The following are some frequently used terms regarding medical device recalls:
Recall strategy means a planned course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.
Recalling company means the company that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the company that has primary responsibility for the manufacture and marketing of the product to be recalled.
Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, re-labeling, destruction, or inspection.
Risk to health means either a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death or that use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.
Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy (calibration, replacement of batteries, and responses to normal wear and tear). Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.
Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer. For example the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use.
Health Hazard Evaluation
An evaluation of the health hazard presented by a medical product being recalled or considered for recall is conducted by the FDA and takes into account the following factors:
Whether any disease or injuries have already occurred from the use of the product.
Whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard. Any conclusion shall be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion of the individual(s) making the health hazard determination.
Assessment of hazard to various segments of the population, e.g., children, surgical patients, pets, livestock, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be at greatest risk.
Assessment of the degree of seriousness of the health hazard to which the populations at risk would be exposed.
Assessment of the likelihood of occurrence of the hazard.
Assessment of the consequences (immediate or long-range) of occurrence of the hazard.
On the basis of this determination, the FDA will assign the recall a classification. This is a Class I, Class II, or Class III classification that indicates the relative degree of health hazard of the product.
Medical Devices — An Overview
The Federal Food and Drug Administration (FDA)`s Center for Devices and Radiological Health (CDRH) is responsible for regulating companies/firms who manufacture, repackage, re-label, and/or import medical devices that are sold in the U.S. In addition, the CDRH regulates radiation emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, etc.
The CDRH maintains information collected from device experience reports on medical devices which may have malfunctioned or caused a death or serious injury. This data is contained in the:
Medical Device Reporting (MDR) database – The MDR files contain reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 – 1996, and the voluntary reports up to June 1993. The database currently contains over 600,000 reports.
Manufacturer and User Facility Device Experience (MAUDE) database – The MAUDE data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. The database currently contains about 1.2 million reports.