Abstract
To comply with the large global need for surgery, surgical equipment that fits the challenging environment in low- and middle-income countries (LMICs) should be designed. The aim of this study is to present a context-specific design of an electrosurgical unit (ESU) and a monopolar handheld to improve global access to surgery. This paper presents both a detailed description of electrosurgery in clinical practice in LMICs and the design of an ESU generator and monopolar handheld for this specific setting. Extensive fieldwork (by means of surveys, interviews, observations, and collection of maintenance records) was done by authors RO, KO, and LH. Feedback from users working in Kenya on the first demonstrator designs was obtained, after which the designs were adapted into conceptual prototypes. These were further evaluated by surveying respondents who attended the annual meeting of the College of Surgeons of East, Central, and Southern Africa (COSECSA) in Kigali, Rwanda in December 2018. Conceptual prototypes were developed for (a) an affordable ESU that is compact and battery powered and (b) a robust reusable monopolar handheld that can be cleaned in the autoclave and by chemicals (e.g., glutaraldehyde solution). The conceptual prototypes were positively received by the 51 respondents of the survey. The findings from the field work and the feedback from users during the design phase have led to a clear understanding of the specific needs and potential solutions. The presented conceptual prototypes need to be further developed into functional prototypes, which could be implemented in Kenya and other settings for further evaluation.
Issue Section:
Special Papers
References
1.
Meara
,
J. G.
,
Leather
,
A. J. M.
,
Hagander
,
L.
,
Alkire
,
B. C.
,
Alonso
,
N.
,
Ameh
,
E. A.
,
Bickler
,
S. W.
,
Conteh
,
L.
,
Dare
,
A. J.
,
Davies
,
J.
,
Mérisier
,
E. D.
,
El-Halabi
,
S.
,
Farmer
,
P. E.
,
Gawande
,
A.
,
Gillies
,
R.
,
Greenberg
,
S. L. M.
,
Grimes
,
C. E.
,
Gruen
,
R. L.
,
Ismail
,
E. A.
,
Kamara
,
T. B.
,
Lavy
,
C.
,
Lundeg
,
G.
,
Mkandawire
,
N. C.
,
Raykar
,
N. P.
,
Riesel
,
J. N.
,
Rodas
,
E.
,
Rose
,
J.
,
Roy
,
N.
,
Shrime
,
M. G.
,
Sullivan
,
R.
,
Verguet
,
S.
,
Watters
,
D.
,
Weiser
,
T. G.
,
Wilson
,
I. H.
,
Yamey
,
G.
, and
Yip
,
W.
, 2015
, “
Global Surgery 2030: Evidence and Solutions for Achieving Health, Welfare, and Economic Development
,” Lancet
,
386
(9993
), pp. 569
–624
.10.1016/S0140-6736(15)60160-X2.
Henry
,
J. A.
,
Frenkel
,
E.
,
Borgstein
,
E.
,
Mkandawire
,
N.
, and
Goddia
,
C.
, 2015
, “
Surgical and Anaesthetic Capacity of Hospitals in Malawi: Key Insights
,” Health Policy Plan.
,
30
(8
), pp. 985
–994
.10.1093/heapol/czu1023.
Henry
,
J. A.
,
Windapo
,
O.
,
Kushner
,
A. L.
,
Groen
,
R. S.
, and
Nwomeh
,
B. C.
, 2012
, “
A Survey of Surgical Capacity in Rural Southern Nigeria: Opportunities for Change
,” World J. Surg.
,
36
(12
), pp. 2811
–2818
.10.1007/s00268-012-1764-04.
Kouo-Ngamby
,
M.
,
Dissak-Delon
,
F. N.
,
Feldhaus
,
I.
,
Juillard
,
C.
,
Stevens
,
K. A.
, and
Ekeke-Monono
,
M.
, 2015
, “
Ekeke-Monono M. A Cross-Sectional Survey of Emergency and Essential Surgical Care Capacity Among Hospitals With High Trauma Burden in a Central African Country
,” BMC Health Serv. Res.
,
15
(1
), p. 478
.10.1186/s12913-015-1147-y5.
Wong
,
E. G.
,
Gupta
,
S.
,
Deckelbaum
,
D. L.
,
Razek
,
T.
,
Kamara
,
T. B.
,
Nwomeh
,
B. C.
,
Haider
,
A. H.
, and
Kushner
,
A. L.
, 2014
, “
The International Assessment of Capacity for Trauma (INTACT): An Index for Trauma Capacity in Low-Income Countries
,” J. Surg. Res.
,
190
(2
), pp. 522
–527
.10.1016/j.jss.2014.01.0606.
Elkheir
,
N.
,
Sharma
,
A.
,
Cherian
,
M.
,
Saleh
,
O. A.
,
Everard
,
M.
,
Popal
,
G. R.
, and
Ibrahim
,
A. A.
, 2014
, “
A Cross-Sectional Survey of Essential Surgical Capacity in Somalia
,” BMJ Open
,
4
(5
), p. e004360
.10.1136/bmjopen-2013-0043607.
Chao
,
T. E.
,
Burdic
,
M.
,
Ganjawalla
,
K.
,
Derbew
,
M.
,
Keshian
,
C.
,
Meara
,
J.
, and
McQueen
,
K.
, 2012
, “
Survey of Surgery and Anesthesia Infrastructure in Ethiopia
,” World J. Surg.
,
36
(11
), pp. 2545
–2553
.10.1007/s00268-012-1729-38.
Groen
,
R. S.
,
Kamara
,
T. B.
,
Dixon-Cole
,
R.
,
Kwon
,
S.
,
Kingham
,
T. P.
, and
Kushner
,
A. L.
, 2012
, “
A Tool and Index to Assess Surgical Capacity in Low Income Countries: An Initial Implementation in Sierra Leone
,” World J. Surg.
,
36
(8
), pp. 1970
–1977
.10.1007/s00268-012-1591-39.
Ng-Kamstra
,
J. S.
,
Greenberg
,
S. L. M.
,
Abdullah
,
F.
,
Amado
,
V.
,
Anderson
,
G. A.
,
Cossa
,
M.
,
Costas-Chavarri
,
A.
,
Davies
,
J.
,
Debas
,
H. T.
,
Dyer
,
G. S. M.
,
Erdene
,
S.
,
Farmer
,
P. E.
,
Gaumnitz
,
A.
,
Hagander
,
L.
,
Haider
,
A.
,
Leather
,
A. J. M.
,
Lin
,
Y.
,
Marten
,
R.
,
Marvin
,
J. T.
,
McClain
,
C. D.
,
Meara
,
J. G.
,
Meheš
,
M.
,
Mock
,
C.
,
Mukhopadhyay
,
S.
,
Orgoi
,
S.
,
Prestero
,
T.
,
Price
,
R. R.
,
Raykar
,
N. P.
,
Riesel
,
J. N.
,
Riviello
,
R.
,
Rudy
,
S. M.
,
Saluja
,
S.
,
Sullivan
,
R.
,
Tarpley
,
J. L.
,
Taylor
,
R. H.
,
Telemaque
,
L.-F.
,
Toma
,
G.
,
Varghese
,
A.
,
Walker
,
M.
,
Yamey
,
G.
, and
Shrime
,
M. G.
, 2016
, “
Global Surgery 2030: A Roadmap for High Income Country Actors
,” BMJ Global Health
,
1
(1
), p. e000011
.10.1136/bmjgh-2015-00001110.
Organization WHO
, 2010
, “
Medical Devices: Managing the Mismatch: An Outcome of the Priority Medical Devices Project
,” World Health Organization, Geneva, Switzerland.11.
Sarvestani
,
A. S.
, and
Sienko
,
K. H.
, 2018
, “
Medical Device Landscape for Communicable and Noncommunicable Diseases in Low-Income Countries
,” Globalization Health
,
14
(1
), p. 65
.10.1186/s12992-018-0355-812.
Neighbour
,
R.
, and
Eltringham
,
R.
, 2012
, “
The Design of Medical Equipment for Low Income Countries: Dual Standards or Common Sense
,” Appropriate Healthcare Technologies for Developing Countries
, 7th International Conference.10.1049/cp.2012.146213.
Malkin
,
R. A.
, 2007
, “
Design of Health Care Technologies for the Developing World
,” Annu. Rev. Biomed. Eng.
,
9
(1
), pp. 567
–587
.10.1146/annurev.bioeng.9.060906.15191314.
Malkin
,
R. A.
, 2007
, “
Barriers for Medical Devices for the Developing World
,” Expert Rev. Med. Devices
,
4
(6
), pp. 759
–763
.10.1586/17434440.4.6.75915.
Castillo
,
L. G.
,
Diehl
,
J. C.
, and
Brezet
,
J.
, eds., 2012
, “
Design Considerations for Base of the Pyramid (BoP) Projects
,” Proceedings of the Northern World Mandate: Cumulus Helsinki Conference
, Helsinki, Finland, pp. 24
–26
.16.
Oosting
,
R.
,
Dankelman
,
J.
,
Wauben
,
L.
,
Madete
,
J.
,
Groen
,
R.
, eds., 2018
, “
Roadmap for Design of Surgical Equipment for Safe Surgery Worldwide
,” IEEE Global Humanitarian Technology Conference
(GHTC
), San Jose, CA, pp. 1
–8
.10.1109/GHTC.2018.860191317.
Wang
,
K.
, and
Advincula
,
A. P.
, 2007
, “
Current Thoughts
,” Electrosurgery Int. J. Gynecol. Obstet.
,
97
(3
), pp. 245
–250
.10.1016/j.ijgo.2007.03.00118.
Oosting
,
R.
,
Wauben
,
L.
,
Groen
,
R.
, and
Dankelman
,
J.
, 2018
, “
Equipment for Essential Surgical Care in 9 Countries Across Africa: Availability, Barriers and Need for Novel Design
,” Health Technol.
,
9
(3
), pp. 1
–7
.https://link.springer.com/article/10.1007/s12553-018-0275-x19.
Oosting
,
R. M.
,
Wauben
,
L. S.
,
Mwaura
,
S. W.
,
Madete
,
J. K.
,
Groen
,
R. S.
, and
Dankelman
,
J.
, 2019
, “
Barriers to Availability of Surgical Equipment in Kenya
,” Global Clin. Eng. J.
,
1
(2
), pp. 35
–42
.10.31354/globalce.v1i2.6120.
Valleylab,
2018
, “
Manual Valleylab Force FX
,” Medtronic inc, Fridley, MN, accessed Jan. 5, 2018,
https://cdn.shopify.com/s/files/1/1046/1086/files/ValleyLab-Force-FXc-Electrosurgical-Generator-User-Manual.pdf21.
Forrester
,
J. A.
,
Torgeson
,
K.
, and
Weiser
,
T. G.
, 2019
, “
Minimum Specifications for a Lifebox Surgical Headlight for Resource-Constrained Settings
,” JAMA Surg.
,
154
(1
), pp. 80
–82
.10.1001/jamasurg.2018.420522.
Marks
,
I. H.
,
Thomas
,
H.
,
Bakhet
,
M.
,
and Fitzgerald
,
E.
, 2019
, “
WFSA Performance Standard Anaesthetic Equipment for Low and Low-Middle income (LMIC) Countries
,” BMJ Global Health, accessed Jan. 28, 2020, https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=2ahUKEwiKks6E27fnAhVMIlAKHf6iA8IQFjAAegQIAhAB&url=https%3A%2F%2Fgh.bmj.com%2Fcontent%2Fbmjgh%2F4%2F5%2Fe001785%2FDC1%2Fembed%2Finline-supplementary-material-1.pdf%3Fdownload%3Dtrue&usg=AOvVaw115YlGO4qHx63k6Yj4bJjr
23.
Meeuwsen
,
F. C.
,
Guédon
,
A. C.
,
Arkenbout
,
E. A.
,
van der Elst
,
M.
,
Dankelman
,
J.
, and
van den Dobbelsteen
,
J. J.
, 2017
, “
The Art of Electrosurgery: Trainees and Experts
,” Surg. Innovation
,
24
(4
), pp. 373
–378
.10.1177/155335061770520724.
Johnson & Johnson
, 2018
, “
Cidexmanual
,” Johnson & Johnson, Irvine, CA, accessed Jan. 5, 2018, https://www.hopkinsmedicine.org/hse/forms/cidexopa/opainstruction.pdf25.
Chawla
,
S.
,
Kurani
,
S.
,
Wren
,
S. M.
,
Stewart
,
B.
,
Burnham
,
G.
,
Kushner
,
A.
, and
McIntyre
,
T.
, 2018
, “
Electricity and Generator Availability in LMIC Hospitals: Improving Access to Safe Surgery
,” J. Surg. Res.
,
223
, pp. 136
–141
.10.1016/j.jss.2017.10.01626.
Santos
,
A. L.
, and
Wauben
,
L. S.
, 2014
, “
System Design Perspective of Healthcare Provision in Humanitarian Aid
,” FormAkademisk-forskningstidsskrift for design og designdidaktikk
, 7(3).10.7577/formakademisk.79027.
Mohedas
,
I.
,
Sabet Sarvestani
,
A.
,
Daly
,
S. R.
, and
Sienko
,
K. H.
, 2015
, “
Applying Design Ethnography to Product Evaluation: A Case Example of a Medical Device in a Low-Resource Setting
,” pp. 401
–410
.28.
Emmerling
,
D.
,
Dahinten
,
A.
, and
Malkin
,
R. A.
, 2018
, “
Problems With Systems of Medical Equipment Provision: An Evaluation in Honduras, Rwanda and Cambodia Identifies Opportunities to Strengthen Healthcare Systems
,” Health Technol.
,
8
(1–2
), pp. 129
–135
.10.1007/s12553-017-0210-6Copyright © 2020 by ASME
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