Responding to a Medical Device Recall Notice 

Executive Summary

All medical devices carry some risks, and sometimes either the Food and Drug Administration (FDA), which approves medical devices, or the device manufacturer itself determines that the risks outweigh the benefits and issues a recall. Medical device recalls occur regularly, and it’s important that physicians implement procedures to respond when they’re notified of a recall. Establishing an appropriate response is critical for a physician to avoid potential liability and maintain good relationships with patients. 

Recommended Actions

• Have a system in place and train all staff on how to handle a medical device recall. 
• If a recall is issued, obtain complete and accurate information from the manufacturer regarding the recall along with the manufacturer’s recommended action steps. 
• Ensure that you are up to date on information regarding recalls so you can provide efficient care to your patients. 
• According to the FDA, millions of medical devices are recalled annually. A recall is a method of removing or correcting products that violate FDA laws. 

The Safe Medical Devices Act (SMDA) requires manufacturers to report device-related deaths, serious injuries and malfunctions to the FDA. Before issuing a possible recall to patients, physicians or the public, manufacturers will often weigh: (1) the possibility of mitigating the problem with an intervention, (2) probability of device failure, and (3) likelihood of harm. Most often, manufacturers will perform voluntary recalls.    

In the event of a recall or a potential recall, the FDA will conduct a health hazard evaluation. Based on that evaluation, the medical device is then classified for a Class I, Class II or Class III recall, based on the risk the device poses to patient safety. 

• Class I – most serious; occurs when a reasonable chance exists that the product will cause serious health problems or death
• Class II – occurs when either (1) a possibility exists that the product will cause temporary or reversible health problems, or (2) a remote chance exists that the product will cause serious health problems
• Class III – occurs when little chance exists that the product will cause health problems. 

Generally, it is the manufacturer’s responsibility to promptly notify each physician and hospital of a recall. Typically, this involves the manufacturer sending a letter to each physician and hospital. Following are steps physician should utilize upon receiving a recall notice from a manufacturer. 

How to Respond to a Manufacturer Recall Notice 

Have a system in place before you receive a recall letter. 

If you are a physician at a licensed or accredited facility, such as an ambulatory surgery center (ASC) or hospital, the facility should have formal policies and procedures for handling recalls - follow those. 

You should implement your own system to handle medical device recalls. Have an easily accessible tracking system to identify patients who use a particular medical device. In the event of a recall, it will make notifying affected patients easier.  

Be prepared for a high volume of patients calling to obtain further information and schedule follow-ups. Also, have a script available for answering patient calls.

Schedule a meeting with the manufacturer.

As the physician, you want to make sure you have all the accurate information needed from the manufacturer to effectively treat your patients and to be prepared to answer their questions. The manufacturer should reach out to you about the recall and provide you with a majority of this information; however, in case they do not (or if the information they provide is not to your satisfaction), consider asking the manufacturer to clearly identify:

• The product, size, lot number(s), serial number(s), and any other pertinent descriptive information to ensure quick and accurate identification of the product
• The reason for the recall
• Possible hazards or implications involved
• The date range for when the product was manufactured and distributed
• Whether there is a replacement product available
• The manufacturer’s recommendation(s); and/or
•  A ready means for collection of the medical device. 

If you aren’t getting the information you need from the manufacturer, you should reach out to the FDA and other physicians within your specialty who are likely to have also been affected by this recall.  

Follow the manufacturer’s recommended action steps. 

In the recall letter, the manufacturer will describe actions for safe handling of the recalled product (for example: discontinue use, discard, correct the product, return the product). It will also state whether these actions are temporary or long-term. The following should also be included in the recall letter:
•    Recommended treatment or action for users to minimize risks or impact of the affected product
•    Actions to be taken pending correction or removal of the device
•    Alternative products that can be used.

Reach out to patients in a timely manner to provide follow-up care. 

Under FDA law, a physician is not a mandatory reporter of the recall, but it is good practice to meet with your patients after receiving a recall notice. As a physician, you have an ethical obligation to notify patients if you believe a medical device could put them at risk. If you are unable to reach the patient, document that you tried via phone or email at least twice.

By notifying and meeting with your patients, you maintain good relationships with them while reducing the possibility of your involvement in a lawsuit against the manufacturer.

Pursue a course of shared decision-making with the patient. 

Consider the following topics of discussion with the patient:

• The nature of the recall
• Possible symptoms and signs
• Compare the risks and benefits of leaving, monitoring or removing the medical device (and any additional procedures or treatment that may be warranted, such as follow-up visits or therapy)
• Limitations on present knowledge which cannot incorporate future discoveries or fully address all possible outcomes; and 
• Financial considerations. 

It is important to have open and honest communication with your patient. After having this initial conversation, allow the patient time to think about the course of action they want to take. Also, assure the patient that you are monitoring the situation and will keep them up to date.

Stay informed about new information and findings. 

Accurate information should remain the top priority for both you and your patients. Patients will want up-to-date information, and this will allow you to formulate the best possible treatment plans for your patients.

Below are some additional questions you or your patients may have.

Who pays for the associated medical costs in a recall?

For subsequent follow-up visits, procedures and therapy, the patient or their insurer will be responsible for any services performed by their physician. Patients may have to sue the manufacturer to get reimbursed for their out-of-pocket costs. Sometimes the manufacturer will cooperate with payers to reduce costs and any financial burden placed on the patient. The physician will not be liable for such costs.  

Who are the likely parties in a lawsuit, and under what circumstances can they be sued during a recall?

With a recall on a medical device, generally speaking, the manufacturer will be sued and not the physician. However, a physician opens themselves up to liability by:
 

• Failing to obtain informed consent from the patient
• Negligently installing the implant or medical device; and
• Failing to take appropriate action when they received the recall notice, and when that failure resulted in injury to the patient. That’s why it’s important to follow the recommended steps from the manufacturer and schedule follow-up care with the patient after receiving notice of the recall.

Healthcare professionals may also risk liability for failure to adequately maintain records that results in a delay in a patient receiving care. It’s crucial to have complete, accurate and accessible medical records and tracking systems in place.

Additional information on informed consent and creating and sharing treatment plans can be found here. 

Lessons Learned

• Be proactive and implement a procedure to follow when there is a medical device recall. 
• If you receive a recall notice from a manufacturer, follow the recommended steps above. 
• Stay informed about medical devices that you use and potential recalls. 
• Put the patient’s safety first and lean on the side of caution. Respect, education and shared decision-making can ease patient concerns about a medical device recall. Physicians can promote patient satisfaction by optimizing the quality of care they offer. 

Potential Damages

When a medical device is recalled, most of the time the manufacturer will be sued and not the physician. However, the physician should follow the recommended steps within this article to decrease exposure to potential lawsuits. 

Profession selection: Physician
Specialty selection: All specialties
Product type: Business of Medicine