Medical Device Use-Safety : Incorporating Human Factors Engineering into Risk Management

By Pitsillos, S.

Book Id: WPLBN0000696223
Format Type: PDF eBook
File Size: 249,379 KB.
Reproduction Date: 2005

Title:	Medical Device Use-Safety : Incorporating Human Factors Engineering into Risk Management
Author:	Pitsillos, S.
Volume:
Language:	English
Subject:	Government publications, Political science., Government Printing Office (U.S.)
Collections:
Historic Publication Date:
Publisher:	Pueblo-GSA


Citation APA MLA Chicago Pitsillos, S. (n.d.). Medical Device Use-Safety : Incorporating Human Factors Engineering into Risk Management. Retrieved from http://gutenberg.cc/

Description
Government Reference Publication

Excerpt
Introduction: This guidance describes how hazards related to medical device use should be addressed during device development as part of the risk management process. Potential use-related hazards are best identified and addressed using human factors engineering (HFE) 2. The process of incorporating these approaches in the risk management processes is explained. Documenting these efforts can demonstrate that the device manufacturer has undertaken efforts to control use related hazards. The goal is to minimize use-related hazards, assure that intended users are able to use medical devices safely and effectively throughout the product life cycle, and to facilitate review of new device submissions and design control documentation.

Table of Contents
Table of Contents Page 1.0 Introduction...........................................................................................................................5 1.1 Use-Related Hazards ....................................................................................................................................................6 1.2 Use Scenarios Resulting in Hazards .........................................................................................................................8 2.0 Risk Management...................................................................................................................8 3.0 Human Factors .......................................................................................................................9 3.1 HF in the Use of Medical Devices: Overall Considerations ..............................................................................9 3.2 Human Factors Considerations for the Device-User System...........................................................................10 4.0 Advantages and Level of Effort ..........................................................................................14 5.0 Apply Human Factors Engineering (HFE) Approaches Within the Risk Management Process .........................................................................................................................................15 5.1 Device Use Description ..............................................................................................................................................17 5.2 User Interface Design Information in Standards and Guidelines ..................................................................18 5.3 Apply Analytic and Empirical Approaches to Identify and Understand Use-Related Hazards ............19 5.4 Analytic HFE Approaches........................................................................................................................................20 5.5 Empirical HFE Approaches (Use Studies)............................................................................................................25 5.6 Prioritize and Assess Use-Related Hazards ..........................................................................................................27 5.7 Mitigate and Control Use-Related Hazards .........................................................................................................27 5.8 Verify and Validate User Interface Design...........................................................................................................28 6.0 Document Risk Management Activities for Device Use ...................................................29 6.1 Device Overall..............................................................................................................................................................29 6.2 Device User Interface.................................................................................................................................................29 6.3 Device Use.....................................................................................................................................................................30 6.4 Device User Population..............................................................................................................................................30 6.5 Device Use Environments .........................................................................................................................................30 6.6 Use-Related Hazards ..................................................................................................................................................30 6.7 Verification and Validation......................................................................................................................................30 7.0 References for Further Reading .........................................................................................31