What is the Safe Medical Device Act?
In 1990, The Safe Medical Device Act (SMDA) is federal legislation which was designed so that the FDA could quickly be informed of any medical product that has caused or suspected to have caused a serious illness, injury or death.[1] The FDA will then take immediate action to track and/or recall the product for further action. This law was passed to protect the public. Hospitals are required by law to report to manufacturers and to the FDA any device that malfunctions (mechanical or user errors) and causes serious injury/illness, or death to patients or employees. Reporting must be completed within ten working days after an event is determined to be reportable. SMDA requires medical device reporting by Device User Facilities and its referenced by the Joint Commission (EC.6.10.7).
Later in 1997, SMDA of 1990 was renamed to FDA Modernization Act of 1997. It became the guidance on FDA’s Transition Plan for Existing Postmarket Surveillance Protocols and device categories. [2]
What are Medical Devices?
A Medical Device is defined by SMDA of 1990 as any instrument, apparatus, of other article that is used to prevent, diagnose, mitigate or treat a disease or to affect the structure or function of the body with the exception of drugs. Medical devices included but are not limited to the following:
- Ventilators
- Patient restraints
- Monitors
- Dialyzers
- Gauze pads
- Hospital beds
- Implants (e.g. breast)
- CT scanners
- Wheelchairs
- Syringes
- Tongue depressors
- Infusion pumps
- Laboratory equipment
- Defibrillators
- Thermometers
- Ivitro diagnostic kits/reagents
- Computers connected to medical equipment
What is a Medical Device Report (MDR)?
The FDA has designed a medical reporting program called MedWatch. This system encourages health care professionals to consider reporting adverse events and product problems as a fundamental health care responsibility. All health care professionals are expected to report adverse events, even if they are uncertain that the product caused the event and even though they do not have all the details. Hospitals are required to use the FDA Form 3500A for reporting product problems associated with medical devices. Personnel are to fill out the MCL Form #740 incident report and the FDA Form 3500A for reporting Medical Device malfunctions will be compiled by the Risk Management Department.
Reporting
Report to the manufacturer and FDA when the facility has information that reasonably suggests a device has or may have caused or contributed to a patient’s death. Report to the manufacturer when the facility has information that reasonably suggests that a device has or may have caused or contributed to patient’s serious injury (requiring medical or surgical intervention).
All reports must be filed using the FDA Form 3500A within 10 work days.
Reference
- ↑ 101st Congress. Safe Medical Devices Act of 1990. http://thomas.loc.gov/cgi-bin/bdquery/z?d101:HR03095:@@@L&summ2=m&
- ↑ U.S. Department Of Health And Human Services Food and Drug Administration Center for Devices and Radiological Health., "SMDA to FDAMA: Guidance on FDA’s Transition Plan for Existing Postmarket Surveillance Protocols". Document issued on: 11-2-98. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm106753.htm
Links
How to Report a Problem (Medical Devices)
Slideshow