An overview of the FDA device reporting rules
Just the facts . . . they're all here
Hospital-based home care companies are sure to have questions about the new Food and Drug Administration (FDA) medical device incident reporting rules. Hospital Home Health has anticipated what many of these questions will be. Here are the answers:
* Why were the rules passed?
It may be hard for home care companies to believe, given the amount of paperwork they already do, but the Safe Medical Devices Act (SMDA) was not passed to create more paperwork. Congress passed the rules to increase protection for public health.
These rules stem from congressional investigations showing that medical device manufacturers and importers weren't reporting many adverse incidents to the FDA, although hospitals and other facilities that used medical devices often voluntarily reported problems to manufacturers and importers.
One congressional study found that less than 1% of device problems occurring in hospitals were reported to the FDA, and that the more serious the problem was, the less likely it was to be reported to the FDA.
To improve the medical device reporting system, Congress passed the Safe Medical Devices Act of 1990, under which most health care providers had to report device-related deaths and injuries to the device manufacturers and/or the FDA. This act was expanded in December 1995 to include home health care companies.
* What must be reported?
The SMDA requires that hospital-based home health care companies and other health care providers file reports of device-related deaths to both the FDA and device manufacturers, if the manufacturers are known. Device-related injuries must be reported to device manufacturers; if the manufacturer of a device involved in an injury isn't known, then the incident must be reported to the FDA.
If you report any incidents to either the FDA or device manufacturers, you must also file a semiannual report listing all of the reports you made. (See resource list for instructions on obtaining semiannual report forms, p. 31.)
* When must reports be filed?
Incidents related to, or which may have been caused by medical devices must be reported to the FDA and/or the device manufacturers within 10 working days of the event. The FDA considers "working days" to be Monday through Friday, excluding federal holidays.
* Who should be responsible for device incident reporting?
The FDA rules require that health care providers designate a contact person to be responsible for filing incident reports, making sure that your company is in compliance with the rules, and for corresponding with the FDA about device-related incident reporting.
The fact that one person must be designated to do this does not mean that that person is legally responsible for the reports. Your company and its officials have the ultimate responsibility for compliance with the requirements.
* What does the FDA do with the information I file?
The FDA enters all medical device reports into a computerized database called the Manufacturer and User Device Experience database, or MAUDE. This allows the FDA to sort the data to look for trends. In addition to finding problems caused by medical devices, this helps the FDA identify user error trends that could indicate that a device needs to be designed or packaged differently to help prevent user error.
* Are the reports I file with the FDA kept confidential?
Under the Freedom of Information Act (FOIA), any medical device incident report is available for public disclosure. Most documents held by U.S. government agencies are covered by the FOIA, and FDA documents are no exception. However, the reports are also covered by the Privacy Act, which governs access to an individual's U.S. government records. The FDA will delete the following information from reports before making them available to those who request the reports under the FOIA:
-- any personnel, medical or similar information, including serial numbers of implanted devices, which would constitute an invasion of personal privacy;
-- any information that constitutes a trade secret or confidential commercial or financial information.
The FDA may divulge the identity of the facility to the manufacturer of the device that is the subject of a report. If the FDA penalizes an agency for noncompliance with the SMDA rules, the agency's identity will not be protected. No patient information will be released in any case. Employees' names are not to be listed anywhere on the FDA's forms, so there is no risk of employees' names being made known to device manufacturers or the public.
However, home care agencies and other health care providers must establish their own medical device incident records that do include employees' and patients' names so that the FDA can contact these people should an investigation be necessary. The FDA can request additional information even after an event has been reported.
* Can reports to FDA be used as evidence in civil actions?
By law, these reports cannot be admissible as evidence or otherwise used in any civil action unless the facility, individual or physician who made the report knew that the information in the report was false.
* How are the regulations enforced?
The FDA has the right to inspect, routinely, industries it regulates to determine compliance with this and other regulations. This means that your agency can be inspected with or without warning.
The FDA likens its inspections to being audited by the Joint Commission on Accreditation of Health Care Organizations or the Health Care Financing Administration, but with a focus on the SMDA reporting requirements.
If the FDA arrives at your doorstep, this is what you can expect:
-- The FDA investigator will issue an FDA Form 482, Notice of Inspection to the person at your company who has been designated to be responsible for SMDA reporting.
-- The FDA investigator will request access to your files that contain any information about patient deaths and serious injuries or illnesses that may have involved medical devices. The investigator will look in these files to see whether you have been reporting device-related incidents to the FDA and device manufacturers as required.
-- If the investigator observes problems you have had complying with the incident reporting rules, the investigator will give the person responsible for incident reporting at your company an FDA document called "Form 483, Inspectional Observations." This form will list the problems the investigator found in your files. Also, your company will be given an education package identifying what you need to do to keep the problems you had from recurring, so you can avoid being penalized in the future.
-- The inspection report written by the investigator will be forwarded to the FDA's Center for Devices and Radiological Health (CDRH) for analysis.
The FDA recommends that companies be prepared for inspections by maintaining current and accurate records, and by making sure that you have appropriate device-related problem reporting policies and procedures in place.
* Can I be penalized for not complying?
Yes. Though the FDA's medical device incident reporting rules were passed in 1990, the FDA wasn't given the power to impose civil penalties for noncompliance with the act until August 1995. As was explained in the February 1996 issue of Hospital Home Health, the FDA may impose a fine of up to $15,000 for a single violation of the SMDA reporting rules, and up to $1 million for a series of violations.
If your company is inspected and is found to be out of compliance with the medical device reporting rules, this is what you can expect to happen:
-- The FDA will begin a civil penalty action by filing a complaint with the FDA's Dockets Management Branch, and serving it on you. The complaint will state the violations your company is alleged to have committed, and the amount of penalties sought.
-- Your company will be given the opportunity to request a hearing. If you opt to do this, you will experience something similar to a trial, presided over by an administrative law judge who will issue an initial decision. Both your company and the FDA may appeal this initial decision with the Departmental Appeals Board of the Department of Health and Human Services. After that, your company may request judicial review of the Board's decision by filing an appeal in the U.S. Circuit Court of Appeals, District of Columbia Circuit. *
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