Laser and Intense Pulse Light Source Systems - Adverse Incident Reporting to the Medicines and Healthcare products Regulatory Agency (MHRA)

 Introduction

Most lasers and intense pulse light source systems and their associated equipment are classified as medical devices. A medical device is an instrument or associated accessory which is used for diagnosis and/or treatment of disease, or for monitoring patients. A fuller description of what is classified as a medical device is given in the indicated section below.

 An adverse incident is an event that causes, or where there is the potential to cause an unanticipated or unwanted situation involving patient safety, the equipment user or other people. The adverse event may be a result of a number of situations, including the device design; operating instructions; training or working practice; equipment storage; maintenance.

 When an adverse event does occur, it is important that the incident is reported immediately to the MHRA. All adverse incidents however insignificant they may appear, including user error, should be reported to the Agency. What may appear to be a minor incident to an individual user may have greater significance especially if the Agency has received similar reports from other medical establishments.

 The MHRA investigates all UK adverse incidents related to medical devices wherever the event(s) occurred i.e. in the NHS environment or the private healthcare sector.

 The MHRA

The MHRA is an Executive Agency of the Department of Health and its primary role is to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.

 The Devices section (formerly known as the Medical Devices Agency) of the MHRA is comprised of approximately 150 staff who are specialists in the following fields: medical and nursing staff, professionally qualified technologists and scientists (including microbiologists, chemists, materials scientists, engineers, toxicologists, pharmacists and physicists).

 The Devices section of the Agency undertakes two distinct roles; regulatory matters affecting medical devices and the investigation of adverse incidents related to the medical equipment.

 A Medical Device

A Medical Device is defined as an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software for it proper application, but does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in it function by such means.

The proper application, as intended by the device's manufacturer, to be used for humans beings for the purpose of:

• i. diagnosis, prevention, monitoring, treatment or alleviation of disease.
• ii. diagnosis, prevention, monitoring, treatment or alleviation of or compensation for an injury or handicap.
• iii. investigation, replacement or modification of anatomy or of a physiological process.
• iv. control of conception.

A medical device will be CE marked and will fulfil the criteria detailed in the European Medical Device Directive (93/42/EEC) to be recognised as a medical device.

Examples of Laser related Adverse Incidents

Laser and Intense Pulse Light Source (IPLS) adverse events may be the result of a number of situations encountered in the clinical environment. The examples given below are not an exhaustive list.

• Patient/user skin abrasion, including burn.
• Continuous system quality assurance failure.
• Device malfunction or mechanical failure e.g. shutter fails to open/close.
• System software error or defect.
• Laser/IPLS accessory breaks/fails.
• Operator Manual ambiguous or the provision of conflicting user information.
• Manufacturer/user equipment technical or safety issues not being resolved.

MHRA Adverse Incident Centre

Adverse events pertaining to use of a medical device are reported to the Adverse Incident Centre (Tel: 0207 972 8080) or via the on-line MHRA Adverse Incident Report Form (http://devices.mhra.gov.uk). An adverse event may be reported by any person involved in using or receiving treatment from a medical device, including NHS staff, private healthcare staff, academic and research staff or a member of the public.

Investigation of a Reported Adverse Incident

Once an adverse event is reported to the Agency, the matter is investigated and the reason for the failure will be sought. During the enquiry the investigating Responsible Officer will liase with the incident reporter, medical establishment and manufacturer in order to prevent further incidents of this nature reoccurring at the incident site or else where.

As a result of the investigation, the Responsible Officer may advise the manufacturer to change the design of the equipment, withdraw the device from clinical sites or issue a Customer Advisory Notice to all users of the equipment.

 Some investigations may highlight that the incident occurred as a result of the device being used in way that it was not intended, or the manufacturer's operating instructions were not adhered to.

 In certain instances the MHRA may issue a Medical Device Alert, which alerts users to a potential hazard involving a particular device or group of devices. The Medical Device Alert will contain specific information of the action that should be taken with regard to the device at issue.

It is important to notify the MHRA of any incident or near-incident that occurs with any medical device, including lasers, intense pulse light source systems or their associated accessories so that such an event can not occur again.

An equipment user, engineer or patient may feel that it is a "one-off" event, but other medical or academic establishments may also have similar "one-off" events, which may result be as a result of a serious system problem.

Information and Contact List

The MHRA produces a Medical Device Alert at the beginning of each year, which provides comprehensive guidance on the reporting of adverse incidents. This guidance can be found on the MHRA web-site. (http://devices.mhra.gov.uk)

If you have any questions regarding a Laser or Intense Pulse Light Source device or whether an incident should be reported to the Agency please contact one of the following people or the MHRA Adverse Incident Centre, or visit our web-site.

MHRA Laser and Intense Pulse Light Source Contacts

Mrs Mel King                             Mr Charles Apps

Medical Device Specialist           Medical Device Specialist

0207 972 8286                           0207 972 8246

MHRA Adverse Incident Centre - Devices

0207 972 8080

MHRA

Hannibal House

Elephant and Castle

London SE1 6TQ

MHRA Web Address

http://www.mhra.gov.uk

http://devices.mhra.gov.uk

http://medicines.mhra.gov.uk