Dive Brief:
- The Food and Drug Administration and Health Canada published notices Wednesday about the potential for burn injuries in patients treated with Johnson & Johnson’s Megadyne electrodes.
- FDA and Health Canada officials are working together to raise awareness among healthcare providers and facilities about safe use of Mega 2000 and Mega Soft patient return electrodes.
- J&J discontinued its Mega Soft pediatric electrode pad in May in response to reports of burns. The company has also recently restricted the use of other pads to people aged 12 years and older.
Dive Insight:
Concerns about the safety of Megadyne pads have mounted over the past year. Healthcare professionals use the pads to prevent the risk of burns in procedures that use electrosurgical instruments. However, the FDA issued a Class I recall notice about Mega 2000 and Mega Soft pads in July 2023. J&J’s Megadyne had received reports of 63 injuries linked to the problem at that time.
J&J discontinued a pediatric pad in May and limited the use of its other products in June. The company publicized its actions, sending out a press release and an urgent medical device correction, but the FDA and Health Canada have deemed it necessary to amplify the message.
The FDA sent a letter to healthcare providers about the situation Wednesday. In parallel, Health Canada published a health professional risk communication. The FDA said it was working with its counterpart in Canada to raise awareness.
Both agencies reiterated the messages previously communicated by J&J. Healthcare providers should not use Mega Soft pediatric patient return electrodes in any age group, the FDA said, and should limit use of Mega 2000 pads and other Mega Soft devices to people aged 12 years and older.
“The reports of burns include up to third-degree burns requiring intervention, which may lead to prolonged hospital stay, scarring, and additional surgeries,” the FDA wrote. “Burn injuries may lead to long-lasting impacts on patients, especially under the age of 12 years.”
The labels for certain Mega Soft devices currently say they are suitable for use in people above a certain weight. However, the FDA and Health Canada told healthcare professionals not to use the devices in patients under the age of 12 years.