Human Factors Usability in the Review of New Medical Devices FDA/CDRH. Considering Usability for Pharmaceutical Aerosol Devices.

Transcription

1 Human Factors Usability in the Review of New Medical Devices FDA/CDRH Considering Usability for Pharmaceutical Aerosol Devices Ron Kaye Human Factors Pre-Market Evaluation Team Leader Office of Device Evaluation Center for Devices and Radiological Health U. S. Food and Drug Administration Presented at: IPAC-RS Conference Bringing Value to the Patient in a Changing World March 29, 2010 Ron.kaye@fda.hhs.gov Terminology Human Factors Engineering (HFE) most often and traditionally used Usability Traditionally applied to computer-based (i.e., screen or GUIbased) Technology, also used for medical devices Can be confusing We often use HF/Usability. 1

2 Overall HF Perspective on Safe and Effective Device Use Use Problems in Design: Noticed, Reported, Understood Use error Can be detected Detection will guide effective corrective actions Can be minimized or eliminated by design modification 2

3 HF Pre-Market Evaluation Team Staff of three Heavily tasked with consults Increasingly involved in review of combination products More involved with pen- and auto-injector products than PAD currently We do review and expect to do more of these in the future Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management CDRH Guidance: Focuses on managing userelated risk Harm resulting from use error (including incorrect treatment) Consistent with national and international standards Used for review of pre-market submissions Currently being updated GuidanceDocuments/ucm pdf 3

4 Device Failure Hazards vs. Use-Related Hazards HF/Usability in the Evaluation of Pharmaceutical Aerosol Devices PAD, are combination products Reviews involve CDER and CDRH Office of Combination Products CDRH/ODE HF/Usability in Pre-market Evaluation Reviews HF content in premarket submissions for medical devices including combination products CDER/OSE Division of Medication Error Prevention and Analysis (DMEPA) Provides pre-marketing reviews of all proprietary names, labels and labeling 4

5 Evaluation Needs Use problems come in two main flavors: 1. Anticipated Known problems very helpful, expert review, risk analysis techniques Can be difficult to identify all hazards analytically 2. Unanticipated May be most important focus Identified in user-based review and evaluations analyses If not, then identified in final/validation testing Efforts Necessary to Achieve Optimized Design Analyze device users, uses and use environments Preliminary Evaluations (variety of analytical methods) Test prototypes, observe and analyze use, modify design Formative evaluations (less formal, number of participants can be small) Users involved Discover and understand use-related problems Prove the concept works with users Validation 5

6 Design Considerations Error tolerance good attributes for many devices Features of the user interface (UI) that prevent use errors following likely incorrect actions (or lack of action) by user Potential difficulties are anticipated/identified Design of the UI to control their likelihood Examples: Simple and effective set-up Breath counter for dosing accuracy Ability to check for dose remaining Methodology Considerations Major issues are best addressed prior to final/validation testing through early and iterative user involvement in formative evaluations Test protocol prioritized according to identified criticality of tasks that may be present in the form of use scenarios. Environment of actual system use and design configuration are addressed Subjective assessment measured meaningfully Rating scales are not helpful for validation testing, narrative data is expected Performance measured meaningfully Performance (a.k.a. usability ) goals, such as 80% of users were successful indicates up to 20% failure rate. 6

7 Methodology Considerations User preference and ease of use do not necessarily = optimum design Aspects of use with a low frequency of occurrence can be as important or more than those that tasks that are performed often. Consider the atypical: use conditions uses users Human Factors/Usability Approach Preliminary Analyses Who are the users What kinds of problems do users have (or have they had in the past) with this kind of device Focus group, walk-through, etc Formative Evaluations Involve users in casual interaction and evaluation of prototypes, system components Then use more structured evaluations of simulated use focusing on important aspects to clarify use-related issues and explore whether unanticipated use problems exist. 7

8 Human Factors/Usability Approach (Continued) Modify design and re-evaluate as necessary Perform HF/Usability Validation Minimum of 15 test participants Performance data on critical tasks Subjective data on critical tasks All performance failures described Through analysis and perspective of users involved Human Factors/Usability Approach (Concluded) Human Factors Report Summary of initial analyses, formative testing Detailed summary of Validation protocol Results and discussion of residual error Conclusion that device is safe and effective for intended users, uses, and use environments HF data including Validation support this 8

9 National and International HF Standards applicable to HF Medical Devices ANSI/AAMI/ISO 14971:2001 Risk Management ANSI/AAMI HE74: 2001, Human factors design process for medical devices ANSI/AAMI HE75: 2009, Human factors design principles for medical devices (in progress) Thank You Ron Kaye Human Factors Pre-Market Evaluation Team Leader FDA/CDRH/ODE/HFPMET