Terms relating to recalls sometimes get confusing. While “recall” is often used as a term to describe any sort of product removal from distribution, it is more complex than that. There are different classes of recalls, and types of recalls.

Here are some of the main terms used by RASMAS in referring to recalls. Some terms are regulatory terms, from agencies such as the Food and Drug Administration. Other terms are generally accepted within the RASMAS Community.

• CBER: The Center for Biologics Evaluation and Research is the U.S. government agency that monitors and regulates vaccines, organs and blood. Part of the Food and Drug Administration, it regulates under the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.
• Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
• Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
• Closed: In relation to recalls, a recall is “closed” when a certain percentage of recalls are returned or accounted for.
• FDA Enforcement Report: Published weekly by the Food and Drug Administration, the report contains information on actions taken in connection with agency regulatory activities. Inquiries about individual actions should be directed to the companies involved. More
• Mandatory recall: XXX
• Market withdrawal: This process occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
• Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
• Phantom recall: Recent news stories have referred to a phantom recall, when a product is removed from the shelves without press attention.Rapid Recall Exchange: A trademarked process by the organization GS1 to track recalls.
• Recall Complete:
• RASMAS: Originally named for Risk and Safety Management Alert System, and now just called RASMAS.
• Technical Service Bulletin: A notice that a car manufacturer sends to a dealer or repair shop about a problem with a car. These are typically items that do not rise to the level of formal recall, but would be fixed when a car is still under warranty.
• Undeclared ingredient: A frequent reason for a recall is an ingredient that is not listed on the ingredient list for a product. For instance, because of peanut allergies, undeclared peanuts in a product will necessitate its removal from the shelves.
• Voluntary recall: Most recalls are technically “voluntary” in that the manufacturer issues the recall notice, not the government. However, many “voluntary” recalls are done with the cooperation of FDA and USDA officials.
• Warning Letters: xxx
• Withdrawal: The complete removal of a product from the market.

FALLS CHURCH – Leading medical and recall news headlines from Noblis Health Innovation for Tuesday, January 11, 20111. Click on the underlined item for the actual link to the story:

• FDA eyes regulation of wireless networks at clinics, hospitals: As more hospitals and clinics plug patient monitoring equipment and other devices into traditional data networks, the closer the U.S. Food and Drug Administration (FDA) comes to regulating the networks as medical devices.
• CMS counts 4,000 providers initially registering for EHR incentives: In the first four days since its launch, about 4,000 healthcare providers initiated registration for the electronic health record incentive program, according to the Centers for Medicare and Medicaid Services. The agency provided the preliminary count as of Jan. 6.

Follow the latest recall and health news at twitter.com/RASMASrecall.

WASHINGTON, D.C. - In an open letter to then nation’s health professionals, Margaret A. Hamburg, M.D., Commissioner of the Food and Drug Administration, yesterday discussed issues relating to the release of the new H1N1 vaccine. The letter, released on the F.D.A. website, includes background information on the supply of H1N1 vaccine. A full transcript of the letter is at www.fda.gov.

A few facts on this year’s effort:

• Over 41 million doses of the vaccine were out as of Nov. 10.
• The H1N1 vaccines are made in the same facilities as annual flu vaccines. The lots are evaluated by looking to see if they are both “sterile” and “potent.”
• Before issuing the vaccine, it was tested on 3,600 patients.
• Children under nine should have two doses of the vaccine.
• This is the first time in history that any vaccine has been available at the time that an influenza pandemic has struck.
• She writes that this season, manufacturers tapped into a “reserve supply of eggs made by additional flocks of chickens.  These flocks were available under contracts put in place for just this purpose – to respond to a possible pandemic.”

Other news of interest in the field of health safety and recall:

• Superbugs in Scotland: Five patients died in Scotland in part because of the Clostridium difficile bug, which killed two patients and contributed to the deaths of three others. Eight elderly people in ward 31 at Dundee’s Ninewells Hospital were also found to have the infection, according to Scotland’s Daily Record.
• Pharmacy safety: The safety of pharmacy workers continues to be an issue. In Florida, a minor theft of beer was solved with a DNA sample, according to reporter Wendy Victora of the the Northwest Florida Daily News. And in Washington state, pharmacy workers worried about the dangers of robbery because of the popularity of opiate drugs like OxyContin are taking drastic measures to keep safe, according to a guest essay in The Seattle Times.
• TMI? A Minnesota couple found a unique way to share the birth of their daughter with the world by live-streaming the delivery on the Internet, reports the New York Daily News.