Supervision of medical devices is ineffective
Central government supervision of medical devices is too limited. In addition, government agencies’ conditions need to be strengthened if supervision is to be more effective, according to the Swedish National Audit Office’s audit.
Central government supervision of medical devices has been too limited in relation to the size of the market and the large volume of medical devices used and manufactured in-house in the healthcare sector.
One reason for the shortcomings is that the Medical Products Agency has given priority to other tasks, such as regulatory work and government assignments. This means that for many actors, the probability of being made subject to supervision is low.
The Medical Products Agency has also not been able to direct supervision where it is most beneficial. This is in part due to the healthcare sector’s under-reporting of adverse events and incidents, and to some actors not registering with the Medical Products Agency, even though they are obliged to do so.
These problems are exacerbated by the fact that the Agency’s IT system for supervision lacks functions that would facilitate a risk-based approach to supervision and follow-up of supervisory results.
The audit also shows that the Medical Products Agency has not shared its supervisory results to a sufficient extent and that actors have poor knowledge of the regulations.
“Communicating the supervisory results to a greater extent could help increase regulatory compliance and ultimately prevent unsafe products from being placed on the market,” says Kristina Lindholm, Project Leader for the audit.
The Health and Social Care Inspectorate is responsible for overseeing healthcare providers’ in-house manufacture of medical devices and the use of medical devices in the healthcare sector.
The Health and Social Care Inspectorate’s supervision has been limited, as patient safety risks have been deemed to be higher in other areas. The Health and Social Care Inspectorate has lacked expertise in the field of medical devices and does not have access to comprehensive data on which products are manufactured in-house in the healthcare sector.
Neither the Medical Products Agency, the Health and Social Care Inspectorate, nor the Government follow up on the supervisory results to a sufficient extent. Follow-up is essential to enable government agencies and the Government to detect and remedy problems and assess how supervision functions as a whole.
“In the medical technology field, new products that are related to health and life are constantly being developed. The Government needs to monitor developments, follow up on results from the supervisory work and clarify the responsibility of government agencies to contribute information and knowledge about the regulatory framework,” says Deputy Auditor General Claudia Gardberg Morner.
Recommendations in brief
Recommendations to the Government include reviewing and considering shifting responsibility for supervision of medical devices manufactured in-house from the Health and Social Care Inspectorate to the Medical Products Agency.
Recommendations to the Medical Products Agency include sharing information on the supervisory results to a larger extent with the medical device industry and the healthcare sector.
The recommendation to the Health and Social Care Inspectorate is to develop its expertise on medical devices and medical device safety to be better able to take this into account in the agency’s risk analysis and regular supervision.
Medical devices
Medical devices have a medical purpose. Devices may include wound dressings, syringes, needles, X-ray and radiation therapy apparatus, software and laboratory medicine products such as HIV and COVID-19 tests. They may also include assistive devices and systems or software for analysing X-rays or ECGs.
Medical devices manufactured in-house are products that the healthcare sector manufactures, modifies and uses in-house for patient categories whose needs cannot be met by an equivalent product on the market. For example, medical gas facilities in a hospital, software or products used to provide medical information about samples from human tissue.