Egentillverkning: En strategi för ökad robusthet inom vården
(2024) EEML05 20241Department of Biomedical Engineering
- Abstract
- The Swedish Armed Forces and the government have given the self-governing regions the responsibility to ensure medical device availability. This means that the regions should be able to provide healthcare that cannot be postponed for a period of six months without any deliveries. Simultaneously, new regulations have been implemented, resulting in stricter rules regarding medical devices. Hence, it has become more challenging for companies to introduce medical devices to the market. There are also stricter regulations applying to the production of medical devices by the healthcare units, i.e in-house production. The purpose of this study was to investigate possible ways to use in-house production as a tool to achieve resilience in... (More)
- The Swedish Armed Forces and the government have given the self-governing regions the responsibility to ensure medical device availability. This means that the regions should be able to provide healthcare that cannot be postponed for a period of six months without any deliveries. Simultaneously, new regulations have been implemented, resulting in stricter rules regarding medical devices. Hence, it has become more challenging for companies to introduce medical devices to the market. There are also stricter regulations applying to the production of medical devices by the healthcare units, i.e in-house production. The purpose of this study was to investigate possible ways to use in-house production as a tool to achieve resilience in healthcare, in line with the prevailing regulations.This was accomplished through analyzing the regulations, work procedures, Digitalisering IT och MT’s quality management system, as well as holding interviews with individuals in relevant work positions within the organization. Based on the literature review and interviews, a list of requirements was developed, from which proposals for new working methods and changes were derived, which can be applied within the region. The proposals were discussed and resulted in the conclusion that in-house production can be part of the solution to increase the resilience in healthcare, but should not replace external manufacturers. However, a distinct plan is required to guarantee the availability of medical devices. The main focus should be on reuse, and stricter requirements should be placed on external manufacturers. (Less)
Please use this url to cite or link to this publication:
http://lup.lub.lu.se/student-papers/record/9161722
- author
- Widstrand, Jonna LU and Fornell, Disa LU
- supervisor
- organization
- alternative title
- In-house production: A strategy for increased resilience in healthcare
- course
- EEML05 20241
- year
- 2024
- type
- M2 - Bachelor Degree
- subject
- language
- Swedish
- id
- 9161722
- date added to LUP
- 2024-06-20 13:15:02
- date last changed
- 2024-06-20 13:15:02
@misc{9161722,
abstract = {{The Swedish Armed Forces and the government have given the self-governing regions the responsibility to ensure medical device availability. This means that the regions should be able to provide healthcare that cannot be postponed for a period of six months without any deliveries. Simultaneously, new regulations have been implemented, resulting in stricter rules regarding medical devices. Hence, it has become more challenging for companies to introduce medical devices to the market. There are also stricter regulations applying to the production of medical devices by the healthcare units, i.e in-house production. The purpose of this study was to investigate possible ways to use in-house production as a tool to achieve resilience in healthcare, in line with the prevailing regulations.This was accomplished through analyzing the regulations, work procedures, Digitalisering IT och MT’s quality management system, as well as holding interviews with individuals in relevant work positions within the organization. Based on the literature review and interviews, a list of requirements was developed, from which proposals for new working methods and changes were derived, which can be applied within the region. The proposals were discussed and resulted in the conclusion that in-house production can be part of the solution to increase the resilience in healthcare, but should not replace external manufacturers. However, a distinct plan is required to guarantee the availability of medical devices. The main focus should be on reuse, and stricter requirements should be placed on external manufacturers.}},
author = {{Widstrand, Jonna and Fornell, Disa}},
language = {{swe}},
note = {{Student Paper}},
title = {{Egentillverkning: En strategi för ökad robusthet inom vården}},
year = {{2024}},
}