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. 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).