Where to find more information
The following are instructions for getting further information about Safe Medical Device Act (SMDA) incident reporting available from various sources. Providers of this information recommend that when home care companies contact them to request any of this information, they also ask what new information is available, as new manuals and guides are frequently published. (Additional resources appear in Hospital Home Health,, February 1996, p. 24.)
* The Rockville, MD-based Food and Drug Administration's (FDA's) Q & A booklet.
This book is being distributed by other organizations including:
-- The American Hospital Association. The AHA's publishing company, American Hospital Publishing, will have the Q & A booklet available sometime this month. For further information, write or call: AHA Services, P.O. Box 92683, Chicago, IL 60675-2683. Telephone: (800) AHA 2626. Fax: (312) 280-6015.
-- Emergency Care Research Institute (ECRI), a nonprofit, independent health service research firm, will also offer the Q & A booklet, as part of its SMDA educational package. See the last item in this list for more information on this.
-- The World Wide Web. The FDA will make the Q & A booklet, as well as other information about the SMDA reporting rules available through its homepage, which will be hyperlinked to the book's address. The FDA's homepage address is: http://www.fda.gov/fdahomepage.html
* FDA User Facility Reporting.
The FDA publishes this free quarterly bulletin to assist hospitals, nursing homes, and other device user facilities to comply with medical device incident reporting rules. In the past, "FDA User Facility Reporting" has covered issues such as problems that health care providers have had filling out MedWatch forms, changes to the existing reporting rules, and common questions readers ask about complying with reporting rules. To get on the mailing list for this publication, call or write to the publication's editor, Nancy Lowe, Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health (HFZ-230), 1350 Piccard Drive, Rockville, MD 20850. Telephone (301) 443-2436.
* Informational video.
The FDA plans to conduct a video conference in April or May for hospital-based home care companies and other providers to ask the FDA their questions about the reporting rules. The video conference will be taped and copies of it will be made available to providers, Lowe says. Since a date has not yet been set for the conference, Lowe advises HHH readers to contact her this month to obtain further information about this.
* The final rule.
There are several ways to obtain the FDA's final rule detailing the new medical device incident reporting regulations.
-- The rule can be found in the Dec. 11, 1995 Federal Register . You can obtain the final rule at a public or university library that serves as a federal depository library.
-- You can also obtain the final rule from the Federal Register Online. The address for this is: wais.access.gpo.gov. This is the document you will need:
Medical devices; medical device user facility and manufacturer reporting, certification and registration. (1995). U.S. Department of Health and Human Services, Food and Drug Administration. Federal Register, 60(237). Dec. 11, 1995. Docket No. 91N-0295, RIN 0910-AA09.
-- Also, readers may obtain the final rule from the FDA's automated fax system by following these steps:
1. Dial (800) 899-0381 or (301) 827-0111 from a touch-tone telephone.
2. Listen to the initial greeting. Press 1 to access the Division of Small Manufacturers Assistance (DSMA - pronounced "disma") section.
3. The system will ask for the number of the document you wish to receive. Press 2 to request the final rule. Enter 366, which is the "shelf" number for the final rule. You will be prompted to confirm your request by pressing 1 for yes, and 2 for no. Press the pound sign again to end document selection and go on to the next step.
4. The system will ask for your fax number. Enter your number, including the area code, but do not dial 1 before the area code. Then press the pound sign (#).
5. You will be asked for your telephone number for the cover sheet of the faxed document you will receive. Enter this in the same way as you did your fax number.
* Coding manual and instructions.
You can also get the coding manual and instructions for filling out the FDA's device incident reporting forms through the same automated fax system that provides the final rule. Follow the same steps, but request document number 853.
* FDA medical device incident reporting forms.
Many of the forms you will need are enclosed in this issue of Hospital Home Health, but you can also get them from the FDA's automatic fax system. Follow the same steps as for getting the final rule, but enter document 854. The semiannual report forms are document 409.
* Internet and telnet access to FDA forms.
The FDA has a system called Electronic Docket that provides medical device regulations, forms, Safety Alerts and other information 24 hours a day, 7 days a week. There are two ways to access Electronic Docket:
-- If you have a video terminal or personal computer (communications program must have VT emulation) with a modem that can operate at a baud rate of 2,400, 4,800 or 9,600 and the "kermit" file transfer protocol (FTP) system, dial (800) 252-1366 or (301) 594-2741 on your modem, and a message will appear on the screen with the word "connect." Then press "enter" two or more times and the message, "Welcome to Electronic Docket" will appear on the screen. The system will give you the prompt, "Connecting to Electronic Docket," and then the main menu will appear. Select number one on the main menu for further instructions.
-- If you have Internet access, you can telnet to the FedWorld GateWay system operated by National Technical Information System. The access address is fedworld.gov. Follow the prompts to the GateWay system, select "D>Connect to Gov't sys/database" and enter "18" for the Electronic Docket. The National Technical Information System's help desk number is (703) 487-4608.
* ECRI.
This nonprofit, independent health service research firm offers several resources and programs that can help you ensure that your company's staff members are knowledgeable about the FDA's regulations:
-- A manual titled Medical Device Reporting under SMDA includes pointers on how to implement the regulations, analysis of the regulations, copies of the rules, sample policies and procedures, reporting forms and tools, risk management checklists, incident investigation techniques and tools, and handouts for staff development and training. Price: $245, or $195 if purchased before publication. For further information write or call ECRI: 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000.
-- The Continuing Care Risk Management Program helps providers comply with the FDA's new addition to the SMDA. The program offers instructional literature, self-assessment questionnaires, telephone help lines, and computerized services for use with the electronic filing system offered by the FDA. Write or call Amy Goldberg-Alberts in ECRI's risk management department, at the contact listed above. *
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