April 1997 Bulletin

Need MedWatch guidelines on reports

by

Mark N. Melkerson, MS and

A. Seth Greenwald, D.Phil.(Oxon)

Mark N. Melkerson, MS, is branch chief, Orthopaedic Devices Branch, Division of General and Restorative Devices, Office of Device Evaluation, Food and Drug Administration.

A. Seth Greenwald, D.Phil (Oxon) is director of orthopaedic research at the Mt. Sinai Medical Center, Cleveland, Ohio, and serves as consultant to the Academy's Committee on Biomedical Engineering and the Orthopedic and Rehabilitational Devices Advisory Panel for the FDA.

MedWatch, like most regulatory programs, raises many questions from orthopaedists. What is its purpose? Who is involved? What information is collected? What constitutes a reportable event? What are the safeguards for the orthopaedist who identifies a problem? How does the Food and Drug Administration (FDA) intend to use and disseminate the information collected? This article attempts to address these questions.

In 1993, the FDA introduced a new system for reporting adverse events associated with the use of human drugs, devices and biologics, called MedWatch. This unifying program replaced the existing voluntary device Problem Reporting Program (PRP) begun in 1973 and the mandatory Medical Device Reporting (MDR) program begun in 1984. Through MedWatch, FDA hoped to involve the entire health care community and foster an uncomplicated, yet more effective, adverse event reporting system.

Prior to the MedWatch program, there were some gaps in the reporting of adverse events to the FDA. For example, there was no standardized method or form for reporting events. Manufacturers were only required to report events made known to them if they had sufficient information. Also, there were no requirements for health care facility representatives to report adverse events to manufacturers. As part of the Safe Medical Devices Act (SMDA) of 1990, the MedWatch program included a mandatory requirement for "user facilities," defined as hospitals, nursing homes and outpatient treatment centers, to submit adverse event reports to both manufacturers and FDA.

In addition to the mandatory user facility reporting, the MedWatch program continues the voluntary reporting program and the mandatory manufacturer and distributor reporting programs while adopting simple standardized reporting forms. For more information or copies of the MedWatch forms call (800) FDA-1088.

The SMDA of 1990 identifies a reportable event as a death, life-threatening event or serious injury. A serious injury is further defined as an event where medical or surgical intervention was required to preclude impairment of a body structure or function. This definition of a reportable event includes a broad range of orthopaedic procedures and events. If taken literally, reportable events include things such as patella failure, modular acetabular cup failure, spinal fixation failure, particle disease resulting in hip revision, artificial ligament failure, threaded external fixation pin failure, broken femoral stem and pulmonary embolus. Because of this broad range of events, the Academy's Committee on Biomedical Engineering and FDA have discussed preparation of a guidance document on what constitutes reportable orthopaedic events. The health care community is still encouraged to report any event; even if they are not sure that the product caused the adverse event or do not have all the details regarding the event.

Of further and perhaps most concern to orthopaedists is accessibility to the information contained in the MedWatch reports. It is understood by FDA that confidentiality must be maintained for the MedWatch program to succeed. Under the Freedom of Information (FOI) Act, any report is available for public disclosure after it has been purged of confidential information such as patient and reporter identification. The FOI Act further states that reports are not admissible into evidence nor can they be used in any civil action involving parties unless the facility or individuals, including the physician making the report, knew the information was false. Because of MedWatch report confidentiality concerns, FDA has sought to provide further protection of reporter and patient confidentiality in the regulation entitled "Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules" Federal Register, 60, (63):16962-16968, April 3, 1995.

Because of the belief that the evaluation of the safety and effectiveness of orthopaedic devices should not be based solely on premarket assessments, FDA uses MedWatch reports to assess postmarket performance of orthopaedic devices. To make the MedWatch program more useful for orthopaedists, the following efforts need to be made: all orthopaedists need to be encouraged to participate; guidelines for the types of reportable orthopaedic events need to be developed; better protection for reporters of adverse orthopaedic events needs to be established; and a viable means of making the findings from the MedWatch reports available for the utilization of orthopaedists needs to be developed.


Home Previous Page