Help your field staff understand FDA rules
Staff education is key to compliance
Once you have laid down your company's internal process for reporting medical device-related incidents under the Food and Drug Administration regulations, you can get down to educating your staff about it.
You may be able to simplify teaching your staff about the Rockville, MD-based FDA's reporting rules by using educational materials your hospital has been using to educate their staff, says Ronni P. Solomon, JD, vice president of legal affairs at Emergency Care Research Institute **CRI), a nonprofit, independent health service research firm in Plymouth Meeting, PA. Hospitals have had to comply with the Safe Medical Devices Act (SMDA) since 1991.
Educating your staff members about the rules can be done in a short inservice or in a regular staff meeting, consultants and providers say. Solomon and FDA spokespeople say these are the items that should be covered in the inservice or meeting:
* What the FDA medical device-related incident reporting rules mean for home care.
Give a brief overview of the FDA's reporting rules, Solomon says. This could include the fact that hospitals have had to comply with the rules since 1991, and that the rules have been expanded to include home care to further protect public health.
"It's important to explain why we have to do this to get buy in from staff," says Debrah D. Wonder, BSN, PHN, MS, the director of education and program development at the Hospital Home Health Care Agency of California in Torrance.
* How your company's reporting procedure will work.
This section of your inservice or staff meeting would be the time to introduce your flow chart, if you choose to use one, and to explain how medical device incident reporting has been added to your existing risk management and quality improvement systems, 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.
Tell staff why they have to report
Solomon recommends explaining to staff that any incident reports made to the FDA or device manufacturers must be written objectively. In addition to ensuring that the FDA will be able to conduct high quality medical device report analysis, objectively written reports will protect staff members and companies from accusations by medical device manufacturers that they misused devices.
When writing reports, field staff members should make sure they stick to the facts, Solomon says. They should not speculate or draw conclusions as to what happened, and they should not express their opinions or editorialize, she says.
"The example I always found in hospitals was when a nurse would find a patient on the floor in his or her room. The nurse would write, 'Patient fell out of bed.' But you don't know that they fell out of bed. Just write what you found, which is that the patient was found on the floor," Solomon says.
Also, staff members should understand that reporting an event to the FDA does not constitute an admission that medical personnel, user facility, distributor, manufacturer or product caused or contributed to the event.
* What constitutes a reportable event.
Home care providers as well as other health care facilities are responsible for making a judgment about when an incident should be reported. According to the FDA's rule, any serious injury or death to a patient or employee that may have been contributed to or caused by a medical device must be reported. (For answers on how to report incidents, see story, p. 29)
Of course, this leaves open the question of what constitutes a serious injury. "It's broad, so be sure to teach this," Solomon says. The FDA gives a three-pronged definition of a serious injury, which Solomon recommends explaining to staff members:
-- an injury or illness that is life-threatening;
-- a permanent injury, impairment, or damage;
-- an injury that necessitates medical or surgical intervention to preclude permanent impairment.
"That last part is the gray area," Solomon says. To help employees decide what incidents fall under this regulation, Solomon offers this rule: "If the manufacturer could make a better device with your information, then report it."
The FDA also acknowledges that it isn't always known whether a medical device contributed to an incident. FDA officials suggest that if any of the following assessments applies to the incident, it should be reported:
-- the medical device actually caused or contributed to the outcome;
-- the medical device cannot be ruled out as a possible cause of the event;
-- the health care professional suspects that the medical device was involved, because there is no other plausible explanation for the incident.
Staff members should be told that they do not have to report medical device incidents that are caused entirely by user error, Solomon says. For example, a nurse may have incorrectly programmed an infusion pump.
However, if the misuse of the medical device was caused by poor design or poor labeling, then the incident should be reported, under the FDA rule, Solomon says. *
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