Here are nine notes:
1. The market for implantable medical devices in the United States reaches $150 billion per year.
2. Tracking allows providers to understand which devices are working for each specific patient and would allow for the recall of defective devices.
3. The Government Accountability Office found the majority of recalls of high-risk devices end without all affected devices being fixed or removed.
4. The Food and Drug Administration requires high-risk devices to carry a unique identifier. The identifiers are of limited use because individuals using the devices are linked to the identifiers.
5. Registries in some cases are compiled to track specific devices, but the devices are limited and inefficient in that they have to be created one-by-one for each device. The devices also offer insufficient information about or access to the rest of a patient’s medical history.
6. One possible solution is to include the unique device identifier in the health insurance filing when the device is inserted into a patient. This would allow for enhanced evaluation on the efficiency of the devices and would make it easier to track a patient if things went awry.
7. Another approach would include the device identifier in a patient’s electronic health record. This should be done in addition to the insurance claim.
8. Critics claim these approaches are too much work for the government and providers, but the benefits seem to outweigh opposition.
9. Centers for Medicare and Medicaid Services have not stated whether they will move forward with the proposals.
More articles on orthopedic devices:
ChoiceSpine launches posterior cervical system — 5 key notes
NuVasive leadership shake-up: Meet 6 new executives
Rivanna Medical’s Accuro receives FDA clearance: 4 observations
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
