Frequently Asked Questions
What is MedSun?
What organizations manage MedSun?
Who can participate in MedSun?
What commitments must an organization make to participate in MedSun?
What are the benefits to a healthcare organization of participating in MedSun?
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 reporting institution and the reporters' names after reports are filed with MedSun?
How is the information kept confidential?
How is the information shared with the participating healthcare organizations?
Which healthcare organizations are currently participating in MedSun?
How do I find out more about MedSun?
A. MedSun-which stands for the Medical Product Safety Network-is a project under the direction of the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). It is designed to collect data on adverse events and situations indicating the potential for harm involving medical devices. Representatives from participating hospitals,nursing homes, and other healthcare facilities are specially trained in reporting deaths, serious injuries, and close calls involving medical devices. The Web-based MedSun data entry system resembles FDA's MedWatch Form 3500A, which is currently used for reporting under the Safe Medical Devices Act (SMDA). The objective of the MedSun pilot program is to determine if the MedSun system proves useful in helping CDRH obtain better data on problems with medical devices from the clinical community.
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A. The Center for Devices and Radiological Health (CDRH) of FDA sponsors MedSun. CDRH has contracted with Social & Scientific Systems, Inc. (SSS) to carry out the study. Click here to find out more about CDRH and SSS and their role in MedSun.
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A. Currently, 350 hospitals and nursing homes are participating in the project. The selection of these facilities was based on a number of factors including the size and location of these organizations, as well as their willingness to participate by submitting reports to the MedSun system. For more information, or to be considered for participation, please call 1-800-859-9821 or e-mail: medsun@s-3.com
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A. MedSun healthcare facilities must agree to participate in the pilot study for 12 months. As part of the program they have to appoint at least two representatives, commit to a training program that is generally done in a group session, and agree to report adverse events (both mandatory serious events and voluntary events that have the potential for serious injury). More details are available on the Requirements page.
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A. There are numerous benefits that participants enjoy, the greatest being feedback and experience sharing among participating facilities. Benefits include a monthly newsletter reviewing reports; special CDRH alerts, advisories, and recall notices; access to special analyses of MedSun and FDA's Manufacturer and User Facility Device Experience (MAUDE) databases; and an annual MedSun Representatives Conference. For additional information, see the Benefits to Your Organization section of this Website.
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A. No. Filing reports through MedSun fulfills your requirement to respond 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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A. Yes, MedSun will forward a copy of the report to the manufacturer that produces the particular device or devices mentioned. This report will include institutional identifiers as required under SMDA. This way, the manufacturers will be able to follow-up concerning reported events. This is the same procedure that is followed today when a facility submits a hard-copy MedWatch 3500A form.
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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. FDA's contractor SSS is also committed to maintaining the confidentiality of all persons and organizations from whom study data is collected. All SSS employees and consultants are required to sign an "Assurance of Confidentiality" in which they pledge to keep all information about respondents confidential. Violation of this pledge is grounds for disciplinary action, including dismissal, and may make the employee subject to criminal or civil penalties. Details of the security and confidentiality provisions will be made available to participating healthcare organizations.
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A. Information is shared with participants in a number of ways including:
- A monthly newsletter that describes reports received by MedSun during the month (without identifiers).
- Special analyses can be conducted upon request, making use of the MedSun data as well as FDA's Manufacturer and User Facility Device Experience (MAUDE) database.
- The MedSun Representatives' annual conference provides a forum for participants and FDA to discuss ways they have used the project and the data in their patient safety efforts.
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A. For a list of current sites, please contact SSS at 1-800-859-9821 or email medsun@s-3.com.
A. For more information, please call SSS at 1-800-859-9821, or email medsun@s-3.com
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