Testing of central nervous system shunt devices.
This paper presents the results of a study performed by the U.S. Food & Drug Administration (FDA) under the Conformance Assessment to Voluntary Standards program. The ASTM voluntary standard F647-85 (American Society for Testing and Materials: Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurological Applications) was evaluated as to the adequacy of its test methods and the reasonableness of its application to currently marketed shunt devices. The objective of this study was to assess the impact of ASTM: F647-85 on the safety and effectiveness of shunt devices and thereby assist the FDA in setting priorities for its mandatory standards development activities. By searching the FDA's postmarketing surveillance database and by testing seventeen shunt devices and three catheters from six manufacturers, it was determined that these devices conform with most of the ASTM standard requirements. However, no single device conformed to all of the requirements of the standard. Suggestions for improving the voluntary standard's impact on the safety of shunt devices are presented.
DiNovo
J A
JA
U.S. Food & Drug Administration, Winchester, MA.
Tylka
C R
CR
March
E
E
D002490:Central Nervous System / Q000601:surgery*; D002557:Cerebrospinal Fluid Shunts / Q000295:instrumentation*; D004867:Equipment Design / Q000592:standards; D004869:Equipment Safety / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D006849:Hydrocephalus / Q000601:surgery*; D007231:Infant, Newborn; D008422:Materials Testing; D012015:Reference Standards; D014481:United States; D014486:United States Food and Drug Administration