Comment from Megan Wainwright
AnonymousSupportIndividual
Summary: The commenter, a patient with complex health conditions, advocates for the regulation of NarxCare as Software as a Medical Device (SaMD) by the FDA. They argue that such regulation is necessary to ensure safety, transparency, and accountability for tools that directly impact patient care and to prevent medical errors.
Please regulate NarxCare as Software as a Medical Device so it can be properly reviewed and regulated by the FDA as it should be. These tools directly impact patient care and must meet standards for safety, transparency, and accountability. I have had multiple near-death occasions because doctors decided based on the meds I take for chronic pain that I "must" be lying, including a dissection and stroke last summer after I fainted and hit the back of my head. I was sent home from the ER three separate times, until a fellow patient in the waiting room brought the triage nurse's attention to my frank stroke symptoms. I spent weeks and weeks in the hospital and still have lingering symptoms of weakness and neurogenic scoliosis because of the stroke. I have multiple genetic, interlocking, rare, and complicated health conditions and I tell my doctors now that I would rather die than go back to the ER to be blown off and treated like a drug seeker. I now live with a GJ feeding tube because of ignored abdominal pain. The pain from the surgery is not well controlled, and now my blood pressure is high. This obviously puts me at further risk of cardiovascular events in the future. Please fix this so that NarxCare is regulated as software as a medical device so that more patients like me don't nearly die before we are treated.
Thank you