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FDA to consider patient feedback on medical devices

To the average Kentucky patient, medical devices look otherworldly, as if they stepped aboard an alien spaceship for their operation. It’s hard to entrust your well-being to a machine that you know nothing about. Given the horror stories of defective device injuries, you may be apprehensive to let your provider use complex tools and implants to treat you.

The FDA aims to regulate these devices to make sure that they are not only safe, but as effective as possible. While the FDA already relies on pre-market testing and ongoing medical expert assessment, it will now begin listening to what patients think about medical devices as well.

Considering patient feedback could help bridge the gap between the medical world and the general public. Patients are sometimes unsatisfied with their treatment. Although medical professionals may believe they know what’s best for you, they can never be an expert on your life.

To measure satisfaction, the FDA plans to examine patient-reported outcomes, or PROs. A PRO is essentially how you view your own health status. It does not include what your doctor thinks about your condition. You may have already created a PRO before if your provider asked you to rate your pain on a scale of 1-10, for example.

The FDA plans to gather PROs and analyze the data en masse to determine which devices are more preferred. If a device is more popular, it may indicate that it works better than its competitors.

PROs could improve the medical market so that patients can regularly access better devices. As a result of the FDA’s focus on PROs, biomedical engineers may pay more attention to what you think as the end user of their product. Ideally, this means fewer defective products on the market.

This new measurement can’t guarantee that medical devices will be perfect. Injuries from defective medical products can leave you seriously hurt and in need of reimbursement, at the very least.