>Healthcare Solutions </li></ul><ul><ul><li>US: Harvard Risk Management Foundation, Brigham and Women’s Hospital, Children’s Hospital, Florida Hospitals Network </li></ul></ul><ul><ul><li>HSE </li></ul></ul><ul><ul><li>NHS </li></ul></ul>
  4. 4. Research Focus <ul><ul><ul><li>“ How can software be classified as a medical device?” </li></ul></ul></ul><ul><ul><ul><li>US-MDDS- Medical Device Data Systems (MDDS) 21 CFR 880.6310 </li></ul></ul></ul><ul><li>EU -MDD – Medical Devices Directive 93/42/EEC (MDD) with amendment M5 (2007/47/EC) </li></ul>
  5. 5. Research Focus <ul><li>To apply the two regulations against the software catalogue in use by private European hospital. </li></ul><ul><ul><li>Will the outcome be different for each regulation? </li></ul></ul><ul><ul><li>Where bespoke HIT development is involved, does HIT classification position a hospital as a medical device manufacturer? </li></ul></ul><ul><ul><li>If the outcome is different for each regulation are there any indications as to why? </li></ul></ul><ul><ul><li>What further research could be developed on the findings? </li></ul></ul>
  6. 6. Point of Change - US FDA Centre for Devices and Radiological Health made the clear statement ; “ Under the Federal Food and Drug Cosmetic Act, Healthcare Information Technology software is a medical device” 25 th February 2010 Dr. Jeffery Shuran Director
  7. 7. Point of Change - EU In May 2010 the UK agency Medical and Health related Regulatory Agency (MHRA) reviewed all incidents where were reported and concludes as software related issues. Table 1: Percentage of reported incidents reported as software issues.
  8. 8. USFDA - Medical Device Data Systems (MDDS) 21 CFR 880.6310 <ul><li>15 th February 2011: The new rule was announced </li></ul><ul><li>18 th April 2011: MDDS rule became effective </li></ul><ul><li>16 th May 2011: All medical device manufacturers must be registered and list their medical devices </li></ul><ul><li>All manufacturers must implement a FDA compliant Quality System within 12 months of registering. </li></ul><ul><li>18 th April 2012: A medical device reporting system for devices must be implemented by manufacturers for their listed devices. </li></ul>
  9. 9. USFDA - Medical Device Data Systems (MDDS) 21 CFR 880.6310 <ul><li>The electronic transfer of medical device data </li></ul><ul><li>The electronic storage of medical device data </li></ul><ul><li>The electronic conversion of medical device data from one format to another format in accordance with a preset specification </li></ul><ul><li>The electronic display of medical device data </li></ul>
  10. 10. Medical Devices Directive 93/42/EEC (EU-MDD) <ul><li>2005: EU Commission introduced amendment M5 2007/47/EC </li></ul><ul><li>May 2010 : EU Commission brought the rule into force </li></ul>
  11. 11. Medical Devices Directive 93/42/EEC (EU-MDD) “ medical device’ means any instrument, apparatus, appliance, software , material or other article, whether used alone or in combination , including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose
  12. 12. Medical Devices Directive 93/42/EEC (EU-MDD) <ul><li>Diagnosis, prevention, monitoring, treatment or alleviation of disease </li></ul><ul><li>Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap </li></ul><ul><li>Investigation, replacement or modification of the anatomy or of a physiological process </li></ul><ul><li>Control of conception </li></ul>
  13. 13. Application: EU-MDD Decision diagram. (COCIR, 2010)
  14. 14. Application: EU-MDD Audit Decision Matrix
  15. 15. Application: US-MDDS Decision diagram for qualification of software (HIMSS Analytics, 2010)
  16. 16. Application : US-MDDS Audit Decision Matrix
  17. 17. Software Catalogue
  18. 18. Results Summary
  19. 19. Results Summary <ul><ul><li>Will the outcome be different for each regulation? </li></ul></ul><ul><ul><li>Significant Yes – Where is the harmonisation that was intended </li></ul></ul><ul><ul><li>Where bespoke HIT development is involved, does HIT classification position a hospital as a medical device manufacturer? Yes </li></ul></ul>
  20. 20. Results Summary <ul><ul><li>What further research could be developed on the findings? </li></ul></ul><ul><ul><li>The evaluation of complementary regulation, standards and guidelines? GAMP ? </li></ul></ul><ul><ul><li>The implications to software evaluation and selection? </li></ul></ul><ul><ul><li>Comparison across vendors of similar products? </li></ul></ul><ul><ul><li>Private versus public institutions? </li></ul></ul><ul><ul><li>What about the software found at GPs </li></ul></ul>
  21. 21. Results US-MDDS
  22. 22. Harmonised Standards
  23. 23. Thank you <ul><li>Email: [email_address] </li></ul><ul><li> frank.maxwell@gmail.com </li></ul><ul><li>Linkedin: http://ie.linkedin.com/in/frankmaxwell </li></ul>
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