usability validierung von medizinischer software durch ...€¦ · warum usability-tests?...
TRANSCRIPT
Michael Engler
Usability Validierung von medizinischer Software durch
Usability-Tests
Fahrplan
• Warum Usability-Tests?
• Was ist zu tun?
• Was ist zu beachten?
25.06.2013 © Michael Engler IT-Consulting 2
Warum Usability-Tests?
Infusionspumpen
„Volume in the syringe is inadequate to deliver the programmed dose.
PRESS CONFIRM“
• Dosis bestätigen vs. Fehlermeldung bestätigen
25.06.2013 © Michael Engler IT-Consulting 3
Motivation
Heading 1
• Master Text
• Master Text
• Master Text
• Master Text
• Master Text
• Master Text
25.06.2013 © Michael Engler IT-Consulting 4
Guidance for Industry and FDA Premarketand Design Control Reviewers
Medical Device Use-Safety:Incorporating Human Factors
Engineering into Risk Management
Document issued on July 18, 2000
This document replaces the draft guidance document of August 3, 1999, entitledDevice Use Safety: Incorporating Human Factors in Risk Management .
U.S. Department of Health and Human Services
Food and Drug AdministrationCenter for Devices and Radiological Health
Division of Device User Programs and Systems AnalysisOffice of Health and Industry Programs
Page 1 of 5 IDE_HF.WPD
U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Office of Health and Industry Programs
Division of Device User Programs and Systems Analysis
1350 Piccard Drive, HFZ-230
Rockville, MD 20850
Telephone: (240) 276-3222 • Facsimile: (240) 276-3232
Human Factors Points to Consider for IDE Devices
“One of the most important lessons of abnormal events, ranging from minor incidents to
serious accidents, is that they have so often been the result of incorrect human actions.”
International Atomic Energy Commission, 1988
Purpose
This enclosure is intended to help sponsors of an Investigational Device Exemption (IDE)
determine how much attention to pay to human factors during the premarket review and analysis
process and future device design and development. Included in this document is a brief
explanation of human factors engineering and the human factors engineering process.
The extent to which human factors is considered, both by the sponsor and the Office of Device
Evaluation (ODE), for any device should be governed by the complexity of the device and the
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 is minimized. To be effective, human
factors must be an integral part of the product development process from concept through
production. The objective is to produce a device with an effective, efficient and safe user-device
interface.
For more information, please contact one of our human factors specialists at 240-276-3238 or
by FAX at 240-276-3232.
Background
In the premarket review, ODE will verify that a manufacturer 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:
Contains Nonbinding Recommendations Draft - Not for Implementation
Draft Guidance for Industry and Food and Drug Administration
Staff
Applying Human Factors and Usability Engineering to Optimize
Medical Device Design
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.
Document issued on: June 22, 2011
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
guidance. Submit written comments to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit
electronic comments to http://www.regulations.gov. Identify all comments with the docket
number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document, contact Ron Kaye at [email protected] or (301)
796-6289, or Molly Story at [email protected] or (301) 796-1456.
When final, this document will supersede Medical Device Use-Safety: Incorporating
Human Factors Engineering into Risk Management (Issued July 18, 2000).
U.S. Department of Health and Human Services Food and Drug Administration
Center for Devices and Radiological Health Office of Device Evaluation
Warum Usability-Tests?
25.06.2013 © Michael Engler IT-Consulting 5
Warum Usability-Tests?
Zusammenfassend:
• Nutzungsfehler vermeiden
• Normen erfüllen
• Gate für Entwicklung
25.06.2013 © Michael Engler IT-Consulting 6
Was ist zu tun?
Schritte der Usability Validierung
• Planen
• Rekrutieren
• Vorbereiten
• Testen
• Nachbesprechen
• Analysieren und berichten
25.06.2013 © Michael Engler IT-Consulting 7
Was ist zu tun?
Planen
25.06.2013 © Michael Engler IT-Consulting 8
vs.
Was ist zu tun?
Planen: Klinische Prüfung vs. Usability-Test
• Beurteilung:
– Hohes Risiko?
– Auftretenswahrscheinlichkeit?
– Test am Patienten zu vertreten?
– Objektive Messungen nötig?
– Beobachtung nötig?
25.06.2013 © Michael Engler IT-Consulting 9
Was ist zu tun?
Heading 1
• Master Text
• Master Text
• Master Text
• Master Text
• Master Text
• Master Text
25.06.2013 © Michael Engler IT-Consulting 10
Was ist zu tun?
Test-Aufgaben formulieren
25.06.2013 © Michael Engler IT-Consulting 11
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.
Was ist zu tun?
25.06.2013 © Michael Engler IT-Consulting 12
? Rekrutieren
Was ist zu tun?
Vorbereiten
• Checklisten erstellen
• Test als Teilnehmer durchspielen
• Pilottest durchführen
• Testumgebung vorbereiten und prüfen
• Nutzung des Prototypen sicherstellen
• Teilnehmer erinnern
25.06.2013 © Michael Engler IT-Consulting 13
Was ist zu tun?
25.06.2013 © Michael Engler IT-Consulting 14
Was ist zu tun?
Auswerten
• Master Text
• Master Text
• Master Text
• Master Text
• Master Text
• Master Text
25.06.2013 © Michael Engler IT-Consulting 15
Was ist das Ergebnis?
25.06.2013 © Michael Engler IT-Consulting 16
Was ist zu beachten?
Neuigkeiten und Wissenswertes
• UOUP kommt
• FDA-Draft Guidance von 2011
• AAMI HE 75
25.06.2013 © Michael Engler IT-Consulting 17
Was ist zu beachten?
25.06.2013 © Michael Engler IT-Consulting 18
Michael Engler IT-Consulting
Usability – Requirements – Agility
michael.engler (at) systemkontext (punkt) de
Mobil +49 (0) 1522 – 92 404 98
Rüttenscheider Platz 12
45130 Essen
http://www.systemkontext.de
25.06.2013 19 © Michael Engler IT-Consulting