Risk Management Considerations for a Medical Device Recall Notice

Executive Summary

 Although the FDA does not provide guidance on how physicians should respond to a medical device recall notice, such 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 to identify patients who use specific medical devices to effectively and in a timely manner contact patients affected by a recall.
• Schedule a meeting with the manufacturer of the recalled medical device to make sure it has provided all the information needed to effectively treat patients and answer their questions.
• Develop a course of action with a patient affected by a medical device recall, considering the nature of the recall, the limited scope of information available and financial concerns.

The Food and Drug Administration (FDA) is the federal regulatory agency authorized to approve medical devices. All medical devices carry some risks, and sometimes either the FDA or the device manufacturer determines that the risks outweigh the benefits and issues a medical device recall notice. According to the FDA, more than 10 million medical devices were recalled in 2020.

A medical device recall removes or corrects devices that violate FDA laws; a recall is initiated when the manufacturer either makes a correction or removes the device from where it is used or sold. 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, although the FDA has the authority to mandate a recall.

When a manufacturer decides to initiate a recall or a potential recall, the manufacturer will notify the FDA. The FDA then conducts a health hazard evaluation and classifies the medical device as either a Class I, Class II or Class III recall, based on the risk the medical 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 causeserious health problems
• Class III – occurs when littlechance exists that the product will cause health problems.

The recalling manufacturer is responsible for notifying each of its affected suppliers, which is generally a physician or hospital. Unless it is a direct-to-consumer product, a manufacturer will not directly notify patients.

The FDA does not provide guidance on how physicians should respond to a recall notice and there is no requirement that physicians notify their patients about the recall. Accordingly, most of the time a manufacturer will notify just the physician (and not the patient). This creates significant concern for the physician as to whether and how they should appropriately notify and treat their patients affected by a recall in the absence of any mandated guidance from the FDA.

Upon receiving a recall notice, the physician should immediately carry out the recalling manufacturers’ recommendations. To do so, it’s important that physicians implement procedures upon notice of a recall. Establishing an appropriate response is critical for physicians to avoid any potential liability and maintain good relationships with their patients.  Most facilities such as hospitals and ASCs have formal policies and procedures for handling recalls, and physicians should adopt those. Following are risk management steps that outpatient or private practice physicians should utilize upon receiving a recall notice from a manufacturer.

Steps for Effectively Responding to a Manufacturer Recall Notice

1. Physicians should have a system in place before receiving a recall letter.

Physicians should implement their own system to handle medical device recalls. That system should include an easily accessible tracking system to identify patients who use a particular medical device. In the event of a recall, it will help the practice more efficiently notify patients who may be affected. 

Physicians should be prepared for a high volume of patients calling to obtain further information and schedule follow-ups and should develop a script to answer affected patients’ calls.

2. Physicians should schedule a meeting with the manufacturer.

Physicians need to make sure they have all the accurate information needed from the manufacturer to effectively treat their patients and answer their questions. The manufacturer should reach out to the physician about the recall and provide them with a majority of this information; however, in case the manufacturer does not (or if the information provided is not to the physicians’ satisfaction), the physician should 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 of the product’s manufacture and distribution
• Whether there is a replacement product available
• The manufacturer’s recommendation(s)
• A ready means for collection of the medical device.

If physicians are not receiving the information they need from the manufacturer to their satisfaction, they should reach out to the FDA and other physicians within their specialty who are likely to have also been affected by this recall. 

3. Physicians should 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 also will state whether these actions are temporary or long-term. The following information also should be included in the recall letter:

• Recommended treatment or action for users to minimize risks or impacts of the affected product
• Actions to be taken pending corrective or removal of the device
• Alternative products.

4. Physicians should reach out to patients in a timely manner to provide follow-up care.

Physicians have an ethical obligation to notify their patients if they believe a medical device could put their patients at risk. If physicians are unable to reach the patient, they should document that they tried to reach the patient via phone or email at least twice. By notifying and meeting with patients, physicians maintain good relationships with their patients while reducing the possibility of a lawsuit.

5. Physicians should 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 that cannot incorporate future discoveries or fully address all possible outcomes
• Financial considerations.

It is important to conduct open and honest communications with patients. After having this initial conversation, allow the patient time to think about which course of action they want to take. Physicians should also assure the patient that they are monitoring the situation and will keep them up to date.

6. Physicians should stay up to date with new information and findings.

Accurate information should remain a physician’s top priority. Patients will want up-to-date information, and this will allow them to formulate the best possible treatment plans for their patients.

For subsequent follow-up visits, procedures, and therapy, the patient or their insurer will be responsible for any services performed by the 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. 

Generally, when there is a recall on a medical device, the manufacturer will be sued and not the patients’ physician. A physician opens themselves up to liability by:   

1. Failing to obtain informed consent from the patient
2. Negligently installing the implant or medical device
3. Failing to take appropriate action when receiving the recall notice and when that failure resulted in injury to the patient. That is 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.
4. Failing to adequately maintain records that results in a delay in a patient receiving care. This is a reason why it is crucial to have a complete, accurate and accessible medical records and tracking system in place.

Since medical device recalls occur regularly, it’s important that physicians implement procedures upon notice of a recall. Establishing an appropriate response is critical for a physician to avoid any potential liability and maintain good relationships with their patients. By following the recommended steps within this article, physicians will decrease exposure to potential lawsuits. Physicians should always put the patients’ safety first and lean on the side of caution. Respect, education and shared decision-making can soothe patients concerns about a medical device recall.

Lessons Learned

• Obtain the necessary informed consent from each patient before providing a medical device.
• Do not delay when contacting and informing patients of a medical device recall in order to avoid any further harm to the patients.
• Confirm that you have the latest information and findings regarding the medical device recall to ensure the best possible treatment plans for patients.

Potential Damages 

Manufactures tend to be sued for medical device defects rather than physicians; however, a physician that provides a patient with a medical device they know has been recalled can face severe legal action for negligence. Although the frequency of claims is relatively low, a physician should implement and follow procedures for handling recalls to prevent potential lawsuits.