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ASTM Selected Technical Papers
Medical Devices: Measurements, Quality Assurance, and Standards
By
CA Caceres
CA Caceres
1
Clinical Systems Associates, Inc.
.
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HT Yolken
HT Yolken
2
National Bureau of Standards
.
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RJ Jones
RJ Jones
3
American Medical Association
.
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HR Piehler
HR Piehler
4
Carnegie-Mellon University
,
editors; with the assistance of J. W. Schick
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ISBN-10:
0-8031-0235-6
ISBN:
978-0-8031-0235-4
No. of Pages:
321
Publisher:
ASTM International
Publication date:
1983

A timeworn but nevertheless accepted cliche is “medicine is more an art than a science.” This applies not only to the practice of medicine but also to the evaluation of medical practice, and the research that forms the basis of that practice. This is certainly true in the development and use of the shunt for hydrocephalus. The following outlines the development of the shunt, explores the pathophysiologic basis for the use of the shunt, attempts to correlate the principles learned in these two processes, and highlights primary concerns with standardization efforts.

1.
Milhorat
,
T. H.
,
Hydrocephalus and the Cerebrospinal Fluid
,
Williams and Wilkins
,
Baltimore
,
1972
.
2.
Pollay
,
M.
,
Clinical Neurosurgery
, Vol.
24
,
1977
, pp. 254-269.
3.
Bering
,
E. A.
, Jr.
,
Journal of Neurosurgery
, Vol.
19
,
1962
, pp. 405-413.
4.
Foltz
,
E. L.
and
Aline
,
C.
,
Surgical Neurology
, Vol.
15
,
1981
, pp. 283-293.
5.
Davidoff
,
L. M.
,
Archives of Surgery
, Vol.
18
,
1929
, pp. 1737-1762.
6.
Davidson
,
R. J.
,
Journal of Neurosurgery and Psychiatry
, Vol.
39
,
1976
, pp. 640-646.
7.
Pudenz
,
R. H.
,
Journal of Neurosurgery
, Vol.
25
,
1966
, pp. 602-608.
8.
Watts
,
C.
,
Avula
,
X.
,
Keith
,
H. D.
, and
Pulliam
,
M.
, “
An Investigation of Cerebrospinal Fluid Shunt Valves
,” (Final Report, Phase I,
Literature Survey
), USPH FDA 223-79-5064, pp. 13-16,
1980
.
9.
Laurence
,
K. M.
and
Coats
,
S.
,
Archives of Disease in Childhood
, Vol.
37
,
1962
, pp. 335-362.
10.
Foltz
,
F. L.
and
Shurtleff
,
D. D.
,
Journal of Neurosurgery
, Vol.
20
,
1963
, pp. 1064-1079.
11.
Hakim
,
S.
,
Venges
,
J. G.
, and
Burton
,
J. B.
,
Surgical Neurology
, Vol.
5
,
1976
, pp. 187-210.
12.
Linder
,
M.
,
Diehl
,
J. T.
, and
Sklar
,
F. H.
,
Journal of Neurosurgery
, Vol.
55
,
1981
, pp. 183-186.
13.
Keith
,
H. D.
,
Avula
,
X.
,
Schelich
,
C.
, and
Watts
,
C. C
, “
An Investigation of Cerebrospinal Fluid Shunt Vaves
,” Final report, Phase II (Technical report), USPH FDA 223 79 5064, pp. 15-20,
1981
.
14.
Dawson
,
B. H.
,
Dervin
,
E.
, and
Heywood
,
O. B.
,
Developmental Medicine and Child Neurology
(Suppl.
35
),
1975
, pp. 78-84.
15.
Fox
,
J. L.
,
McCullough
,
D. C.
, and
Green
,
R. C.
,
Journal of Neurology, Neurosurgery, and Psychiatry
, Vol.
36
,
1973
, pp. 302-312.
16.
Watts
,
C.
,
Neurosurgery
, Vol.
9
,
1981
, pp. 97-98.
17.
Wilcox
,
D. P.
,
Texas Medicine
, Vol.
76
,
1980
, pp. 66-67.
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