KHI project fosters patient input into recently approved home hemo-dialysis device

By ASN Staff

During an August 2015 public workshop hosted by the Kidney Health Initiative (KHI), a public-private partnership between the American Society of Nephrology (ASN) and the Food and Drug Administration (FDA), patients were asked for their thoughts on how best to contribute to future medical device development.  “Patient representatives argued that the care partner requirement effectively ruled out home treatment for those patients who lived alone or who could not afford to hire a care partner".1

The FDA stated that they “were willing to reconsider this issue but needed a systematic way to evaluate risk”. The medical device development company, NxStage, whose representatives also attended the KHI meeting approached the FDA representatives to propose a “patient-centric approach”.

This connection lead NxStage and the FDA through a productive process to mitigate risks with the new device and has finally lead to an approval of the home hemo-dialysis device.

Please read the full article on the FDA’s blog, FDA Voice.

For more information on the KHI project, please see the article in AJKD.  KHI and its Patient and Family Partnership Council would like to see more companies take advantage of this opportunity to integrate patients and care partner thoughts into product development.  Learn more about KHI by visiting their website at www.kidneyhealthinitiative.org.

 


Resources

FDA Voicehttps://blogs.fda.gov/fdavoice/index.php/2017/09/how-patient-preferences-contribute-to-regulatory-decisions-for-medical-devices/

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During an August 2015 public workshop hosted by the Kidney Health Initiative (KHI), a public-private partnership between the American Society of Nephrology (ASN) and the Food and Drug Administration (FDA), patients were asked for their thoughts on how best to contribute to future medical device development.  “Patient representatives argued that the care partner requirement effectively ruled out home treatment for those patients who lived alone or who could not afford to hire a care partner".1

The FDA stated that they “were willing to reconsider this issue but needed a systematic way to evaluate risk”. The medical device development company, NxStage, whose representatives also attended the KHI meeting approached the FDA representatives to propose a “patient-centric approach”.

This connection lead NxStage and the FDA through a productive process to mitigate risks with the new device and has finally lead to an approval of the home hemo-dialysis device.

Please read the full article on the FDA’s blog, FDA Voice.

For more information on the KHI project, please see the article in AJKD.  KHI and its Patient and Family Partnership Council would like to see more companies take advantage of this opportunity to integrate patients and care partner thoughts into product development.  Learn more about KHI by visiting their website at www.kidneyhealthinitiative.org.

 


Resources

FDA Voicehttps://blogs.fda.gov/fdavoice/index.php/2017/09/how-patient-preferences-contribute-to-regulatory-decisions-for-medical-devices/

Date:
Thursday, September 28, 2017