Managing Medical Devices Catriona Blake Team Manager: Imaging, acute and community care.
Background Guidance on managing medical devices was first issued in –January 1982 (HEI 98), amended Aug 1984 Revisions: –DB9801, supplements 1&2 –DB2006(05)
Managing Medical Devices Issued April 2014 Wide ranging external consultation No document number – version control Minor amendments annually Main changes: –Includes aspects from DB on battery management and Clinical investigations –Shorter, merged chapter on appropriate selection –Updated examples
Contents –Systems of management –Appropriate equipment and selection of devices –Receiving a new device –Clinical investigations… –Training –Instructions for use –Maintenance and repair –Decontamination –Decomissioning and disposal of devices
Systems of management Management responsibility and policies Device management procedure Records Deployment Monitoring and audit
Appropriate acquisition and selection of devices Acquisition policies Methods of acquisition Factors to consider before acquisition Rationalisation
Appropriate acquisition and selection of devices (2) Modifying and changing use Safety performance Installation & Maintenance Documentation and monitoring The acquisition cycle
Clinical Investigations Included in policy Ethics & MHRA approved? Informed consent Decontamination
Receiving a new device Acceptance checks Special considerations Legal requirement for electrical safety testing
Training Policy on training Training for professional users Training for end users Training for repair and maintenance service providers Documentation
Instructions The importance of effective instructions Instructions for the end user Documentation
Maintenance and repair Policies Choosing a service Contracts Training Spare parts Breakdowns
Decontamination Check before purchase Correct procedure When to decontaminate
Decommissioning and disposal Planning for replacement Decommissioning Disposal Sale or donation for reuse
Batteries Battery Maintenance Power sources
Any questions?