The term "medical device" covers a wide range of products used everyday in health and social care settings.

Devices include items such as needles, syringes, infusion pumps, endoscopes, examination gloves, dressings, walking sticks and blood glucose meters.

In other words, any instrument, apparatus, appliance, material or health care product, excluding medicines, used for, or by a user for:

Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, or alleviation of, or compensation for, an injury or impairment
Investigation, replacement or modification of the anatomy or of a physiological process
Control of conception

Medical devices used for the diagnosis or treatment of disease, or for monitoring of patients, such as X-ray systems, ultrasound imagers and CT/MRI scanners
Powered and unpowered surgical implants (e.g. implantable defibrillators, Pacemakers, heart valves, orthopaedic prostheses, bone cements)
Patient monitoring equipment (e.g. cardiac monitors)
Examination gloves
Catheters (e.g. urinary, cardiac)
Surgical instruments and equipment
Medical devices used for critical care, such as ventilators and defibrillators
Medical devices used for the care of disabled people, such as wheelchairs, special support seating, and orthotic and prosthetic appliances
Patient hoists

What is not a medical device?

Medical devices do not include general workshop equipment such as power or machine tools, or general purpose laboratory equipment. Drug inhalers, pre-filled syringes and certain other medicine/device combinations also fall into this category.

Defect reporting/Investigation

An adverse incident is an event which causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, clients, staff, or other persons. Every Health & Personal Social Services employee has a duty to see that all safety related incidents and potentially harmful products are reported, even on suspicion. For example, adverse incidents may arise due to:

• shortcomings in the design or manufacture of the medical device, non-medical equipment, plant or building item

• inadequate instructions for use

• inadequate servicing and maintenance

• locally initiated modifications or adjustments

• inappropriate user practices

• inadequate training/induction

• inappropriate management procedures

• the environment in which it is used or stored

• selection of the incorrect type of device for the purpose

• environmental conditions (e.g. electromagnetic interference)

• location (e.g. devices designed for hospitals may not be suitable for use in ambulances).

Procedure for reporting equipment failures & problems

Any failure of equipment, which is not related to wear and tear, should be reported directly to the Clinical Governance Department. This includes equipment which has caused injury or had the potential to cause injury to staff, patients or others. The following steps should be followed when an equipment failure occurs:

Take the device out of action and mark it ‘Do Not Use’.

Complete an Accident/Incident/Near Miss (AINM) form and forward to the Clinical Governance Department. Remember to complete all parts of the form including the model name, serial/batch number, & CE marking. Describe fully and accurately the nature of the fault and any actions taken to correct it.

Inform the Clinical Governance Department immediately by telephone if the equipment failure had a direct impact on patient care.

Decontaminate any device which can be decontaminated without destroying the evidence (see Control of Infection Policy), and obtain a certificate to that effect.

Wrap any devices which cannot be decontaminated in two clinical waste bags and label them clearly stating – date of incident, number of incident/accident/near miss form, whether or not the equipment is decontaminated and a description of the contents.

Put a sign on any equipment which is too big to move stating ‘Do not use’, label it with the date of reporting and the AINM form number.

Arrange for either the Clinical Governance Department to collect the equipment or for the porters to bring the equipment over to the Clinical Governance Department.

Once the equipment failure has been reported to the Clinical Governance Department, specific information regarding the equipment may be requested from the Head of Department, if not addressed by the AINM form.

The Medical Devices Co-ordinator will use this information to complete a NIAIC (Northern Ireland Accident Incident Centre) form. If the incident was a serious one or could have had serious consequences, they will liase directly with NIAIC to arrange for a NIAIC engineer to accompany a representative from the Trust to examine the equipment. Where appropriate this visit will include a representative from the manufacturer of the equipment.

For less serious incidents NIAIC will either collect the smaller pieces of equipment or we will post the equipment to them if it has been decontaminated. Larger pieces of equipment may be photographed by NIAIC.

Once NIAIC has investigated the incident, a report is sent to the Medical Devices Co-ordinator who will then relay the information to the individual who reported the equipment failure initially. This may take some time.

Unique circumstances may arise where staff need to deviate from this procedure, for example where clinical staff may need to re-use large pieces of equipment urgently once NIAIC has given the go ahead to have it repaired. If this is the case it is important to inform the Clinical Governance Department of the equipment failure immediately by telephone to discuss realistic time scales; allowing the Medical Devices Coordinator to liase directly with NIAIC to make the necessary arrangements for further investigation.

Further information can be found in NIAIC notice SN(NI) 2003/01, Reporting Adverse Incidents, available online at NIAIC or from the Clinical Governance library in McKinney House.

If anyone has any queries please do not hesitate to contact Patrick Keenan, acting Clinical Risk Manager, mph 2546 or Eugene Doherty, Medical Devices Coordinator, mph 2327 for more information.

Remember to report all incidents and save evidence when and where ever possible as this is the only way to identify trends and highlight hazards.

NIAIC Issue Guidance Publications

Anyone accessing this information must bear in mind that this information is directed at health and social care professionals and has been prepared taking into account the specialist knowledge of these intended recipients. Members of the public should contact their GP or other health advisor if the content of a notice causes personal concern.

Medical Devices

What is a medical device?

What is not a medical device?

Defect reporting/Investigation

Procedure for reporting equipment failures & problems

NIAIC Issue Guidance Publications

Contact Details