The Safe Medical Devices Act (SMDA) is federal legislation that promotes the security and safety of medical devices and products. In particular, the Act came into existence back in the 1990s owing to the need by the government to combat injuries and illnesses brought about by the consumption of wrong products (Curfman et al. 976). From MedWatch, the hospitals have to follow laid down instructions on how to report mishandling of medical devices. The instructions from med watch also govern the administration and prescription of over-the-counter medicines ("MedWatch Voluntary Report"). The Safety Medical Act requires hospitals to report any instance of harmful products to the manufacturer of the product or the Food and Drugs Administration (FDA).
On the other hand, the Safe Medical Devices Act affects the manner of maintaining and managing the medical equipment. This is particularly aimed at restricting injuries and illnesses to the employees and other users of the equipment. In the event that these injuries occur, the act provides a 7-day time frame for which the employees need to record the complaint to the relevant institutions ("MedWatch Voluntary Report"). However, this time frame is not fixed and can be varied based on the flexibility of both the complainant and the relevant stakeholders involved. Furthermore, the act directs the health care institution to obtain enough information from the suppliers and manufacturer of the specific medical equipment on the safety consideration in using these facilities. This, therefore, will reduce the incidents of patient injuries as a result of defaults in the usage of medical equipment. On the other hand, the manufacturers and importers need to report to the Food and Drug Administration (FDA) if one or more of the devices result in injuries to the patients or health care professionals ("MedWatch Voluntary Report").
The report needs to be made within the first seven days in which the complaint is made by the victims. This will enable the FDA to provide new guidelines on storage and maintenance of the equipment to prevent future injuries. In addition, the Act provides FDA with the authority to determine the warranty for which the medical equipment will be in use. On average the medical devices should have a life span of 12 to 24 months for which their outcomes are at satisfactory and safety levels ("MedWatch Voluntary Report").
Works Cited
Curfman, Gregory D., and Rita F. Redberg. "Medical devices—balancing regulation and innovation." New England Journal of Medicine 365.11 (2011): 975-977.
Kramer, Daniel B., Shuai Xu, and Aaron S. Kesselheim. "Regulation of medical devices in the United States and European Union." (2012): 848-855.
"MedWatch Voluntary Report".Accessdata.Fda.Gov, 2017, https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
