Recall Procedures: Does Your System Keep Patients Safe?

Medical product recalls happen on a regular basis – for hospital systems, this is just a fact of life. What varies between institutions, though, is how well they respond to recalls and it’s what sets them apart. Hospital administrators need streamlined procedures for reaching patients and pulling recalled products from their shelves if they’re going to keep patients safe, because it can be a matter of life or death.

Data Integrity And Tracking

When there’s a problem with a product or medication, the FDA may issue a recall, but it’s important to note that the term doesn’t mean the same thing in FDA lingo as it does in other sectors. Rather, the FDA states that when a medical device is recalled, there isn’t always an imminent risk. Instead, there may be a malfunction, a potential risk, or a combination thereof; in some cases, all that’s necessary is a relabel, monitor, or adjustment of settings on a device. Not every recall represents an immediate crisis. In most cases, it’s the manufacturer that recalls a device because of a problem, though the FDA can mandate a recall.

Because only a minority of recalls represent an urgent concern, the FDA typically only requires manufacturers to issue warning letters to patients, patients may not always know when they’re affected by a recall. That’s because doctors and hospitals lose track of patients. This is true even when a device needs to be closely monitored, and in order to keep patients safe, hospital systems need better data reconciliation and patient tracking systems. While some patients will always go missing because they choose to ignore follow-up, using multiple points of contact can help hospitals ensure patient data remains up to date.

Automation And Administration

Following up with patients across multiple platforms is a lot of work, and it’s not something most hospitals can do without substantial support. Luckily, with increased automation, it’s easier for hospitals to reach patients quickly by scanning files and contacting them via portal when there is a recall issue. Similarly, portals should eliminate many challenges involved in tracking patients.

Administering recall systems can’t just fall on the shoulders of hospitals and doctors. Manufacturers also need an established protocol for reaching patients in the event of a recall. Industry experts stress that software-related recalls are on the rise, so manufacturers should have a clear protocol for managing software issues and should reevaluate their recall communication practices regularly.

Are Recalls Successful?

The best way to evaluate device recall practice is by assessing the success of actual recalls. What’s been pulled from the market, and do patients know about it? Too often patients don’t know that there has been a product recall until they see an advertisement or public alert about the issue. For example, many patients taking Zantac for reflux only learned that the product had been recalled for containing a carcinogen after seeing news reports or advertisements for class action lawsuits related to the product. That’s hardly the best practice, and it doesn’t always equip patients to understand the risks involved.

One way to make medical device recalls more effective would be to ensure that there are meaningful, legal consequences when doctors fail to alert patients to potential risks. This would force medical systems to undertake more rigorous patient tracking systems or face consequences like medical malpractice.

As described by Rosenfeld Injury Lawyers, medical malpractice hinges on several key factors, including the existence of a doctor-patient relationship and duty of care, and that the doctor breached that duty. Because product dangers may not emerge until after they’ve been in use for a length of time, it may be necessary to extend the scope of duty of care for the well-being of patients.

When it comes to recall success, items shipped to hospitals for use by medical professionals are easier to track and recall than anything prescribed for outpatient use, purchased over the counter, or implanted in patients. Among drugs recalled in 2019, doctors regularly identified problems in products they administered via visual examination, which allowed them to keep patients safe. Many VA hospitals also use a scanning system to track products that, if properly synced with product barcode databases, can alert doctors and nurses to recalled products before those products reach patients; the recall alert simply pops up when the item is scanned.

Supply Chain, Lifecycle Planning, And More

Hospitals are responsible to their patients when a product is recalled, but good patient tracking – and therefore reliable data systems – are critical to the institutions broader mission. That includes lifecycle management (cycling out products at the end of their lifespan) and providing compliance support and follow-up care. Ideally, recalls are primarily a worst-case scenario. More importantly, if the FDA were to take a harder line on recalls, requiring actual recalls rather than warning letters, patients would be more likely to get the information they need. The FDA has the power to do this, but typically declines to act.

As a federal agency, the FDA has the power to track patients in ways that individual hospitals may not be able to, and it has a responsibility to patients because of their oversight role. Subgroups like the Office of Regulatory Affairs also need to play a larger role in administering recall programs. Individual hospitals can only connect with patients if those patients are responsive. There’s no single strategy that will keep all patients informed, but that doesn’t mean hospitals and the FDA alike can’t be more aggressive in addressing product recalls.