The Committee for Hygiene, Construction and Technology has compiled a new recommendation on environmental conditions and their control in Reprocessing Units for Medical Devices. The aim of this publication is to present information on the state of the art and experience with respect to hospital hygiene, microbiology and audits. This information lays the groundwork for the formulation of requirements for the environmental conditions and their control and for bringing the current publication into line with the state of the art.
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.
Often, there is a need for external persons to work in the Reprocessing Unit for Medical Devices (RUMED); such tasks include technical activities, training, inspections, audits and reference visits.
With this recommendation the Quality Task Group aims to create awareness of the role of “external persons” with regard to occupational health and safety and hygiene.
With this recommendation the Quality Task Group aims to create awareness of the role of “external persons” with regard to occupational health and safety and hygiene.
Requirements for Construction or Reconstruction of a Reprocessing Unit for Medical Devices (RUMED)
Part 11: Heating, ventilation and air conditioning (HVAC) system in a RUMED
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.
Part 11: Heating, ventilation and air conditioning (HVAC) system in a RUMED
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.
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: Heating, ventilation and air conditioning (HVAC) system in a RUMED
Recommendation from Steri-World 06/2018.
Recommendations by the quality task group (108 – update)
Recommendations by the quality task group (108 – update)
The information provided by the manufacturer serves as THE BASIS FOR PROCESSING
each and every medical device (MD) and makes stringent demands on
the organizational skills of a Reprocessing Unit for Medical Devices (RUMED) [1]
with regard to the practicability and implementation of such processing measures.
The revision of EN ISO 17664:2017 is an opportune moment to examine the
changes made to the standard as well as their implications for everyday practice.
This present publication also updates Recommendation 46 of the Quality Task
Group.
each and every medical device (MD) and makes stringent demands on
the organizational skills of a Reprocessing Unit for Medical Devices (RUMED) [1]
with regard to the practicability and implementation of such processing measures.
The revision of EN ISO 17664:2017 is an opportune moment to examine the
changes made to the standard as well as their implications for everyday practice.
This present publication also updates Recommendation 46 of the Quality Task
Group.