Risk Assessment: It's a Risky World Out There


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Presented by Fallbrook Engineering President/CEO Richard Meyst for UCSD's Overview of FDA Regulations for Medical Device Professionals and SDSU's Current Good Manufacturing Practices: Advanced Topics.

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Risk Assessment: It's a Risky World Out There

  1. 1. “Risk Assessment: It’s aRisky World Out There.” By Richard Meyst President/CEO Fallbrook Engineering, Inc. 355 W. Grand Ave. Suite 4 Escondido, CA 92025 richardm@fallbrookeng.com www.fallbrookeng.com 1 © 2010 Fallbrook Engineering, Inc.
  2. 2. Fallbrook OverviewMedical Product Design & Development 2 © 2010 Fallbrook Engineering, Inc.
  3. 3. Fallbrook Overview Fallbrook Engineering is a privately held engineering consulting firm headquartered in San Diego County. Fallbrook has been facilitating the advanced design and development of medical technology products for healthcare companies for over 25 years.© 2010 Fallbrook Engineering, Inc. 3
  4. 4. Fallbrook History Founded 1981, celebrating 29 years of continuous service Incorporated 1993 Expanded to 60+ associates in 1997 Located in new offices in Escondido in 2007© 2010 Fallbrook Engineering, Inc. 4
  5. 5. Richard Meyst, President/CEO Fallbrook Engineering, Inc.  BSME, MSME  Owner & principal  38 years in engineering, project management, product design and development  Principal Investigator on Phase I & II National Institutes of Health SBIR grants  Awarded 14 patents© 2010 Fallbrook Engineering, Inc. 5
  6. 6. Project Experience Biotech applications Therapeutic apparatus Diagnostic devices & consumables Electro-mechanical instrumentation High volume, sterile disposables Software driven systems Regulatory compliance FDA, ISO, CE, UL, CSA© 2010 Fallbrook Engineering, Inc. Risk Management 6
  7. 7. Client Profiles BioMed - Biotech - Pharmaceutical Large-cap, well established corporations Mid-cap companies Research Institutes Start-up Companies Individuals Joint ventures© 2010 Fallbrook Engineering, Inc. 7
  8. 8. Some Fallbrook Success Stories© 2010 Fallbrook Engineering, Inc. 8
  9. 9. Background All products and processes have an associated risk. Every enterprise should have a methodology for identifying and evaluating the risks it faces and should have a process for generating intervention plans to reduce the risks to an acceptable level. This process is generally referred to as a Risk Management Plan (RMP).© 2010 Fallbrook Engineering, Inc. 9
  10. 10. IntroductionApplication of Risk Management to Medical DevicesRisk Management is “a procedure for a manufacturer toidentify the hazards associated with medical devices and theiraccessories, including in vitro diagnostic medical devices,estimate and evaluate the risks, control these risks, andmonitor the effectiveness of the control.” 1Today we will cover an overview of the basics, benefits, need,methods, and standards used in doing risk management ofmedical devices. We will also touch on the use of risk in thePharmaceutical Industry. 1 ANSI/AAMI/ISO 14971:2007© 2010 Fallbrook Engineering, Inc. 10
  11. 11. Agenda  Some basic definitions  What is Risk Management?  Benefits to using Risk Management  Why use Risk Management?  What standards apply?  What are the tools used to do the analysis?  When do you do Risk Management?  Who should participate in the process?  Some examples© 2010 Fallbrook Engineering, Inc. 11
  12. 12. OverviewRisk management tools can be applied fromproduct concept generation all the way tothe end of the product life cycle.This approach can enhance your odds ofproducing a product that will meet theneeds of the marketplace, be givenmarketing clearance by regulatory agencies,ensure safety to the user/patient and befinancially successful.© 2010 Fallbrook Engineering, Inc. 12
  13. 13. Vocabulary: some basic definitions  risk management: Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, and controlling risk  risk analysis: Systematic use of available information to identify hazards and to estimate the risk© 2010 Fallbrook Engineering, Inc. 13
  14. 14. Vocabulary, cont.  hazard: A (foreseeable) potential source of harm to the patient or other persons arising directly from the device  harm: Physical injury or damage to the health of people, or damage to property or the environment© 2010 Fallbrook Engineering, Inc. 14
  15. 15. Vocabulary, cont.  severity: Measure of the possible consequences of a hazard  risk: Combination of the probability of occurrence of harm and the severity of that harm Risk = Severity X Probability of Occurrence  intended use/intended purpose: Use of a product, process, or service in accordance with the specifications, instructions, and information provided by the manufacturer© 2010 Fallbrook Engineering, Inc. 15
  16. 16. The Risk Management Process “… a process for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the control.” — risk analysis — risk evaluation — risk control — post-production monitoring© 2010 Fallbrook Engineering, Inc. 16
  17. 17. Why use risk management? It will: – save development time – maintain competitiveness – result in a safer product – save development costs – speed regulatory approval – limit downstream liability And… it is a requirement.© 2010 Fallbrook Engineering, Inc. 17
  18. 18. Schematic of Risk Management Process 1© 2010 Fallbrook Engineering, Inc. 1 ANSI/AAMI/ISO 14971:2007 18
  19. 19. Overview of Risk Management for Medical Devices ANSI/AAMI/ISO 14971:2007© 2010 Fallbrook Engineering, Inc. 19
  20. 20. Or, in a more “logical” view…© 2010 Fallbrook Engineering, Inc. 20
  21. 21. © 2010 Fallbrook Engineering, Inc. 21
  22. 22. Who should participate?  Management  Clinical  R&D  Marketing  Manufacturing  Regulatory  Quality  Real users© 2010 Fallbrook Engineering, Inc. 22
  23. 23. When do you do Risk Management?It is a full life-cycle process for your products – When you select a product to develop – Throughout the development process – During clinical testing – At the beginning of manufacturing – While the product is being sold © 2010 Fallbrook Engineering, Inc. 23
  24. 24. Summary of Main Standards thatapply to Risk Management  Federal Register, FDA, 21 CFR, Parts 808, 812 and 820 Medical Devices; Current Good Manufacturing Practices (CGMP); Subpart C, 820.30(g)  AAMI/ANSI/ISO 14971:2007 - Medical devices—Application of risk management to medical devices. This standard, used by the FDA and the EC Notified Bodies, provides a full life-cycle process for corporate Risk Management. – The Association for the Advancement of Medical Instrumentation (AAMI) is a unique alliance of over 6,000 members united by the common goal of increasing the understanding and beneficial use of medical instrumentation. – The American National Standards Institute (ANSI) is a private, non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system. – The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies.© 2010 Fallbrook Engineering, Inc. 24
  25. 25. Summary of Main Standards thatapply to Risk Management, cont.  ISO 10993 Biological Evaluation of Medical Devices  IEC 60601 Medical Electrical Equipment  IEC 60812 Analysis techniques for system reliability – Procedures for failure mode and effects analysis (FMEA)  IEC 61025 Fault Tree Analysis (FTA)  IEC 61882 Guide for hazard and operability studies (HAZOP studies)  IEC 61010 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use© 2010 Fallbrook Engineering, Inc. 25
  26. 26. Tools to get the job done  Fault Tree Analysis (FTA)  Failure Mode Effects Analysis (FMEA)  Failure Mode Effects Criticality Analysis (FMECA)© 2010 Fallbrook Engineering, Inc. 26
  27. 27. Fault Tree Analysis (FTA) A technique that determines how top-level system failure effects can be caused by individual or combined lower level faults.  It is a deductive top-down approach – Considers multiple failures originating from any system element – Disposables – Mechanical Devices – Electrical and software components – Manufacturing process – Operator  An FTA can also be used to identify areas where additional investigation is required using Failure Modes, Effects Analysis (FMEA) or using experimental testing.© 2010 Fallbrook Engineering, Inc. 27
  29. 29. Failure Modes and EffectsAnalysis (FMEA)FMEA is a qualitative approach suited forreviews of medical devices. The FMEAtechnique  considers how the failure modes of each system component can result in system performance problems and  ensures that appropriate safeguards against such problems are in place.© 2010 Fallbrook Engineering, Inc. 29
  30. 30. Failure Modes, Effects, andCriticality Analysis (FMECA) FMECA is the quantitative analysis and evaluation of potential component failure modes, the effects each failure would have on overall unit performance, and the criticality of the resulting degraded performance relative to safety or system functions.© 2010 Fallbrook Engineering, Inc. 30
  31. 31. The difference betweena FMEA and a FMECA A FMEA is qualitative, while a FMECA is quantitative. In a FMECA, the probability of a specific failure occurring is given as a numerical prediction. FMEAs employ probability of failure categories based on probability ranges. The proper category is determined by the experience and expertise of the analyst, instead of a mathematical probability calculation involving actual component failure rates used in the FMECA.© 2010 Fallbrook Engineering, Inc. 31
  32. 32. Some comments about IVD’s  In vitro diagnostic medical devices do not create a “direct risk” to the patient – They are not applied in or on the human body  However “indirect risks” can result – Erroneous decisions – False positives – False negatives© 2010 Fallbrook Engineering, Inc. 32
  33. 33. More on IVD’sSome common hazards for the patient – Batch variations, batch to batch inconsistency – Common interfering factors – Carry-over effects – Specimen ID errors – Stability problems of reagents – Problems with specimen collection, preparation, stability – Inadequate specifications – Inadequate test characteristics© 2010 Fallbrook Engineering, Inc. 33
  34. 34. More on IVD’s Some potential hazards for the user – Radioactive, infectious, toxic or other harmful ingredients – Packaging design – Potential contamination during handling, operation and maintenance – Non-specific instrument-related energy hazards© 2010 Fallbrook Engineering, Inc. 34
  35. 35. Users and Human Factors Engineering Identifying, Understanding, and Addressing Use-Related Hazards Center for Devices and Radiological Health © 2010 Fallbrook Engineering, Inc. Office of Health and Industry Programs Division of Device User Programs and Systems Analysis 35
  36. 36. Users and Human Factors Engineering The frequency and consequence of hazards resulting from medical device use might far exceed those arising from device failures. 1 1 Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc © 2010 Fallbrook Engineering, Inc. e/GuidanceDocuments/ucm094460.htm 36
  37. 37. © 2010 Fallbrook Engineering, Inc. 37
  38. 38. Users and Human Factors Engineering Use-related hazards occur for one or more of the following reasons:  Devices are used in ways that were not anticipated  Devices are used in ways that were anticipated, but inadequately controlled for  Device use requires physical, perceptual, or cognitive abilities that exceed those of the user  Device use is inconsistent with user’s expectations or intuition about device operation  The use environment affects device operation and this effect is not understood by the user  The user’s physical, perceptual, or cognitive capacities are exceeded when using the device in a particular environment © 2010 Fallbrook Engineering, Inc. 38
  39. 39. Users and Human Factors Engineering “Can the intended users use the device safely and effectively?”  Apply HFE principles  Do both analytic and empirical reviews.  Evaluate throughout the development cycle © 2010 Fallbrook Engineering, Inc. 39
  40. 40. Pharmaceutical Risk Management The FDA’s Risk-Based Approach Initiative Some comments on where this is headed… “Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century: A Risk-Based Approach” were proposed in August 2002.© 2010 Fallbrook Engineering, Inc. 40
  41. 41. Process Analytical Technology This was followed by FDAs PAT (Process Analytical Technology) initiative in 2004. PAT is “a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.” It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.© 2010 Fallbrook Engineering, Inc. 41
  42. 42. Risk Goals for Pharma  ensure that the most up-to-date concepts of risk management and quality systems approaches are incorporated into pharmaceutical manufacturing systems  encourage manufacturers to use the latest scientific advances and technologies  make sure review and inspection programs operate in a coordinated and synergistic manner  ensure standards are applied consistently  promote innovation  encourage effective and efficient use of resources to address the most significant health risk© 2010 Fallbrook Engineering, Inc. 42
  43. 43. Risk Analysis, Sterile Drugs“Sterile Drug Products Produced by Aseptic Processing” (draft) Incorporates risk-based approaches – Promotes innovation – Encourages technologies that increase sterility assurance Liberalizes some old standards – Promotes drug quality  Clear and consistent communication promotes voluntary compliance with FDA regulations – Unprecedented outreach:  Extensive advisory committee, PQRI, industry organization, and public input CDER/CBER/ORA consensus document – Reference:http://www.fda.gov/ohrms/dockets/ac/03/slides/3951S2_04_Famulare %20Friedman-Wright_files/slide0003.htm © 2010 Fallbrook Engineering, Inc. 43
  44. 44. Summary Risk management is woven throughout US and international medical regulations. It’s really a matter of applying common sense…© 2010 Fallbrook Engineering, Inc. 44
  45. 45. Where to Get More Information AAMI Medical Device Software Risk Management (http://marketplace.aami.org/eseries/scriptcontent/docs/Preview %20Files/TIR320412%20preview.pdf) FDA’s Medical Device Reporting data files (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.cfm) FDA’s Manufacturer and User Facility Device Experience Database (http://www.fda.gov/cdrh/maude.html ) CDRH Safety Alerts, Public Health Advisories, and Notices (http://www.fda.gov/cdrh/safety.html ) FDA Enforcement Reports – recalls and legal actions (http://www.fda.gov/opacom/Enforce.html ) ECRI’s Medical Device Safety Reports (http://www.mdsr.ecri.org/) The Institute of Safe Medical Practices (ISMPs) Medication Safety Alert (http://www.ismp.org/MSAarticles/Calendar/calendar.html) Joint Commission on Accreditation of Healthcare Organizations (JCAHO’s) Sentinel Events (http://www.jcaho.org) © 2010 Fallbrook Engineering, Inc. 45
  46. 46. Thank you for your interest.I look forward to answering yourquestions. Richard Meyst richardm@fallbrookeng.com© 2010 Fallbrook Engineering, Inc. 46
  47. 47. Don’t letyour projectbecome atrain wreck!© 2010 Fallbrook Engineering, Inc. 47