Participation

MedSun sites are selected based on a number of factors, including type, size and location of the facility. The objective is to have a representative sample of device-user facilities. Most sites are hospitals, including many of the nation’s teaching hospitals and more than 20 pediatric hospitals. The network also includes outpatient diagnostic and treatment facilities, and home health services and nursing homes.

MedSun sites are asked to:
  • Commit to reporting for a 12-month period.
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  • Submit at least 10 reports per year (this includes reports indicating potential for harm)
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  • Designate at least two staff members to be MedSun representatives:

    • One from Risk Management or Quality Improvement

    • One from Biomedical or Clinical Engineering

    • Other persons such as the Patient Safety Officer, OR Manager, or Clinical Educator can be included on the team. Nurses, laboratorians and others may also participate in connection with the subnetworks.
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  • Have both representatives attend an orientation that is generally conducted through a Webcast. In the orientation session, MedSun representatives are specially trained to report, using the secure Internet-based reporting system.

  • Agree to submit mandatory (under SMDA) medical device adverse event reports through MedSun. These are reports where a device has or may have caused or contributed to the death or serious injury of a patient.
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  • Agree to report to MedSun, on a voluntary basis, events that involve problems with medical devices that indicate potential for harm (such as close calls).
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  • In addition, MedSun sites may be asked to 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. MedSun sites are also asked to consider taking part in subnetworks.
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