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What Legal Requirements Do I Have To Consider Before Purchasing A CT System?
1st March, 2023 17h04
Implementing a CT modality into your practice not only requires special veterinary expertise and building alterations but also include dealing with legal standards and meeting the legal requirements for permission to operate a computed tomography system.
Compliance with general laws and regulations on radiation protection (including structural requirements) as well as requirements for qualification or prerequisites for permission to use and perform CT scans are regulated on a country-specific basis. The laws on radiation protection, expertise and permission to perform CT scans vary greatly from one country to another.
Therefore, inform yourself about your respective legal situation at the local authorities and competent bodies.
Structural requirements often need to be discussed and cost estimates obtained from architects, electricians and other professionals - involve them early.
Include these costs in the business plan or in the acquisition costs.
Using Germany as an example, we would like to highlight what may need to be legally observed and complied with.
What are the regulations and legal requirements for performing CT scans (example Germany)?
In Germany, the legal requirements for commissioning CT scanners are based on the “Strahlenschutzverordnung” (StrlSchV).
The “Richtlinie zur Strahlenschutzverordnung (StrlSchV) und zur Röntgenverordnung (RöV)” furthermore regulates the special requirements and course contents for the expertise of CT examinations based on this - constructional requirements, on the other hand, are regulated among others according to DIN 6812/15.
Courses to obtain a required qualification can be rare and demand additional financial commitment. In some cases, you have to be prepared for a certain waiting period and the duration of the course can extend to months (due to the obligation to provide evidence of processed case numbers).
The competent bodies and authorities include the ´Landestierärztekammern´, the ´Bundesamt für Strahlenschutz´ and the ´oberen Landesbehörden´. The homepage of the ´Bundestierärztekammer Deutschland´ provides current dates and information on contact points for legal questions regarding CT expertise, permits and construction requirements.
If possible, the CT scanner should only be purchased after permission has been granted by the licensing and supervisory authorities to operate the device in your practice or clinic. Unnecessary inconveniences and delays can thus be prevented.
Special expertise in radiation protection for computed tomography (CT)
The prerequisite for course registration and for acquiring the ´Spezielle Fachkunde im Strahlenschutz für die Computertomographie´ is a currently valid X-ray qualification which is normally obtained with the veterinary licence or graduation ("tierärztliche Approbation") and this expertise must be updated every 5 years in accordance with § 48 StrlSchV.
The guideline specifies the following about the implementation of the courses for CT expertise: "This expertise in radiation protection can be acquired either according to the ´classical model´, i.e. acquisition of expertise and special course in radiation protection, or through a ´combination course´".
Among other things, both courses require 50 documented CT examinations, the processing of which always requires a high-quality image viewer. www.veheri.com is a specialized collaborative veterinary imaging platform that can be utilised for this.
The exact meaning of both courses, as well as course contents, are listed in detail in the guideline.
In Germany, however, the technical performance of the scans is not the sole preserve of the specialized veterinarian. Staff with other appropriate training, which is listed separately in the guideline, may also carry out the CT scan independently after appropriate training.
In practice, this means that the positioning, anaesthesia monitoring and also the operation of the equipment can be carried out by an appropriately trained veterinary assistant or other technical-medical staff which considerably contributes to the relief of the veterinarians.
Technical assistance: In some countries, particularly strict laws apply regarding permission for the technical performance of scans. This sometimes results in only a narrow range of qualified staff being allowed to perform CT scans. Pay particular attention to this point, as appropriate personnel is sometimes scarce and additional personnel costs may be incurred. This, as well as the possible external reporting of the scans, should be included in the business plan for running costs if possible, if they are not fully charged to the pet owners!
For further details, please see the guidelines to "Strahlenschutz in der Tierheilkunde".
Take a step-by-step approach to prepare yourself in the best possible way. Check your state requirements and meet them before the acquisition of the CT system, if possible, to avoid unnecessary delays. Acquire the necessary personnel for performing and also interpreting the CT scans at an early stage in the form of additional employment or external contracts (e.g. teleradiology as well as external specialist staff).
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