Medical Devices, Medical Equipment and Decontamination

Medical Devices, Medical Equipment and Decontamination

There is effective deployment, monitoring, control, maintenance and decontamination of medical devices, instruments and medical equipment used throughout the organisation, with relevant staff training and regular updates.

This standard includes the following:

• Management
• Procurement
• Safety, maintenance and quality assurance
• Active Implantable Medical Devices (AIMD)
• Decontamination
• Decontamination – on-site sterile services department

The CHKS Standards criteria address these elements of medical devices, medical equipment and decontamination through succinct criteria statements that are supported by guidance which helps the organisation understand the intent of the criteria, so that it can be applied in the local context.

Additionally, references are provided to direct further reading on the relevant topic.

Throughout the standards, the criteria are linked to key assessment frameworks including ISO 9001, the Care Quality Commission, Quality Statements, and the Health Information and Quality Authority (Ireland) National Standards.