Patients deserve high-quality care options, thoroughly grounded in research to ensure the best possible outcomes. It sounds like an obvious staple of the health-care world, but this is not always the case.
Efforts exist to better understand the effects of prescription drugs – both benefits and risks – but no such efforts exist to discover the same in medical devices. In fact, many devices have little accompanying data pertaining to their effectiveness, reliability or quality once they are released to the market. Instead, these things are learned “in the field” when they are used in association with the treatment of patients. Rarely is that information shared.
This isn’t to say clinical trials are not done – far from it in fact. But the information these trials offer often fails to answer the questions that arise from in-practice situations.
Medical professionals are working to change this. A joint project from the Center for Health Policy at Brookings, the Food and Drug Administration and clinician, industry, payer and patient representatives will seek to outline the process for creating a national system that captures important device-related information as they are used in the field.
The medical device post market surveillance system, as it is being called, aims to improve safety surveillance while supporting device evaluation capabilities. The data gleaned here will further allow clinicians to analyze the device’s capabilities, overall quality and how it compares to other devices in the same space.
To succeed, however, the system will need to determine how to gather this information while minimizing the reporting required from clinicians. Research shows the average clinician may spend as little as four minutes with a patient, and most spend 8-15 minutes reporting afterward. It is not possible for these numbers to actually decrease if additional reporting time is required.
This new evidence must also be delivered in real time in order to offer any benefit. In a fast-paced industry such as health care, data that is reported late will likely be reported for a device that has already become obsolete.
While these are important challenges, the idea of a medical device post market surveillance system offers benefits to everyone involved in health care. Patients deserve high-quality options and such a system makes those options possible.
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