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Research Papers

Application Failure Mode and Effects Analysis Reveals Failure Modes for Interferential Stimulation Therapy in Treating Chronic Constipation

[+] Author and Article Information
Andre Yi Feng Tan

Surgical Research Group,
Murdoch Childrens Research Institute,
50 Flemington Road,
Parkville, Victoria 3052, Australia;
Department of Paediatrics,
The University of Melbourne,
Parkville, Victoria 3010, Australia
e-mail: andre.tan@mcri.edu.au

Don Black

Surgical Research Group,
Murdoch Childrens Research Institute,
50 Flemington Road,
Parkville, Victoria 3052, Australia
e-mail: don.black@mcri.edu.au

John Medwyn Hutson

Surgical Research Group,
Murdoch Childrens Research Institute,
50 Flemington Road,
Parkville, Victoria 3052, Australia;
Department of Paediatrics,
The University of Melbourne,
Parkville, Victoria 3010, Australia;
Department of General Surgery,
The Royal Children’s Hospital,
50 Flemington Road,
Parkville, Victoria 3052, Australia
e-mail: john.hutson@rch.org.au

Bridget Rae Southwell

Surgical Research Group,
Murdoch Childrens Research Institute,
50 Flemington Road,
Parkville, Victoria 3052, Australia;
Department of Paediatrics,
The University of Melbourne,
Parkville, Victoria 3010, Australia;
Department of Gastroenterology,
The Royal Children’s Hospital,
50 Flemington Road,
Parkville, Victoria 3052, Australia
e-mail: bridget.southwell@mcri.edu.au

1Corresponding author.

Manuscript received December 3, 2014; final manuscript received June 8, 2015; published online August 6, 2015. Assoc. Editor: Carl Nelson.

J. Med. Devices 9(4), 041008 (Aug 06, 2015) (9 pages) Paper No: MED-14-1281; doi: 10.1115/1.4030857 History: Received December 03, 2014

Transcutaneous electrical stimulation (TES) is used to treat chronic constipation in the home environment. Incorrect application of TES may lead to ineffective therapy. We used an application failure mode and effects analysis (AFMEA) to analyze and rank problems. In developing mitigation options to minimize or eliminate failure modes, we identified design and engineering requirements for a new, simple-to-use stimulation system to deliver TES at home for treating chronic constipation, and educational material required to train clinicians, patients, and users. This provided a structured approach to the analysis and design of an improved device for treating chronic constipation.

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Figures

Grahic Jump Location
Fig. 1

The Fuji Dynamics INF4160 (“FD09”) electrical stimulator, with leads and 4 cm × 4 cm electrodes connected. The FD09 features an interferential stimulation mode that most portable/hand-held, battery-operated TENS devices do not have.

Grahic Jump Location
Fig. 2

Prescribed electrode positioning for TES for overcoming STC in children. One set of electrodes was placed in front right and back left positions and the lead connected to the first stimulation channel (Ch1). The other set of electrodes was placed in front left and back right positions and the lead connected to the second channel (Ch2). The dotted lines indicate the electrode leads passing behind the person, as seen from both the front and rear views.

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