Data Transparency and Quality Metrics

Transcription

1 Data Transparency and Quality Metrics Ann Ferriter Division of Analysis and Program Operations Office of Compliance Center for Devices and Radiological Health

2 Why are we interested in transparency? What information can FDA provide? How would the data be available? How can we measure medical device quality? What additional information is needed? 2

3 How can FDA act to support stakeholders in incorporating differentiating quality data into their decisions? Stakeholders Industry Agencies Device Purchasers and Payers Patients and Users Physicians, providers and healthcare facilities FDA Premarket Reviewers ORA Investigators and Compliance Officers Import Staff Data Investigational 483 Observations WL citations QS subsystems inspected Recall Root causes Violations Device failure modes MDRs Device failure modes Mfg Evaluations NSE decision reasons (deidentified) Complaints of Regulatory Violations Decisions What design problems should industry avoid? What are common manufacturing problems? What devices should CMS purchase? What are the risks and benefits of this device? What risks should firms mitigate? Where is this firm having problems?

4 Data transparency: FDA shares information Ad Hoc Analysis provided: FDA provides infrequent and varying analyses Enhanced Data transparency: FDA provides a flexible, comprehensive, daily updated database structured for analysis Systematic analyses: FDA provides consistent, predictable analyses of enforcement data to support device quality improvements Transparency initiative will work to provide information to stakeholders to support data driven decisions. 4

5 CDRH Public Database (Now) Searchable? Exportable Results? Downloadable Tables? 510(k)s Y Y Y Registration & Listing Y N Y Adverse Events (MAUDE) Y N Y Recalls Y Y N Premarket Approvals (PMAs) Y Y Y Inspections Y N N Device Classification Y N Y Total Product Life Cycle Y N N Radiation-Emitting Products Y N N X-Ray Assembler Y N Y Medsun Reports Y Y N CLIA Y Y Y MPRIS Y * * 5

6 Enhanced Data Transparency Public TPLC Data Access (Future) Public Access to Releasable data Application Programming Interface (API) software to software interface Flexible User Interface 6

7 Enhanced Data Transparency CDRH Public Database (Future) 7

8 Systematic Analyses Program Analyses Analysis of post-market data including recalls, allegations, and inspections Results of analysis Trends Causes, Device Failures, Violations Device types, Firm Characteristics FDA processes Conclusions indicate areas for additional focus Process Improvements Educational opportunities Product Area Analyses Detailed review of premarket submissions, recall documentation, epidemiological resources, publications, and establishment inspection reviews Results of analysis For clinicians, patients, users, manufacturer/distributors Suggestions/recommendations focusing on design, manufacturing, training, reminders, etc. Timelines by specific product code or manufacturer Chronological representation of preand post-market data 8

9 How can and does Industry share? Participation in consensus standards Regulatory reporting FDA, NIH Proposals to FDA Publications and analysis 9

10 Case for Quality Transparency Summary Enhanced Data Transparence Data can be used to improve device quality Information on device failures is most important Recalls Adverse Events FDA is working on an Application Programming Interface Systematic Analysis Analyzed information benefits provides additional benefits FDA has released the Medical Device Recall Report 10

11 Measuring Quality Inspection does not improve the quality, nor guarantee quality. Inspection is too late. The quality, good or bad, is already in the product. W. Edwards Deming "To measure is to know. Sir William Thomson Kelvin 11

12 What is Medical Device Quality? Regulatory Definition Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance 21 CFR 820.3(s) 12

13 Currently Measured Elements Industry Compliance Defect counts Supplier audits Process variance Design Validation Device Verification Complaints FDA Inspection data Allegations of Regulatory Violations Pre-market approval or clearance Clinical Trial results Recalls Adverse Events 13

14 Potential Elements of Quality Safety Compliance Effective ness Ease of Use Reliability Quality Design Consistency Service Performance Features 14

15 Comparison of Quality Information Current FDA Information Safety Adverse events, recalls, complaints Effectiveness Pre-market clearance, clinical trials, registries Compliance Inspections, allegations Potential Future Safety Effectiveness Compliance Reliability Consistency Performance Features Service Design Ease of Use 15

16 Other Stakeholder Perspectives Device Purchasers and Payers Cost, reliability, service Patients and Users Appearance, effectiveness, features Physicians, providers and healthcare facilities Safety, effectiveness, performance, consistency 16

17 Risks and Benefits of Providing more Risks Invalid conclusions Inadequate comparisons Over simplifying a complex problem Incorrect data Market effects Quality Data Benefits Improved data and analyses Informed decisions Increased awareness Market forces drive quality Increased device quality 17

18 Questions How do you measure quality? What other data would helpful to identify trends in quality? How will this data assist you in identifying trends in your products? 18