FDA Issues Letter to Health Care Providers Over Safe Use of Megadyne Patient Return Electrodes
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Following recalls, reports of burn injuries and a discontinuation, the Food and Drug Administration published a letter to health care providers raising awareness over the safe use of some Megadyne products.
The MEGA 2000 and MEGA SOFT products are soft pads employed during electrosurgery that were found to cause burns when used with some patients. Megadyne and the FDA have received 99 injury reports so far, with the FDA stating that some have been as serious as third-degree burns. There have been no reports of death.
In its letter, the FDA reemphasized instructions to only use MEGA 2000 and some MEGA SOFT products on patients aged 12 or older and to cease use of MEGA SOFT Pediatric Patient Return Electrodes.
Following a 2023 recall of MEGA 2000 and several versions of MEGA SOFT electrodes, Megadyne issued a voluntary recall and global discontinuation of MEGA SOFT Pediatric Patient Return Electrodes in May 2024.
According to its discontinuation and recall announcement, Megadyne conducted an investigation that revealed that several concurrent factors may lead to burns, and the “combination of these conditions may be more likely when the pad is used with infants and small children.”
Lawyers are accepting Megadyne lawsuits from patients who experienced injury from using Megadyne products.
Megadyne Product Recalls Began in 2023 Following Burn Injury Reports
Megadyne, which is a medical device subsidiary of Johnson & Johnson, issued the initial recall of some of its electrode products in June 2023. The FDA identified this as a Class I recall, the most serious type.
According to the FDA recall notice, surgeons send electric currents through a patient’s body during electrosurgery to stop bleeding or to aid in the cutting of soft tissue, because some tissues break down more easily when heated via electricity. Return electrode pads – like the ones sold by Megadyne – contact the patient’s skin during surgery to safely conduct the electric current through the patient’s body without causing harm.
Megadyne initiated the recall after receiving reports of burn injuries in both pediatric and adult patients. They discovered that some injuries were as serious as third-degree burns, which the FDA said can result in scarring or the need for additional surgery.
According to Stanford Medicine, third-degree burns can damage underlying bones, muscles and tendons.
Risks of Burns May Have Been Highest in Children
Following the June 2023 recall, Megadyne sent stakeholders a medical device correction note in December stating that providers should only use MEGA SOFT Universal, Universal Plus and Universal Dual Pads on patients who are 12 or older.
The FDA sent its own reminder in March 2024 urging health care facilities to discontinue the use of those products on patients under 12.
When Megadyne announced its recall and discontinuation of MEGA SOFT products in May 2024, it explained that an analysis revealed that one of the most significant risk factors for burns is the patient being an infant or small child.
Since these were pediatric pads designed for patients who weigh between 0.8 and 50 pounds, children were the primary audience for these products.
Of the 99 total injuries reported, Megadyne said that four were associated specifically with the pediatric product that it opted to discontinue.
The FDA is working with Megadyne to update the labeling on affected products that are still being manufactured.
Editor Lindsay Donaldson contributed to this article.