The FDA wants you to file medical device incident reports, too
Ask your hospital risk manager how to bring agency into compliance
Now is the time to start preparing to comply with the new U.S. Food and Drug Administration (FDA) medical device incident reporting rule for home health care companies, which takes effect April 11, under the Safe Medical Devices Act (SMDA).
The FDA, based in Rockville, MD, requires that home health care companies and other providers file reports of deaths related to medical device problems to both the FDA and the companies that made the devices, if they are known. Device-related injuries must be reported to manufacturers, but if the manufacturer isn't known, the incident must be reported to the FDA.
The FDA doesn't have the funds to print and distribute much information about how to comply with the new rule, so HHH will share with you as much as possible, and tell you how to get more information as it becomes available.
FDA officials, hospital risk managers who have complied with the rules since 1991, and consultants offer the following tips for complying with the FDA rules:
* Learn how the FDA rule affects home care.
Hospital-based home care company managers don't need to slog through all 75 pages of the FDA's final rule on medical device incident reporting, says Nancy Lowe, MA, an FDA consumer safety officer. (But if you do want to read the entire rule, see p. 31, for instructions on how to obtain it.)
"It addresses all these things that importers and manufacturers have to be aware of, so most of it you don't need to read," she says.
Instead, home care managers should have a basic understanding of why they need to file reports of medical device-related incidents, Lowe says. (See story for more information on why Congress passed the device reporting rule, p. 29)
However, John C. Metcalfe, JD, BA, FASHRM, the director of risk management services at Memorial Health Services in Long Beach, CA, recommends reading the whole rule.
"The rule is updated from time to time, and it's important to keep current with the rule," Metcalfe says.
Metcalfe says he has reread the rule several times since his hospital first had to comply with it in 1991.
* Designate a person or team to write new policies and procedures.
The FDA rules require that hospital-based home care companies designate one person to oversee device-related incident reporting. (See reporting form, enclosed.) Depending on the size of your company, you might delegate the job of writing the necessary policies and procedures to one person, says Ronni P. Solomon, JD, vice president of legal affairs at ECRI, a nonprofit, independent health service research firm in Plymouth Meeting, PA.
Or, you could set up a team to tackle this job. At First American Health Care, in Brunswick, GA, home care clinical education director Peggy Lee, RN, BSN, assembled an adverse drug committee at the company's corporate level, in response to the FDA's new rule. The committee members included Lee, the infusion manager, the medications coordinator for the QI department, and the infection control manager.
SMDA team meets twice annually
At Memorial Health Services in Long Beach, CA, the SMDA team meets twice a year to review the company's reporting policies and procedures, says Metcalfe. These meetings also serve as a time for the team to review the device-related incidents that were reported, to double-check that the reports were filled out correctly, and to file semiannual reports to the FDA if any incidents were reported during the six months prior to the meetings. (A copy of the FDA reporting form is inserted into this issue of HHH. Information on how to obtain the semiannual reporting form and the coding manual you will need to fill out the forms appears in the resource list, p. 31) Whether you designate a person or a team to serve as the FDA liaison, field staff should be able to contact these point people 24 hours a day, says Tucson, AZ-based consultant Emanuel Furst, PhD, who helped hospitals and nursing homes comply with the SMDA regulations when they were first implemented in 1991. (See p. 28 for tips on educating staff on complying with the FDA rules.)
"People's ability to know what happened diminishes 24 hours after the event. Memory fades, details get confused, settings on devices get changed, packaging gets thrown out. You need to get going as soon as the incident happens," Furst says.
* Review your hospital's existing reporting policies and procedures.
Because hospitals have had to comply with the SMDA since 1991, you may be able to model your company's new policies and procedures on your hospital's policies, Solomon says.
* Modify your incident reporting forms to accommodate SMDA rules.
The FDA asks that providers keep records of the people who are involved with any incidents that occur, in case a follow-up investigation is necessary. Home care companies are responsible for deciding how they want to maintain this information.
Memorial Health Services' system for recording medical device incidents include the following documents:
-- FDA device-related incident report;
-- internal incident report;
-- letter to device manufacturer reporting event;
-- letter of receipt of report from manufacturer;
-- device testing results from the hospital's biomedical engineering department;
-- device testing results from device manufacturer;
-- documentation of when the device was given to its manufacturer and in what condition;
-- documentation of when the manufacturer returned the device to the hospital, and in what condition.
Hospital-based home care providers should also keep records of incidents that they decide don't need to be reported to either the FDA or device manufacturers, says Furst.
"If you decide an event isn't reportable, you should document this, and why you made this decision, just as you would with reportable events," Furst says.
Form aids internal tracking
ECRI, an independent nonprofit health services research agency based in Plymouth Meeting, PA, offers an internal reporting form that providers can use to track device-related incidents internally. (A sample copy of this form is enclosed in this issue of HHH. See resource list for information about ECRI's instructional packages and seminars for complying with FDA reporting rules, p. 31.)
* Keep device-related incident records separate.
Hospital-based home care providers should keep their medical device reports separate from other risk management records, Furst says. This way if an FDA investigator shows up at your company, you can easily access your records. This doesn't mean you have to duplicate documents such as patient records, Furst says. You can just keep a note in the device-related incident referring to the patient's records.
* Set up a process for reporting incidents.
"You have to have a process for how you're going to handle these incidents," says Metcalfe.
At Memorial Health Services, Metcalfe has set up a system that includes the following components:
-- the device that is suspected to have caused or contributed to the incident is "sequestered," with a tag on it indicating what happened and when, and who is going to inspect the equipment;
-- the device is not given back to its manufacturer until the hospital has investigated the incident;
-- the hospital's biomedical engineering department investigates the incident. If necessary, the hospital will call in a consulting firm to help investigate the incident, to ensure the investigation is objective;
-- once the incident has been investigated, the hospital will turn the device over to its manufacturer, if that company wants to see the device.
Creating a flow chart to illustrate your reporting procedure is a good way to make sure that incidents are handled correctly, says Furst. (See sample flow charts, enclosed.)
"Device-related deaths and injuries occur infrequently, so it's often difficult to maintain staff awareness of the reporting procedure for these events," Furst explains.
* Monitor compliance with reporting rules.
The first quarter or two after you implement the new SMDA reporting rules is when you should watch closely to see that employees are complying with the new regulations, Wonder says.
Pay special attention to your first line supervisors, because they are the people who will catch any problems reporting incidents that field staff may have, Wonder says. She says she will likely do this by periodically asking her company's first-line supervisors whether they have had any medical device incidents to report, and if so, how they were reported. *
* Nancy Lowe, Consumer Safety Officer, Food and Drug
Administration/Center for Devices and Radiological
Health, 1350 Piccard Drive/mail code HFZ-230,
Rockville, MD 20850. Telephone: (301) 443-2436
* Emanuel Furst, Consultant, P.O. Box 42102, Tucson,
AZ 85733. Telephone: (602) 745-0765.
* Debrah D. Wonder, Director of Education and
Program Development, Hospital Home Health Care
Agency of California, 2601 Airport Drive, Suite 110,
Torrance, CA 90505. Telephone: (310) 530-3800.
* Peggy Lee, Director of Clinical Education, First
American Health Care, 3528 Darien Highway,
Brunswick, GA 31525. Telephone: (800) 677-4251.
* John C. Metcalfe, Director of Risk Management
Services, Memorial Health Services, 2801 Atlantic
Avenue, Long Beach, CA 90801. Telephone: (310)
933-2121.
Correction: How to file FDA semiannual reports
An article announcing the Rockville, MD-based Food and Drug Administration's new medical device incident reporting rules in the February issue of Hospital Home Health contained an error.
The Safe Medical Devices Act of 1990 only requires that providers file semiannual reports to the FDA and/or device manufacturers in January and June if they have reported any device-related incidents in the six months prior to the filing deadline. If no reportable incidents have occurred, providers should not file semiannual reports, according to the FDA. HHH regrets the error. *
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