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quarta-feira, 22 de julho de 2015

Incident – Orthopedic Implant “out-of-date” applied to the patient

Brief description of the incident:

On July 2015, Hospital X receives a box of implant material "counter-consumption", that is, the hospital only pay the material consumed.
The box with the material was delivered by a competent company, which has certified "quality".
During a surgical intervention the implant material was applied to the patient.
After surgery, implant data is sent to the provisioning service to be introduced into the system for later payment.
The supply system does not allow the introduction of the material data, stating that this material would be " out-of-date ".

  1. Application of “out-of-date” implant material to the patient (several clinical implications).
  2. Lack of written confirmation, by the company, regarding the conformity of delivered medical devices, in particular the compliance with the terms of validity.
  3. Lack of internal procedures in the institution/user service to allow for the validation compliance of incoming medical devices.

Possible corrective measures to be implemented:
  • Full disclosure to the patient. State "what will be his the future clinical monitoring plan, what can be made in his case and what corrective measures the hospital is developing to prevent the occurrence of a similar incident in the future .
  • Inform the company that provided the medical device and request the development of a corrective plan for the future.
  • Review any internal control procedure of this implant material and develop control measures/internal verification in order to confirm the quality of the material to be used.
    • Test the proposed measures and correct as needed.
  • Inform (removing the identity of everyone involved) all companies that provide identically material, requesting information on the quality mechanisms and implemented security, and forcing the length of the internal security measures which have subsequently been developed.
  • Notify the national authorities of the incident and of the corrective measures implemented.
  • Report the incident on your national incident reporting system.

In your opinion, what other corrective measures can be implemented?

Let your opinion in the comments section. Thank You

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