23 September 2024
Statement from AMDR: Separating the Facts from the Myths about FDA Regulated, Reprocessed LigaSures™
In September 2020, a Medtronic-funded study purporting to show soiled reprocessed LigaSure devices was published in the Journal Surgical Endoscopy. After an exhaustive, year-long independent review by the publisher, an important correction was added to the article, indicating that funding from Medtronic was not disclosed properly. The study authors were also found to have failed to disclose that the alleged soiled devices were not supplied by the users of the devices, but instead were procured, tested, and supplied by the study authors by Medtronic.
Medtronic has a vested interest in inhibiting the FDA regulated practice of reprocessing because every device reprocessed is one fewer device sold. These disclosure failures call into question the research integrity of the study. Failure to disclose the chain of custody for any product evaluated in a study, especially one purporting to show product soiling, is especially troubling.
Recently, misleading claims based on this data have surfaced questioning the safety of reprocessed devices. Medtronic has published a website dedicated to the promotion of the claims made in the journal article – without (again) disclosing that Medtronic funded the study and that Medtronic supplied the allegedly soiled devices.
That’s doubling-down on bad science, and it’s beneath Medtronic. The medical community should join in demanding that Medtronic immediately stop promoting biased research.
AMDR calls on Medtronic to remove the website and for Medtronic sales representatives to stop promoting misleading information.
Click here to read the full statement, including more information about the safety, efficacy, and environmental and cost benefits of FDA regulated medical device reprocessing.