Program Analyst Lonnie Collins cross-checks lot numbers on a package of recalled defective surgical sponges.
The Department of Veterans Affairs has developed a remarkably efficient system for getting recalled drugs and medical devices off its shelves in a hurry.
Product recalls are inconvenient, but necessary. In 2002, for example, Kellogg recalled 750,000 packages of Pop-Tarts because their package labeling failed to mention they contained eggs, which some people are allergic to.
In 2003, Disney recalled 40,000 “Woody” dolls. (Woody’s buttons posed a choking hazard.)
In 2006, Dell recalled four million laptops because of a fire hazard with their batteries.
More recently, 54 million packages of various over-the-counter products like Tylenol, Motrin, Benadryl, St. Joseph aspirin, and Rolaids were recalled because they smelled funny, and were giving people stomach aches and diarrhea.
“When we pull an unsafe product off the shelf and return it to the supplier, we’re safeguarding the lives of our patients.”
— Dave Sine, Director, VHA Product Recall Office
“We want to find the recalled product fast, get it off our shelves, and get it sequestered,” said Dave Sine, who runs the Product Recall Program for the Department of Veterans Affairs. “Our goal is to have Class 1 recalls off the shelf and removed from use within 24 hours.”
The four main reasons why medications are recalled? Incorrect labeling, faulty packaging, compromised sterility, and problems with potency. Any one of these situations could be dangerous for patients. But the most dangerous are the Class 1 recalls. These are the products that can cause serious harm or even death.
The VA, which runs 152 hospitals and nearly 950 outpatient clinics nationwide, deals with thousands of product recalls each year. Recall alerts from the FDA, manufacturers, and other sources come directly into the VA’s National Center for Patient Safety in Ann Arbor, Mich., where the Department’s Product Recall Office is located.
“However, not all of those recalls are relevant,” Sine explained. “In fact, our due diligence process here at the Product Recall Office rules out approximately 80 percent of all recalls because they’re simply non-applicable to VA.
Wheat vs. Chaff
For example, the recalled product may not have been sold in the United States or, if it was, might not have been sold to the VA, Sine explained.
“That eliminates a huge amount right there,” he said.
Then there are false alarms. What looks like a product recall may be a simple notice from the manufacturer, such as an update on how to properly store a particular medication.
“It’s our job to weed through the mountain of information that floods into our Product Recall Office every day,” Sine said. “We don’t want our hospital staff getting bogged down in all this. So we filter it for them as best we can, and send them only the items we’re reasonably certain apply to their hospital or clinic.
“In other words,” he continued, “if there’s a product recall on a particular brand of hand sanitizer, for example, it makes no sense to alert every VA facility in the country if we know that only four of them — let’s say in Oregon — are using that brand of hand sanitizer.
“We’ve gotten very efficient at this,” he added.
VA’s Class 1 recall compliance rate is now 97 percent, up from the 64 percent it was before the Product Recall Office was established in 2008. Prior to that, each VA hospital was doing its own filtering.
“Putting our recall operation under one roof made all the difference,” Sine explained. “We estimate our centralized process saves the Department over 400,000 hours each year.”
Closing the Loop
When there’s a legitimate recall in progress, Sine’s office receives continuous updates on how the recall process is unfolding at each affected VA facility.
“Our new VHA Alerts and Recalls website allows the Facility Recall Coordinator at each hospital to send up-to-the-minute reports to our office here in Ann Arbor,” he explained. “For instance, when certain lots of the H1N1 flu vaccine were recalled in 2009, we were able to send hourly reports to VA leadership in Washington, letting them know how the recall effort was progressing.”
Sine said that as each affected lot of vaccine was found and sequestered, the Facility Recall Coordinator would post it on the website, where it could be viewed not only by the Product Recall Office in Ann Arbor, but by every VA hospital and clinic nationwide. One by one, each VA facility eventually posted the ‘All Clear’ signal on the website, indicating that all the affected lots of H1N1 had been accounted for.
“By ‘closing the loop’ in this manner, we can identify those hospitals that may require additional assistance from their Network Recall Coordinator or from our Product Recall Office Help Desk,” Sine explained.
“Some days Ann Arbor doesn’t send us any recalls alerts,” said Lynda Brettschneider, the Patient Safety Manager for the Pittsburgh VA Healthcare System. “Some days we get a ton. We received seven of them in this morning, for example, and they’re already off our shelves. Four were drugs products, and three were various food items. The majority of our recalls are food and drugs. Those are the heavy hitters.
“We got one for ground beef today, and one for frozen yogurt,” she continued. “So we alerted the Canteens (cafeterias) at all three of our campuses, and we also alerted our Food and Nutrition Units — the folks who feed our patients.
“We got a recall for a specific brand of mouthwash so we sent that one to our Dental Unit,” she explained. “We received one for a cholesterol drug, so we sent that out to all three of our pharmacies. We sent those out this morning, and they’re all closed out already. They’re off our shelves.”
So what happens to the frozen yogurt, mouthwash, and other stuff once they’re pulled off the shelf?
“We just follow the manufacturer’s instructions,” Brettschneider said. “If they want us to send it back, we send it back. If they want us to destroy it, we destroy it.
“I remember a couple years back we had a big peanut butter scare,” she said. “That was a Class 1 Recall. I remember that one, because I like to eat those peanut butter crackers, the kind you get from the vending machine.”
The Shock Heard ’Round the World
It’s one thing to go find a product and get it off the shelf. It’s an entirely different issue when there’s a recalled product that’s already been implanted in a patient — something like a heart valve, or a pacemaker, or a hip replacement. What happens then?
“We notify the patient right away,” said Dr. Ed Keung, who heads VA’s National Cardiac Device Surveillance Center based in San Francisco, Calif. “We don’t want to necessarily throw them on an operating table and remove the device. We’ll simply ask them to come in so they can sit down and discuss options with us.”
Keung said one particular product recall stands out in his mind above all the others.
“One time we had a recall on a defibrillator lead,” he said. “The ‘lead’ is a wire that’s connected to the defibrillator. When the defibrillator detects abnormally fast heart beats, it delivers high voltage shocks — via the lead — to restart your heart. When it shocks you, it hurts, but it saves lives. Some patients describe it as being kicked by a mule.”
Keung said the problem with this particular high voltage lead was that it was prone to breaking, which would cause the device to shock you even though you didn’t need to be shocked. If the wire happened to break, the device might zap you 30 or 40 times within a short period.
“Unfortunately, about 4,500 of these units had already been implanted in VA patients,” Keung said.
Fortunately, however, VA’s Remote Surveillance Service allows Keung and his team to closely and remotely monitor all 4,500 patients. “We would be able to tell quickly if any of the leads were breaking, or if any of our patients were receiving inappropriate shocks,” he explained.
Keung said that one Sunday back in 2008, for example, VA’s Remote Surveillance Service alerted his team that a heart patient’s defibrillator had just initiated an “unscheduled transmission” — an alert indicating something abnormal was happening to the defibrillator.
“The data revealed that the patient, who lives in Gainesville, Fla., had a broken lead in her defibrillator,” Keung said. “We knew that if we didn’t act quickly, she might experience multiple, painful shocks.
“I called the veteran and let her know about the broken lead and its potential danger. She went to the emergency room and they deactivated the device. The following day, she received a new lead.
“She was pretty happy about that,” Keung said. She wrote me a nice note, thanking me, which made me feel good.”