DB2008(04)

This document provides guidance on some of the issues that purchasers and users may want to consider when assessing whether devices can be used in combination with other devices and equipment. The bulletin advises on what steps you can take to verify that the combination has been validated for safety, quality and performance. As no guidance can cover all possible scenarios, you should always consider whether there are additional factors that you need to take into account.

DB2008(03)

This guidance document relates to medical lasers and other types of optical radiation devices, including light emitting diodes (LEDs) and intense light/heat sources, referred to as intense pulsed light (IPL) (sources) systems in the text. Equipment used in conjunction with the optical radiation equipment, such as optical fibres, contact tips, articulated arms etc. are also reviewed.

This document reflects the changes in equipment technology and technical and safety standards that have been initiated since the last edition. It updates and replaces DB 9602 ‘Guidance on the safe use of lasers in medical and dental practice’.

DB2008 (02)

This Device Bulletin provides an overview of medical device and estates related adverse incident reports received by the Northern Ireland Adverse Incident Centre (NIAIC) and Medical Device/Equipment Alerts (MDEAs) issued by NIAIC in 2007.

This Device Bulletin provides guidance on the NIAIC’s voluntary adverse incident reporting system; encourages users to report adverse incidents involving medical devices and provides information on the dissemination of Medical Device/Equipment Alerts.

DB 2006(06)

This document is aimed at healthcare professionals. It updates and replaces our previous guidance provided in DB(NI)2001/04 'Advice on the Safe Use of Bed Rails'.

Managing Medical Devices

This Device Bulletin updates and replaces previous guidelines published in DB 9904(NI)

‘Medical device and equipment management for hospital and community-based organisations’  (including supplement 1 'Checks and tests for newly-delivered medical devices'and supplement 2 'Guidance on the sale, transfer of  ownership and disposal of used medical devices') and also DB 2000(02) ‘Medical devices and equipment management: repair and maintenance provision’.

A revised edition of DB 2000(04). Guidance for healthcare professionals

The purpose of this device bulletin is to provide information and guidance to all Involved with the purchase, management and use of non-invasive blood pressure measurement devices. This document replaces DB2000(03) Blood Pressure Measurement Devices - Mercury and Non-mercury.

This Device Bulletin provides an overview of medical device/equipment related adverse incident reports received by the Northern Ireland Adverse Incident Centre (NIAIC) in 2005, and records recent developments in adverse incident reporting.

DB Not Published in Northern Ireland - available on the MHRA's Website (Northern Ireland - NIAIC guidance on incident reporting please see MDEA(NI)2006/01  (PDF 81 KB))

This Device Bulletin provides guidance on our voluntary adverse incident reporting system, encourages users to report adverse incidents involving medical devices and provides information on the dissemination of medical Device Alerts.

Guidance on the safe and effective use of batteries and chargers for medical devices

This Device Bulletin has been prepared in consultation with a wide range of stakeholders to give general guidance to users, carers, health services, healthcare professionals, manufacturers and others involved in the provision, use and maintenance of medical devices and equipment with a battery.

This Device Bulletin provides an overview of medical device related adverse incident reports received by the MHRA in 2004, and records recent developments in adverse incident reporting

(Northern Ireland - for NIAIC guidance on incident reporting please see MDEA(NI)2005/01)  (PDF 217 KB)

This Device Bulletin provides guidance on our voluntary adverse incident reporting system, encourages users to report adverse incidents involving medical devices and provides information on the dissemination of medical Device Alerts.

GUIDANCE ON THE STABILITY OF WHEELCHAIRS

This document identifies a wide variety of issues affecting wheelchair stability and gives guidance on reducing or removing the risks whilst trying to maintain independent mobility for an individual wheelchair user.

ADVERSE INCIDENT REPORTS 2003

This Device Bulletin includes: a review of the MHRA year's activities in the product areas covered by each of MHRA technical sections; information on how to report adverse incidents; a digest of the year's statistics, a summary of MHRA customer surveys and a current MHRA publication list.

COMMUNITY EQUIPMENT LOAN STORE GUIDANCE ON DECONTAMINATION

This Device Bulletin is aimed specifically at community equipment loan stores. It provides generic guidance on the handling and decontamination of loan equipment.

MANAGEMENT OF MEDICAL DEVICES PRIOR TO REPAIR, SERVICE OR INVESTIGATION

This device bulletin provides advice on setting up safe systems of work and outlines the various legal requirements associated with decontamination activities. It should be consulted as part of the process of establishing a decontamination regimen.

THE SAFE USE OF AMBULANCE STRETCHER TROLLEYS

This document is intended to raise awareness amongst all those involved in the selection, purchase, use, inspection, maintenance and repair of ambulance stretcher trolleys, with a view to reducing the number of adverse incidents involving these devices.

GUIDANCE ON THE SAFE USE OF WHEELCHAIRS AND VEHICLE MOUNTED PASSENGER LIFTS

This document is intended to provide guidance to service providers, users and healthcare professionals involved in the provision and use of wheelchairs or transport services.

INFUSION SYSTEMS

This publication replaces MDA DB9503 'Infusion Systems', and MDA DB9703 'Selection and Use of Infusion Devices for Ambulatory Applications'.

ADVERSE INCIDENT REPORTS 2002

This Device Bulletin includes: a review of the MHRA year's activities in the product areas covered by each of MHRA technical sections; information on how to report adverse incidents; a digest of the year's statistics, a summary of MHRA customer surveys and a current MHRA publication list.

This is a revised compilation of the guidance previously issued in DB9605 and DB2002/05(NI)

This revised and updated Device Bulletin Replaces Device Bulletin DB 9670 "Decontamination of Endoscopes". The areas of particular concern addressed in this Bulletin include:

Types of agent that present an infection risk.

Guidance on reprocessing various types of endoscope.

Guidance on the use of disinfectants.

This Device Bulletin includes guidance previously issued by the Northern Ireland Defect & Investigation Centre, HPSS Management Executive, now known as the Northern Ireland Adverse Incident Centre (NIAIC).It provides a convenient source for all the warning notices relating to medical devices issued during 1996, which are still in force.

The aim of this bulletin is to provide advice and guidance on the management and use of point of care testing (POCT) in vitro diagnostics devices (IVDs). It is written for people involved in the management and use of point of care testing (POCT) services in primary and secondary care including managerial, scientific, technical, clinical and nursing staff. While many of the issues addressed are more relevant to the performance of POCT in a hospital environment, the principles are equally applicable to their use in outpatient clinics, community care and GP practices.

The Northern Ireland Adverse Incident Centre (NIAIC) and the Medical Devices Agency (MDA) has produced this bulletin to address issues in the management of in vitro diagnostic medical devices (IVDs). It builds on and provides additional information to the NIAIC publication DB 9904 (NI) 'Medical device equipment management for hospital and community-based organisations', but can also be used as a stand-alone document

This Device Bulletin includes:

A Review of the years activities in relation to Adverse Incident Reports;

A digest of the years statistics for NIAIC and the Medical Devices Agency;

A current list of warning notices issued.

Advice on the Safe Use of Bed Rails  (PDF 111 KB)

This Device Bulletin :-

highlights the potential dangers associated with the use of bed rails;

draws attention to the need for full risk assessment (and regular re-assessment) of the suitability of the bed rail;

highlights the importance of regular maintenance;

provides general guidance for reducing the risk of entrapment;

identifies other literature which may be useful for background information or reference material when assessing the potential risk of entrapment;

provides information which can be used to develop local policy to ensure the safe use of bed rails;

comments on the use of bed rails in relation to the Medical Devices Regulations 1994, SI 3017.

This Device Bulletin aims to :-

provide sufficient information for health services and healthcare professionals to assist wheelchair users, prescribers and transport providers in making informed decisions;

enable users seated in wheelchairs to travel as safe as is practicable in public, local authority, private or voluntary sector vehicles;

provide guidance for the transportation of unoccupied wheelchairs.

This Device Bulletin includes guidance previously issued by the Northern Ireland Defect & Investigation Centre, HPSS Management Executive, now known as the Northern Ireland Adverse Incident Centre (NIAIC).It provides a convenient source for all the warning notices relating to medical devices issued during 1995, which are still in force.

It is intended as:-

A reference work;

A source for training;

A checklist for risk managers.

Reviews adverse incidents reported in 2000

EQUIPPED TO CARE: THE SAFE USE OF MEDCIAL DEVICES IN THE 21ST CENTURY (PDF 117 KB)

Intended to help professionals understand their role in the safe use, purchase and management of medical devices; provide managers with pointers to best practice for training, purchase and maintenance of medical devices; ensure that arrangements for the purchase, use and maintenance of medical devices are firmly embedded within the local framework for clinical governance.

Provides guidance on the purchase, operation and maintenance of benchtop steam sterilizers that have a forced air removal system to provide Type B or Type S sterilization cycles. These sterilizers are marketed as vacuum benchtop steam sterilizers or porous load benchtop steam sterilizers. Sterilizers with Type N cycles (the traditional benchtop steam sterilizer) are covered in Device Bulletin DB9605 (NI)1 and are not referred to in detail in this publication.

Replaces the earlier bulletin "The Reuse of Medical Devices Supplied for Single-Use Only", issued in 1995 (DB 9501 ((NI)).

Provides information and guidance to all involved with the use, purchase and management of non-invasive blood pressure measurement devices.

Builds on and provides additional guidance to that contained within Device Bulletin DB 9904(NI), but can be used as a stand-alone document. The guidance contained in the Bulletin covers the management of the repair and maintenance process, and sets out good practice for the organisation that carries it out.

GUIDANCE ON THE SALE, TRANSFER OF OWNERSHIP AND DISPOSAL OF USED MEDICAL DEVICES  (PDF 89 KB)

Supplement to “Medical Device and Equipment Management for Hospital and Community-Based Organisations (DB 9904 (NI)

CHECKS AND TESTS FOR NEWLY DELIVERED MEDICAL DEVICES  (PDF 108 KB)

Replaces HEI 95 "Code of practice for acceptance testing of medical electrical equipment", which is now withdrawn, and extends the scope of pre-first-use checks and tests to non-electrical medical devices;

Is a supplement to DB 9904 (NI) "Medical devices and equipment management for hospital and community-based organisations. The bulletin is self contained and can be used as a stand-alone document.

MEDICAL DEVICE AND EQUIPMENT MANAGEMENT FOR HOSPITAL AND COMMUNITY-BASED ORGANISATIONS

Training and maintenance are the two factors with the greatest impact on the safe use of medical devices. User knowledge and skills have major implications for safety. Both generic and specific training is needed. Planned Preventive Maintenance following manufacturer's guidance helps insure devices are safe and reliable.

WHEELCHAIR AND VEHICLE PASSENGER LIFTS:

SAFE WORKING PRACTICES