Rising Regulatory and Congressional Scrutiny of Facilities Using Radiation-Emitting Devices
LawFlash/Client Alert
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published on:
02/05/2010 -
by:
Energy and FDA & Healthcare Practices
The New York Times recently published a series of articles that highlighted medical issues associated with excessive or incorrect radiation exposures in therapeutic applications. The articles suggest that, in many cases, the events occurred due to inadequate staffing and training, user failure to follow or properly implement device quality assurance plans and procedures, and/or software issues. In our experience, these are not unusual problems and happen with some frequency in many different types of radiation-licensed activities. In fact, this issue has garnered congressional scrutiny as evidenced by plans by the U.S. House of Representatives’ Subcommittee on Health, Employment, Labor, and Pensions to hold a hearing on February 10 titled “Medical Radiation: An Overview of the Issues.”
The Nuclear Regulatory Commission (NRC) and various state radiation control agencies oversee medical uses of radioactive materials and devices through licensing, inspection, and enforcement programs. The NRC and these agencies issue medical use licenses to medical facilities and authorized physician users, and develop guidance and regulations for use by licensees. The NRC maintains a committee of medical experts to obtain advice about the use of radioactive materials in medicine.
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