Changing Regulatory Requirements for Electronic Medical Devices Dirk Smith Co-Founder Minnetronix Inc.

Transcription

1 Changing Regulatory Requirements for Electronic Medical Devices Dirk Smith Co-Founder Minnetronix Inc.

2 250 employees, 20 years in business 130+ Class II/Class III device programs in our history 100+ engineers with over 1.5M development hours on complex electromechanical medical devices, including drug delivery devices FDA-registered, ISO Certified Our medical device background: Development partner Med device manufacturer Technology developer

3 A Brief Survey of Recent Regulatory and Compliance Changes Objective Discuss the current general landscape of compliance Provide a sample of impactful changes Point to standards and resources for further information Focus on device compliance of electronic, electromechanical and programmable devices

4 Scope For This Talk: Device Compliance Quality Management System ISO CFR Part 820 International Device Compliance Laws EU Medical Medical Device Device Directive Standards 21 CFR Guidance 800 Series Documents Non-med Cert s/licenses Other Device country-specific Approvals law CE-Mark FDA Clearance/Approval International Approvals IEC Medical Device Regulatory Affairs

5 ME Standards History: Editions and Major Amendments 1972 (US), UL (Underwriters Laboratories) published the UL 544 standard for medical and dental equipment (new medical standard) 1977, IEC 601-1, Edition 1 published for medical equipment (new medical standard) 1988, IEC 601-1, Edition 2 published (revised standard) 1994 (US), UL , Edition 1 standard published (harmonized with IEC , Edition 2 + Amendment 1 + US Deviations) 2005, IEC , Edition 3 published (Completely revised standard) 2005 (US), AAMI published the AAMI ES standard (harmonized with IEC , Edition 3 + US Deviations). This marked the transition of the US National medical standards from UL to AAMI. 2012, Amendment 1 to IEC , Edition 3 published, re-named Edition 3.1 (major corrections to standard) 2012 (US), ES :2005(R)2012 published (harmonized with IEC , Edition 3 with Amendment 1 Edition 3.1)

6 IEC : Medical electrical equipment Part 1- General requirements for basic safety and essential performance Hurdles? Required Path? or Rules of the Road?

7 Current Device Compliance Landscape Overall goal remains unchanged safety Increased complexity of standards, coincident with increased complexity of devices Harmonization of international standards Emphasis on risk management Hot Topics: usability, connectivity and compatibility

8 , 2 nd to 3 rd Editions 3 rd edition published 2005, widely recognized/required by 2013 Nearly worldwide harmonization (China pending) 100 pages longer, new approach, not backward compatible Risk assessment and process requirements (ISO 14971) Emphasis on Basic Safety AND Essential Performance Electrical safety in terms of Operator and Patient protection Incorporation of PEM (SW) requirements into the standard Many specific mechanical, electrical and labeling changes Intertek White Paper: IEC : The New Philosophy of the 3rd Edition, Sept

9 : Basic Safety and Essential Performance Basic Safety freedom from unacceptable RISK directly caused by physical HAZARDS when ME EQUIPMENT is used under NORMAL CONDITION and SINGLE FAULT CONDITION Examples: shock, drop, burn, pinch. Essential Performance Performance necessary to achieve freedom from unacceptable RISK NOTE Essential Performance is most easily understood by considering whether its absence or degradation would result in an unacceptable RISK Failure to provide essential performance is an unacceptable RISK, in normal and single fault conditions Examples: heating range on a warming blanket, flow accuracy on an IV pump

10 , Edition 3.1 Published in 2014 FDA Deadline for compliance: August 1, 2016 EU transition January 1, 2018 Clarifies application of risk management and essential performance Additional software and usability testing and process requirements Numerous mechanical, electrical, labeling requirements changes UL Whitepaper: The New Paradigm for Medical Device Safety Addressing the Requirements of IEC Edition 3.1, 2015

11 ISO 14971:2012 Application of Risk Management to Medical Devices ISO now specifically required by Notable change in latest version: AFAP vs ALARP As Far as Possible, no longer As Low as Reasonably Practical Eliminates financial considerations from determination Still maintains state of the art considerations for AFAP

12 ISO 14971:2012 ALARP Approach Table from AFAP Approach

13 ISO 14971:2012 When is enough Risk Mitigation enough? When further mitigation does not further reduce risk When a more effective, yet incompatible mitigation already exists Risk / Benefit Analysis Required for all identified risks An essential element in assessing acceptable risks and overall residual risk for a product Important to base on clinical risk and benefit Useful to benchmark existing devices, objective evidence At the end of the day, manufacturer responsible for process and determination of acceptability of risk

14 Electromagnetic Compatibility Requirements and Tests 4 th Edition, published 2014, required by FDA 4/2017 ESD air discharge to 15kV Required data in labeling / IFU s Cell phone (wireless communications devices) proximity requirements Altitude considerations for operator insulation General environmental requirements expanded

15 Additional New and/or Updated Collateral Standards , IEC (2006) Medical device software Lifecycle process, development and maintenance Safety classifications and associated process and documentation requirements (Ed ) /IEC (2007) Usability User-centered design process, requirements -> validation Usability Engineering File (Am ) Alarms Important to differentiate indicators and alerts from alarm Audio alarm tones defined in the standard, by priority (Ed ) Home Healthcare Environmental requirements; electrical, temp, drop, fluid ingress, etc. User training and competency considerations in usability process Data security, integrity, privacy

16 Guidance Documents and Peripheral Standards Notable FDA Guidance Doc s Applying HF and Usability RF Wireless Technology in Medical Devices Infusion Pumps Total Product Lifecycle Management of Cybersecurity in Medical Devices Content of Premarket Submissions for Software IEC Health Software (draft) Applies to stand-alone software, not running on dedicated hardware Addresses full product lifecycle

17 Navigating the Compliance Roadway Regulatory landscape continues to change Expect updated versions of standards and guidance doc s Complexity of standards continues to increase, as does the complexity of devices Many expert resources to assist developers Development and manufacturing partners Test agencies Regulatory and compliance specialists

18 Questions/Comments?

19 Thank You!