Safe Medical Device Act (SMDA) 1990

Instructional Objectives:

The employee will demonstrate, by answering the review questions, complete knowledge of:

What is the Safe Medical Device Act(SMDA)?

The SMDA Federal is 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. The FDA will then take 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.

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 Cat scanners
Wheelchairs Syringes Tongue depressors Infusion pumps
Laboratory equipment Defibrillators Thermometers In vitro diagnostic kits/reagents


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.

What to do if an incident occurs?

  1. Attend immediately to the medical needs of injured patient/employee
  2. Immediately report to appropriate supervisor
  1. Remove device from area and appropriately label it
  1. Call Bio Med


End---> Take the test to get credit


  1. Subject: Medical Device Reporting(MDR) and Medical Device Tracking(MDT). Available at: Accessed May 3 ,2001.
  1. Medical Devices Act of 1990: Current Hospital Requirements and Recommended Actions. Available at:

Accessed May 3,2001