July / August 2006
What You May Not Know About Medical Product Recalls
Several high-profile recalls have focused renewed attention on medical product safety and highlighted the complexity of the recall process. Consider the following:
- A 1999 study showed that patients taking Vioxx experienced twice as many deaths as those on a comparison drug, yet the safety panel evaluating the data allowed the study to continue. Vioxx was not taken from the market until 2004, after 88,000 patients using the drug had had heart attacks and 38,000 had died.
- In March 2005, a recall was issued for an AstraZeneca inhalation product. When the product was returned to the wholesaler, it was accidentally sent out again to hospitals, and a second recall had to be issued.
- In July 2005, Guidant issued a voluntary recall notice for its defibrillator. Court documents revealed that a letter alerting doctors about potential electrical malfunctions in the Guidant defibrillator had been written prior to that time, but not sent. As a result, doctors continued to implant the device.
The medical product recall process is a critical component of patient safety, but it is complex and can be disrupted at many points. Mitretek Healthcare became aware of these vulnerabilities in the course of developing an automated system for notifying hospitals about recalls. As part of its mission as a public interest organization, Mitretek hosted a forum in which manufacturers, distributors, hospitals, and the Food and Drug Administration (FDA) shared their observations about problems with the recall process and made suggestions for improvement.
Problems with medical products stem from a variety of sources. “Software often plays a key role in today’s sophisticated medical products,” said Kimber Richter, deputy director for medical affairs at the FDA’s Office of Compliance, Center for Devices and Radiological Health. “If users of a device discover that a product is not working properly, sometimes the solution is to modify the software.” Problems may also arise from manufacturing processes in which the wrong material is used or when product contamination occurs. Unanticipated risks may result from off-label use of a pharmaceutical product.
Manufacturers and the FDA become aware of product risks through complaints from hospitals, doctors, patients, and competitors. FDA analyses of adverse event reports may reveal a problem, as can FDA inspection of manufacturing facilities. Sometimes, recognition of the problem is delayed when manufacturers dismiss early warning signs, when they do not obtain adequate medical input when assessing risk, or when the root cause of the problem is not correctly identified. Once a problem is recognized, the manufacturer carries out an investigation, and if action is warranted, may issue a recall or other type of alert.
Even to those in the healthcare industry, though, misconceptions abound regarding recalls. One misconception is the term “recall.” Products that may be defective in some way are not always removed from the shelves and no longer used, as one might expect. In fact, the notice might be for a change in instructions for a product’s use, such as cleaning a device in a different way. In other cases, manufacturers may recommend an action such as additional training in the use of the device in order to increase safety. Or, the recall might consist of a modification in software that was preventing a device from working properly.
A second misconception is that the FDA initiates all recalls. In most cases, the manufacturer carries out what is termed a “voluntary recall.” After becoming aware of a problem through a complaint from a hospital, doctor, or patient, the manufacturer conducts a risk assessment and if appropriate, issues a recall. Only in rare cases does the FDA mandate a recall, as in cases where a significant public health hazard is present and the manufacturer has been unresponsive.
The manufacturer is asked to notify the FDA of voluntary recalls, but this step is not always carried out. As a result, hospitals that rely on the FDA Web site for notification may miss critical recalls. The Enforcement Report is provided as a part of the FDA’s public information program, but is not intended as an up-to-date or comprehensive source of information on recalls. A 2005 study by Mitretek indicated that for Class I recalls, the average delay for an announcement to appear in the Enforcement Report was 56 days. Each day of delay represents additional exposure for patients using the product.
Medical products are often delivered to the hospital by wholesalers and distributors, rather than by the manufacturer. These organizations constitute one more link in the notification chain, and therefore one more point where communication about recalls can fail. The manufacturer may notify the wholesaler, but the wholesaler may not pass along the information to the distributor or the recipient hospital.
Once the recall notice reaches the hospital, delays in taking action can further jeopardize patient safety. The manufacturer may send the notice to a department that has no knowledge of the correct routing, for example. “Every manufacturer addresses their recall notices to the hospital differently,” noted Cindy Kilgore, assistant vice president of material management at the Inova Health System, based in northern Virginia. “They may go the administrator, buyer, end user, or accounts payable.” Inventory databases at the hospital may not be complete, or may not include lot numbers that are needed to identify specific batches of a product.
If a hospital is using a product that is recalled, the instructions in the recall notice must be followed, and the hospital’s actions documented. The hospital then sends a card to the manufacturer indicating that the notification was received and indicating a disposition. “Sometimes when a hospital discovers that it is not using the recalled product, the card is not returned to the manufacturer,” pointed out Claude Grant, senior vice president for quality and regulatory affairs at Cardinal Health. If the hospital does not “close the loop,” the manufacturer remains uncertain as to whether the hospital received the notice at all. “Even if the product is not in use, the hospital should return the reply card to the manufacturer,” Grant added.
Some hospitals report that after they return the reply card, they continue to receive requests from the manufacturer asking that they respond to the notice. Clearly, routing problems may occur at the manufacturer’s site as well. Hospitals also complain that when they call a manufacturer to ask about a recall, the manufacturer will release information only to people with specific job titles, such as “risk manager,” rather than to the individual requesting the information, who may be a physician or other staff person designated by the hospital.
Moving Toward Solutions
One conclusion reached by the forum participants was that standardization is lacking at many levels in the recall process. Beginning at the most basic level, the format of recall notices is not consistent. Moreover, the faxed copies are sometimes barely legible scanned images of documents. Hospital representatives at the meeting said that receiving information in a clear and standard format would be useful.
A second conclusion was that the most tenuous parts of the recall chain are the points at which information is handed off from one organization to another. Although each hospital rightly decides what starting point and routing works best for its own system, sometimes the variability between hospitals makes it difficult for the manufacturer to deliver the notice to the correct point of contact. Seen from the other perspective, manufacturers differ in the point of contact from which the hospital can obtain information about a recall, and in their policies for releasing information.
Forum participants saw an important role for information technology (IT) to automate the recall process, but only after steps are taken to improve the information flow. Other areas where IT can serve a valuable role is in improved inventory management and the use of radio frequency identification (RFID) technology for tracking products. However, at this stage, RFID is considered too expensive and not sufficiently mature for widespread application in hospitals.
Finally, participants at the forum made a compelling case for the need to continue a dialog among the various stakeholders in the recall process. Members of each group represented at the forum expressed surprise at some of the facts that were uncovered in the presentations and discussions and believed that further interaction would be fruitful in clarifying problems and defining solutions.
Judith Lamont is a consultant to Mitretek Systems. She has a PhD in experimental psychology from Tufts University, an MS in technical writing from Rensselaer Polytechnic Institute, and a BA in English from Middlebury College. She can be reached at email@example.com.