Handling of Medical Devices: Reforms and Regulations

With the evolving technology and changing regulations, the medical device sector is set to grow quickly soon. Even though they are an integral part of patient care they present several unique problems which are not sufficiently addressed by the device manufacturer or the medical community in general. Medical device is widely used by professionals in a clinical setup, by patients, family members at home. As step towards better understanding the rules, regulations, and the required reforms for the safe use of medical devices various measures taken by different regulatory authorities to ensure the minimization of use error are discussed. Human factor engineering and ergonomics are considered while designing a medical device. It is evident that all the stakeholders involved contribute to the safety of the medical device keeping in mind the welfare of the patient but is that enough and what can be done is discussed in this review work.

PrediGen: A tool to track the genealogy of medical device predicates in the United States

In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (“FDA”) before they can be marketed. Novel medical devices have to undergo a premarket authorization (PMA) process before they can proceed to market, and this process can be fairly cumbersome, expensive, and time-consuming. An alternate faster and less-pricey pathway to going to market is the 510(k) pathway. In this approach, if the device manufacturer can show that their device is substantially equivalent in safety and effectiveness to a pre-existing FDA-approved marketed device (or “predicates”), they can go to market with their device. Due to the possibility of daisy-chaining predicate devices, it can very quickly be difficult to unravel the logic and justification of how a particular medical device’s equivalence was established. From patients’ perspective, this minimizes transparency in the process. From a vendor perspective, it can be difficult to determine the right predicate that applies to their device. PrediGen (short for “Predicates Genealogy”) is being developed as an approach to graphically map the connectivity of various predicates in the medical device field using data publicly made available by the FDA, and by combining text mining and novel natural language processing (NLP) techniques. Besides enabling a better understanding of the risks and benefits of the 510(k) process, this tool can increase consumer confidence in the medical devices that are currently in the marketplace.