The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has launched a new initiative targeted at giving the patients a voice in the agency’s decision making process on medical devices. I became aware of this effort by the FDA when recently reading this article which describes CDRH’s program called Patient Preference Initiative.

As a part of this new initiative CDRH held a two day public workshop in late September in which they invited patients, caregivers, health care providers, researchers, and industry representatives to discuss methods to incorporate patient preference into the regulation of medical devices before and after the products go to market. Discussions amongst attendees were focused around thoughts on questions such as:

  • How do we integrate patient preference into clinical trial design?
  • How can we use patient preference data for post market and compliance issues?
  • What disease areas or device types are best suited for patient preference input?

During the workshop CDRH also announce that the center will be establishing a Patient Engagement Panel that would serve the purpose of providing advice to FDA’s Medical Device Advisory Committee regarding issues that are important to patients.

Workshop discussions alluded to that fact that the FDA’s assessment of benefits and risks of medical devices was viewed as one of the most important responsibilities of the agency pertaining to medical device regulation. In the 2012 FDA Guidance Document: “Factors to Consider when Making Benefit-Risk Determination in Medical Device Premarket Approvals and De Novo Classifications” the agency provided medical device manufacturers an insight as to what the FDA considers when making their benefit-risk determinations. Important points in the guidance document include collecting patient-centric metrics to measure benefits and ways of measuring patient’s tolerance for risks.

The first step for the FDA to properly incorporate patient preferences into medical device regulation is to determine how to accurately and reliable measure patient preferences for diagnosing and treating their conditions. The question of how much risk is acceptable to a patient when compared to the potential benefits of a device may vary from person to person.

As all important decisions this process will take time and I do not foresee patient preference immediately influencing the landscape of how medical devices are regulated. However, at the end of the day the purpose of these devices is to improve the health and quality of life of patients so it is great to see that the FDA is putting more emphasis on the voices of those patients who may need these devices, the caregivers who would be helping patients use them, and the health care professionals who may prescribe them.

In the future we may see FDA approving devices for a subset of patients who along with their health care practitioner are fully aware of the information they need to make their own-well informed decisions regarding the safety and effectiveness of a medical device and have accepted the risks of a medical device for its potential benefits.

-Suyesh

 

Image Credit: visual.dichotomy at flickr

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