F E AT U r E D A r T i C l E
Bar Code Solutions for those Pharmaceutical and Medical Device Recalls That Never End
M
ary Jo, a twenty‑something mother of two, lay dying in a New York hospital. Her kidneys were failing. She needed a transplant in a hurry. After weeks of waiting, her husband Barry proposed a solution. He offered to donate one of his own kidneys. He did not realize what was to happen. During surgery, something went wrong. Doctors removed Barry’s kidney and were tying off his renal artery with a Hem‑o‑lok surgical clip. Little did doctors know that the clip was defective. The Hem‑o‑lok dislodged after surgery. At 29 years old, Barry’s luck ran out. He lay in a hospital bed and bled to death. Had doctors been able to check the Hem‑o‑lok clip before surgery, they would have known that it was a recalled prod‑ uct. Today we do not have a good way to track and remove recalled medical products. The problem of defective merchandise is becoming rampant. New products are intro‑ duced into the market each year. Some are legitimate, such as generic drugs. Others are cheap counterfeits that may do harm. Consumers may end up buying devices and drugs without knowing their authenticity. Today we have no universal system for track‑ ing drugs and medical devices in the United States other than what the Food and Drug Administration (FDA) publishes on its Web site. The FDA’s Web site is incomplete and
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requires a great deal of time and research. Users may spend hours researching lot num‑ bers and later realize that it does not cover the product categories in question. End users need a better solution. Drugs and medical devices are not fail‑ safe and suffer from breakdowns and quality control issues like everything else. Luckily we have the technology today to better monitor such problems. The use of bar coding could be the solution. Bar coding can now be used with Internet mobile devices, such as smart phones and wireless devices. Technologies such as Microsoft Tags allow users to check the recall status and authenticity of a prod‑ uct with a swipe of a mobile phone. Current methods to track and return recalled products are ineffective. The FDA Web site, for example, tracks only certain product categories. In the case of medical devices, the FDA currently tracks about 14 types of medical devices, well short of the number of device types actually used in the market. Finding information on the site requires time‑consuming research. Users may review hundreds of serial numbers and/or lot numbers published by the FDA and compa‑ nies. Users then have to manually compare the information with the lot number on the product label. If someone at a clinic or hospi‑ tal were to check a large batch of products, he or she would likely make an error. Many hospitals use radio‑frequency iden‑ tification (RFID) systems to track and locate devices and drugs. The problem with this method is that items can be missed if they were not assigned an RFID code. Several years ago, a major hospital with a good system for identifying recalled devices found that doc‑ tors at more than 40 hospitals implanted recalled devices in over 50 patients. In the case of the Hem‑o‑lok clip, the manufacturer
stated that it had complied and had notified the hospital. Someone at the hospital dropped the ball, and a patient lost his life. Some healthcare companies have set up their own registries to track products. These private registries have shortcomings. Registries may cover a small category, and the information may not be available to all doctors and hospitals. Kaiser Permanente, for example, has a system to track implanted joints. The company has a list of patients and doctors who have implants. The registry data, however, is not available to all hospitals outside their system. Other registries exist to track specific products, such as orthopedic joints and replacement parts. Even within these narrow registry databases, recalled products can be missed. Another problem arises when a consumer tries to return an over‑the‑counter recalled product. Often the customer is turned away because the recalled product is not on the store’s recall list. The customer is then stuck with a potentially defective product until the store can update its records. It’s bad enough that customers ended up with a recalled product that may be potentially dangerous. It’s even worse when they can’t return it. There must be a better way. The FDA has offered ideas to improve the current process. The agency has suggested the use of a unique ID for each device and a database of all recalled products. These ideas alone, however, will not solve the problem. How does this ensure that information is available to consumers, pharmacists, doc‑ tors, hospitals, and so on? It doesn’t. Before a device is used in surgery, wouldn’t it be better if doctors could use a cell phone connected to the Internet and scan a bar code on the packaging? That would cer‑ tainly do it and doesn’t take long at all. Many
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