Usability Validierung von medizinischer Software durch ...€¦ · Warum Usability-Tests? Infusionspumpen „Volume in the syringe is inadequate to deliver the programmed dose. PRESS

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


Motivation

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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This document replaces the draft guidance document of August 3, 1999, entitledDevice Use Safety: Incorporating Human Factors in Risk Management .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




Zusammenfassend:

• Nutzungsfehler vermeiden

• Normen erfüllen

• Gate für Entwicklung


Was ist zu tun?

Schritte der Usability Validierung

• Planen

• Rekrutieren

• Vorbereiten

• Testen

• Nachbesprechen

• Analysieren und berichten


Was ist zu tun?

Planen


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?


Was ist zu tun?

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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.

Was ist zu tun?


? Rekrutieren

Was ist zu tun?

Vorbereiten

• Checklisten erstellen

• Test als Teilnehmer durchspielen

• Pilottest durchführen

• Testumgebung vorbereiten und prüfen

• Nutzung des Prototypen sicherstellen

• Teilnehmer erinnern


Was ist zu tun?


Was ist zu tun?

Auswerten

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Was ist das Ergebnis?


Was ist zu beachten?

Neuigkeiten und Wissenswertes

• UOUP kommt

• FDA-Draft Guidance von 2011

• AAMI HE 75


Was ist zu beachten?


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

Documents

Usability Validierung von medizinischer Software durch ...€¦ · Warum Usability-Tests? Infusionspumpen „Volume in the syringe is inadequate to deliver the programmed dose. PRESS