Dive Brief:

• Megadyne’s recall of electrode pads was classified by the U.S. Food and Drug Administration as a Class I event due to the risk of serious burn injuries, the agency said in a Tuesday notice. 
• Megadyne contacted customers last month after receiving reports of burns linked to its reusable electrode pads. The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths.
• The Class I recall covers 21,200 MEGA 2000 and MEGA Soft reusable electrodes sold in the U.S. In an emailed statement, a spokesperson for J&J wrote that the notification was not a product removal, and Mega Soft pads may continue to be used. 

Dive Insight:

Megadyne is a subsidiary of Johnson & Johnson’s Ethicon segment that makes tools used in electrosurgery, procedures that involve the use of electric current to heat or cut tissue or to stop bleeding. The company sells electrode pads that are applied to a patient’s skin to conduct the current from the body to reduce the risk of excessive heating.

Since April 2018, the company has received 63 complaints of serious patient burns globally. A review of the complaints and the device failed to identify design or manufacturing defects or definitively identify the root cause, Megadyne wrote in its recall notice. The company determined that in some of the instances, users did not follow the instructions for use.

“The Mega Soft pad [instructions for use] includes proper setup steps, including that the Mega Soft pad must be thoroughly rinsed after cleaning to ensure residue from cleaning solutions are removed prior to pad use. Failures to follow the Mega Soft pad [instructions] may contribute to patient burns if cleaning solution residue is not properly rinsed off,” the company said in its letter to customers.

A J&J spokesperson wrote in an email that the electrode pads are a safe alternative to disposable return electrodes when used in accordance with the products’ labeling.

To minimize risk, Megadyne is asking customers to confirm personnel are following the instructions for use and to place a cleaning and care visual aid near the operating room. The actions are intended to prevent burns that could result in prolonged hospital stays, scarring and additional surgeries. The severity of those risks led the FDA to categorize the recall as a Class I event.