The introduction of a new sterile barrier system (SBS) constitutes a significant change to the instrumentation circuit. The Quality Task Group has compiled a recommendation to support this process.
In an efficient quality management system processes must be monitored. The process monitoring measures must be planned and the outcomes documented. In that way discrepancies can be recognized at an early stage and remedial action taken.
Part 10 of the publication Requirements for Construction or Reconstruction of a Reprocessing Unit for Medical Devices (RUMED) focuses on compressed air for medical use, generally known simply as medical compressed air.
Part 11 of the publication series “Requirements for Construction or Reconstruction of a Reprocessing Unit for Medical Devices (RUMED)” focuses on the heating, ventilation and air conditioning (HVAC) system in a RUMED.