Requirements for Participating in MedSun

MedSun participants are selected based on a number of factors including size and location of the facility. The objective is to have a representative sample of device user facilities. Current participants include large teaching facilities, small hospitals, urban hospitals, suburban hospitals, and nursing homes. In addition, there are some outpatient diagnostic and treatment facilities and home health services associated with MedSun hospitals included.

MedSun participating facilities are asked to:

• Commit to reporting for a 12-month period in this pilot program
• Designate at least two staff members to be their MedSun representatives:
1. One from Risk Management or Quality Improvement
2. One from Biomedical or Clinical Engineering
3. Other persons such as the Patient Safety Officer, OR Manager or Clinical Educator may be included on the team.
• Have both representatives attend orientation that is generally done as a group session. In the orientation session, representatives are specially trained in reporting deaths, serious injuries, and close calls involving medical devices.
• Agree to report to MedSun adverse events that involve problems in the use or operation of medical devices (including malfunctions) that result in serious illness, injury, or death.
• Agree to report to MedSun, on a voluntary basis, events that involve problems in the use or operation of medical devices that have the potential for serious injury, illness, or death.
• Participate in periodic rapid response surveys concerning particular medical products. These surveys serve as an important source of ongoing communications between the clinical community and FDA on critical device problems.