Background/introduction
Quality assurance (QA) of radiological equipment is mandatory and regulated by national radiation safety legislation from,
e.g.,
the Swedish Radiation Safety Authority (SSM).1 Traditional tasks for medical physicists have therefore included annual and post-maintenance quality control (QC) as part of a healthcare provider QA-program for radiological equipment.
The terms QA and QC are both associated with requirements on a Quality Management System (QMS).2 While QA relates to how a process is performed or how a product is made,
QC covers the inspection aspect of quality...
Description of activity and work performed
To reach the targeted objectives,
the task group decided to modernise the existing QC-methods,
where medical physicists perform manual tests of radiological equipment.
Possible sources of error were derived from existing post-maintenance QC-results and known deviations of radiological equipment performance.
The most probable source causing deviation in equipment performance was found to be improper maintenance,
i.e.
maintenance not executed according to manufacturer specifications.
Over time,
radiological systems have become more robust and reliable,
which is a reason why modern equipment rarely,
if ever,
spontaneously yields...
Conclusion and recommendations
A comprehensive QA-program for radiological equipment has been developed in the County of Västerbotten,
Sweden.
The QA-program,
implemented in a Quality Management System,
is based on collaboration between healthcare providers,
manufacturers of radiological equipment and the Swedish Radiation Safety Authority.
Traditional QC-tests performed by medical physicists have been replaced by validating and employing manufacturer QC-methods,
which are mandatory as part of preventive and corrective maintenance work.
Results from manufacturer QC-tests,
in the form of service reports,
are evaluated and stored in an inventory system (Maximo,...
Personal/organisational information
Department of Radiation Sciences,
Umeå University,
SE-901 85,
Umeå,
Sweden
References
1.
The Swedish Radiation Safety Authority,
https://www.stralsakerhetsmyndigheten.se/en/ (2018).
2.
ISO 9000:2015,
”Quality management systems – Fundamentals and vocabulary”,
International Organisation for Standardization (2015).
3.
IEC 61223-2-6,
“Evaluation and routine testing in medical imaging departments - Part 26: Constancy tests Imaging performance of computed tomography X-ray equipment”,
International Electrotechnical Commission (2006).
4.
IEC 60601-1-3,
“Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment”,
International Electrotechnical Commission (2008).
5.
Mathieu K.
B.,...