Risk Management

Safe Medical Devices Act: Reporting Requirements and Risk Management Concerns

By Pamela S. Schremp, RN, MSN, CRNO

Argus, September, 1992

A new law mandating the reporting of injuries resulting from defective medical devices is generating concern among ophthalmologists, risk managers and others that the reports could be interpreted as an admission of liability by the user.

The Safe Medical Devices Act of 1990 (SMDA) (Public Law 102-629) requires ambulatory surgery centers, hospitals, outpatient diagnostic centers and other user facilities to report all incidents in which a medical device or user error may have caused or contributed to the death, serious injury or serious illness of a patient. Physicians’ offices are exempt from reporting such incidents, but surgicenters such as those run by many ophthalmologists are not. Additionally, the new law’s interim guidelines require that user error by, for example, an ophthalmologist working in a hospital must be reported.

All reports filed under the SMDA are available for public disclosure under the Food and Drug Administration’s (FDA) Freedom of Information Act, although information that constitutes an invasion of personal privacy is presumably deleted from the report prior to its release. However, the FDA recognizes that submission of a report is not necessarily an admission that the submitter, the device, the facility or its employees caused or contributed to the event being reported. The law does state that reports are not admissible into evidence unless the report contains false information and the facility, individual or physician filing the report knew this information was false.

Reports, however, can be obtained by a plaintiff’s attorney and possibly used as background information to build a case. To protect against this, reports should include a disclaimer indicating that it is submitted “in accordance with the Safe Medical Devices Act (21 CFR 803.32 (c)) and does not constitute an admission that the device, the reporting facility or its employees caused or contributed to the event which is the subject of the report.”

User facilities have always had the option to voluntarily report such events to the manufacturer. However, prior to November 1991, when the SMDA took effect, few reports were ever filed. Consequently, the federal government enacted mandatory reporting by user facilities to assist in the detection of defective medical devices and assure their rapid removal from the market.

Final regulations for the SMDA have not yet been promulgated. Tentative final rules were issued in November 1991, with broad definitions that left room for interpretation. For example, a “device” refers to any instrument, apparatus, implement, machine, in vitro reagent or other related article intended for use in the diagnosis or treatment of a patient (21 USC 331 (h)). Under this definition, most equipment used by ophthalmologists, including lasers, microscopes, tonometers and intraocular lenses, is subject to SMDA requirements.

“Serious injury or illness” means those injuries that are life threatening, result in permanent body function impairment or permanent damage to a body structure, or necessitate immediate medical or surgical intervention to prevent permanent body function impairment or permanent damage to a body structure (21 CFR 803.3) (r). The last phrase of the definition has created confusion and left room for interpretation.

Examples of ophthalmic related incidents that presumably must be reported under the SMDA include removal or exchange of an intraocular lens due to pseudophakic bullous keratopathy, severe corneal ulcer in an extended wear contact lens patient requiring hospitalization, and laser beam reflection causing a burn to a resident wearing the wrong goggles in a hospital-sponsored eye clinic. Even though the observer wore the wrong goggles, the last example is reportable as user error under the SMDA’s tentative final rules. The rules included user error to assist the manufacturer in obtaining information that might make the device safer or easier to use.

Reports must be submitted to the manufacturer within 10 working days after the facility becomes aware of information that reasonably suggests a possibility that a device may have caused or contributed to the death, serious injury or serious illness of a patient of the facility. If the manufacturer is unknown, the event must be reported to the FDA. Events in which a device may have caused or contributed to a patient’s death must be reported to the FDA as well as to the manufacturer. The user facility must also submit a semiannual summary of previously reported events to the FDA by Jan. 31 and July 31 of each year.

Even though final regulations for the SMDA have not yet been released, tentative rules are in effect, and all ophthalmologists are advised to become acquainted with them. To obtain a copy, contact OMIC, 655 Beach Street, San Francisco, CA 94109.

Ophthalmologists who own or manage ambulatory surgery centers should establish policies and procedures for determining if an event is reportable and for sequestering equipment (including disposables such as tubing) that may have been involved in a reportable event until its safe use can be assured. These policies should address:

To what extent will the center investigate the event?

How and under what circumstances will the device be released to the manufacturer?

Who will be responsible for putting the SMDA into operation, including recordkeeping and report submission? Be sure to include a disclaimer statement in every SMDA report submitted to the manufacturer and to the FDA.