General Hospital Dr. Manuel Gea González is a specialty public hospital located in Mexico City. Currently, the General Management of the Hospital is interested in implementing the Post Market Surveillance Unit to minimize adverse incidents related to the use of medical devices. Therefore, the objective of this work was to develop post market surveillance procedures to systematize actions to report and follow up on adverse incidents due to the use of medical devices. Three standardized post market surveillance operating procedures were developed: (1) Collection of incident information; (2) Evaluation of information and notification of adverse incidents; and (3) Monitoring of notifications of adverse incidents. In a pilot test, a sample of 147 nurses (34%) was trained, which means that 55 medical services (93%) have at least one nurse authorized to report adverse incidents due to the use of medical equipment.

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Post Market Surveillance Standardized Operative Procedures for a High Specialty Hospital in Mexico

  • Daniel A. Manzano-Soto,
  • M. Ximena Ruíz-Y-García,
  • Martha R. Ortiz-Posadas

摘要

General Hospital Dr. Manuel Gea González is a specialty public hospital located in Mexico City. Currently, the General Management of the Hospital is interested in implementing the Post Market Surveillance Unit to minimize adverse incidents related to the use of medical devices. Therefore, the objective of this work was to develop post market surveillance procedures to systematize actions to report and follow up on adverse incidents due to the use of medical devices. Three standardized post market surveillance operating procedures were developed: (1) Collection of incident information; (2) Evaluation of information and notification of adverse incidents; and (3) Monitoring of notifications of adverse incidents. In a pilot test, a sample of 147 nurses (34%) was trained, which means that 55 medical services (93%) have at least one nurse authorized to report adverse incidents due to the use of medical equipment.