Health information technology has been touted as crucial to better healthcare, but a new report says an entirely new regulatory agency is needed to oversee this largely unregulated sector, which can also injure or kill patients if it’s not operating properly.
In pushing for a new oversight body, the respected Institute of Medicine, an independent research and advisory organization, is explicitly advising that the Food and Drug Administration (FDA) not be tasked with the job – a recommendation that is bound to be controversial. [Read More]
The TRICARE Management Activity directed Science Applications International Corp. to provide credit monitoring services for up to 4.9 million beneficiaries whose health information was stored on backup computer tapes stolen from an SAIC employee’s car in San Antonio. Read More
The Department of Health and Human Services (HHS) has unveiled an easy-to-read, standardized template to help consumers learn more about the privacy and security policies and data practices of personal health record (PHR) products. Read more.
The Health Information Management Systems Society is asking its members to lobby Congress for a “nationwide patient identity solution” to improve accuracy of patient medical records and reduce errors traced to misidentification. Read more
For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices. From 2005 through 2009, firms initiated 3,510 medical device recalls, an average of just over 700 per year. FDA classified the vast majority—nearly 83 percent—as class II, meaning use of these recalled devices carried a moderate health risk, or that the probability of serious adverse health consequences was remote. Just over 40 percent of the recalls involved cardiovascular, radiological, or orthopedic devices. FDA has used recall data to monitor individual recalls and target firms for inspections. However, it has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls. Thus, FDA is missing an opportunity to use recall data to proactively identify and address the risks presented by unsafe devices. Read the entire report at the GOA website.
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.
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 Monday, March 21. Click on the underlined item for the actual link to the story:
Medwatch alert: Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers.