FALLS CHURCH – Noblis Health Innovation’s RASMAS is one of the most extensive alert databases in the country, including over 19,400 alerts since 2004. In 2009, more than 3,200 alerts were released to healthcare organizations.
With recalls regularly in the news, we put some common questions about recalls to Bill Klein of RASMAS.
RASMAS tracks recalls in fields that include biologics, biomedical devices, blood products, children’s consumer products, engineering and facilities, food, information systems, laboratory products, medical supplies, OR products, pharmaceuticals, radiology products, tissue and veterinary products.
Q: What are the federal agencies that issue recalls?
Klein: In the U.S., those agencies are the Food and Drug Administration, United States Department of Agriculture, National Highway Transportation Safety Agency and Consumer Products Safety Commission. Centers for Disease Control also will release product related health notices including vaccines.
Q: It seems that with the growing volume of recalls, it is hard for the consumer to keep up. What is an easy way for the consumer to handle these risks?
Klein: Most, if not all, of the above agencies have RSS feeds or e-mail distribution lists. There also are aggregation sites that cover most consumer alerts. Recalls.gov is a good place to start.
Q: Should consumers go through medicine cabinets and pantries looking for recalled items, or is that overkill? And if they should, how often and what procedure should they use?
Klein: They definitely should look at their shelves when they can get the details of the recall such as product lot numbers or expiration dates. These lot numbers then can be checked against the notice. Some bulk foods are problematic (e.g. spinach, melons, cilantro) as they may not have any identifier other than the brand on the label or carton.
Q: Compared to other risks in life, how frequent are the risks from most recalled items?
Klein: The likelihood of being impacted by the typical recall is probably low. However, when impacted the consequences could be severe. This is particularly the case for individuals that are vulnerable for medical or age reasons.
Q: How many types of recalls are there?
Klein: There are various notices from manufacturers and regulators such as Public Health Notices, Recalls, Field Corrections, Market Withdrawals, etc., that have a concise definition and circumstance. Recalls do not always mean the product must be returned to the manufacturer, and Market Withdrawals do not necessarily mean that a company must take the item off the shelves. Recall notices specify the course of action for the recipient of the notice .
Q: Is the government more or less aggressive about recalls today than in the past?
Klein: That’s hard to determine exactly, and it depends upon whom you ask. We’ve seen a dramatic increase in the number of recalled products, but we may be getting better at finding them.
Q: Do companies voluntarily issue their own recalls, or are most recalls started at the urging of government?
Klein: Most recalls are initiated by the manufacturer. I’ve heard 1 percent quoted as the number of involuntary, government mandated, recalls.
Q: Do you see companies getting over their fear of recalls and instead treating them as a normal and occasional part of the cost of doing business in a modern economy?
Klein: More and more. At RASMAS, we take an approach that recalls are a fact of life for companies. With the increasing complexity and number of products on the market, recalls will occur. Many products that are tested and put on the market later are found to have problems that are not readily apparent when the product is designed. With the addition of software to many products, products that may be defective can be reprogrammed to repair the issue. Much of industry is moving to a place where recalls are not a manufacturing and distribution issue alone, and effectively managing recalls are part of good brand management and exemplary customer service.
Q: What is the statute of limitations on a safety recall? When is it finished? Or does it have to do with how much of that item is in circulation?
Klein: There is no single answer to this. A recall is “complete” when the company meets the agreed upon expectations of the agency that regulates the product.
Q: Are goods made overseas inherently more dangerous, or do we pay more attention to them?
Klein: They are less regulated, inspected less frequently, and therefore there is more risk. However, American distributors have the same responsibilities, no matter where the product originates.