{"id":634,"date":"2021-03-28T22:21:40","date_gmt":"2021-03-28T22:21:40","guid":{"rendered":"http:\/\/www.tgfrconsulting.com\/blog\/?p=634"},"modified":"2024-01-20T22:19:11","modified_gmt":"2024-01-20T22:19:11","slug":"task-analysis","status":"publish","type":"post","link":"https:\/\/www.tgfrconsulting.com\/blog\/archived\/risk-management\/task-analysis\/","title":{"rendered":"Task Analysis"},"content":{"rendered":"
\n\n\n

Task analysis breaks down the use of the device into discrete sequences of functions or tasks. \u00a0This analysis considers the complete therapy to gain a more complete view of the therapy delivery as well as interaction of the user, patient, and device.\u00a0 This complete view of the therapy drives all subsequent risk and design activities.<\/p>\n\n\n\n

Identifying the Mission Phases<\/strong><\/h2>\n\n\n\n

The first process step identifies the overall \u201cmission\u201d.\u00a0 In most cases the \u201cmission\u201d is the delivery of a single therapy or execution of a single procedure.\u00a0 <\/p>\n\n\n\n

The following figure presents a pictorial sequence of a single \u201cmission\u201d, consisting of the operations associated with a single drug delivery.<\/p>\n\n\n\n

\"Therapy<\/figure>\n\n\n\n

These phases associated with drug delivery can easily be modified and applied to all manner of devices.\u00a0 The following table summarizes each operational phase identified and the possible failure modes<\/p>\n\n\n\n

Phase<\/td>Description<\/td><\/tr>
Acquisition<\/td>The device ships from the manufacturer to the user.\u00a0
Possible failure modes would include shipping damage<\/td><\/tr>
Training<\/td>The training of the users
Possible failure modes would include to complete training<\/td><\/tr>
Deployment<\/td>Moving the device to a position of use, such as loading a disposable into the COW (computer on wheels)
Possible failure modes might be storing a prefilled device in the wrong dose bin due to labeling or physical damage to the device while pushing a device on wheels.<\/td><\/tr>
Setup<\/td>Setting up for delivery of the procedure.
Possible failure modes might include improper configuration by the clinician<\/td><\/tr>
Programming<\/td>Programming the device for the procedure.\u00a0
Possible failure modes might include setting the wrong dose<\/td><\/tr>
Delivery<\/td>Delivering the therapy.\u00a0 This may be modified depending upon the therapy
Possible failure modes might include failure of the device to deliver\u00a0<\/td><\/tr>
Handoff between
users<\/td>		This is the presentation of status during shift changes. 
 
Possible failure modes might be failure of the clinicians to discuss status when changing shifts.<\/td><\/tr>
Teardown<\/td>This is tearing down the setup for the procedure.
Possible failure modes might include sharp objects being exposed<\/td><\/tr>
Service<\/td>This includes cleaning and service.
Possible failure modes might include allowing cleaning solutions into the device<\/td><\/tr>
Manage Exceptions<\/td>Handling alarms and issues.\u00a0 Exceptions are generally handled outside of normal operational context.
Possible failure modes might include unnecessary interruption of the therapy<\/td><\/tr>
Global<\/td>Global includes things such delivering electrical power \u2013 those things that move across other phases
Possible failure modes might include battery depletion<\/td><\/tr><\/tbody><\/table>
Example Mission Phases<\/figcaption><\/figure>\n\n\n\n

Identifying Actors<\/strong><\/h2>\n\n\n\n

When defining the operational phases, consider phases based upon the actors performing the functions or tasks.\u00a0 In the expanded task analysis, the actors include<\/p>\n\n\n\n

Actor<\/td>Description and Actions<\/td><\/tr>
Administrator<\/td>The administrator usually handles the Acquisition, Training and Deployment<\/td><\/tr>
Clinician<\/td>The clinician handles the setup, programming, handoff between users, managing exceptions, and teardown<\/td><\/tr>
Device<\/td>The device handles delivery of the therapy and many of the global tasks<\/td><\/tr>
Bio-Med
Technician<\/td>		The bio-med technician handles service, including the cleaning.<\/td><\/tr><\/tbody><\/table>
Example Actors <\/figcaption><\/figure>\n\n\n\n

Functions<\/strong> <\/h2>\n\n\n\n

Once operational phases have been identified, the next step details the functions for each operational phase.\u00a0 Each phase should be decomposed to 10-12 constituent functions, as shown below<\/p>\n\n\n\n

\"Function<\/figure>\n\n\n\n

The functions may be tasks performed by the user or functions performed by the device, which is why the more general term of \u201cfunction\u201d is applied.\u00a0<\/p>\n\n\n\n

Failure Modes<\/strong><\/h2>\n\n\n\n

Following function identification, a multi-disciplined team identifies the failure modes for each task or function.\u00a0 Failures are initiating events that will eventually lead to a hazard and trigger a hazardous situation.\u00a0 Initially, identify all failure modes, including device and user errors for every function in the \u201cmission\u201d (the delivery of the therapy or treatment).\u00a0 Next steps associate hazards, sequence of events and hazardous situations to these failure modes. At present task analysis focuses on the failure modes for the “mission” functions and tasks<\/p>\n\n\n\n

Further Reading<\/strong><\/h2>\n\n\n\n
Topic<\/td>Reference<\/td><\/tr>
Human Factors and
Task Analysis<\/td>		IEC. (2015). IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices.<\/em> ISO.<\/td><\/tr>
Human Factors and
Task Analysis<\/td>		Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff FEBRUARY 2016
https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/applying-human-factors-and-usability-engineering-medical-devices<\/a><\/td><\/tr>
Mission Phases<\/td>Barba, R. J. (2004). Failure Mode Effect Analysis Applied to the Use of Infusion Pumps. Proceedings of the 26th Annual International Conference of the IEEE EMBS.<\/em><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

<\/p>\n\n\n<\/div>","protected":false},"excerpt":{"rendered":"

Medical Device Task Analysis will form the basis of future risk and workflow development<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[61,8],"tags":[56],"class_list":{"0":"post-634","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-archived","7":"category-risk-management","8":"tag-task-analysis","9":"anons"},"yoast_head":"\nTask Analysis - TGFR Consulting LLC<\/title>\n<meta name=\"description\" content=\"Medical Device Task Analysis will form the basis of future risk and workflow development\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.tgfrconsulting.com\/blog\/archived\/risk-management\/task-analysis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Task Analysis - 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