3.256.
Paragraph 3.179 of GSR Part 3 [3] states that:
“Registrants and licensees…shall ensure that all practicable measures are taken to minimize the likelihood of unintended or accidental medical exposures arising from flaws in design and operational failures of medical radiological equipment, from failures of and errors in software, or as a result of human error.”
Paragraph 3.180 of GSR Part 3 [3] requires that the registrants and licensees promptly investigate if such exposures occur. General strategies for addressing those problems include the regular maintenance of medical radiological equipment and software, a comprehensive programme of quality assurance, continuing education and training of staff, and the promotion of a safety culture. Lessons identified from events that have occurred should be used for preventing or minimizing unintended and accidental medical exposures, as described in para. 3.266.
3.257.
Minimization of the likelihood of unintended or accidental medical exposures in diagnostic radiology and image guided interventional procedures can be brought about by:
The introduction of safety barriers at identified critical points in the process, with specific quality control checks at these points. Quality control should not be confined to physical tests or checks but can include actions such as the correct identification of the patient.
Actively encouraging a culture of always working with awareness and alertness.
Providing detailed protocols and procedures for each process.
Providing sufficient staff who are educated and trained to the appropriate level, and an effective organization, ensuring reasonable patient throughput.
Continuous professional development and practical training and training in applications for all staff involved in providing radiology services.
Clear definitions of the roles, responsibilities and functions of staff in the radiology facility that are understood by all staff.
3.258.
Preventive measures should include reporting of incidents and near incidents, analysis and feedback, including lessons from international experience [123]. Preventive measures should also include checking of the robustness of the safety system of the facility against reported incidents (see Ref. [123] for a review of case histories from a collection of unintended and accidental medical exposures in image guided interventional procedures).
3.259.
In addition to the guidance in paras 3.256–3.258, the following three-step strategy (commonly called ‘prospective risk management’) can help to prevent unintended and accidental medical exposures in a radiology facility:
Allocation of responsibilities to appropriately qualified health professionals only and ensuring that a management system is in place that includes radiation protection and safety;
Use of the lessons from unintended and accidental medical exposures to test whether the management system, including for radiation protection and safety, is robust enough against these types of event;
Identification of other latent risks by posing the questions ‘What else could go wrong?’ or ‘What other potential hazards might be present?’ in a systematic, anticipative manner for all steps in the diagnostic and image guided interventional radiology process.