The medical system is complex and multifaceted. The impact of one change has to be considered in so many ways that may not be intuitive initially. You cannot simply look at patient care, but you also have to consider laws surrounding insurance or doctor’s responsibilities, privacy considerations or the cost of care and the challenges that exist in someone’s home that could impact their medical care from a doctor. Change control is most important when it is working in a system that is complicated or muddled so the medical field is one of the best examples for how change control can work.
Because of the importance of medical change control and the need to keep any changes in the industry standardized, the FDA has actually created requirements for change control. This is especially crucial in the area of medical devices, because those devices impact such a wide range of people. When changes are made to these devices then those changes need to be standardized in order to ensure that they are implemented the same way by all manufacturers. This is the only way to lessen the danger to patients as well as the risk for a lawsuit. Devices can impact the way that medications interact with your body or how your body functions on its own so ensuring the device is changed in the most effective way is literally a life or death issue.
There are other aspects of medical care that also require change control processes. For example, when changes are made to medications then a change control process is just as important as it is for medical devices. Again, the medications that a patient takes will interact with other medicines in their cabinet whether they are prescription or purchased over the counter. There could even be foods that interact with your body differently based on the medications that you take. This means that even when you develop the change, you have to test it on a wide range of patients to know all of the different ways that the change could affect different people.
The stage of approval is also crucial in the area of medical change control because of the legal ramifications of any change that could be implemented. The change control board or committee that exists for this process must be a team of people who understand each aspect of the medical industry in their own way. Some should have a scientific and medical understanding of these changes, but others should have an understanding of the legal ramifications while others still should have an understanding of hospital administration or even nursing. If the right team is assembled with an understanding of all of these various aspects of the medical field then you should be able to get the most holistic view of each change before it is approved.
Medical change control is one of the most crucial across all industries. Software changes or others can impact businesses and may indirectly impact lives but medical changes hold our lives in their hands. Patients rely on these processes to be created and implemented with their best interest in mind, so we have a great responsibility to make sure that happens.
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