Device Bulletins

Device Bulletins are issued by the MHRA. Device Bulletins contain guidance and information on medical devices of a more general management interest. They are written as a result of experience gained from adverse incident investigations, contacts with manufacturers and users, and other sources of information.
Device Bulletins must be issued to all staff with responsibility for training, for setting organisational policies for equipment management and any other relevant staff.
For current Device bulletins please click on the following link to the MHRA website.
NIAIC continues to publish a NI version of device bulletin DB2010(01) providing information on reporting adverse incidents and disseminating alerts for HSC in Northern Ireland
This device bulletin is available here DB2010(NI)-01 (PDF 77KB)

Device Bulletins - 2014

Number Issue
Date
Title
April 2014
This Device Bulletin updates and supercedes -
DB2006(05) published in November 2006 and
DB2005(03) published in October 2005
The purpose of this document is to outline a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices and medical device training. It is intended primarily for people in hospital and community based organisations that are responsible for the management of reusable medical devices, to help them set up and develop systems that promote the use of the medical devices for safe and effective health care.
20 Feb 2014
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. Revised January 2014

Device Bulletins - 2012

Number Issue
Date
Title
DB2006(06)v2.0
November 2012
This Device Bulletin replaces and updates DB2006(06) published in December 2006.
This document provides updated guidance to take into account changes in devices and practices, as well as information gained from the investigation of adverse incidents.
DB2006(03)v2
September 2012
This Alert replaces and updates DB2006(03) first published in July 2006.The measurement of blood pressure is important in the diagnosis and monitoring of a wide range of clinical conditions. In this document we review the advantages and disadvantages of mercury, aneroid, electronic manual sphygmomanometers and automated blood pressure measuring devices. This should help to ensure the most appropriate technology is selected for use.

Device Bulletins - 2011

Number Issue
Date
Title
DB2011(01)
Feb 2010

Device Bulletins - 2010

Number Issue
Date
Title
DB2010(02)
10 Feb 2010
DB2010(01)
9 Feb 2010
DOCUMENT HAS BEEN REVISED AND RE-PUBLISHED IN 2014

Device Bulletins - 2009

Number Issue
Date
Title
DB2009(01)
June 09

Device Bulletins - 2008

Number Issue
Date
Title
DB2008(04)
September 08
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)
April 08
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)
May 08
DB 2008 (01)
April 2008

Device Bulletins - 2006

Number Issue
Date
Title
DB 2006(06)
December 2006
THIS DOCUMENT HAS BEEN REPLACED BY DB2006(06)v2
DB 2006(05)
November 2006
This document has been replaced by DB(NI)2014-02 published April 2014
DB2006(04)
October 2006
A revised edition of DB 2000(04). Guidance for healthcare professionals
DB2006(03)
July 2006
THIS DOCUMENT HAS BEEN REPLACED BY DB2006(03)v2
DB2006(01)
NA

Device Bulletins - 2005

Number Issue
Date
Title
DB2005(03)31
Oct 2005
This document has been replaced by DB(NI)2014-02 published April 2014
DB2005(01)
NA

Device Bulletins - 2004

Number Issue
Date
Title
DB2004(02)
NA
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.

Device Bulletins - 2003

Number Issue
Date
Title
DB2003(06)
NA
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.
DB2003(05)
NA
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.
DB2003(04)
NA
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.
DB2003(03)
NA
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.
DB2003(02)
NA
Infusion Systems
This publication replaces MDA DB9503 'Infusion Systems', and MDA DB9703 'Selection and Use of Infusion Devices for Ambulatory Applications'.

Device Bulletins - 2002

Number Issue
Date
Title
DN(NI)2002/06
May-2003
This is a revised compilation of the guidance previously issued in DB9605 and DB2002/05(NI)
DN(NI)2002/05
03-Dec-02
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.
DB(NI)2002/03
28-Jun-02
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.
DB(NI)2002/02
28-Jun-02
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

Device Bulletins - 2001

Number Issue
Date
Title
DB (NI) 2001/04
26-Nov-01
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.
DB (NI) 2001/03
17-Dec-01
Guidance on the Safe Transportation of Wheelchairs (PDF 84 KB)
FOLLOWING A REIVEW THIS PUBLICATION HAS BEEN ARCHIVED BY MHRA

Device Bulletins - 2000

Number Issue
Date
Title
DB 2000/06 (NI)
1-May-01
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.
DB 2000/05 (NI)
16-May-01
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.
DB 2000/04 (NI)
07-Nov-00
Replaces the earlier bulletin "The Reuse of Medical Devices Supplied for Single-Use Only", issued in 1995 (DB 9501 ((NI)).
DB 2000/03 (NI)
07-Nov-00
Provides information and guidance to all involved with the use, purchase and management of non-invasive blood pressure measurement devices.
DB 2000/02 (NI)
07-Nov-00
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.

Device Bulletins - 1999

Number Issue
Date
Title
DB 9904 (NI) Supp 2
30-Apr-02
Supplement to “Medical Device and Equipment Management for Hospital and Community-Based Organisations (DB 9904 (NI)
DB 9904 (NI) Supp 1
14-May-01
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.
DB 9904 (NI)
07-Oct-99
Medcial 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.
DB 9903 (NI)
20-Jul-99
Emergency Service Radios & Mobile Data Terminals: Compatibility Problems with Medical Devices
DB 9902 (NI)
20-Jul-99
The Safe & Effective Use of Batteries for Medical Devices
DB 9901 (NI)
17-Feb-99
The Validation and Periodic Testing of Benchtop Vacuum Steam Sterilizers

Device Bulletins - 1998

Number Issue
Date
Title
DB 9803 (NI)
21-Jul-98
MRI Static Magnetic Field Safety Considerations - The Projectile Effect Caused by the Influence of the Static Magnetic Field

Device Bulletins - 1997

Number Issue
Date
Title
DB 9703 (NI)
03-Jul-97
Selection and Use of Infusion Devices for Ambulatory Applications
DB 9702 (NI)
20-Jun-97
Electromagnetic Compatibility of Medical Devices with Mobile Communications
DB 9701(NI)
14-Apr-97
Adverse Incident Reports 1996

Device Bulletins - 1996

Number Issue
Date
Title
DB 9607 (NI)
14-Mar-97
Decontamination of Endoscopes
DB 9606 (NI)
22-Nov-96
Wheelchair and Vehicle Passenger Lifts:
Safe Working Practices
DB 9605 (NI)
14-Mar-97
The Purchase, Operation and Maintenance of Benchtop Stem Sterilizers

Device Bulletins - 1995

Number Issue
Date
Title
DB 9505 (NI)
22-Mar-96
Symbols Used on Medical Devices and Their Packaging
DB 9504 (NI)
02-Apr-96
The Management of Infusion Systems
DB 9503 (NI)
25-Mar-96
Infusion Systems
DB 9502 (NI)
22-Mar-96
Product Approval Scheme for Sterile Single Use Plastics Administration Sets and Air Inlet Assemblies
DB 9501 (NI)
22-Mar-96
The Reuse of Medical Devices Supplied for Single Use Only
Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates Investment Group (HEIG)
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