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Risk Management Research 2016 ISO 14971:2016

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Risk Management Research 2016

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Risk Management Research 2016 ISO 14971:2016

  1. 1. Risk Management within Medical Devices MScSED - Module: MCT626 Researcher: Niamh St John Lynch Advisor: Dr Owen Molloy Date: 04 May 2016
  2. 2. Experience Qualifications / Experience Quality Manager  J&J, Boston Scientific, Beckman Coulter / Danaher, Merit Medical, Bioniche / Mylan, Phardiag / Menarini Group 20 Years in IT, Pharmaceutical and Medical Devices BSc Cognitive Science (Hons) MSc Neuropharmacology Certified to ISO 14971:2016 Certified to ISO 13485:2016 Certified to GMP/GDP/RP Niamh Lynch (nee St John)
  3. 3. Contents Background Definitions Introduction Problem Overview Research Question Literature Review Research Methodology Conclusion
  4. 4. Requirements Relevance? Background Risk management is central to all Medical Device manufacturers and with the changes to ISO 14971:2012 and more recently ISO 13485:2016 All Medical Device companies need to review their approach
  5. 5. ISO 14971 Risk Management Risk Plan Risk Analysis Risk Evaluation Risk Control Effectivene ss Monitoring Risk Acceptabilit y Risk Report Risk Benefit Analysis ISO 14971:2012 Risk Plan Risk Analysis Risk Evaluation Risk Control Effectivene ss monitoring of controls Risk Report ISO 14971:2007/20 09 Risk Analysis Risk Evaluation Risk Control ISO 14971:2001 Risk Assessment Only ISO 14971- 1:1998 21 CFR Part 820 required for device modification includes Design Control and Validation including labelling and packaging QSR 1996 Medical Device Amendment Class III medical devices to go through PMA FDA GMP 1976
  6. 6. Definition of Risk “the combination of the probability of occurrence of harm and the severity of that harm” Q9 (2006)
  7. 7. Definition of Risk Management “the systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk”, Q9 (2006).
  8. 8. Why Perform Risk Management? Reduce Risk to Patients Reduce Risk to Business reduce cost Risk management attempts to identify, measure, mitigate or control risks, which as we defined above, are the opportunity for loss or injury in order to protect the public from harm arising from new medical devices or changes to existing medical devices
  9. 9. What is a Medical Device?  Medical Device - “Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for human beings for one or more of the specific purpose(s) of the following:  Diagnosis, prevention, monitoring, treatment or alleviation of disease;  Diagnosis, monitoring, treatment, alleviation of or compensation for an injury;  Investigation, replacement, modification, or support of the anatomy or of a physiological process;  Supporting or sustaining life  Control of conception  Disinfection of medical devices  Providing information for medical purposes by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action or on the human body by pharmacological, immunological or metabolic means, but which
  10. 10. Problem Overview  Patient Harm, Injury and Death continue to occur  Product Recalls and Failures continue  Risk Management System Requirements require ‘robust’ risk techniques  Risk Management Systems continue to be difficult to maintain  Risk Management Systems are for the most part, not integrated within it’s QMS  FMEA is main tool used in Medical Devices – not robust enough to identify all risk
  11. 11. Literature Review Lit Review Demonstrates: FMEA is the tool of choice for manufacturing, manufacturing services and suppliers to the industry. Ref. Dumbrique, R. (2010). Implementation of Risk Management in the Medical Device Industry. Master’s Theses Paper 3855. San Jose State University. SJSU Scholar Works
  12. 12. Research Question Two key questions : Do Medical Device companies continue to rely heavily on Failure Modes and Effects Analysis (FMEA) as the primary tool for risk assessment (ref. Lopez, et al (2010), Kamm (2005) and Lu Gan (2012)? Does the FMEA adequately support Risk Management throughout the full lifecycle of the Product Development Process to meet relevant Medical Device standards, ISO 13485:2016 and ISO 14971:2012?
  13. 13. Failure Modes Effects Analysis
  14. 14. FMEA Limitations Some of the limitations of the FMEA listed by McDowall (2005 and Gan, 2011) include: Components can be tedious and difficult to analyze when part of complex systems Compound failure effects cannot be analyzed Cost and time consuming, unless carefully controlled Successful completion requires expertise, experience and good team skills Incorporating all possible factors influencing the system, such as human errors can result in lengthy analysis, difficult to manage. Data redundancies can be a problem and is time consuming
  15. 15. How Can Technology Help? A software risk management tool is proposed to overcome these significant problems within the industry. The aim for the software tool suggested is to streamline the process, create efficiencies within the Quality Management System (QMS), reduce real risk to the business and ensure compliance to the relevant regulatory standards and authorities.
  16. 16. Research Methodology A combination of methodologies are required to conduct this research: Content Analysis Literature Review Data Surveys for current status Experimental Research & Development relevant architectural design
  17. 17. Useful Websites  ASQ: http://www.asq.org  FDA: http://www.fda.gov ; http://www.21cfrpart11.com  ICH: http://www.ich.org  IEE: http://www.iee.org  ISPE: http://www.ispe.org/gamp/  BSI: http://www.bsi-global.com  NIST: http://csrc.nist.gov/publications/nistpubs/index.html  WHO: http://www.WHO.org  EU: http://ec.europa.eu  GHTF: http://ghtf.org now http://www.imdrf.org
  18. 18. Q&A Go Raith Maith Agat Thank You

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