25 September 2017 - Since we launched our Patient Preference Initiative as part of our medical device regulatory decision-making process in September 2013, we’ve seen increasing evidence of the benefits of soliciting patient feedback – most recently, in giving kidney patients more therapy options and enhancing the safe use of a glucose monitor by pediatric patients with Type 1 diabetes.

In August, for the first time we cleared an expanded indication for a home haemodialysis machine so it could be used without a care partner being present, a decision based in part on asking kidney patients about their tolerance for risk.

Home dialysis may improve a patient’s quality of life, allowing them to undergo the lengthy treatments in the comfort of their home without the need to travel three times a week to a dialysis center. However, due to a risk of rare but serious events associated with performing haemodialysis alone in the home, we had previously required the presence of a care partner during the treatment.

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