To err is human. Pete Davis VP of Research & Development Neomend a subsidiary of Bard Davol

Transcription

1 To err is human Pete Davis VP of Research & Development Neomend a subsidiary of Bard Davol 1

2 Really an R&D guy presenting risk analyses?? 2

3 Risks exist because perfection doesn t! 3

4 Communicating to Management the Value of Risk Management 4

5 Risk Analysis Steps Why Risk Management Why Communicate Doing a Hazard Analysis...quickly How to Communicate to Them 5

6 What is important It s about the Specs! A problem well defined is a problem half solved. John Dewey 6

7 What does Quality control? 7

8 Quality Does not Design. Does not Manufacture. Does not Distribute. Use? Possibly. Words No. Control? Yes. 8

9 Again, what does quality control? 9

10 Think about these? 10

11 Any impact on Customers Patients Business Environment 11

12 Thoughts? 12

13 Writing Instrument Standards H i g h l i g h t e r ISO 11540: Caps for writing and marking instruments intended for use by children up to 14 years of age -- Safety requirements Specifies safety requirements for cap size, ventilated caps (vent area, air flow) and marking. Annex A describes the test for air flow. Caps which do not comply should have the instrument or its packaging labelled with a warning as to the dangers of asphyxiation from pen caps. ASTM D (2005) Standard Practice for Labeling Art Materials for Chronic Health Hazards Scope 1, chronic health hazards known to be associated with a product or product component(s), when the component(s) is present in a physical form, volume, or concentration that in the opinion of a toxicologist (see ) has the potential to produce a chronic adverse health effect(s). 13

14 Importance of Risk Management Prepare and respond to your Customers! Business strategy Business security Provide a Competitive advantage Communicate information Good news Bad news Not counting everything else Regulatory requirement 14

15 Evolving Process 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Feasiblity and Research Prototyping Development Clincal Trial Distribution Post-Market Survellance Known Unknown = Risk Risk needs a multi-functional approach! 15

16 New requirements Medical Device Directive 93/42/EEC (M5) Add s Usability - See Annex I, 1st paragraph Subset of Risk Management EC Medical devices -- Application of usability engineering to medical devices 16

17 Structure Design (ISO 14971) Usability (EC 62366) Process (ISO 14971) New Risks? Risk Analysis process Mitigation & Control 17

18 What is Usability Usability is a characteristic of the User Interface that establishes Effectiveness, Efficiency, ease of User learning and User satisfaction. Medical practice is increasingly using Medical Devices for observations and treatment of patients. Use Errors caused by inadequate Medical Device Usability have become an increasing concern. Many of the Medical Devices developed without applying a Usability Engineering Process are nonintuitive, difficult to learn and to use. The Usability Engineering Process is intended to achieve reasonable Usability, which in turn is intended to minimize Use Errors and to minimize use-associated Risks. 18

19 What is Usability The Usability standard specifies a Process for a Manufacturer to analyze, specify, design, Verify and Validate Usability, as it relates to Safety of a Medical Device. The Engineering Process assesses and mitigates Risks caused by Usability problems associated with Correct Use. If the Usability Engineering Process has been complied with and the acceptance criteria documented in the Usability Validation plan have been met then the Residual Risks are presumed to be acceptable. 19

20 What is Usability? 20

21 Risk Management System ISO 14971: Medical devices Application of risk management to medical devices Selected definitions Risk Management Sections Areas that feed into Risk Management Performing a Risk Analysis 21

22 Risk Risk has two components: a) the probability of occurrence of harm; b) the consequences of that harm, that is, how severe it might be. 22

23 Definitions Risk (as defined by dictionary.com) exposure to the chance of injury or loss; a hazard or dangerous chance harm - physical injury or damage to the health of people, or damage to property or the environment hazard - potential source of harm 23

24 Definitions Cont d hazardous situation - circumstance in which people, property, or the environment are exposed to one or more hazard(s) New consideration residual risk - risk remaining after risk control measures have been taken Note: not mitigation 24

25 Definitions Cont d risk - combination of the probability of occurrence of harm and the severity of that harm risk analysis - systematic use of available information to identify hazards and to estimate the risk NOTE Risk analysis includes examination of different sequences of events that can produce hazardous situations and harm. 25

26 Do you want more definitions? Pressure is identifying a problem before launch! Yes No 26

27 More risk assessment - overall process comprising a risk analysis and a risk evaluation Risk analysis + Risk evaluation risk control - process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels 27

28 More risk estimation - process used to assign values to the probability of occurrence of harm and the severity of that harm risk evaluation - process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk 28

29 More risk management - systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk risk management file - set of records and other documents that are produced by risk management safety - freedom from unacceptable risk 29

30 5 Steps 1. Risk analysis 2. Risk evaluation 3. Risk control 4. Overall residual risk evaluation 5. Production and post-production information 30

31 Risk Control Order...risk control options in the priority order listed... a) inherent safety by design; b) protective measures in the medical device itself or in the manufacturing process; c) information for safety. 31

32 Structure Design (ISO 14971) Usability (EC 62366) Process (ISO 14971) New Risks? Risk Analysis process Mitigation & Control 32

33 ISO Flow Chart Do you want to see them? Yes No 33

34 Risk Analysis 34

35 Risk Analysis 35

36 Risk control 36

37 Overall residual risk evaluation 37

38 Production and post-production information 38

39 Risk Management Report Prior to release for commercial distribution Audit the risk management process. Ensure that: the risk management plan has been appropriately implemented; the overall residual risk is acceptable; appropriate methods are in place to obtain relevant production and post-production information. 39

40 Risk Management Report Cont d The results of this review shall be recorded as the risk management report and included in the risk management file. The responsibility for review should be assigned in the risk management plan to persons having the appropriate authority. Compliance is checked by inspection of the risk management file. 40

41 Pre control? Occurrence = 100% 41

42 Risk: Combination of Occurrence and Severity Occurrence Severity High ALARP Reduce Reduce Med Acceptable ALARP Reduce Low Acceptable Acceptable ALARP Neither of the others Medical Intervention Death 42

43 Sources of information Design Customers Internal experience Risk Mgt Monitoring Feed back Patent filings Competitive Products 43

44 At your company? Risk Management Procedure Risk File 44

45 The Risk/Hazard Analysis Process Fun & Challenging Exciting & Tense Fulfilling & Thorough Better than climbing Everest Memorable More? 45

46 An Alternative Risk Analysis Activity People Duration Risk analysis Team 1-2 days Risk evaluation 1-2 (max) 1 day Risk control Team via TBD Overall residual risk evaluation Review and approve entire document Team Team 1 day TBD 46

47 Consider the following order Usability Risk Analysis Only focus is Use, User, and Hazardous Situations Design Risk Analysis Only focus is Design Usability is Input to Design Process Risk Analysis Only focus is Processes IFU/Labels Perform Usability Design Review 47

48 Which is Best Do what is Effective Efficient Increases information 48

49 Part 1 - Risk Analysis Address only Harm Severity Hazardous situations No numbers! 1 day typical 2 days if absolutely necessary Very complex product? Break into smaller chunks 49

50 Part 2 - The Numbers Severity Likelihood of Occurrence 3 - Death or Medical Intervention, Malfunction (reported to authorities) 2 - Product Specification, Packaging, Labeling(reportable to authorities) ALARP Reduce Reduce Acceptable ALARP Reduce 1 - No or little (trivial) harm Acceptable Acceptable ALARP Occurrence > 1 - Low 2 - Medium 3 - High [1] ALARP = As low as reasonably practicable 50

51 Part 2 - Risk Evaluation Phase Addressed by select subset of the Team The others will be able to comment on later. Skill set Product use Human impact (clinical / safety issues) 51

52 Part 3 - Risk Control This is where the work begins. How is Risk controlled? How is risk control demonstrated? 52

53 Populate the list in these phases Design (show how risk is controlled by the design) Documents Procedures, reports... Return to Control person(s) 53

54 Part 4 - Post-control Numbers Back to the 2 people. They fill-in the numbers. 54

55 Next Production (show how risk is controlled) Documents Procedures and reports No inspection references Return to Control person(s) 55

56 Next Labeling (show how risk is controlled) Reference the IFU/DFU... Identify the specifics Labeling is the risk control point of last resort Return to Control person(s) 56

57 Part 4 - Post-control Numbers Back to the 2 people. They fill-in the numbers. Draft the final version 57

58 Part 5 - Overall Risk Phase Team regroups Reviews and comments Do a red-face test on the numbers Hopefully little adjustment Confirm the post control numbers Agree that the overall risk is acceptable 58

59 Summary Risk Statement Risk Analysis: Product name (version?) Performed per ISO (2007) The overall risk is acceptable using the criteria defined in the Risk Management Plan (Procedure???, Rev.?) 59

60 Risk analysis = Done! 60

61 Doing a Risk Analysis Activity People Duration Risk analysis Team 1-2 days Risk evaluation 1-2 (max) 1 day Risk control Team via TBD Overall residual risk evaluation Review and approve entire document Team Team 1 day TBD 61

62 Communicating Telling good news is easy! Keeping bad news quiet is easy! Telling bad news is the hard! 62

63 What I Look For Facts...not Fiction Solutions...not the problem(s) Remember one of the 1st slides? Timing, $$, resources Impact on the Business. Recovery strategy & solutions 63

64 Example 1. A clearly defined problem statement 2. Action plan Containment + Corrective + Preventive 3. Solution (or high likelihood options) 4. Non-people resources (Est. $$ s) 5. People resources needed for success 6. Timing - estimated completion date 7. Impact of the do nothing option Without mentioning regulations or agencies? 64

65 How is the Risk standard set? Who How / Where When Why 65

66 Who sets the standard? Management (Them...careful We are Them) By approval of the Risk Management Procedure By review of information provided at Management Review Assumes information is being provided By supporting and implementing related change 66

67 Is complacency an option? 67

68 Questions & Answers 68