Health Technology Management and Canada's Medical Devices Special Access Program

• Author / Creator

  Maier, Roland K

• Health Technology Management (HTM) encompasses a broad array of processes spanning technical, clinical, and administrative disciplines in order to optimize the efficient use of healthcare resources. It employs a ‘lifecycle’ approach, evaluating technologies at each stage of maturity from concept through use and finally discontinuance. Health technologies exist in various forms; one of them being medical devices. In Canada, medical devices are controlled through the federal Food and Drugs Act and Regulations. While most medical devices require licensing to be sold in the market, provisions exist in the regulations for healthcare professionals to access unlicensed devices. One mechanism is through application to Health Canada’s Medical Devices Special Access Program (MDSAP). This thesis examined the MDSAP in order to understand its role in HTM. Three separate, yet related studies, were conducted. The first study employed a scoping literature review to determine the landscape of available information and to identify more focused areas of required research. The second study reviewed two cases to determine why and how the MDSAP was used to obtain devices in a hospital setting. The third study conducted key informant interviews to compare and contrast key stakeholder perspectives on roles and responsibilities, knowledge and information needs, and program utilization. Each study employed qualitative content analysis to generate findings. The scoping study determined that the literature was generally limited, yet suggested the MDSAP roles in HTM are: as an arbiter in technology selection, as a route to technology procurement, and as a facilitator of health technology innovation. The two-case study determined the MDSAP was used for the introduction of new health technology, which comprised 5 general processes: Technology Development, Knowledge Transfer, Evaluation, Acquisition, and Patient Management, and the program played an essential role in the Acquisition stage for the two novel technologies under consideration. Four drivers of program use were identified. These were: change agents, clinical need, innovation, and new evidence. The combination of driving forces triggered the sequence of processes. The MDSAP is a regulatory policy that impacts the management of health technology. It can result in the accelerated replacement of existing technology, organizational change, and innovation in the development of best clinical practice. The study on stakeholder produced four themes: the MDSAP authorizes access to needed medical devices, physicians drive MDSAP demand in the interest of patient care, global forces impact the MDSAP, and the improved management of health technology is a priority need. This study suggests HTM’s next steps should include initiatives that enhance the collection and dissemination of unlicensed medical device data. The three studies’ findings were aligned. They inform components of the four major stages of the technology lifecycle – premarket, adoption, real-world use, and decommissioning – and demonstrate the role and impact of the MDSAP in HTM.

• Subjects / Keywords

  • Special access program
  • Medical devices
  • Health technology management
  • Canada

• Graduation date

  Fall 2017

• Type of Item

  Thesis

• Degree

  Master of Science

• DOI

  https://doi.org/10.7939/R3ZG6GN0Z

• License

  This thesis is made available by the University of Alberta Libraries with permission of the copyright owner solely for non-commercial purposes. This thesis, or any portion thereof, may not otherwise be copied or reproduced without the written consent of the copyright owner, except to the extent permitted by Canadian copyright law.