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U.S. Department of Health and Human Services

Medical Devices

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Challenges for Device Postmarket Surveillance

Medical devices range from the simple (e.g., toothbrushes, adhesive bandages) to the complex (e.g., lasers, MRI machines, implants for many parts of the body). The kinds of devices, their complexity and the way they’re used is growing and changing rapidly.

Optimal device performance frequently depends on ease of use, adequate training and experience with a device, proper maintenance, as well as many factors specific to a patient’s clinical condition. Device quality is also affected by design issues and manufacturing processes and procedures. Furthermore, use of critical care technologies, such as ventilators, dialysis and infusion therapy, are rapidly moving from hospitals and other traditional health care settings into patients’ homes, and are often being operated not just by health care professionals but by patients and lay caregivers. Implants, such as orthopedic joints, heart valves and intraocular lenses are expected to last for decades, making it critical to understand device performance for many years after implantation.

For all these reasons, it is critical that the FDA generate, obtain, and synthesize postmarket data using a wide variety of sources and methods --- no one source or approach can provide a complete picture of a device’s use. Ultimately, better data will lead to better decision-making, potentially leading to better medical devices and better health for patients.