Stripping the US Safety Net

The recently passed Republican budget bill in the U.S. House of Representatives, dubbed the "One Big Beautiful Bill Act," is poised to significantly impact Medicare and Medicaid beneficiaries, particularly those with disabilities and injured workers, by dramatically shrinking the U.S. social safety net.

Drilling down on the necessity of dental X-rays

Dental x-rays

When my son and daughter were youngsters, once a year I'd have a disagreement with their pediatric dentist. He wanted to do routine annual X-rays, and I would protest because neither child ever had any cavities. His response: Dental X-rays are an important diagnostic tool, representing a small speck in the sea of radiation that we receive by inhabiting planet Earth. It turns out we both were right. Dental X-rays are essential for detecting serious oral and systemic health problems, and generally the amount of radiation is very low. But new thinking on dental X-rays is that the "one size fits all" schedule is outdated. "The notion of bite-wing X-rays every year and a full set of X-rays every three years for every patient should go in the garbage can," says Stuart White, a dentist and professor emeritus at the UCLA School of Dentistry. Instead, decisions should be made individually. Emphasizing that "without dental X-rays we would go back 120 years, and disease detection would be primitive and awful," White says dentists must strive to minimize unnecessary exposure. And this is where the discussion gets complicated because the amount of radiation you receive depends on how the dentist takes pictures of your teeth. For example, if your dentist uses slow film and round collimation (the piece of equipment placed near your face during X-rays), you're going to get approximately double the dose that you would from digital imagery and rectangular...

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FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare

Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices. 

The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation.

 

“If the device indicates it has detected an error during a self-test the FDA advises users to keep recalled HeartStart AEDs in service until a replacement from Philips Healthcare or another AED manufacturer is obtained,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”

 

These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. Users, who may include consumers and first responders, should contact Philips Healthcare   immediately for a replacement AED unit.

 

An AED is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.

 

In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock. The notification also directed users to a Maintenance Advisory .

 

The FDA will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that have persistently contributed to recall and adverse events associated with AEDs. 

 

In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.

 

For more information:

• FDA Medical Devices
• FDA Safety Communication: Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Automated External Defibrillators (AED)
• FDA issues proposal to improve the quality of automated external defibrillators
• Philips Maintenance Advisory

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman  1.973.696.7900  jon@gelmans.com  have been representing injured workers and their families who have suffered occupational accidents and illnesses.

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