Total recall

The high-profile drug and device recalls of recent years have set the backdrop for healthcare organizations to establish more efficient, proactive systems that can better identify early signs of troubled products.

Drug and device recalls have been continually cited as causes for increased scrutiny of the Food and Drug Administration's device approval process because of safety concerns, as well as for the drug shortages affecting hospitals and health systems.

The FDA noted in a letter to government officials that it has experienced “significant increases” in the number of recalls for the drugs, devices and diagnostics that are regulated by the federal agency.

“In recent years, the agency has experienced significant increases in the number of recalls of FDA-regulated products, some of which involve the largest and most complex recalls in FDA history,” the agency wrote.

Robert Pezzin, interim vice president of supply chain for Nexera, the supply-chain management and consulting firm owned by the Greater New York Hospital Association, says the financial burden of a recall, including developing the systems to manage a recall along with the costs when a product is recalled, often falls to hospitals, rather than manufacturers.

Pezzin works on-site at West Penn Allegheny Health System, based in Pittsburgh.

“What we see is every organization is burdened with developing its own process and system,” Pezzin says. “That takes considerable resources and finances. Right now, you don't see that being funded by the manufacturers or by the FDA to assist hospitals in standardizing this practice.”

Along with the costs incurred for the labor and expense of pulling products from shelves and returning them to a manufacturer—some companies will refund the freight cost—finding alternative drugs or devices can carry additional costs.

“A substitute product could carry a premium over what you were using before,” Pezzin says.

Recalls have pushed hospitals and health systems to establish automated responses rather the manual systems that many facilities still have in place, says Kathy DeLacio, director of procurement and administration for corporate contracting at West Penn Allegheny. Depending on the product and the nature of the recall, it can take between a few days to a month to get a response to a recall from a vendor about a return authorization.

The FDA's role is to oversee a manufacturer's management of the recall, according to the GAO, but other stakeholders that take part in the recall efforts include manufacturers, distributors, hospitals and patients.

“There is the need to automate and compress the timeframe from which a hospital or a healthcare system is notified of a recall,” DeLacio says. “By the time you get it out to all your end users, especially when you have implantables involved, time is of the essence.”

Johnson & Johnson is one example of a pharmaceutical and device manufacturer that has reported numerous recalls over the past several years.

With J&J already dealing with a number of over-the-counter product recalls, DePuy Orthopaedics, a subsidiary of the New Brunswick, N.J.-based company, recalled its ASR hip system in August 2010. The company said the implant had a high early failure rate, which led to more revision surgeries. The recall prompted hundreds of lawsuits.

“DePuy has a comprehensive process in place for evaluating and acting on any concerning product performance data and rapidly alerting customers if necessary,” DePuy spokeswoman Mindy Tinsley said in a statement responding to an interview request. “We constantly evaluate our processes for improvement.”

The recalls, including the hip implant, were a key complaint in allegations of wrongdoing from J&J shareholders in a recent lawsuit. The recall for the implantable device affected 93,000 patients worldwide.

The ASR hip systems recall is expected to cost J&J $184 million in “reasonable and customary costs of testing and treatment associated with the recall” over the next five years, according to a company report.

Recent recalls have also put the FDA under examination. Following a Senate hearing in April that addressed the agency's handing of recalls, the Government Accountability Office released a report two months later that recommends the federal agency take a more proactive stance in analyzing and assessing data in order to better aid its oversight of the medical device recall process.

“The agency has a plethora of data available on thousands of recalls, but at present, is not effectively reviewing and analyzing these data in a systematic manner,” the GAO authors wrote. “More routine analyses of these data could help FDA identify trends in the numbers and types of devices being recalled, as well as the underlying causes of device recalls.”

The GAO reported that there were 3,510 medical device recalls from 2005 to 2009. During 2008 and 2009, manufacturing issues were the greatest cause of recalls for medical devices, according to the report.

The FDA said it supported the GAO findings, and earlier this year the agency's Center for Devices and Radiological Health announced the creation of a recall improvement team, which is expected to support public understanding of the recall process.

The GAO noted in the report that hundreds of hospitals and other stakeholders are increasingly relying on electronic communications technologies that provide subscription-based notifications for recalls, rather than notices from the manufacturers issuing the recall. The systems can cost several thousands of dollars a year, according to the GAO.

Kathleen Murray, director of performance assessment and regulatory compliance at Beth Israel Deaconess Medical Center in Boston, says the hospital revamped its recall process in 2006 and implemented a system from an outside vendor to supply information about recalls.

It also created a policy that lays out the hospital's formal response to recalls for regulated products. “Time spent managing the aftermath of the steps necessary for a recall has been reduced significantly since we have centralized and standardized and structured our program,” Murray says.

In addition, Beth Israel Deaconess created what it calls a “first-response team” that will meet within eight hours if a recall requires patient notifications. For the recall of Medtronic's Sprint Fidelis heart lead, the hospital established a call-in number and extended clinic hours to reach a group of 260 patients, including those who had the implant placed at BIDMC and those who had the implant placed at another hospital but were patients at BIDMC. “It certainly has benefited our institution to stay abreast of all incoming notifications and to consider each one of them as what it means for our future,” Murray says.

She says she has noticed an increase in information about implantable devices, although it may not be a recall or formal notification.

The CDRH issues two types of notifications: The public health notification provides information about a risk associated with the use of a medical device and how to avoid or reduce the risk; and a preliminary public health notification is information also provided to the healthcare community and will likely be updated. The manufacturer, in most instances, makes the recall.

“As the technology is emerging and as the knowledge is gained through patient experience or device failures or near misses, there's been a greater sharing of that kind of information,” Murray says.

While the technology may be advancing faster than the systems established to monitor it, small steps have been taken. The FDA is expected to issue within the next two years a final rule on the development of a unique device identifier system, a program that will better track and identify devices.

The system stems from the passage of the Food and Drug Administration Amendments Act of 2007. Some of the issues that have been attributed to the slow rollout of a UDI system include establishing different labeling requirements, such as a linear or two-dimensional bar code, or radio frequency identification, for different devices; whether hospitals will implement the technology needed to support the systems; and the FDA's lack of authority over hospitals to require adherence to the UDI system, according to the GAO.

The UDI system is expected rely closely on the involvement of hospitals although the GAO report expressed concern about the support of hospitals that have not yet established automated inventory systems.

Also at work are two national registries that will gather information about knee and hip replacements. The Agency for Healthcare Research and Quality awarded a $12 million grant to the University of Massachusetts Medical School to establish a nationwide registry of 33,000 total joint replacement patients.

The registry will gather data about joint replacement failure, technical or mechanical issues, the impact of the replacement on a patient's mobility, function, pain and quality of life, and a patient's ethnic, socioeconomic and demographic group, according to UMass.

Another registry, the American Joint Replacement Registry, completed its first pilot with 16 hospitals in July. The organization, which was formed in 2009, has received financial support from manufacturers, trade associations and medical groups and is expected to have annual costs of $4 million. It also plans to gather data about total hip and knee replacements.

The AJRR's first round of data collection—what the organization calls “level 1” data—gathers information about the patient, procedure, surgeon and hospital.

It plans to collect increasingly complex data as AJRR becomes more established, but the goal is to ensure that every hospital that provides total joint replacements in the U.S. share their level 1 data, according to Dr. David Lewallen, a professor of orthopedic surgery at the Mayo Clinic and chairman of the AJRR.

“While it doesn't provide all the answers we want as to what's going on, it allows us to ask intelligent questions,” he says.

The registry is modeled after other national registries in countries like Norway, Sweden, Australia and the UK—the latter two national registries were responsible for identifying the problems with the ASR hip implant system that led to the recall. It is expected to release an annual report to hospitals and health systems, manufacturers, physicians, payers and other stakeholders.