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The Consumers Union is calling on U.S. manufacturers of hip and knee implants to back products with a 20-year warranty, stating, “Transparency and clear lines of accountability will ultimately move companies to reduce defects and improve quality because it will be in their own financial best interest to do so.” Among the group’s suggested basic warranty requirements:
- Covers the implant for at least 20 years
- Covers the full costs of replacing the flawed device, including the device, surgeon and hospital costs as well as the related patient out-of-pocket costs.
- Does not require the failed device be replaced with the same product or a product from the original device maker if the product has been recalled by FDA or the company, is the subject of FDA warnings, is under investigation by FDA or if the product is no longer being sold by the company.
- Establishes a clear system for patients to use, including a toll-free number and a registration number to track the claims process, with physicians charging the device company, not the patient.
- Does not require the patient to pay out-of-pocket expenses; for example, the patient should not have to pay the device maker or surgeon first and get reimbursed later.
- Provides the patient with full information concerning a warranty claim denial and provides a process to allow the patient to appeal the decision.
- Does not limit or eliminate a patient’s right to sue if they use the warranty.
- Does not disqualify patients across the board because they have specific diseases or illnesses that are not related to the failure of a device.
- Does not disqualify patients for normal activities, including falls.
- Does not disqualify patients due to information that is not routinely available to them, such as information that is on the device packaging or placed into their medical records and not routinely provided directly to the patients in the course of getting the implant.
Source: Warranties for Hip and Knee Implants, Consumers Union Safe Patient Project, September 9, 2013 bit.ly/BONEZONE_warranty_1013.
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