Doc menu

Section I

Incident Reporting

 

 

a) IRR99 Incidents and Inspections

Regulation 25 requires the Employer to make an immediate investigation in the event that an overexposure to persons (staff, comforters or carers, and members of the public) has been suspected.  The investigative reports should be made available to the local radiation safety committee and be kept for at least two years. In the event of a confirmed overexposure, a notification of the radiation incident must be made to the relevant Inspector of the Health & Safety Executive (HSE) (see http://www.hse.gov.uk/radiation/ionising/) and reports should be made via this e-mail link notification.for.ionising.radiation@hse.gsi.gov.uk

In addition, concerning radiation equipment, Regulation 32(6) states: “Where a radiation Employer suspects or has been informed that an incident may have occurred in which a person while undergoing a medical exposure was, as the result of a malfunction of, or defect in, radiation equipment under the control of that Employer, exposed to ionising radiation to an extent much greater than that intended, he shall make an immediate investigation of the suspected incident”

Such incidents are normally of a complex nature and the RPA must be involved before a report is notified to HSE.
Confirmed over-exposures due to equipment malfunction or defect must be immediately reported to the relevant Inspector at HSE – over-exposures due to human error should not be reported to HSE but rather to another appropriate authority (see IR(ME)R). An IRR’99 investigation under Regulation 32(6) is not formally required if the malfunction or defect results in exposures less than intended but it is good practice for the Employer to investigate such circumstances also.

Following an investigation into the suspected over-exposure incident due to equipment malfunction or defect the Employer must keep the immediate report for a period of at least two years from the date it was made.  Records of detailed investigations must be kept for a period of at least 50 years (Regulation 32(7a,b). 

Further information is available from sections 40 - 66 of the HSE guidance for notification of incidents involving radiation equipment entitled “Guidance Note PM77 (Third edition) Equipment used in connection with medical exposure (HSE, 2006)”.
This Guidance Note contains advice on compliance with IRR’99, for Employers who have control of equipment used in connection with medical exposure to ionising radiation. The Guidance Note supplements the advice in L121 (HSE, 2000).

Health & Safety Executive (HSE) Inspections
A HSE Inspector will check:

  • That the Employer has established a suitable QA programme
  • That clearly established QA tests exist
  • That action levels are clearly defined
  • That staff responsibilities are clearly defined
  • That records of procedures, results and any actions taken are kept

The standard used by the HSE Inspectors is IPEM Report 91 available at ipem.ac.uk/publications/ipemreports/Pages/default.aspx

b) Employers Guidance - Joint HSE and DH guidance.
The regulatory requirements for medical exposure to ionising radiation: an Employers overview: (ISBN 0 7176 2134 0 Reference HSG223 HSE Books). This guidance is particularly useful for Trust / Health Board Chief Executives as it provides an explanation of the responsibilities of Employers under ionising radiation protection regulations on how to manage the use of radiation in the workplace.

c) Medicines & Healthcare products Regulatory Agency
It is good practice to ensure that comprehensive and effective systems are in place for the reporting of medical device related adverse incidents to the Medicines & Healthcare products Regulatory Agency (MHRA), and that these systems are regularly reviewed and maintained. This would include instances where a near miss arises from equipment malfunction. In addition, the adverse incident reporting process for medical devices should be followed, managed by the Medicines and Healthcare products Regulatory Agency.

The following are examples of recent MHRA Medical Device Alerts:
i)    Medical Device Alert (MDA/2009/014) – regarding the report of an x-ray tube head falling onto an x-ray table. See
http://webarchive.nationalarchives.gov.uk/20141205150130/http://www.mhra...
ii)    Medical Device Alert (MDA/2008/001) – regarding the under-reporting of adverse incidents involving medical devices. See
http://webarchive.nationalarchives.gov.uk/20141205150130/http://www.mhra...

d) Devolved Administrations

In Scotland, the Incident Reporting & Investigation Centre (IRIC) co-ordinates the investigation of adverse incidents on behalf of the Scottish Government Health Directorates (SGHD.) IRIC maintains close links with MHRA and SGHD. See
http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-invest...
 Adverse incidents may be reported via http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-invest...

In Northern Ireland, guidance for reporting adverse incidents is contained in the
Northern Ireland Adverse Incident Centre (NIAIC) - http://www.dhsspsni.gov.uk/index/hea/niaic.htm
Reporting Adverse Incidents information is available at: http://www.dhsspsni.gov.uk/index/hea/niaic/niaic_reporting_incidents.htm

In Wales, guidance for reporting adverse incidents is contained in Welsh Health Circular 1997 (28). This is only downloadable from an NHS Wales intranet site.

Content tools

Accessibility controls

Text size

AA A

Colour