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Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED

Edgewell Personal Care Company (NYSE: EPC) today expanded its voluntary nationwide recall of three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 to the consumer level as outlined in the table below. One additional batch has been added to the original recall announced on July 29, 2022. A

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edgewell-personal-care-issues-voluntary-nationwide-recall-banana-boat-hair-scalp-sunscreen-due-0

 
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LivaNova (TandemLife) Adds Software Update to Recall for LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

The LifeSPARC System is being recalled because users can inadvertently cause extended pump stop. A software update will address this issue.

http://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-adds-software-update-recall-lifesparc-system-risk-unintentional-extended-pump

 
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LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure

The LifeSPARC System is being recalled because users can inadvertently cause extended pump stop. A software update will address this issue.

http://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-adds-recall-lifesparc-system-may-experience-unintentional-extended-pump-stops

 
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LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

The LifeSPARC System is being recalled for risk that users can inadvertently cause extended pump stop when replacing the controller after software malfunction.

http://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-recalls-lifesparc-system-risk-unintentional-extended-pump-stop-during-controller

 
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FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward
http://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

 
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XIII Encuentro Regional de la Red de Evaluación de Tecnologías en Salud de las Américas 

Washington DC, 22 de noviembre de 2022 (OPS)– Los días 7, 8 y 9 de noviembre de 2022 se llevó a cabo el XIII Encuentro Regional de la Red de Evaluación de Tecnologías en Salud de las Américas (RedETSA) en la ciudad de Brasilia, Brasil. Representantes de 18 países debatieron sobre el proceso de evaluación de tecnologías sanitarias (ETS) en todas las etapas del ciclo de vida de las tecnologías, para afrontar los retos de su incorporación en los sistemas de salud. El evento se organizó en conjunto al III Congreso de la Red Brasilera de Evaluación de Tecnologías en Salud (Rebrats). 
 
Participaron de la apertura del evento Marcelo Queiroga, Ministro de Salud de Brasil; Socorro Gross Galiano, Representante de la oficina de país de OPS/OMS en Brasil;  Sandra Barros,   secretaria de ciencia, tecnología, innovación e insumos estratégicos en salud; Vania Canuto, directora del Departamento de gestión e incorporación de tecnologías en salud; y Alexandre Lemgruber, asesor regional en gestión de tecnologías sanitarias de la OPS.
 
Como parte del Encuentro, se desarrollaron jornadas científicas abiertas y organizadas conforme a las diferentes etapas del ciclo de vida de las tecnologías sanitarias (regulación-evaluación-incorporación-uso-monitoreo). Participaron 311 personas de manera presencial y 228 personas de forma virtual gracias a la transmisión directa del evento. 

Mayores informaciones disponibles por el enlace https://www.paho.org/es/noticias/22-11-2022-xiii-encuentro-regional-red-evaluacion-tecnologias-salud-americas

 
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La OPS pone el tratamiento para la COVID-19 a disposición de 16 países

Washington, DC, 21 de diciembre de 2022 (OPS) – En un esfuerzo por aumentar el acceso equitativo a los tratamientos para la COVID-19, la Organización Panamericana de la Salud (OPS) entregó más de 11.000 viales de un medicamento para mejorar el tratamiento de pacientes gravemente enfermos de COVID-19 en 15 países de América Latina y el Caribe. 

El medicamento, tocilizumab, ha demostrado reducir la mortalidad en pacientes hospitalizados con COVID-19 grave o crítico, que se deterioran rápidamente o necesitan mayores niveles de oxígeno, y que tienen una respuesta inflamatoria significativa.  

La compra, con valor de más de 2 millones de dólares, fue realizada por la OPS con el apoyo del Gobierno de Estados Unidos.

Fuente:

https://www.paho.org/es/noticias/21-12-2022-ops-pone-tratamiento-para-covid-19-disposicion-16-paises
 
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WHO urges action to protect children from contaminated medicines CRM:0557163

Geneva, 23 January 2023 – WHO is releasing an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.
Over the past four months, countries have reported on several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG). The cases are from at least seven countries, associated with more than 300 fatalities in three of these countries. Most are young children under the age of five. These contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts, and should never be found in medicines.
Based on country reports, WHO has issued three global medical alerts addressing these incidents. The  Medical Product Alert N°6/2022 on 5 October 2022 focused on the outbreak in the Gambia, Medical Product Alert N°7/2022 on 6 November 2022 focused on Indonesia, and Medical Product Alert No1/2023 on 11 January 2023 focused on Uzbekistan.
WHO’s medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO Member States.  These medical product alerts requested, inter alia: (a) the detection and removal of contaminated medicines from circulation in the markets, (b) increased surveillance and diligence within the supply chains of countries and regions likely to be affected, (c) immediate notification to WHO if these substandard products are discovered in-country; and otherwise inform the public of the dangers and toxic effects of the substandard medicines at issue.
Since these are not isolated incidents WHO calls on various key stakeholders engaged in the medical supply chain to take immediate and coordinated action.

For more information go to WHO urges action to protect children from contaminated medicines