Frequently Asked Questions (FAQ)
What commitments must my institution make to participate in MedSun?
What are the benefits of participating in MedSun?
How is information shared with MedSun sites?
If we report to MedSun, do we still have to report adverse medical device events to FDA and manufacturers on MedWatch Form 3500A?
Do product manufacturers have access to the names of the reporting institution and reporter after a report is filed with MedSun?
How is the information kept confidential?
Are MedSun reports included in public databases?
How do I find out more about MedSun?
What commitments must my institution make to participate in MedSun?
A. Health care facilities must agree to participate in the program for 12 months. As part of the program, at least two representatives must participate in a training program that is generally conducted through a Webcast, and agree to submit 10 reports per year (both mandatory serious events and voluntary events that have the potential for harm). More details are available on the
Participation page.
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What are the benefits of participating in MedSun?
A. MedSun participants express great satisfaction in knowing that they are playing an important role in ensuring the safety of medical products. They also recognize the benefit of receiving feedback and personal follow up from MedSun program staff after they submit a report and of sharing information with other MedSun representatives. A list of additional benefits is available on the
Benefits page.
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How is information shared with MedSun sites?
A. Information is shared with participants through the following:
• A monthly newsletter that includes descriptions of reports (without identifiers) received through MedSun.
• Special analyses that can be conducted upon request, making use of data from the MedSun and FDA's
Manufacturer and User Facility Device Experience (MAUDE) databases.
• Regional meetings for MedSun representatives that provide a forum for participants and FDA to discuss
medical device problems and solutions.
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If we report to MedSun, do we still have to report adverse medical device events to FDA and manufacturers on MedWatch Form 3500A?
A. No. Filing reports through MedSun fulfills your requirement to report to FDA under the Safe Medical Devices Act (SMDA). In addition, representatives can indicate that they want a copy of the MedSun report sent on their behalf to the manufacturer, thus fulfilling their reporting requirement under SMDA.
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Do product manufacturers have access to the names of the reporting institution and reporter after a report is filed with MedSun?
A. Yes. MedSun forwards a copy of the report to the manufacturer of the device. This report includes institutional identifiers as required under SMDA, which allows the manufacturer to follow up about the reported event. This is the same procedure that is followed when a facility submits a MedWatch 3500A form.
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How is the information kept confidential?
A. FDA protects the identity of persons submitting reports and the reporting institutions to the full extent allowed by statute and by regulation, as is done in the current SMDA reporting system. Details of the security and confidentiality provisions are available to participating MedSun sites.
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Are MedSun reports included in public databases?
A. After their identifying information has been removed, MedSun reports go into the public FDA MedSun and MAUDE (Manufacturer and User Facility Device Experience) databases.
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How do I find out more about MedSun?
A. For more information, please e-mail
medsun@s-3.com or call 1-800-859-9821.
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