Implementing the Safe Medical Devices Act in a hospital.
Implementation of the Safe Medical Devices Act (SMDA) by a "medical device user facility" requires the introduction of new responsibilities, processes, and accountabilities. The complexity of a program will vary with the number of devices included, as well as the medical activities of the particular facility. The implementation of the SMDA is described in a 145-bed, acute care, county hospital, along with some of the practical problems and solutions associated with its implementation. Both the event reportability section and the tracking section of SMDA have been implemented. The greatest difficulty in the event reportability section lies in the ambiguous definitions that determine event reportability. This ambiguity may be clarified when the final regulations are published. In respect to device tracking, questions remain unanswered that relate to the manufacturer-facility interface and disposition of explanted devices.
McQuien
R G
RG
MED+EQUIP Services, San Ramon, CA 94583.
Shepherd
M
M
D002140:California; D003659:Decision Making, Organizational; D004282:Documentation; D004869:Equipment Safety / Q000592:standards*; D005568:Forms and Records Control; D006744:Hospital Bed Capacity, 100 to 299; D006766:Hospitals, County / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011367:Professional Staff Committees / Q000458:organization & administration; D016730:Program Development; D012107:Research Design; D017751:Safety Management / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration