A USER-BASED PERFORMANCE STANDARD:

for the design, evaluation, and selection of medical devices

This Performance Standard was developed by the TDICT Project, in conjunction with line healthcare workers and the HIV Office of the Centers for Disease Control. It steps back from device specific criteria to look at overall procedures and the fundamental standards which must be met by all products, in all phases of use. Download a pdf version of this document.

Performance Standard vs. Selection Criteria

Generalized/ Generic Device Specific Applications
Based on Procedure Based on Device
Encompasses Product Life Cycle Point of Use Only

MAJOR CATEGORIES

I. PATIENT SAFETY & QUALITY OF CARE

II. USER SAFETY

III. USER FIT AND SATISFACTION

IV. PATIENT FIT AND SATISFACTION

V. PRODUCT LIFE-CYCLE

VI. ADMINISTRATIVE FIT AND SATISFACTION


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Trauma Foundation Bldg. #1, Rm. #300
San Francisco General Hospital
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