Teleconference targets medical device reporting
Regulation expands requirements
Same-day surgery managers can get information about the new regulation on medical device reporting from a free, live satellite teleconference by the U.S. Food and Drug Administration in Rockville, MD.
An FDA teleconference from 1 to 4 p.m. May 7 will discuss the new reporting requirements. (For more information on the teleconference, see editor's note at end of story.)
Hospitals, surgery centers, and certain other facilities have been required to report deaths and serious injuries related to medical devices since 1991. But new FDA rules expand the incidences that must be reported and require reports on a specific form.
The medical device reporting regulation, which was published in the Federal Register on Dec. 11, 1995, and becomes effective July 31, brings greater uniformity to the reporting mechanism, according to Mary Lou Pijar, an FDA public health adviser.
In one significant change, same-day surgery managers must now report incidents related to user error, Pijar says. Device-related deaths or serious injuries must be reported if they occur to employees, as well as patients.
According to an FDA bulletin, facilities are now required to:
* report device-related deaths to the FDA and manufacturer within 10 working days on MedWatch Form 3500A;
* report serious injuries to the manufacturer (or the FDA, if the manufacturer is unknown) within 10 working days on MedWatch Form 3500A;
* provide semi-annual summaries of death and serious injury reports each Jan. 1 and July 1 on Form 3419.
The FDA is also asking facilities to report malfunctions that don't result in death or serious injury to manufacturers on Form 3500A.
Follow these steps to obtain forms
A code manual is available to assist providers in filling out the forms.
Providers also may use an automated fax system from their touch-tone phones to request forms and information. If documents are 19 or fewer pages, they will be automatically faxed to you within a few minutes. Documents more than 19 pages will be faxed after normal business hours.
Call (800) 899-0381 or (301) 827-0111. Press 1 at the initial voice prompt, 2 at the second voice prompt, and then enter the three digit number of the following documents. Press the pound (#) sign after each selection.
336, final rule (77 pages, single spaced);
407, baseline report form 3417;
408, annual certification form 3381;
409, semiannual report 3419;
853, Medwatch form instructions;
854, Medwatch form 3500A.
For a copy of the codes to help fill out the semiannual report, fax a request to FDA at (301) 443-8818.
Same-day surgery managers should designate a staff person as the medical device reporting contact and maintain an event file related to medical device incidents, according to the FDA. Information about events that were "evaluated but not reported" should be kept in that file, as well as copies of all reports, the FDA says.
Same-day surgery manager must also develop written procedures outlining how they plan to comply with the medical device reporting regulation.
Publication of a final medical device reporting regulation has been pending since the adoption of the Safe Medical Devices Act of 1990.
[Editor's note: To receive the FDA teleconference, you must have access to a Ku-band or C-band satellite dish. To receive the satellite coordinates, register by calling: (800) 305-0748. You will be asked to provide your fax number to receive further information. For information about the medical device reporting regulation, fax questions to: (301) 594-2235.] *
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