The Medical Imaging & Technology Alliance (MITA)—the trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices—has submitted a comment letter to the Federal Trade Commission opposing the application of right to repair provisions for medical devices in the draft Energy Labeling Rule.
In its letter, MITA raised deep concerns that applying “right to repair” policies—which historically have focused on consumer electronic products—to FDA-regulated medical devices would have significant unintended consequences, presenting new and unnecessary risks to competition, patient and operator safety, device performance, and cybersecurity.
“Medical devices are heavily regulated throughout their lifecycle by the FDA, except in cases when a device is being repaired by a non-manufacturer servicing organization,” says Patrick Hope, the executive director of MITA. “Independent servicing organizations are not regulated or monitored by the FDA, nor are they required to have any quality, safety, or regulatory controls in place to ensure that they return the device to safe and effective condition for its intended use after servicing.”
“Proper device service doesn’t come from a manual, and granting unregulated businesses unfettered access to service materials by applying right to repair policies to FDA-regulated medical devices raises serious patient safety concerns and risks,” Hope adds.
MITA noted that patient groups have opposed right to repair provisions in state legislatures, and the nation’s first right to repair law in New York exempts medical devices.
The Energy Labeling Rule, first promulgated in 1979, requires energy labeling for major home appliances and other consumer products to help consumers compare the energy usage and costs of competing models.