New medical device regulations from FDA
Stiff fines to be imposed for noncompliance
The Food and Drug Administration (FDA) has issued new medical device regulations that expand the current law to include all alternative sites that use medical devices, including home health.
Though these regulations entail yet more paperwork for home health agencies, the price of not complying isn't worth it. You can be fined $15,000 per violation, up to $1 million.
Beginning April 11, home health care providers will be required to comply with the Safe Medical Devices Act of 1990 (SMDA). Under the final rule issued by the Rockville, MD-based FDA, a home care company's adverse incident reporting, record-keeping, forms, and written policies and procedures now must parallel those followed by hospitals, nursing homes, and other health care facilities since the SMDA went into effect in 1991.
When the first proposal for SMDA regulations targeting manufacturers, hospitals, and nursing homes was released, it did not seem to be the FDA's intention to impose the law's reporting requirements on home health companies, says Ronni P. Solomon JD, vice president of legal affairs at ECRI, an independent, nonprofit health service research agency based in Plymouth Meeting, PA.
This changed on Dec. 11, 1995, however, when FDA officials released the SMDA final rule in the Federal Register, which includes language that extends the law's reach to cover "outpatient treatment and diagnosis facilities," which include home health care.1
"What the amendments did is extend the reporting requirements throughout the chain of use, rather than just have the manufacturers [report]," says Robert B. Nicholas, Esq., a partner with the Washington, DC, law firm, McDermott, Will, & Emery. "The rule that came out on Dec. 11 is the final rule with respect to reporting for the user community," he says.
Solomon adds, "I believe this is the first time that the FDA will have any direct regulatory authority over home health agencies."
Ironically, the new FDA rules were issued within days of the publication of a controversial study in the Annals of Internal Medicine , questioning the safety and efficacy of the Landmark midline catheter, a device widely used in the home infusion industry.2 (See information on Landmark catheter, p. 22, and the Special FAXBulletin, reprinted and inserted in this issue.)
Reporting responsibilities expanded
In addition to extending SMDA to cover more facilities, including home health care, the new FDA regulations increase reporting responsibilities among providers. These include requirements to keep ongoing records of any adverse events within your facility and to submit semiannual reports to the FDA that are a compilation of any reports submitted during each six-month period. Even if no events occur, providers still must submit the semiannual report indicating this fact.
Further, the definition of a reportable event has been expanded to include, among other provisions, the requirement to report on incidents in which devices have caused or may have caused or contributed to a death or serious injury, even if the events occur as a result of user error. Home care companies and device manufacturers also must establish and maintain medical device reporting procedures as part of their written policies and procedures within their company. Likewise, providers must maintain "event files" containing information related to the adverse event, documentation of deliberations and decision-making processes on what course of action was taken, and copies of forms and other information submitted to the FDA and other entities. The law requires a two-year record retention period for reports submitted by clinicians related to medical device events.
"Also, if you decide not to report an event, you should detail your reasoning in this file," Nicholas says.
New reporting forms and coding manuals are being made available through the FDA's MedWatch office, and providers have the option of submitting their semiannual reports electronically. Directions on how to fill out the report properly can be found in the FDA's Mandatory Reporting Coding Manual. (See resources, p. 24.) It's important to note that keeping records of incidents does not require that providers maintain the entire patient file, FDA officials note. Rather, providers reporting on an adverse incident should cross-reference the report to the patient's medical file. (Look for tips on how to comply with these new regulations in the March issue of Hospital Home Health.)
References
1. Medical devices; medical device user facility and manufacturer reporting, certification, and registration (1995). Department of Health and Human Services, Food and Drug Administration. Fed Reg 60 (237). Dec. 11, 1995. Docket No. 91N-0295, RIN 0910-AA09.
2. Mermel LA, Parenteau S, Tow SM. The risk of midline catheterization in hospitalized patients. Ann Intern Med 1995; 123(11): 841-844. *
Resources for Info on FDA Regulations
The following are some resources for finding out more about the Food and Drug Administration's new medical device reporting regulations:
* Medical Device Reporting under SMDA (available early February 1996). A comprehensive guide offering tips on implementation, analysis of the regulation, 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. Contact: ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000.
* Food and Drug Administration (FDA) MedWatch Forms (No. 3500A) and Semiannual Reporting Forms (No. 409). Contact: Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850-4307.
Or, order these FDA documents through an automated fax system, 24 hours a day, seven days a week, by calling: (800) 899-0381. Press 1 at the initial voice prompt, 2 at the second voice prompt, and then enter the three digit "shelf number" for the document(s) you want:
-- Federal Register, Final Rule (Docket 91N-0295), Shelf No. 336;
-- Baseline Report, Form FDA 3417, Shelf No. 407;
-- Annual Certification, Form FDA 3381, Shelf No. 408;
-- Semi-Annual Report, Form FDA 3419, Shelf No. 409;
-- Instructions for Completing FDA Form 3500A with Coding Manual, Shelf No. 853;
-- MedWatch, FDA Form 3500A, Shelf No. 854.
* Health Devices Alerts Data Base. World's largest data base on medical device problems, hazards, and recalls. Available on-line and on CD-ROM. Specialized searches also available. Contact: Eileen Erinoff, Editor, Health Device Alert, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000.
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