Term: The Safe Medical Devices Act

Decription: The Safe Medical Devices Act requires health-care professionals to report death or injuries caused or suspected to have been caused by a particular medical device to the FDA or the product’s manufacturer. It was designed so that the FDA could be quickly informed of these dangerous medical products and could then track or recall the product. The hospital must file the report within ten working days after the event is determined to need to be reported. The Safe Medical Devices Act was signed into law in 1990. It was an update to the Federal Food, Drug, and Cosmetic Act that was last modified in 1976. The 1976 law required new high-risk products to go through a premarket procedure. It required FDA approval based on clinical experience before a product could be marketed. This, however, proved insufficient as FDA employees lacked the necessary information to be able to make informed decisions about said devices. This is the reason The Safe Medical Devices Act was written into law.

A medical device is defined by the Safe Medical Devices Act of 1990 to include any instrument, apparatus, or other article that is used to prevent, diagnose, mitigate or treat a disease as to affect the structure or function of the body with the exception of drugs. A medical device can range from gauze sponges to implanted devices such as pacemakers.

Application:The act enables regulators to observe operability of a device and make necessary corrections to the functionality if something was wrong. Now the FDA could be quickly informed of dangerous medical products and could then proceed to track or recall the product for repair/replacement. The law gave the FDA newfound power to suspend approved medical applications under circumstances where usage of medical devices led to injury or death. The FDA could enforce a recall on items deemed unsafe and had the ability to fine manufacturers up to $15,000 for violating the safety provisions of the act.

Further provisions to the Safe Medical Devices Act of 1990 have since been updated through the signing of the Food and Drug Administration Modernization Act of 1997. Now doctor’s offices and hospitals are required to submit a report summary citing all device-related incidents within the last year of the previous submission. Also, manufacturers are no longer required to file status reports about the device problems to the FDA.

Medical professionals are obligated to report instruments suspected of causing harm to their patients to the FDA. Medical devices are now regulated under a program called MedWatch and in order to submit a report you must fill out a “Reporting Form 3500” found on the FDA’s website. Reports may also be submitted via phone, fax,
or the mail however the hospital must file the report within ten working days after the event is determined to need reporting.

Related Terms:
Federal Food, Drug, and Cosmetic Act
FDA

Resource:
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

Sources:
http://content.healthaffairs.org/cgi/reprint/10/1/192.pdf
http://www.mclno.org/webresources/path_safety/pdf/safety4_14_Elect_training.2.pdf

Graphic:
medical_devices.jpg