What You Need to Know About Medical Device Recalls

Not all medical devices are safe. Patient harm can occur when a device malfunctions, or otherwise causes harm. When a device is deemed dangerous, manufacturers usually issue a device recall. As patients, we should know if we have a dangerous medical device implanted in our bodies, or if we use a dangerous device to monitor our health. Unfortunately, when devices pose danger, we may not receive a notification from our doctors. So, what do you need to know about medical device recalls to reduce your risk of harm?

How common are injuries from medical devices?

More often than you might expect. An investigation by the International Consortium of Investigative Journalists (ICIJ) found that in a recent 10 year period there were more than 1.7 million injuries from medical devices of all types. Additionally, there were almost 83,000 deaths.

What does a medical device recall mean?

A recall is a method of removing or correcting products that violate the laws administered by the Food and Drug Administration (FDA). Importantly, a recall does not always mean the company must stop selling the product, or that doctors must stop using the product.

Although some recalls require removal of products from the market, a recall can also indicate the product must be checked and/or fixed.

A medical device recall is usually a voluntary action taken by the manufacturer and distributors choose to protect the patients from defective products. However, in rare cases, if the situation is urgent, the FDA can initiate court action to force the manufacturer to remove or correct a dangerous device.

In a Healthcare Dive article, an FDA official states that FDA-forced recalls are so rare the total number is likely less than 5! The official continued to state that voluntary recalls are easier and faster than court-ordered mandates.

However, some critics, including patient groups, think that relying on voluntary recalls is flawed, too deferential to the device industry, and thereby puts patients unnecessarily at risk.

The FDA receives thousands of reports every year.

According to the FDA, each year, they receive several hundred thousand reports of medical device issues, including suspected device-associated deaths, serious injuries, and malfunctions.

How does the FDA learn about medical device issues?

The FDA requires mandatory reporters to submit reports of adverse events and product problems associated with medical devices. Mandatory reporters include device manufacturers, importers, and healthcare facilities.

The FDA requires manufacturers and importers to submit their reports within 30 days of learning of an event. However, device user facilities, such as a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility, must submit their reports within 10 days of learning of an event.

Additionally, the FDA encourages healthcare professionals, patients, family caregivers, and consumers to submit reports about serious adverse events that may be tied to a medical device, as well as errors, failures, and product quality issues.

All of these reports are entered into the US government’s MAUDE database (Manufacturer and User Facility Device Experience).

The MAUDE system is not perfect.

Unfortunately, the MAUDE data is not as accurate as it should be, with incomplete, inaccurate, and/or duplicated reports. Importantly, a study published in 2021, reviewed MAUDE entries and found that a significant number of medical device adverse events that caused patient deaths were not categorized as deaths in the MAUDE database.

The FDA classification system.

After the FDA receives a report, they classify each device reported as either a Class I, II, or III event. Unfortunately, it can take the FDA 90 days to even categorize the Class of a recall.

Now the confusing part.

For some reason, the FDA uses opposite scales for recall classifications and device classifications, as follows:

For ratings on the overall potential risk of a device, the FDA classifies labels devices that post the least risk to patients as Class I, with Class III devices posing the highest risk.

Yet, for ratings of “events” of harm or malfunction, the FDA uses Class I to indicate the highest risk to patients, while Class III poses the lowest risk.

If the FDA classifies the device as a Class I hazard, or determines that a device poses a big enough risk to patients, they will issue a public recall notice or safety alert. However, these notifications can come several weeks after a manufacturer has sent the original recall letter to healthcare providers.

How many medical devices does the FDA recall each year?

Even though the FDA receives hundreds of thousands of reports every year, the number of recalls is fairly low.

Recalls of medical devices move dangerously slow.

Examples of recent recalls.

There have been several well-publicized device recalls in the last few years, including:

• Allergan’s recall of breast implant products that caused cancer in hundreds of women,
• Philips’ recall of millions of sleep apnea and ventilator machines.
• Medtronic’s recall of its HeartWare Ventricular Assist Devices that caused strokes and deaths.

How the recall process unfolds.

The process usually begins when a device maker, doctor, or patient identifies and reports a safety or manufacturing issue.

Once manufacturers receive reports of safety issues, they conduct their own investigations, evaluating many factors including the severity of patient harm, the number of affected devices, and the rate of malfunction. Unfortunately, there are no standards for this process, which some experts believe complicates the entire recall process.

In the next step, the device manufacturer sends letters (yes, old-fashioned paper letters) to healthcare providers if either:

• The safety issues require immediate action, such as when patients have died
• The number of cases becomes significant.

Unfortunately, these paper notifications often go to the wrong people in hospitals, creating a significant delay in the process. In fact, it sometimes takes weeks or months for the person responsible for removing or destroying harmful products from hospital inventories to even receive a notification.

Moreover, it can take manufacturers months to identify and track down 100% of the recalled devices. And the process may require repeated communication with hospitals and distributors.

Sadly, all of this delay in the process can mean that doctors may implant or recommend recalled devices before they have had a chance to see the recall notification.

Identifying the location of recalled devices can be tricky.

As you might expect, device recalls do not always cover 100% of a particular product. Sometimes, recalls can pertain to a subset of a product manufactured during a specific timeframe, identified by lot numbers.

Because each lot number only identifies a small subset of recalled devices, the manufacturer may recall 10,000+ lot numbers!

This overwhelming amount of data makes it hard for hospitals to track down recalled devices in inventory, as well as those implanted, or used by, patients. Imagine manually checking a list of 10,000 numbers against existing inventory as well as a registry of patient data!

In contrast, if a company doesn’t know which lots are defective, they will recall the entire product.

Unique identifiers could really help!

UDIs (unique device identifiers) are codes that identify the device itself and the production information. Using UDIs would make it easy to identify recalled products in inventory as well as those in use by patients.

Interestingly in 2013 the FDA issued a rule requiring UDIs to be a part of product labeling. Currently, they require all Class II and III devices, as well as all implantable devices, to have a UDI label.

However, nonsensically, UDIs are rarely used in recalls because the FDA does not require it.

Clearly, adding a device’s UDI to the patient’s electronic health record would allow easy identification of patients with recalled devices. Why isn’t this the law?

How can you know about medical device recalls that affect you?

Patients, the people who are most at risk, are generally the last to know about medical device recalls. Unfortunately, there are no rules that outline who must notify a patient with a recalled medical device, making it easy for patients to either receive a delayed notification or miss the recall altogether.

Unfortunately, instead of proactively notifying affected patients, hospitals and healthcare providers sometimes wait for patients to report symptoms. Surprisingly, some patients only learn about recalls that impact their health on the news or on social media. Of course, if you hear about a recall of a device you use, don’t ignore it!

Since you cannot rely on getting a notification from your doctor or hospital, you can regularly look for recall information yourself.

Fortunately, SoomSafety is an app that helps with this process. You enter your medical device by scanning either the code on your medical device or the code on your patient implant card. SoomSafety then checks for any FDA recall information and suggests next steps if a recall has been issued. And if your device is recalled in the future, you receive a notification.

You can also search in the MAUDE database to see if any reports have been filed. Lastly, you can search online using the name of your device and the phrase “safety alert” or “recall”. These manual searches can be time consuming and frustrating. However, if a device failure could harm you, you could set a monthly calendar appointment to conduct a search.

Learn more…

To learn more about medical device safety and the government’s role in keeping patients safe, read my blog post How Safe Are Medical Devices?