8 Reasons To Only Use FDA Registered Physiotherapy Devices

The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety and efficacy of medical devices.  Here are some reasons why it's important to only use FDA-registered physiotherapy devices:

  1. Safety: FDA registration ensures that the device has undergone rigorous testing and evaluation for safety. This means that the device is designed and manufactured in a way that minimizes potential risks and harm to the patient. Non-registered devices may not meet these safety standards, potentially leading to injury or ineffective treatment.

  2. Efficacy: FDA registration also means that the device has been evaluated for effectiveness. This means that the device has been proven to perform as intended and provide the therapeutic benefit it claims to offer. Non-registered devices may not deliver the promised benefits, leading to wasted time and resources.

  3. Quality Control: FDA-registered devices are subject to ongoing oversight, including inspections and audits, to ensure continued compliance with quality standards. This is not the case with non-registered devices, which may have inconsistent quality.

  4. Traceability: In case of any adverse events or product recalls, FDA registration allows for efficient traceability of the device. This can be crucial in preventing further harm to patients.

As for cheap knock-off devices on Amazon or other online platforms, they may not be appropriate for clinical use for several reasons:

  1. Lack of Regulation: These devices may not have undergone any form of regulatory scrutiny, meaning there's no guarantee of their safety, effectiveness, or quality.

  2. Inaccurate or Misleading Claims: Such devices may make health claims that are not backed by scientific evidence. This can mislead consumers into thinking they're receiving effective treatment when they're not.

  3. Potential for Harm: Without regulatory oversight, these devices may be poorly made or use substandard materials, potentially leading to injury.

  4. Lack of Support and Training: Professional medical devices often come with training and support to ensure they're used correctly. This may not be the case with cheap knock-offs.

For these reasons, it's crucial to only use FDA-registered physiotherapy devices in a clinical setting.

For more information, you can refer to the FDA's website on medical device safety (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-safety.

-Andrew Bruns DC