Usability Validierung von medizinischer Software durch Usability-Tests. Michael Engler

Transkript

1 Usability Validierung von medizinischer Software durch Usability-Tests Michael Engler

2 Fahrplan Warum Usability-Tests? Was ist zu tun? Was ist zu beachten? Michael Engler IT-Consulting 2

3 Warum Usability-Tests? Infusionspumpen Volume in the syringe is inadequate to deliver the programmed dose. PRESS CONFIRM Dosis bestätigen vs. Fehlermeldung bestätigen Michael Engler IT-Consulting 3

4 Heading 1 Motivation Guidance for Industry and FDA Premarket and Design Control Reviewers U.S. FOOD AND DRUG ADM INISTRATION CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Office of Health and Industry Programs Division of Device User Programs and Systems Analysis Applying Human Factors and 1350 Piccard Drive, HFZ-230 Rockville, MD Telephone: M edical Device Use-Safety: Usability (240) Facsimile: Engineering (240) to Optimize I ncorporating Human Factors Medical Device Design Human Factors Points to Consider for IDE Devices Engineering into Risk M anagement One of the most important lessons of abnormal events, ranging from minor incidents to serious accidents, is that they have so often been This the guidance result of incorrect document human is actions. being distributed for comment purposes only. International Atomic Energy Document Commission, issued 1988 on: June 22, 2011 Document issued on July 18, 2000 Purpose You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft This document replaces the draft This guidance enclosure document is intended of to August help sponsors 3, 1999, of entitled an Investigational guidance. Submit Device written Exemption comments (IDE) to the Division of Dockets Management (HFA-305), Device Use Safety: Incorporating determine Human how much Factors attention in Risk to pay Management. to human factors Food during and Drug the premarket Administration, review 5630 and analysis Fishers Lane, rm. 1061, Rockville, MD Submit process and future device design and development. electronic Included in comments this document to is a brief Identify all comments with the docket explanation of human factors engineering and the human number factors listed engineering the notice process. of availability that publishes in the Federal Register. The extent to which human factors is considered, both For by questions the sponsor regarding and the this Office document, of Device contact Ron Kaye at ron.kaye@fda.hhs.gov or (301) Evaluation (ODE), for any device should be governed , by the complexity or Molly Story of the at device molly.story@fda.hhs.gov and the or (301) risks associated with its use. The goal is to assure that the device meets the users' expectations, both stated and implied, so that the likelihood of user error When is minimized. final, this document To be effective, will supersede human Medical Device Use-Safety: Incorporating factors must be an integral part of the product development process from Human concept Factors throughengineering into Risk Management production. The objective is to produce a device with an effective, efficient and safe user-device (Issued July 18, 2000). interface. U.S. Department of Health and Human Services For more information, please contact one of our human factors specialists at or Food and Drug Administration by FAX at Center for Devices and Radiological Health U.S. Department of Health and Human Services Office of Device Evaluation Food and Drug Administration Background Center for Devices and Radiological Health Division of Device User Programs and Systems Analysis In the premarket review, Office of ODE Health will verify and Industry that a manufacturer Programs adequately considered the user and the use environment in the design and development of its medical device. The recently published Quality System Regulation (formerly known as Good Manufacturing Practices) requires most medical device manufacturers to maintain procedures to control and verify the design of the device in order to ensure that specified design requirements are met. Manufacturers are required to establish and maintain procedures: Page 1 of 5 Contains Nonbinding Recommendations Draft - Not for Implementation Draft Guidance for I ndustry and Food and Drug Administration Staff DRAFT GUIDANCE IDE_HF.WPD Michael Engler IT-Consulting 4

5 Warum Usability-Tests? Michael Engler IT-Consulting 5

6 Warum Usability-Tests? Zusammenfassend: Nutzungsfehler vermeiden Normen erfüllen Gate für Entwicklung Michael Engler IT-Consulting 6

7 Was ist zu tun? Schritte der Usability Validierung Planen Rekrutieren Vorbereiten Testen Nachbesprechen Analysieren und berichten Michael Engler IT-Consulting 7

8 Was ist zu tun? Planen vs Michael Engler IT-Consulting 8

9 Was ist zu tun? Planen: Klinische Prüfung vs. Usability-Test Beurteilung: Hohes Risiko? Auftretenswahrscheinlichkeit? Test am Patienten zu vertreten? Objektive Messungen nötig? Beobachtung nötig? Michael Engler IT-Consulting 9

10 Was ist zu tun? Heading Michael Engler IT-Consulting 10

11 Was ist zu tun? Test-Aufgaben formulieren Aufgabe Wechseln Sie die Batterie des Blutzuckermessgeräts. Dann schalten Sie das Gerät wieder ein. Zeit 5 min. Erfolg Gerät ist eingeschaltet und das Batteriefach geschlossen Michael Engler IT-Consulting 11

12 Was ist zu tun? Rekrutieren? Michael Engler IT-Consulting 12

13 Was ist zu tun? Vorbereiten Checklisten erstellen Test als Teilnehmer durchspielen Pilottest durchführen Testumgebung vorbereiten und prüfen Nutzung des Prototypen sicherstellen Teilnehmer erinnern Michael Engler IT-Consulting 13

14 Was ist zu tun? Michael Engler IT-Consulting 14

15 Was ist zu tun? Auswerten Michael Engler IT-Consulting 15

16 Was ist das Ergebnis? Michael Engler IT-Consulting 16

17 Was ist zu beachten? Neuigkeiten und Wissenswertes UOUP kommt FDA-Draft Guidance von 2011 AAMI HE Michael Engler IT-Consulting 17

18 Was ist zu beachten? Michael Engler IT-Consulting 18

19 Michael Engler IT-Consulting Usability Requirements Agility michael.engler (at) systemkontext (punkt) de Mobil +49 (0) Rüttenscheider Platz Essen Michael Engler IT-Consulting 19