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Policy and Regulation Updates

Biodex URGENT MEDICAL DEVICE RECALL – Atomlab™ 500 Dose Calibrator and Atomlab™ 500Plus Dose Calibrator

URGENT MEDICAL DEVICE RECALL – Atomlab™ 500 Dose Calibrator and Atomlab™ 500Plus Dose Calibrator August 24, 2021 Biodex is voluntarily recalling the Atomlab™ 500 Dose Calibrator and the Atomlab™ 500Plus Dose Calibrator. The recall is revision 2.0.00 through Revision 2.0.08, inclusive. The Atomlab™ Dose Calibrators are intended to measure the activity of a radioactive source […]

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FAQs for Patient Shielding

In April of 2019, the American Association of Physicists in Medicine (AAPM) released a position statement outlining reasons for limiting the routine use of fetal and gonadal shielding in medical imaging. This position statement has since been endorsed by the American College of Radiology (ACR), the Canadian Organization of Medical Physics (COMP), the Health Physics […]

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AAPM Position Statement on the Use of Patient Gonadal and Fetal Shielding

PP 32-A AAPM Position Statement on the Use of Patient Gonadal and Fetal Shielding 4/2/2019 12/31/2024 Policy source April 2-3, 2019 Board of Directors Meeting Minutes Patient gonadal and fetal shielding during X-ray based diagnostic imaging should be discontinued as routine practice. Patient shielding may jeopardize the benefits of undergoing radiological imaging. Use of these shields […]

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Subjecting Radiologic Imaging to the Linear No-Threshold Hypothesis: A Non Sequitur of Non-Trivial Proportion

Radiologic imaging is claimed to carry an iatrogenic risk of cancer, based on an uninformed commitment to the 70-y-old linear no-threshold hypothesis (LNTH). Credible evidence of imaging-related low-dose (<100 mGy) carcinogenic risk is nonexistent; it is a hypothetical risk derived from the demonstrably false LNTH. On the contrary, low-dose radiation does not cause, but more […]

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The Protecting Access to Medicare Act (PAMA) includes many implications for imaging providers. Learn more here.

The Protecting Access to Medicare Act (PAMA) signed into law in April 2014 was the last “patch” of the SGR and included many implications for imaging providers. Among these are requirements that health care providers comply with the National Electrical Manufacturers Association (NEMA) XR-29 Standard Attributes on CT Equipment Related to Dose Optimization and Management, […]

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The Joint Commission announces the addition of two new Human Resources (HR) elements of performance (EPs) for accredited hospitals, critical access hospitals, and ambulatory care organizations.

In the March 2016 issue of Perspectives* , The Joint Commission announced the addition of two new Human Resources (HR) elements of performance (EPs) for accredited hospitals, critical access hospitals, and ambulatory care organizations that provide diagnostic imaging services (including those ambulatory care organizations that have achieved Advanced Diagnostic Imaging certification). The new HR requirements, […]

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The Joint Commission Standards Change for Providers of Diagnostic Imaging Services

In the March 2016 issue of “Perspectives”, The Joint Commission announced the addition of two new Human Resources (HR) elements of performance (EPs) for accredited hospitals, critical access hospitals, and ambulatory care organizations that provide diagnostic imaging services (including those ambulatory care organizations that have achieved Advanced Diagnostic Imaging certification). The new HR requirements, scheduled […]

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An Overview of Legislative Policy For Radiation Medicine Devices

Radiation medicine devices are an important part of a medical practice, and the FDA requires that establishments list their devices with them. This is to ensure safety and quality standards before going on the market or being used on consumers. Policy enacted by legislators and government regulators requires that there has been a similar device legally distributed […]

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