On July 8, 2024, the U.S. Food and Drug Administration (FDA) issued an important update regarding the recall of Philips’ MRI coils, specifically the Sense XL Torso (1.5T and 3T) coils. This recall, initially prompted by reports of overheating and consequent patient burns, underscores the need for rigorous adherence to safety protocols in medical imaging.
Background and Initial Concerns
In May, Philips notified its customers about potential overheating issues with the Sense XL Torso coils, which could lead to severe burns during MRI scans. The notification followed 64 complaints and 52 reported injuries linked to the coils overheating between 2011 and 2024. Although these coils were discontinued in 2014, many healthcare facilities continue to use them, prompting a Class 1 recall by the FDA in June. This type of recall is the most serious, highlighting the potential for significant harm.
Philips’ statement in June emphasized the possibility of localized heating during scans, posing a risk of patient injury from excessive heat. Despite the risks, the recall does not mandate the removal of the coils but provides updated instructions for their safe use. Philips expects to release further updates on corrective actions by the end of 2024.
FDA Instructions for Continued Use
The FDA’s latest alert includes specific guidelines from Philips for facilities that continue to use the affected coils:
- Follow Updated Instructions: Facilities should adhere strictly to the revised instructions for use, which have been disseminated to affected customers.
- Avoid High SAR Scans: First level operating mode or high Specific Absorption Rate (SAR) scans should be avoided when using these coils.
- Use Provided Padding: Always utilize the padding provided with the coils to prevent direct contact with the bore.
Additional Safety Measures
In their initial safety alert, Philips advised facilities to:
- Ensure that the anterior portion of the coil is positioned at least 2 inches (5 cm) away from the bore.
- Limit individual patient scan times to no more than 45 minutes.
Common Injuries and Statistics
Burns are among the most common injuries associated with MRI scans. Between 2008 and 2017, the FDA reported that burns accounted for 59% of MRI safety incidents. These injuries typically result from conductive heating of the coils or other metallic objects in the scanning environment. The recent issues with Philips’ MRI coils have highlighted the critical need for stringent safety measures and careful monitoring during MRI procedures.
Legal Recourse for Injured Patients
Patients who have suffered burns or other injuries due to defective MRI coils may seek legal recourse through a product liability lawsuit. This type of lawsuit holds manufacturers accountable for producing and distributing unsafe medical devices. Victims can claim compensation for medical expenses, pain and suffering, lost wages, and other related costs.
The Lawsuit Process and Importance of Legal Representation
The process of filing a lawsuit begins with consulting a personal injury attorney experienced in product liability cases. The attorney will evaluate the details of the case, gather necessary evidence such as medical records and proof of the defective product, and file a complaint to initiate legal proceedings. The discovery phase follows, where both parties exchange information and further evidence is collected.
Having an attorney is crucial for navigating the complexities of a product liability lawsuit. They provide the necessary expertise to handle the case efficiently, from negotiating settlements to representing the victim in court if needed. Legal representation ensures that the victim’s rights are protected and that they receive fair compensation for their injuries.
Potential Damages Recoverable in a Lawsuit
Victims of defective medical devices can recover various types of damages, including:
- Medical Expenses: Covers the cost of medical treatments, surgeries, and rehabilitation related to the injury.
- Lost Wages: Compensation for income lost due to the inability to work following the injury.
- Pain and Suffering: Damages for the physical pain and emotional distress caused by the injury.
- Punitive Damages: In cases of gross negligence, punitive damages may be awarded to punish the manufacturer and deter similar conduct in the future.