The U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has issued a recall for specific Megadyne grounding pads due to potential burn risks when used in veterinary settings. The affected products include the Megadyne MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes. Originally designed for human medical procedures, these devices have been associated with burn injuries in animals, particularly dogs of various ages and sizes.
The recall, initiated on January 14, 2025, does not involve the physical removal of these devices from veterinary practices. Instead, it focuses on updating the usage instructions to enhance safety during electrosurgical procedures. Key updates include:
- Patient Selection: The devices are now contraindicated for use in patients under 12 years old.
- Proper Setup and Placement: Veterinarians are advised to adhere strictly to the updated instructions for cleaning, placement, and setup of the grounding pads to prevent potential burns.
- Avoidance of Additional Materials: No additional materials, such as sheets or towels, should be placed between the patient and the grounding pad during procedures.
The FDA emphasizes the importance of following these updated guidelines to mitigate the risk of burn injuries during electrosurgical procedures in animals. Veterinarians are encouraged to report any adverse experiences or product defects associated with these devices to the FDA.
For more detailed information, veterinarians can refer to the FDA’s “Dear Veterinarian” letter, which provides comprehensive guidance on the recall and updated usage instructions.
By staying informed and adhering to the updated guidelines, veterinary professionals can continue to ensure the safety and well-being of their patients during electrosurgical procedures.
