Recalls & product notifications
Summary
U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) is the federal agency that is responsible for promoting public health through a number of activities, including the reasonable assurance that 1) food is safe, wholesome, sanitary, and properly labeled; 2) human drugs are safe and effective; 3) medical devices intended for human use are safe and effective; and 4) the public health and safety are protected from electronic product radiation.
There are a variety of actions that may be taken by the FDA and/or the manufacturer/distributor related to a product (medical device, drug, food, biologic product) that is defective, could pose a risk to health, or is in violation of FDA regulations. See definitions and terms below. When the action involves a product recall, the manufacturer/distributor is required to notify the FDA and the customer of the specific actions taken. The FDA's role is to monitor recalls and assess the adequacy of the action. The FDA Web site is the primary source for information on the safety and efficacy of products, including recalls and related action steps. Customers also may direct inquiries about specific actions to the manufacturer/distributor.
Definitions and terms
- Recalls and field corrections are actions taken by a manufacturer/distributor to remove a product from the market. Recalls may be conducted on a manufacturer/distributor's own initiative (voluntary recall), by FDA request, or by FDA order. According to the FDA, a recall is a removal or correction of a product that is 1) defective; 2) a potential health risk; or 3) in violation of FDA regulations. The manufacturer or distributor of a product carries out most recalls voluntarily. The FDA has specific guidelines for companies to follow in recalling defective products that fall under the Administration's jurisdiction. These guidelines make clear that the FDA expects these firms to take full responsibility for product recalls, including notification of the FDA, notification of customers, and follow-up checks to assure that all recalls are successful.
Complete information on FDA recalls and corrections may be found on the FDA Web site.
- Medical device notification or safety alerts are issued by manufacturers, distributors, other responsible parties, or the FDA to inform health professionals or others of risk of substantial harm from a medical device. Medical device notifications are issued at the request of the FDA. Safety alerts are issued voluntarily by the manufacturer.
Complete information on FDA notifications and safety alerts may be found on the FDA Web site.
- Other medical device actions include additional options open to manufacturers/distributors. They may take other actions for minor medical device problems or violations that would not necessarily be subject to FDA legal action and do not have the potential to cause serious adverse health consequences. An example of such an action is a device correction notice.
The manufacturer/distributor may also voluntarily remove a product from the market to correct a problem. The manufacturer/distributor may contact the customer directly to request a return of the medical device so the problem can be corrected. In addition, the manufacturer/distributor may issue special instructions for device maintenance or problem correction.
Healthcare policies
Healthcare facilities should have standardized processes in place to receive and disseminate information about product recalls, notifications, and safety alerts to the appropriate departments and individuals. A mechanism should be established to:
- document the date of receipt of pertinent information; and
- date the follow-up and all recommended corrective actions taken, such as removal from inventory, return to the company, or repair.
A sample policy and process flow is available as a resource for issues to consider when developing organization-specific recall policies.
Premier member information
Product notices
Premier’s Safety Institute maintains a listing of product notices and recalls that have been sent to member hospitals. The FDA Web site should be consulted for a comprehensive cataloging of medical product notices and recalls. Specific questions on medical products should be directed to the manufacturer and/or distributor.
Premier business partners
ECRI Alerts Tracker
An on-line system that is customizable to notify key individuals about device recalls and hazards and to establish a follow-up tracking mechanism verifying that appropriate actions were taken.
Premier contract number: PP-SC-010 Web site: http://www.ecri.org.