MedTechbloggen

FDA har startat en process för att minska risken för onödig strålning vid medicinsk behandling. Av den anledningen kommer man att genomföra en offentlig hearing den 30 och 31 mars. Där kommer man också att diskutera ändrade krav på tillverkarna.
FDA sammanfattar åtgärdsförslaget:

“Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams present both benefits and risks. These types of imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions. At the same time, these types of exams expose patients to ionizing radiation (hereinafter “radiation”), which may elevate a person’s lifetime risk of developing cancer. A balanced public health approach seeks to support the benefits of these medical imaging exams while minimizing the risks.

Managing the risks of computed tomography (CT), fluoroscopy, and nuclear medicine imaging procedures depends on two principles of radiation protection: appropriate justification for ordering and performing each procedure, and careful optimization of the radiation dose used during each procedure. These types of imaging exams should be conducted only when medically justified. When such exams are conducted, patients should be exposed to an optimal radiation dose - no more or less than what is necessary to produce a high-quality image. In other words, each patient should get the right imaging exam, at the right time, with the right radiation dose.

FDA can advance this goal by using our regulatory authority judiciously while also collaborating with the healthcare professional community.

This document announces the launch of a cooperative Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. Through this initiative, FDA and our partners will take steps to:

1. Promote safe use of medical imaging devices;
2. Support informed clinical decision making; and
3. Increase patient awareness.

By coordinating these efforts, we can optimize patient exposure to radiation from certain types of medical imaging exams, and thereby reduce related risks while maximizing the benefits of these studies.”