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The Medical Devices Special Access Program in Canada: A Scoping Study
New health technologies enter Canadian healthcare organizations in various ways, and understanding them is essential to the development of a pan-Canadian Health Technology Management (HTM) Strategy, now a priority of governments across Canada. One way is through Health Canada's Medical Devices...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Longwoods Publishing
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5863869/ https://www.ncbi.nlm.nih.gov/pubmed/29595436 http://dx.doi.org/10.12927/hcpol.2018.25398 |
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author | Maier, Roland K. Menon, Devidas Stafinski, Tania |
author_facet | Maier, Roland K. Menon, Devidas Stafinski, Tania |
author_sort | Maier, Roland K. |
collection | PubMed |
description | New health technologies enter Canadian healthcare organizations in various ways, and understanding them is essential to the development of a pan-Canadian Health Technology Management (HTM) Strategy, now a priority of governments across Canada. One way is through Health Canada's Medical Devices Special Access Program (MDSAP), which permits unlicensed devices to be obtained by healthcare professionals. However, the circumstances around and implications of the current use of this program are not clear. A scoping literature review was conducted to clarify these and identify important roles and issues related to the MDSAP. Limited information was found on the MDSAP. Nevertheless, three themes demonstrating the roles of the MDSAP in HTM emerged: arbiter in technology selection, a route to technology procurement and facilitator of health technology innovation. No information suggesting that MDSAP is used to circumvent licensing was found. Rather, it enables desired patient outcomes and product commercialization. |
format | Online Article Text |
id | pubmed-5863869 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Longwoods Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-58638692018-03-28 The Medical Devices Special Access Program in Canada: A Scoping Study Maier, Roland K. Menon, Devidas Stafinski, Tania Healthc Policy Research Paper New health technologies enter Canadian healthcare organizations in various ways, and understanding them is essential to the development of a pan-Canadian Health Technology Management (HTM) Strategy, now a priority of governments across Canada. One way is through Health Canada's Medical Devices Special Access Program (MDSAP), which permits unlicensed devices to be obtained by healthcare professionals. However, the circumstances around and implications of the current use of this program are not clear. A scoping literature review was conducted to clarify these and identify important roles and issues related to the MDSAP. Limited information was found on the MDSAP. Nevertheless, three themes demonstrating the roles of the MDSAP in HTM emerged: arbiter in technology selection, a route to technology procurement and facilitator of health technology innovation. No information suggesting that MDSAP is used to circumvent licensing was found. Rather, it enables desired patient outcomes and product commercialization. Longwoods Publishing 2018-02 /pmc/articles/PMC5863869/ /pubmed/29595436 http://dx.doi.org/10.12927/hcpol.2018.25398 Text en Copyright © 2018 Longwoods Publishing http://creativecommons.org/licenses/by-nc/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial 4.0 License, which permits rights to copy and redistribute the work for non-commercial purposes only, provided the original work is given proper attribution. |
spellingShingle | Research Paper Maier, Roland K. Menon, Devidas Stafinski, Tania The Medical Devices Special Access Program in Canada: A Scoping Study |
title | The Medical Devices Special Access Program in Canada: A Scoping Study |
title_full | The Medical Devices Special Access Program in Canada: A Scoping Study |
title_fullStr | The Medical Devices Special Access Program in Canada: A Scoping Study |
title_full_unstemmed | The Medical Devices Special Access Program in Canada: A Scoping Study |
title_short | The Medical Devices Special Access Program in Canada: A Scoping Study |
title_sort | medical devices special access program in canada: a scoping study |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5863869/ https://www.ncbi.nlm.nih.gov/pubmed/29595436 http://dx.doi.org/10.12927/hcpol.2018.25398 |
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