Quality Management Systems in Healthcare : “Implementation of the Medical Device Regulation”

Sammanfattning: This study investigated how a QMS that is compliant with the Medical Device Regulation (MDR) can be constructed and what the most important aspects are when creating a functional QMS at a Swedish hospital. QMS:s are a fundamental part of a healthcare organization and are used to ensure safe and secure patient care. To establish qualitative healthcare, the Swedish National Board of Health and Welfare has created regulations for hospitals to construct their QMS concerning care processes and handling of medical devices. In addition to these, there are also regulations within the European Union, including the MDR. To facilitate QMS:s work, hospitals can also follow international standards created for quality work. The most common for medical device departments is ISO 13485. Regulations are often perceived as difficult to follow and can be hard to interpret. Swedish regulations mention that a hospital should have a “suitable” QMS based on the organization’s areas of activity. But what is considered appropriate is up to the organization to decide on, which to some extent has been difficult for Swedish hospitals. Furthermore, several studies depict challenges with hospital QMS implementation and getting the QMS to work functionally. A qualitative method has been used to answer the research question where the main source of data gathering has been semi-structured interviews. The interviews have been conducted with quality managers and with experts in regulations and standards for hospitals. The questions were mainly focused on how QMS:s that follow regulations should be constructed and how to effectively implement them in a hospital organization. The study concludes that it basically is impossible to construct a general QMS suitable for every hospital without having to adjust it to the hospital's different and specific work areas, which can look very different from hospital to hospital. Regardless, since ISO 13485 is harmonized with the QMS part of the MDR, it can be helpful for a medical technology department. The authors constructed a gap analysis tool to facilitate the development and implementation process for hospital QMS:s. When it comes to aspects that constitute a successful QMS implementation, the study found the most important aspects being culture, value creation, simplicity, and leadership.