Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Maier, Roland K., Menon, Devidas, Stafinski, Tania
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Longwoods Publishing 2018
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
_version_ 1783308451160522752
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
work_keys_str_mv AT maierrolandk themedicaldevicesspecialaccessprogramincanadaascopingstudy
AT menondevidas themedicaldevicesspecialaccessprogramincanadaascopingstudy
AT stafinskitania themedicaldevicesspecialaccessprogramincanadaascopingstudy
AT maierrolandk medicaldevicesspecialaccessprogramincanadaascopingstudy
AT menondevidas medicaldevicesspecialaccessprogramincanadaascopingstudy
AT stafinskitania medicaldevicesspecialaccessprogramincanadaascopingstudy