A Study of Safety and Performance Requirements for Cryosurgical Devices

摘要

The report fulfills the requirements of FDA Contract 223-77-5037, Task Order No. 2 to research safety and performance requirements for cryosurgical devices and accessories (specifically, cryolesion monitors), identify the hazards and risks. These objectives were met by performing a comprehensive literature search, reviewing manufacture's documentation and FDA Classification Panel's Supplementary Data Sheets, conducting user interviews and an open users meeting, and examining ECRI's files of problems reported with cryosurgical devices and their accessories. This report contains a summary of the state of the art of cryosurgery; a summary of the literature searched and titles of all documents reviewed; a summary of the user, manufacturer, Classification Panel and ECRI Surveys; and a scheme for classifying the various types of cryosurgical devices. This report concludes by recommending which hazards and risks should be addressed by a broad class standard, referenceable standards, specific device standards, and those which cannot be addressed by standards. The rationale for these recommendations is included.