Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to ultrasound diagnostic systems and transducers. The present article covers aspects related to the labeling of such products and also quality system certification.
It is important to mention that due to its legal nature, the guidance document does not introduce new rules or requirements, but provides additional clarifications on the matter, as well as recommendations to be considered by the medical device manufacturers and other parties involved. In the event of discrepancies with the provisions of the applicable legislation, the latter should prevail.
Labeling: Regulatory Background
According to the applicable legislation, in the case of marketing approval applications for medical devices assigned to Class III or Class IV under the county’s risk-based classification, an interested party should also submit a copy of the labeling to be used for the device. In this regard, the authority refers to the concept of the “final draft device labeling.” As it is stated in the present guidance, labeling includes device labels, package inserts, product brochures, operator’s manuals, promotional material that describe the system and associated transducers. At the same time, it is explicitly mentioned that maintenance manuals actually fall outside the scope of the aforementioned concept, the same as graphics and ink colors. The authority states that the “final draft device labeling” to be provided by the applicant should be the same as the labeling that would be used for the medical device once placed on the market and should also meet the applicable requirements set forth by the current legislation.
Acoustic Output Labelling
The document further describes in detail the particular requirements to be considered by the medical device manufacturer with regard to the product’s labeling and how it should be submitted for review and approval by the regulating authority. First, the guidance addresses the aspects related to acoustic output labeling in the operator’s manual. It is stated that a draft version of such a document could be submitted with the initial application for a medical device license, while its final version should be provided by the responsible party before the device becomes available to customers. In this regard, Health Canada also refers to the AIUM labeling standard (AIUM 1998), which could be used as an example of the format in which the information should be provided.
Additionally, the information to be submitted by the applicant should include an explanation of the real-time display features and controls of the system. These aspects are described in more detail in the Guidelines for the Safe Use of Diagnostic Ultrasound issued by Health Canada. The authority additionally emphasizes that in the case of medical devices intended to be used in the context of neonatal cephalic, additional requirements should be applied. In particular, it is stated that all three thermal indices (TIS, TIB, TIC) must be available to be called up by the user, although all three indices are not required to be displayed simultaneously. Additional information on the matter could be found in the AIMU publication Medical Ultrasound Safety (AIUM 1994).
Apart from the aspects described above, the information to be provided by the applicant should cover such matters as:
- Display accuracy and measurement precision;
- Low output systems;
- Acoustic Output Reporting Tables.
In terms of technical information to be submitted, the authority states that the applicant shall also provide the engineering basis for the range of values specified (e.g., preliminary or prototype measurements, theoretical calculations, estimates based on measurements of previously licensed transducers).
General Labelling Information
The document also provides additional information regarding certain specific aspects related to labeling for ultrasound diagnostic systems. In particular, it addresses the following matters:
- Re-use Instructions. The medical device manufacturer shall provide detailed instructions describing the way medical devices should be maintained and serviced between uses in order to ensure their correct operations and the safety of the patients. These instructions should cover such aspects as storage, cleaning, disinfection, and sterilization for all the elements for which it is relevant. It is stated that labeling should recommend the use of sterile, when appropriate, and licensed transducer sheaths, for clinical applications of a semi-critical or critical nature (i.e. intraoperative, transrectal, transvaginal, trans-esophageal, biopsy procedures). If it is necessary to use additional products (e.g., cleaning liquids), there should be a reference to the instructions the labeling of such product contains. Moreover, the cleaning and disinfection procedures to be performed with the use of such additional products should be described in detail in the documentation provided. Such procedures are also subject to validation, while the validation data should be provided to the authority as well.
- Additional labeling. In certain cases, medical device manufacturers shall use additional labeling – for instance, when it is important to provide potential users with additional information regarding the safety and effectiveness concerns related to how the transducer should be used. According to the document, this applies to transcranial, trans-esophageal, intraoperative, transvaginal, ophthalmic or vascular diagnostic systems. This also applies in the case of neurological intraoperative transducers that are subject to special safety requirements. In particular, the manufacturer shall provide additional information about safety measures, especially the ones related to contamination – one should cease using a transducer that is contaminated due to the absence of methods allowing disinfection to a sufficient level.
Quality System Certification
According to the present Health Canada guidance, a medical device manufacturer applying for a license should also provide the authority with a copy of a quality system certificate which confirms that the quality system developed and implemented by the manufacturer complies with the applicable National Standard of Canada, which is CAN/CSA – ISO 13485:03, Medical devices – Quality management systems – Requirements for regulatory purposes.
Apart from the points described above, the guidance also contains several appendices addressing specific aspects. For instance, one of these appendices provides the definitions of the most important terms and concepts used in the context of ultrasound diagnostic systems and transducers. These definitions include the following:
- Contradictions – situations where the device should not be used because the risk of use clearly outweighs any reasonably foreseeable benefits;
- Indications for use stands for the information describing the particular situations when the medical device should be used (e.g., diseases or conditions), covering all potential uses prescribed by the medical device manufacturer. Besides conditions, the indications for use should also cover such factors as patient population or type of tissue applied.
- Precautions describe any special care to be exercised by practitioner or patient for the safe and effective use of a device. The authority also mentions that this definition includes limitations stated for in vitro diagnostic devices (IVDDs).
In summary, the present guidance issued by Health Canada covers the most important aspects associated with the regulatory framework for ultrasound diagnostic systems and transducers. The document outlines the scope of information to be provided in the labeling of such devices and also provides additional recommendations to be considered by the medical device manufacturers and other parties involved.
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