0471 MedSun Program SSB 2020 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Adverse Event Program for Medical Devices:
(Medical Product Safety Network (MedSun))
OMB Control No. 0910-0471
SUPPORTING STATEMENT – Part B: Statistical Methods
While the MedSun sample is not based on statistical methodology, it is a loosely representative
sample of sizes and types of hospitals in the country. The following is a description for how the
sample is drawn and maintained.
1. Respondent Universe and Sampling Methods
The sample size is now 300 sites, with the potential respondent universe including 6,000
hospitals, 17,000 nursing homes, and approximately 20,000 “other” types of health facilities
(outpatient treatment centers, outpatient diagnostic centers, emergency health services, and home
health services). The number in the sample is based on the fact that we have achieved a roughly
representative sample of small, medium, and large hospitals across the country. For purposes of
continuing this as a program, FDA believes that 300 sites (of greater than 100 beds) is the
number we can continue to accommodate in the program. Ongoing training and encouragement
is provided to continue the hospitals’ reporting into the program; it is very labor intensive.
Hospitals in the program have the expectation that each report will receive individual attention,
which the staff currently struggles to achieve due to the number of reports coming in from this
successful program.
Therefore, the program cannot exceed the current number because of cost and time restraints.
Ultimately, while we strive to keep the sample roughly representative as to size of facilities
spread throughout the 5 census regions of the country, the final sample may best be described as
a convenience sample, because in addition to our loosely representative sample, we also include
sites which ask to be part of the program. Because denominator data is unknown for the number
and types of incidents that occur with each of the medical devices in the United States, FDA will
not use the data collected to make national estimates of devices problems, use problems, etc.
The purpose of this postmarket surveillance is to obtain signals that problems are occurring and
to learn as much as possible about the incidents.
Therefore, in the future, if FDA does determine it has the resources to increase the number of
sites above 300, it will identify replacement facilities in the same census region and the same
size as the site being removed. We also take into consideration how willing a potential new
recruit may be to work closely with FDA to continue the program. The greatest participation,
and thus the best signals, is obtained from facilities that have organizational structures and
cultures that are willing to share information in the interest of increased patient safety.
Additionally, most of the current larger hospitals have other types of adjunct facilities as part of
the organization, such as long-term care facilities (similar to nursing homes), outpatient

treatment centers, outpatient diagnostic centers, and home health agencies. The larger
institutions are more apt to have experience with diverse medical devices and, given the volume
of patients admitted each year, are also more likely to have adverse events occur with those
medical devices. Enrollment into the program is voluntary.
2. Procedures for the Collection of Information
After selecting potential candidates based on the criteria described above, replacement facilities
are invited to participate in the program. If they agree to participate, they sign a Memorandum
of Participation which describes the reporting procedure they will be expected to complete (send
adverse event reports via the web – both mandatory and voluntary reports), participate in training
in how to participate prior to submitting adverse event reports, and protect their passwords. The
facilities will report incidents of adverse events via the Internet-based reporting system to FDA.
The facility will answer the questions that currently appear on the Form FDA 3500A MedWatch
form as well as some additional questions (approved under OMB control number 0910-0645).
FDA analysts will review the reports for completeness and will follow up with the facility as
needed to ensure the report is a complete as possible and to more fully understand why the event
may have occurred.
3. Methods to Maximize Response Rates and Deal with Non-response
Every effort will be made to maximize responses. However, in postmarket surveillance that is
based on numerator data, rather than denominator data, obtaining important signals that problems
may be occurring is more critical than obtaining large numbers of reports.
Facilities will continue to use the Internet-based system to report adverse events. FDA's MedSun
postmarket medical device adverse event reporting is considered ‘enhanced’ surveillance, rather
than the ‘passive’ surveillance of our other reporting systems. Since reporting first requires
individuals working within a facility to recognize that an adverse event was related to the use of
a medical device and then to report that incident through the appropriate channels within that
facility, FDA supplies many tools to the hospitals to train staff. However, while FDA will train
each facility in the mechanisms of reporting, facilities will still only forward reports if the ‘lead’
reporter with the MedSun system password learns about a medical device adverse event from
staff, or learns of the potential for an adverse event to occur. It is impossible to predict how
many adverse events will occur per year at each facility. We are striving for an average of 15
reports per year.
If a facility sends less than 2 reports in the first 6-months of entering the pilot, the FDA analyst
calls the facility contact person to ask how the system seems to be working, if the facility needs
more training in the mechanics of working in the pilot project, etc. This gentle probing is to
remind the facility contact person that the success of the project depends on each facility
forwarding all medical device related adverse events. But, if the site continues to perform
poorly, it is cycled out of the program and replaced.
Facilities will voluntarily fill in answers to data fields not currently included in the 3500A form
(OMB approved questions). To encourage the facilities to fill in these data elements, the FDA

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MedSun staff calls the facility’s contact person to ascertain the reason the items were not filled
in. The responses given by the contact person will aid FDA in determining if the questions are
too difficult for the facility to find in a timely manner, or if the facility is not comfortable, for
whatever reason, in providing the answers. This information can then be reflected in changes
brought forth in the next 3-year OMB approval cycle.
4. Test of Procedures or Methods to be Undertaken
The need for user facilities to report adverse events associated with medical devices is currently
mandated by law, so the fundamental mechanics of how to work with a reporting program is
well-known to facilities. Before MedSun, all reporting had been a paper system, so the pilot was
the first test of a new electronic version. Now that we have implemented the full program, our
methods are well-tested and yielding excellent results.
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing
Data
The Office of Surveillance and Biometrics (OSB) in FDA’s Center for Devices and Radiological
Health (CDRH) collects and analyzes the data.

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