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Compliance In Focus
Posted by Ashton Steinhagen on Mon, Sep 14, 2015

Do The Benefits Outweigh The Risk?

I was reading an article on the FDA’s website over concerns related to devices causing serious adverse Do_The_Benefits_Outweigh_The_Riskevents, the determination that the benefits outweigh the risks was the conclusion.  This raises some interesting questions with regards to patient safety.  The article specifically talks about devices that are used primarily as a bridge to transplant (BTT) or destination therapy in relation to severe heart failure.  Having been trained on the particular devices in question and taking care of the patient population whom received the devices, these patients have very few if any options.  Determining whether or not a device is safe is one thing but distinguishing if a device that has been shown to cause serious adverse events is acceptable in a certain patient population is another.

LVADs or left ventricular assisted devices are used to help the left ventricle circulate blood throughout the body in patients whose heart function is severely compromised.  The use of these products not only is a serious surgery but a serious change in lifestyle for the patient.  The patient will no longer be able to take a shower, and will have to be connected to the controller at all times which can be battery operated or electrical, and must do daily dressing changes.  Although these changes might be seen as a burden, there are little, if any, other options available for them.

Title 21 Part 812.30 in the Code of Regulations talks about if the risks to the subjects are not outweighed by the anticipated benefits then approval will not occur.  This raises the interesting point of who makes this determination.  For other devices that are not as concrete as the one mentioned in the article, this could present complicated questions with even more complicated answers. 

Please share your thoughts.

5 Core Elements

photo credit: October 15 - 21, 2010 via photopin (license)

Topics: Medical Devices, FDA, Risk, Title 21 Part 812.30


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