Presentation is loading. Please wait.

Presentation is loading. Please wait.

James Pink Medical Device Risk Management. Requirements The medical device industry is highly regulated and based upon a device specific risk rating for.

Similar presentations


Presentation on theme: "James Pink Medical Device Risk Management. Requirements The medical device industry is highly regulated and based upon a device specific risk rating for."— Presentation transcript:

1 James Pink Medical Device Risk Management

2 Requirements The medical device industry is highly regulated and based upon a device specific risk rating for dealing with the level of regulation to be applied prior to market acceptance All modern medical device regulations cite ISO14971:2007 as being the standard to apply for medical devices

3 Global Harmonisation requirements GHTF safety and performance requirements require risk management to be used as a basis of identifying, evaluating, controlling and continuously monitoring the effectiveness of risk controls.

4 The need for risk management 4 Source GHTF Study Group 1

5 The need for risk management 5 Source GHTF Study Group 1

6 The need for risk management 6

7 Does it mean anything to me as adrug manufacturer If you have a drug delivered by means of a combination product then you are required to ensure that the device meets all safety and performance criteria of medical device regulations. As a result you are required to ensure that devices for drug-device combinations are being designed, manufactured, supplied and used in a way that all risks are controlled and the risks are outweighed by the clinical benefit.

8 The need for risk management 8

9 Risk management process ISO14971:2007 requirements 9

10 Risk Management Organisation 10 Failures in Test Technology limitations User feedback including failures and hazards Summarise knowledge with respect to risks Proof of concept Clinical literature Review Standards Competitor products Create Risk Management Plan Design Planning Simulations and Validations Testing results Supplier Part approvals Bench Testing Clinical investigations Risk Management Reviews Designing Process Validation data Supplier qualification data Manufactured variance analysis Process FMEA Risk Controls and Transfer to Validation, Complaints, Vigilance, Change control and Supply chain Design Transfer Clinical follow-up trends Published articles Complaints investigations Usability trends Survivorship Other PMS analysis New Risks, Frequencies and severities Clinical Validation

11 Risk management process 11 Input New Product development New Process introduction Change to Product Change to process Significant Change Adverse Incident trends Adverse Manufacture trends New markets / users PMS Trends CAPA Trends ActivityOutput Risk Management controls Management Review analysis Adverse trends awareness Manufacturing limits & Controls Supplier limits & Controls Surgeon Training points Post Market Clinical Follow-up Complaints investigator training Change control team awareness CAPA investigator awareness Resources Risk Management Team Risk Management experts Risk Management database Customers and Clinical leads Records Risk Management Plans Risk Management FMEAs Risk Management Reports Meetings, Measures and actions PMS Meetings Product Review meetings Supplier Meetings Change control meetings Intra project Risk Analysis meetings Risk Management review meetings Management Review meeting Surgeon / User feedback Clinical Evaluation updates New Standards, risks and controls

12 Risk management process Risk Management Complaints Analysis Change Control Clinical Evaluation CAPAValidation New Product Development 12 Example A new product development project is initiated. The process requires a plan, defines the information sources and identifies how clinical benefit will be derived from customers. Risk reviews, tools and methods are all defined including the forms, procedures and records required A Final report is written defining residual risks, controls and clinical benefit

13 Risk management process Risk Management Complaints Analysis Change Control Clinical Evaluation CAPAValidation New Product Development 13 Example A change in Valve supplier is proposed for the MDI. The process defines what will happen, how the change is categorised based upon importance and defines the level of process risk management, controls and reviews necessary. Risk reviews, tools and methods are all defined including the forms, procedures and records required

14 Risk Management - Acceptability ISO14971:2007 requirements 14 THIS HAS TO COME FROM A JOINT REVIEW WITH YOU AND YOUR SUPPLIER

15 Risk management acceptability 15 Increasing severity of Harm Increasing probability of occurrence of Harm Severity 5 = Death 4 = Revision / irreversible 3 = Reversible injury 2 = Minor Injury 1 = Inconvenience Probability 5 = <1 in 100 4 = 1 in 100 3 = 1 in 1000 2 = 1 in 10,000 1 = >1 in 100,000 Based upon Surgical procedures

16 Risk management acceptability 16 Increasing severity of Harm Increasing probability of occurrence of Harm Severity 5 = Critical to safety 4 = Critical to function 3 = Customer Image 2 = Upset the customer 1 = Inconvenience Probability 5 = <1 in 100 4 = 1 in 100 3 = 1 in 1000 2 = 1 in 10,000 1 = >1 in 100,000 Based upon Surgical procedures Device fails to deliver appropriate uniform dose over time

17 Risk management acceptability 17

18 Risk management acceptability 18

19 Risk management acceptability 19

20 Risk management acceptability 20

21 Risk management acceptability 21

22 Risk management acceptability 22

23 Risk management acceptability Tips Ensure that you are focussed on the current state of the art with relation to drug - device performance Ensure that you are able to define hazardous situations based upon the major associated failures Be aware that the level of acceptability will be based around your critical to safety and quality requirements. The final clinical harm will be required so that contract design suppliers and manufacturers are aware of the severity of failure. 23

24 Risk management plans ISO14971:2007 requirements 24

25 Risk management plans Concept and Definition Design and Development Transfer to Manufacture and limited market placement Post Market 25 Lifecycle phases If a drug manufacturer uses a device they must develop risk management plans that will ensure all elements of risk are covered from design through to manufacture

26 Risk management plans 26 Hazardous Situation HazardHarmDesign Feature ProbabilitySeverity Valve affects Dose plume Mechanical fatigueToo much drugValve and Actuator Fatigue?3?3 5 Step 1 - Undertake literature review Step 2 - Review previous designs Step 3 - Undertake Design Verification Step 4 - Undertake Design Validation Step 5 - Assign probability value Step 6 - Include in Clinical Evaluation

27 Risk management plans 27 Hazardous Situation HazardHarmDesign Feature ProbabilitySeverity Valve affects Dose plume 1 Mechanical fatigueToo much drugValve and Actuator Fatigue 2 ?33?333 5 Risk Verification Report Risk Management Meeting date 21/12/2009 Summary 1Verified information source from Clinical evaluation report C01989 issue 2 2Design FMEA conducted 21/12/2008 verified 3Test report T18786 revision 1 verified 4Reviewed Test report and confirmed risk control acceptable Conclusion Risks identified in the risk analysis coincide with the original information sources and risk management activities defined within the RM Plan document D001 revision 3 Controls within Design have been reviewed and reduction of probability is consistent with the control Signed ____________Date 21/12/2009

28 Risk management file ISO14971:2007 requirements 28

29 Risk management file 29 Risk Management Plan Clinical Evaluation – PHA* Identification of Characteristics Design FMEA Application FMEA Requirement Process / Supplier FMEA Risk Management Report

30 Risk Analysis ISO14971:2007 30

31 Risk analysis 31 Failures in Test Technology limitations User feedback including failures and hazards Summarise knowledge with respect to risks Proof of concept Clinical / Scientific literature Review Standards Competitor products Create Risk Management Plan Draw up Hazards Design Planning Simulations and Validations Testing results Supplier Part approvals Bench Testing Clinical investigations Risk Management Reviews Designing Process Validation data Supplier qualification data Manufactured variance analysis Process FMEA Risk Controls and Transfer to Validation, Complaints, Vigilance, Change control and Supply chain Design Transfer Clinical follow-up trends Customer Performance evaluation Published articles Complaints investigations Usability trends Other PMS analysis New Risks, Frequencies and severities Clinical Validation Annex G activities MDI Preliminary Hazard Analysis MDI Clinical / Scientific evaluation Preliminary report MDI DFMEA Revision 1 MDI DFMEA Revision 3 MDI PFMEA Revision 1 MDI PMCF Revision 1

32 Risk analysis 32

33 Preliminary Hazard Analysis Review of FDA Guidance provides the following summary of requirements.... 33 CharacteristicHazardous SituationPotential HarmSeverity Dose content uniformityInsufficient Dose uniformity - Design characteristic failure / Actuator / Valve insufficient dose delivered too high dose delivered depends on customer / drug Dose content uniformityDegradation of Dose uniformity over time – Design characteristic failure of actuator / valve over the lifetime of uses As aboveAs Above Aerodynamic particle sizeParticle size is > 5Microns - Design characteristic failure of the MDI (Size and shape of expansion chamber / stem insufficient dose deliveredAs above Spray Pattern and Plum geometry Inappropriate spray pattern and or plume geometry – Design characteristic failure / Actuator / Valve As above LeachingDrug chamber / contact materials leaching - polynuclear aromatics (PNAs), nitrosamines, monomers, plasticizers, accelerators etc. Toxicological effectsdepends on customer / drug and patient contact

34 The preliminary clinical / Scientific report Description of the intended performance Describe reasonable performance expectations Describe indications and claims if known Standards and Regulatory guidance review Literature review based upon common features / exclusion and inclusion criteria Summary of current methods and their limitations including current techniques, instrumentation and surgical technique, current outcomes and expected clinical benefit Evaluation of your experiences from similar devices Confirmation from your customer relating to some of the most important aspects for their Drug Master file. =Compilation of Hazards / Hazardous situations to be included in future risk analysis = Consideration relating to risk acceptability 34

35 The preliminary clinical report Ensure that previous risk analysis are reviewed. Review of Design failures (Where output could not be achieved) Review of failed validations Review of limitations – Technology, Process, Supply chain or Drug delivery Review of customer complaints relating to similar designs or similar intended use 35

36 Risk analysis – PHA for MDI. HazardForseeable sequence of eventsHazardous situationInformation Source Harm Mechanical Dose content uniformity After several actuations the dose content uniformity is compromised Design [See Design FMEA for Valve and actuator design] Process See Process FMEA Use [See usability / AFMEA] FDA Guidance Design and Test data on file Insufficient dose Overdose No dose Chemical Leaching Unintended leaching of toxic compounds from the container / plastic components enter into the drug and are delivered to the patient Design [Selection of the material and manufacturing method – See DFMEA] Process [See PFMEA – Inappropriate moulding parameters – incorrect material spec] Use [See usability / AFMEA] FDA Guidance Design Data on file Toxicological / Poisoning 36

37 Risk management in Design Tip Ensure that there are regular reports relating to the design progress but ensure that risks identified and their references are reported within the phase as this concentrates the minds of the people undertaking the design project 37

38 Risk management documentation in design Risk Management Plan Clinical / Scientific Reports R&D Reports Process Validation reports Supplier qualification reports Design Validation reports Usability reports Identification of characteristics affecting safety Design FMEA Process FMEA Application FMEA Risk management summary Post market clinical follow up and risk reviews Transfer to manufacture risk management control plans 38

39 Risk management in design 39 Prelim Hazard Analysis Risk Analysis Clinical literature Design Standards Competitor products Recalls and advisory Previous RA Intended Use Characteristics Hazard identification Outcomes Reliability data Customer feedback Manufacturing data Risk Report Risk Mgt Plan Failures in Test Technology limitations User feedback including failures and hazards Summarise knowledge with respect to risks Proof of concept Clinical / Scientific literature Review Standards Competitor products Create Risk Management Plan Draw up Hazards Design Planning Simulations and Validations Testing results Supplier Part approvals Bench Testing Clinical investigations Risk Management Reviews Designing Process Validation data Supplier qualification data Manufactured variance analysis Process FMEA Risk Controls and Transfer to Validation, Complaints, Vigilance, Change control and Supply chain Design Transfer Clinical follow-up trends Customer Performance evaluation Published articles Complaints investigations Usability trends Other PMS analysis New Risks, Frequencies and severities Clinical Validation

40 Typical Controls in Design. Functional Testing / Bench Testing Testing against a Standard – Validation i.e. ISO11137, ISO11607, ISO7206-4, IEC 60601-1 – FDA Guidance Simulation – Finite Element – Wear performance Hand Calculation Prototype study Choice of Materials Choice of processes and Technology Focus Group (Human Factor Analysis) Clinical Literature Searches Concept Reviews (Focus Group) – Surgeon / Clinical / User opinion CAD Assembly / Tolerance Study Design of Experiments Tolerance Stack Analysis Assembly Testing Scientific / Engineering Constant Review of Similar Designs Measurement Systems analysis Clinical Investigations Validations MTBF – Stability testing 40 REMEMBER The control will be used in order to give you assurance when you are doing a test that you have covered a risk........

41 Typical controls in Design ISO Standards FDA Guidance Customer Testing methods Bespak Testing methods 41

42 Risk Management in process Risks MouldingMachiningAssemblyCleaningLabellingPackagingSterilisationDistributionStorage Material processing 42

43 Risk Management in process 43 Validation activities should be initiated with risk management Process hazards should derive from the DFMEA Risks MouldingMachiningAssemblyCleaningLabellingPackagingSterilisationDistributionStorage Material processing

44 Risk Management in process 44 Hazards How Moulding can initiate the hazard Leaching Inappropriate material Incorrect Heat and pressure Incorrect additives Inappropriate mould time ????? Sequence of events inappropriate cross linking of polymer leads to plasticiser free radical inappropriate material formulation / ingredient selected Moulding controls Material verification Process Validation of Moulding parameters Goods inwards Verification of raw materials QC Sampling for Leaching Risks MouldingMachiningAssemblyCleaningLabellingPackagingSterilisationDistributionStorage Material processing

45 Typical Controls in Process. Testing Points Trained in a SOP Gauge R&R Process Validation Monitoring and Measurement (SPC Process or product parameters) Poke Yoke Settings Checkmate Verifications / Closed Loop Systems Software validation 5S / Line Clearances Identification and Traceability Physical Location controls Start up verifications In process verifications Routine Maintenance Calibration ISO13485:2003 / Ordinance or FDA Control requirements. Supplier Evaluation – First Article / PPAP Routine Audits 45

46 Risk Controls – Risk benefit ISO14971:2007 requirements 46

47 Risk controls – risk benefit ISO14971:2007 requirements 47

48 Risk Management Report 48

49 Typical Risk Management Report Summarises the Way you did risk management Summarises that the risk controls have been implemented (And verified) Summarises where you got the information Provides a succinct summary of the results of the activities and how controls will be reviewed on an ongoing basis 49

50 Keeping risk management alive

51 Concept diagram - MDI 51 Define the Scope of Project AreaMDI Operator / User COPD Patient Delivery method Valve / Actuator Intended Use Particle Size Number of uses Drug type Indications for use Critical to quality requirements TechnologyMoulding / Machining Develop the ProductDefine the need Select the Risk Management Plan to use Define the Scope of the Project Generic RM Plan Dev Lifecycle Custom RM Plan Dev Lifecycle Develop the Product Implement Process Develop the Product Place on Market PHA DFMEA PFMEA PHA Customer A cceptability Risk control Verification Define the need Design Validation Process Validation change to risk? Risk controls effective? YES NO What the clinical benefit would be Reasonable expected performance Hazards relating to the current use, Technology Risk Manage Report Clinical Benefit V Risk On Market RM Plan Lifecycle Change RM Plan Lifecycle Database


Download ppt "James Pink Medical Device Risk Management. Requirements The medical device industry is highly regulated and based upon a device specific risk rating for."

Similar presentations


Ads by Google