Should Medical Devices Be Regulated as Rigorously as Drugs?

摘要

The term “medical device” applies to a broad set of product categories, ranging from simple, low-risk devices, such as tongue depressors, to complex, high-risk devices that are implanted or sustain life, such as drug-eluting cardiac stents, implantable pacemakers, and deep-brain stimulators. Such devices are intended to be used for diagnosis, prevention, monitoring, treatment, or alleviation of disease and do not achieve their primary intended action by pharmacological, immunological, or metabolic means. At present, medical devices are increasingly integrated into pharmacy practice. For instance, with the availability of medication delivery systems (e.g., insulin pumps) and combination products (e.g., drug-eluting stents), pharmacists are in a position to provide education, to assist in implementing appropriate adjunctive pharmacotherapy when needed, and to support decision-making about where and when to use the devices. Moreover, pharmacists may also be involved in choosing medical devices during the procurement process, monitoring the efficacy of medical devices once they are in use, and managing and reporting adverse events associated with these products. Therefore, it is important for pharmacists to have a good understanding of the regulation of medical devices.