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 monitoringThe 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 trainingTraining for professional usersTraining for end usersTraining for repair and maintenance

service providersDocumentation

Instructions

The importance of effective instructions

Instructions for the end user

Documentation

Maintenance and repair

Policies

Choosing a service

Contracts

Training

Spare partsBreakdowns

Decontamination

Check before purchase

Correct procedure

When to decontaminate

Decommissioning and disposal

Planning for replacement

Decommissioning

DisposalSale or donation for reuse

Batteries

• Battery Maintenance• Power sources

Any questions?