Healthcare insurance companies in the United States are hoping there will be tougher rules for approving and tracking medical devices, according to a Wall Street Journal report.
The Health Insurance Plans trade group penned a letter to U.S. Senator Bob Casey earlier this week about the dangers associated with laparoscopic power morcellators, highlighting the "weakness" of the medical device clearance process and medical device monitoring system.
The letter comes after the FDA warned physicians that the tool shouldn't be used in most women after a series of journal articles focused on the device's risks. Here are eight key concepts from the report:
1. Medical devices similar to ones already on the market can go through the FDA 510(k) clearance process.
2. Devices deemed high-risk receive more stringent FDA reviews, which can include clinical trials.
3. Advanced Medical Technology Association's president and chief executive Steve Ubl said the clearance system is "overwhelmingly safe."
4. Hospitals and device makers are required to report serious problems with devices, logged in the Maude database.
5. The tools used in surgery aren't usually included in medical claims data, which means insurers have difficulty tracking that information.
6. There are current efforts to assign unique device identifiers that would track devices used and any issues patients have.
7. The FDA has not responded to the initial letter.
8. Insurance companies cover medical devices, and stricter regulations could mean less coverage for new innovations.