CPSBC’s two accreditation programs, the Diagnostic Accreditation Program (DAP) and the Non-Hospital Medical and Surgical Facilities Accreditation Program (NHMSFAP) have published policies regarding the introduction of new technology for clinical use:
- DAP New Diagnostic Technology Policy
- NHMSFAP New Technology Policy (Including Artificial Intelligence)
Any new technology must have both a Health Canada licence and either a health technology assessment or already be approved for use in a health authority prior to being submitted for approval by the DAP or NHMSFAP committees. These requirements provide confidence that the new technology is safe and has adequate evidence of efficacy and quality.
Importantly, a Health Canada licence does not indicate that the device has been assessed for effectiveness or safety in clinical care applications. The level of evidence Health Canada reviews before licensing is dependent on the risk classification of the medical device. This risk classification spans from very low-risk medical devices (Class I, e.g. thermometers) to moderate and high-risk devices (Class III, e.g. hip replacement/implanted prosthetics and Class IV, e.g. pacemakers). For low-risk devices, Health Canada does not review evidence of safety and effectiveness but instead relies on the manufacturer’s declaration, or post-market surveillance. For moderate and high-risk medical devices (class III/IV), Health Canada does review evidence of safety and clinical effectiveness.
Due to the potential limitations of the Health Canada medical device regulation process, evidence of clinical safety and efficacy must also be provided, through approval by a health authority or through a health technology assessment. A health technology assessment (HTA) is a multidisciplinary, internationally recognized methodology for assessing the clinical and cost effectiveness of new technologies.
Health technology assessments may be obtained from organizations such as Canada’s Drug Agency (CDA, formerly known as CADTH), National Institute for Health and Care Excellence (NICE), and BC Health Technology Assessment (HTA). The BC HTA program provides evidence-informed advice to support decisions on the provincial or regional adoption of certain non-drug therapeutic interventions (e.g. devices, diagnostics, medical procedures, and programs). More information about the BC HTA program is available in this ºÚÁÏÉç Connector article or on the Ministry of Health website:
