5 Steps in Which Hospitals Can Effectively Respond to a Medical Device Recall

Modern medical science may be over two centuries old, but medical devices have existed since 7000 BC. The oldest-known devices were bowstrings and drills used for amputation and surgery in Balochistan.

Just like pharmaceutical drugs, medical devices play a pivotal role in the healthcare industry. They are used to diagnose, manage, and prevent certain diseases safely and effectively. Ideally, a medical device manufacturer must abide by some industry standards for patient safety.

This means it is not enough that the device performs its job. It must do so without compromising the patient’s health. Unfortunately, not every medical device meets its claims in terms of efficacy or safety.

That is when they must be recalled. In other words, the manufacturer will either pause the production for corrective measures, or they may take it down the market shelves altogether. Just like the Food & Drug Administration (FDA) approves medical devices for commercialization, the agency can issue a recall order.

In 2024, the FDA issued a recall order for 14 medical devices. A product recall can catch physicians and hospitals off-guard without a suitable response plan in place. Moreover, the FDA offers no guidance to hospitals on how to handle a medical device recall.

Nevertheless, it is important to have a response plan to avoid potential liability and preserve patient relationships. In this article, we will discuss five steps that hospitals can take for a successful medical device recall response.

 

Why Are Medical Devices Recalled?

A medical device is generally recalled when it is found to be defective by design, poses a risk to patient health, or its distribution is based on gross deception. The FDA classifies such recalls into three categories – Class I, Class II, and Class III.

Class I medical device recalls are serious, and only issued for tools that can cause severe health complications or death. Class II medical device recalls are issued for products that may have reversible and minor side effects.

Finally, Class III medical device recalls are not related to adverse events. Their manufacturing may have violated the FDA’s regulatory standards. Let’s understand this with the help of some examples – Abbott Laboratories’ glucose monitoring device received a Class I FDA recall order in early 2023.

The device could measure glucose levels in a patient’s body through a small sensor attached to the back of the upper arm. The real-time glucose readings were powered by rechargeable lithium-ion batteries. It was found that these batteries could overheat, thereby causing a spark or catching fire. Besides severe burn injuries, patients were at risk of death.

An example of a Class II medical device recall would be the Bard PowerPort. It is an implantable catheter port that makes it easy to access the vascular system for chemotherapy, dialysis, etc. According to TorHoerman Law, physicians and patients reported cases of catheter fracture and migration, deep vein thrombosis, blood vessel damage, blood clots, and infection.

In March 2020, the FDA recalled three Bard powerport models under Class II. Such recalls are usually accompanied by legal suits against the manufacturer. In this case, over 70 plaintiffs have filed the port catheter lawsuit, alleging that the manufacturer also participated in gross deception regarding its device’s safety.

Class III recall of medical devices is pretty rare. An example would be the recent critical safety communication issued for syringes manufactured in China. The agency believes that these syringes may have quality issues due to manufacturer-induced changes in dimensions. This could lead to syringe breakage or leakage problems.

 

How Hospitals Can Respond to a Medical Device Recall Notice

Now, let’s look at the five steps in which hospitals can successfully respond to a medical device recall.

Staying Prepared for a Recall Notice

Many hospitals panic when a product recall is announced because they do not have a system for responding in place. It is crucial to stay prepared for a sudden recall notice.

This means there must be guidelines communicated to each healthcare professional for a successful response. For instance – patients must be notified, follow-ups need scheduling, and so on. Hospitals must begin by developing a user-friendly tracking system that helps them identify the patients using the recalled medical device.

 

Scheduling a Meeting with the Device Manufacturer

In case of a medical device recall, the manufacturer must contact healthcare facilities and share necessary information for patient treatment and queries. If they don’t, hospitals can schedule a meeting to understand the following –

• The reason behind the recall
• Whether the medical device will be permanently removed or re-produced after corrective action
• Possible complications or risks of the device
• All necessary descriptive information, including the device’s size, serial number, lot number, etc.
• The possible date of manufacturing and availability of replacement devices
• A ready means to collect all the devices
• Any specific actions the manufacturer would recommend

Hospitals can even reach out to the FDA directly or other healthcare institutions that are likely to be affected by the recall.

 

Adhering to the Manufacturer’s Action Steps

The device manufacturer will issue a recall letter with some recommended action steps for safe product handling. These action steps would include –

• Any treatments that may minimize the impact or complications of the recalled device
• Alternative medical devices that can help in the continuation of patient treatment
• Actionable steps for device collection

Hospitals need to stick to the manufacturer’s recommended action steps. This will preserve patient health and market reputation.

 

Shared Decision-Making with Patients

First, it is essential to contact patients promptly to convey medical device recall news. Hospitals must let patients know about the possible complications of the device that led to a recall.

Once done, they must have an open and honest conversation with the patients about the financial considerations, complications, action steps, etc. After all information is relayed, the patient must be allowed to decide the course of action they wish to take. Hospitals must objectively share all details and let the patient take the final call.

 

Staying Up-to-Date with Findings

While patients are given time to make informed choices, healthcare institutions must keep themselves updated on the situation. Accurate information is a top priority. It is the only way to develop effective treatment plans.

Besides staying in touch with the device manufacturer, hospitals can go through the FDA’s medical device recall database for updated details.

 

If the recall belongs to Class I or II, it will most likely have a legal battle attached. Injured patients will sue the medical device manufacturer. Usually, the physician is not dragged into court during a medical device recall.

They will only open themselves to the possibility of liability if they fail to obtain patient consent, implant the device negligently, or do not respond to the recall successfully. With the above-mentioned steps, every hospital should stay recall-response-ready.