Verlab#Blog: Almir Badnjević
The world is changing rapidly, and with it comes a great shift in the way we approach healthcare. The impact of digital transformation and technological advancements has been felt across many different industries, including medicine. Thanks to these developments, the field of medicine has seen unprecedented advances in recent years, with new and innovative tools, services, and remedies being created every day to help improve the quality of care for patients around the world.
One of the most significant impacts of these changes has been in the area of medical technology. This term refers to a wide range of devices, tools, and apparatus that are designed to address a wide variety of health issues and enhance the quality of life for those who use them. From high-risk devices like surgical instruments to low-risk items like blood pressure monitors, medical technology has become an essential part of modern healthcare. But as the field of medical technology continues to evolve and grow, so too does the need for skilled professionals who can help ensure that these tools are used safely and effectively.
Who are clinical engineers and why do we need them?
Clinical engineers are among the most important of these specialists, using their technical and administrative abilities to support and develop patient care in healthcare settings around the world. Despite the rapid growth of the medical device industry in recent decades, the need for careful management of these technologies remains as important as ever. With millions of different types of medical devices now available on the global market, it is more important than ever to ensure that these tools are used safely and effectively to protect the health and wellbeing of patients everywhere. At the heart of it all, the most important factor in the healthcare sector is the safety of the patients who depend on these technologies. Whether in hospitals or medical equipment manufacturers, ensuring that medical technology is used safely and appropriately is essential to protecting the health and wellbeing of those who rely on it most.
The lack of specialized technical staff, including medical bioengineers and clinical engineers, as well as an inefficient maintenance system, can contribute to a range of problems. This has become especially clear during the pandemic, when hospitals and medical equipment have been overburdened and stretched to their limits.
Medical Device management & maintenance: The need for evidence-based approach
With this rapid development comes a great responsibility to ensure that these tools are used safely and effectively to protect the health and wellbeing of patients.
The management of medical technology is complex, requiring efficient and effective maintenance programs that can optimize the use of resources while minimizing the risk of malfunctions and other issues. To achieve this, medical device management and maintenance activities are carried out, with a focus on checking the safety and performance of medical devices relative to international standards, regulations, and manufacturer specifications. Management structures are constantly looking for ways to optimize maintenance programs and reduce costs, while still ensuring that all equipment is operating safely and effectively. This requires careful analysis and substantiation of capital expenditures based on quantifiable factors that impact the full costs associated with medical technology.
As we move forward, it is clear that there is a need to improve the rules and standards of hospital care, as well as to optimize maintenance policies as quickly as possible.
By doing so, we can help ensure that every medical device is safe and accurate every time it is used, and that patients can receive the highest quality care possible. Ultimately, this is the goal of medical technology management and maintenance – to improve the health and wellbeing of people around the world, and to ensure that the benefits of medical technology are realized in the most effective and efficient way possible.
The Medical Device Regulation (MDR) recognized the importance of post-market surveillance and defined a framework to increase it, but there is still a lot to be done in terms of standardizing conformity assessment of medical devices during usage. This is where science comes into practice. The science of metrology helps establish common understanding and standardized evidence to assess device safety and performance.
The Institute of Electrical and Electronics Engineers (IEEE) standards group has taken up the task of working on harmonizing post-market surveillance performance evaluation for medical devices with measuring function.
Their goal is to link medical devices and their performance assessment testing to metrological concepts and terms to develop standards for conformity assessment testing of medical devices. This will help ensure that medical devices are not only effective, but also safe and reliable for patients.
The introduction of a standardized conformity assessment method for testing the safety and performance of medical devices can result in traceable, accurate, complete, verified, unbiased, and standardized data. This method involves independent third-party bodies or manufacturers and distributors testing the quality of medical devices, and the resulting evidence is reliable and unbiased. This approach can solve two challenges: ensuring the safety and quality of medical devices, and creating standardized data that can be analyzed using various techniques. Standardized data has revealed certain patterns for healthcare institutions, and researchers have investigated applying artificial intelligence to this database.
“How to understand the present and predict the future?”
As medicine shifts towards personalized medicine, clinical engineering should also move towards predictive management of medical devices.
In summary, it is essential to ensure that medical devices are safe, effective, and affordable, and the introduction of standardized conformity assessment methods and digital transformation can play a crucial role.
In God we trust, all other bring data!
Full editorial text was published in Health & Technology Journal: https://rb.gy/btixml
