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Aunque pueda contener afirmaciones, datos o apuntes procedentes de instituciones o profesionales sanitarios, la información contenida en el blog EMS Solutions International está editada y elaborada por profesionales de la salud. Recomendamos al lector que cualquier duda relacionada con la salud sea consultada con un profesional del ámbito sanitario. by Dr. Ramon REYES, MD

Niveles de Alerta Antiterrorista en España. Nivel Actual 4 de 5.

Niveles de Alerta Antiterrorista en España. Nivel Actual 4 de 5.
Fuente Ministerio de Interior de España
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Sunday, September 29, 2024

IMPORTANT: Phillips recalls 47,000 units of its HeartStart MRx monitor/defibrillator (Phillips retira 47,000 unidades del Monitor/Desfibrilador HeartStart MRx) March 2017

IMPORTANT: Phillips recalls 47,000 units of its HeartStart MRx monitor/defibrillator (Phillips retira 47,000 unidades del Monitor/Desfibrilador HeartStart MRx) March 2017



Phillips recalled the HeartStart MRx monitor/defibrillator after discovering electrical and battery connection issues that could prevent the device from powering up, charging and delivering an electrical shock therapy.
The FDA announced the recall in a safety alert posted on the agency’s website on March 24.
Phillips recalled 47,632 units in the U.S. that were manufactured from Feb. 11, 2004, to Nov. 4, 2016, and distributed from Feb. 12, 2004, to Nov. 4, 2016.
Medical professionals who are trained in CPR use the HeartStart MRX to pace people with a slow heartbeat or deliver shocks to people with sudden cardiac arrest.
In February, Phillips sent an “Urgent Medical Device Correction” notice to its customers, according to the FDA. The company said that the device could stop pacing and lead to delays in delivering therapy, which could result in permanent organ damage, brain injury or death.
The FDA classified the action a Class I recall, which the agency defines as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The recall affects the following model numbers: 
M3535A (M3535ATZ) 
M3536A (M3536ATZ)
M3536M
M3536MC
M3536M2
M3536M4
M3536M5
M3536M6
M3536M7
M3536M8 
M3536M9.

Monday, May 27, 2024

Lista de pescados con altos contenidos de mercurio emitida por la FDA de EUA.

Contenido de Mercurio en peces y mariscos

Diagnóstico y tratamiento de la intoxicación por metales: plomo, mercurio, arsénico y talio en el primer, segundo y tercer niveles de atención.

Fuente 
 El pescado es uno de los alimentos más nutritivos, su carne está compuesta de elementos importantes como el  omega-3, las vitaminas B y las proteínas magras. Sin embargo, también puede contener algunos contaminantes poco saludables, como el mercurio. 

Este elemento tóxico, presente en el pescado a causa de la contaminación del agua, pueden afectar al desarrollo cerebral y al sistema nervioso de quienes lo consumen. 

Esta realidad causa preocupación en las mujeres gestantes, que ven en este alimento una fuente importante de nutrientes para el crecimiento y el desarrollo de sus bebes.Afortunadamente instituciones especializadas indican que un consumo cuidadoso y moderado de estas especies, alejan los riesgos sobre nuestra salud. 

Con el fin de orientar a los grupos más vulnerables, la Agencia de Alimentos y Medicamentos de Estados Unidos, FDA por sus siglas en inglés (Food & Drug Agency), ha publicado unas directrices para niños, mujeres embarazadas y para las que intentan entrar en proceso de gestación.  

En su lista la FDA ubica al mero, la aguja blanca, la lubina, el pez espada, la perca de alta mar, el tiburón y la caballa (real) como las especies que no deben ser consumidas, por ser las que tienen los más elevados niveles de mercurio en su organismo. 

También, hay otro grupo de peces que se consideran con un elevado nivel de mercurio pero que pueden consumirse de modo restringido, hasta tres raciones de 170 gramos por mes.

En este grupo se incluye a la Lubina de mar, la Corvina, el fletán, el Atún (enlatado, albacora blanca y el de aleta azul fresco, la Trucha marina, la  Anchoa y el Bogavante (americano/de Maine).

Las especies marinas que tienen bajos niveles de mercurio y que se recomienda consumir hasta seis raciones de 170 gramos por mes son los siguientes: 

Carpa, mahi mahi, buey de mar, pargo, cangrejo (azul), arenque, cangrejo (blanco), rape, perca (agua dulce), raya, bacalao, atún (enlatado, troceado ligeramente) y el atún (albacora del Pacífico fresca).

Finalmente la FDA da una lista de pescados que pueden ser consumidos dos veces por semana en raciones de 170 gramos, por tener los más bajos niveles de mercurio.

Afortudamente esta lista es la más larga y por lo tanto ofrece una amplia variedad de opciones para comer este valioso alimento sin temores.

La lista incluye: anchoas, pámpanos, calamar, caviar (cultivado), centollo, abadejo, bagre, coregonos, perca (de mar), vieiras, platija, merluza, arenque, langosta, sábalo, lenguado, cigala, salmón, gambas, almejas, tilapia, ostras, sardinas, esturión (cultivado) y la Trucha de agua dulce.

 
PELIGROS DEL MERCURIO EN EL PESCADO

PELIGROS DEL MERCURIO EN EL PESCADO
50 gramos semanales. Un endurecimiento de la alerta sanitaria emitida por AESAN causa alarma social entre los consumidores y provoca reacciones entre los colectivos de pescadores españoles, que curiosamente instaron a la agencia a desarrollar un informe para evaluar los riesgos de consumo pretendiendo relajar los criterios anteriormente vigentes.
En el pescado y los mariscos el mercurio (Hg) se encuentra mayoritariamente en forma de metil mer­curio (MeHg), la forma más tóxica. Los mayores contenidos se encuentran en los peces predadores. La FAO/OMS (2003) ha establecido la ingesta semanal tolerable provisional (PTWI) para el MeHg en 1,6 μg/kg peso corporal
Se recomienda precaución a las mujeres embarazadas o que puedan llegar a estarlo, mujeres en fase de lactancia y a niños de corta edad (entre 1 y 30 meses), que deben consumir una amplia variedad de pescados, evitando consumir asiduamente las especies más contaminadas, como pez espada y atún rojo, cuyo consumo debe limitarse a una ración semanal.
La recomendación sugerida hasta ahora era que las mujeres embarazadas y los niños menores de tres años no consumieran más de 100 gramos a la semana de pez espada, y no más de dos raciones de atún rojo.
Las grandes especies, situadas en lo alto de la cadena trófica del mar, acumulan en sus tejidos grasos el mercurio que absorben de sus presas en su forma más tóxica ( metilmercurio ). El metal, generado en gran medida por la actividad industrial, es ingerido luego por el hombre, y puede provocar alteraciones graves en el desarrollo neuronal del feto y de los niños de corta edad.
Los datos disponibles de contenidos de Hg y MeHg en el pescado consumido en España, las ingestas estimadas y las evaluaciones de exposición al Hg en la población española, en especial entre los con­sumidores pertenecientes a los grupos de riesgo, no recomiendan aumentar los límites máximos de Hg establecidos por la Unión Europea (UE, 2006) para los pescados. Más bien todo lo contrario; reducirlo.
El propósito de esta alerta buscaba, al parecer, concienciar a las personas incluidas en grupos de riesgo de la peligrosidad de superar las cantidades recomendadas de ingesta y actualizar dicha recomendación al criterio vigente, más restrictivo en cantidades a consumir, pero la alarma ha trascendido a este colectivo, trasladándose a la población, cuya relación beneficio-riesgo ante el consumo de estos pescados es marcadamente beneficiosa.
Por ello, la Agencia Española de Seguridad Alimentaria y Nutrición ha recordado que no considera que el consumo de pescado suponga un riesgo para la población, ya que la ingesta de metilmercurio por consumo de pescado no supera la ingesta diaria admisible definida por la Organización Mundial de la Salud. El pescado es, en términos de alimentación saludable, una parte importante de la dieta. Esto se debe, básicamente, a la calidad de su proteína y su grasa, con aminoácidos esenciales en cantidad más que adecuada, escasa cantidad de grasas saturadas y una importante proporción de ácidos grasos omega 3.
La Agencia Española de Seguridad Alimentaria y Nutrición es un Organismo Autónomo adscrito al Ministerio de Sanidad y Política Social con la misión de garantizar el más alto grado de seguridad alimentaria, como aspecto fundamental de la salud pública y promover la salud de los ciudadanos en el ámbito de la nutrición y en especial en la prevención de la obesidad.
  • Pez espada en grupos de riesgo, consumo semanal inferior a 50 gramos
  • En adultos el beneficio de su consumo es claro.
  • La contaminación de nuestros mares causa directa del incremento de toxicidad en determinadas especies.
Fuentes de exposición:
  • Ocupacional; minería, dentistas, fotografía entre otros.
  • Doméstica; termómetros, espejos, juguetes, baterías.
  • Medicamentos. Laxantes, diuréticos y espermicidas.
Para saber más
Mercury



Página de AESAN http://bit.ly/lZAbXy

Articulo Relacionado 

PELIGROS BOMBILLAS DE BAJO CONSUMO "MERCURIO"


Dr Ramon REYES, MD,
Por favor compartir nuestras REDES SOCIALES @DrRamonReyesMD, así podremos llegar a mas personas y estos se beneficiarán de la disponibilidad de estos documentos, pdf, e-book, gratuitos y legales..

Con el interés de revolucionar la producción y el consumo del pescado fresco se puso en marcha en coordinación con la empresa Maimón Fish Farm un plan para la producción y exportación del pez tilapia. Esta iniciativa promueve la cría de tilapias en jaulas flotantes ubicadas en altamar, en los alrededores de la Bahía de Las Calderas.


Friday, March 1, 2024

Drug Expiration Dates — Do They Mean Anything?

Drug Expiration Dates — Do They Mean Anything?


If your medicine has expired, it may not provide the treatment you need. In this Consumer Update video, FDA Pharmacist Ilisa Bernstein explains how expiration dates help determine if medicine is safe to use and will work as intended.

What Your Pharmacist Can't Tell You About Drug Expiration Dates: 'It's Complicated'

One of the most common questions people ask health care providers is, Can I use my old drugs past their expiration dates?
The short, safe answer is a simple “no.” However the truth of the matter is much more intricate, a lot more interesting, and requires a bit of knowledge about the Food and Drug Administration (FDA).
In the late 1970s, the FDA first began requiring expiration dates on both prescription and over-the-counter medications.
“To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing,” reads the agency’s regulation. The FDA permits “reasonable variation,” meaning manufacturers are given a little leeway, so long as the any medication marketed in the United States contain between 90 percent to 110 percent of the amount of the active ingredient claimed on the label.
“Just having the slight variation of 90 to 110 percent, well, it would be very difficult, from a manufacturing standpoint, to hone it down even more than that,” Dr. Lee Cantrell, of the California Poison Control System and UC San Francisco School of Pharmacy, told Medical Daily.
The legal code adopted by the FDA also notes that manufacturers must account for storage conditions (and reconstitution conditions for certain drugs) in the expiration date. As a result of FDA rules, then, you will find a date, usually following the letters ‘EXP,’ either printed on the label or stamped onto the bottle or carton of drugs you buy, and in other cases, crimped into the tube of certain ointments you purchase.
The expiration date of most medicines is 12 to 60 months after manufacture, reports Pharmacy Times. According to Pittsburgh-Post Gazette, pharmacists further shorten the time a medicine can be used when they add their own "discard after" or "beyond-use" date to the prescription label itself. From manufacturer to FDA to pharmacist, the underlying principle is maximum safety.
And, to underscore its own message, the FDA made a brief video a few years back:


Seems like the end of the story, at least from the FDA’s perspective. However, if you are looking for an intelligent rebuttal of expiration dates, the best place to turn is to the very same alphabet soup government agency, the FDA.

Stockpiled Drugs

In the mid-1980s, as described by an article appearing in Biosecurity and Bioterrorism, the Air Force approached the FDA about “the possibility of safely extending the expiration dates of some of the drugs that it had stockpiled.” The Department of Defense routinely stockpiles medications for future use by both the military and civilians. This expensive process includes costs for planning, proper storage, and also reeplacing expired drugs. Since the latter cost eats up a significant portion of the Air Force budget, the Shelf Life Extension Program (SLEP) was proposed and undertaken by the FDA in 1985 to determine the actual shelf life of stockpiled drugs. In short, SLEP was born to save taxpayer dollars.
In its inaugural 1985 run, the program tested 56 drugs and found it was possible to extend the shelflife of 80 percent of them (and 84 percent of the tested lots) by as much as three years.With lots of dollars saved, the program naturally didn’t end there. An update of SLEP in 2006 investigated stability profiles for 122 different drug products (slightly more than 3,000 different lots) and resulted in a lifespan extension of at least one year beyond the original expiration date for 88 percent of the lots. The average additional time added to each drug was 66 months.
Among the drugs tested and approved for continued use were two antibiotics, amoxicillin(commonly prescribed to children) and ciprofloxacin (commonly called 'cipro' and used to treat anthrax infections), an antihistamine (diphenhydramine, often used to treat allergies), and a morphine sulfate injection (a painkiller).
drugsDrug Safety Derek Gavey, CC by 2.0
Certainly, the FDA has provided comprehensive information suggesting required expiration dates may not be as firm as most consumers suppose, and this is substantiated by the work of others. In 2009, The Medical Letter, an independent nonprofit that provides unbiased drug-prescribing recommendations to professionals, reviewed the most recent data on the same subject. Importantly, the publication addresses safety first.
The authors found just one report of a patient who may have been harmed by taking an expired drug. This singular case, involving a patient who may have suffered kidney damage after taking expired tetracycline (an antibiotic), occurred more than 40 years ago. (Since that era, tetracycline products have been reformulated.)
Noting storage in heat and high humidity may shorten a drug’s half-life, The Medical Letterreport also acknowledges that in many published studies a variety of medications stored under “stress” conditions remained chemically and physically stable for up to nine years beyond their expiration dates. Generally, the authors warn, liquid drugs are not as stable as solid dosages, and should a liquid become cloudy, discolored, or show signs of precipitation, it should not be used.
“Many drugs stored under reasonable conditions in their original unopened containers retain 90 percent of their potency for at least 5 years after the expiration date on the label, and sometimes much longer,” The Medical Letter report concludes, with one important caveat: “Epinephrine in EpiPen is an important exception” as these products gradually lose potency once the expiration date passes.
EpiPen
Cantrell and his colleagues travel an inspired path to scientific gold, arriving at a similar conclusion for their 2012 study.
In his wanderings, Cantrell “stumbled across” a box of drugs, all of which had expired 28 to 40 years prior. Unearthed in a family-owned pharmacy generations old, the box contained drugs which had remained in their original, unopened containers for decades. In “the name of science,” Cantrell and friends undertook analysis of the drugs.
In the lab, tablets were dissolved, isotopes diluted, chromatography tests run. Three times, the science crew tested and retested samples for listed active ingredients. What did they discover?
Of the 14 drugs, 12 (or 86 percent) were present in concentrations at least 90 percent of the labeled amounts, which is the generally recognized minimum acceptable potency.  Surprisingly, three of these compounds were present at greater than 110 percent of the labeled content. The team found two compounds (aspirin and amphetamine) in amounts of less than 90 percent; meanwhile, another ingredient (phenacetin) appeared at greater than 90 percent in one drug but less than 90 percent in another.
“Given the potential cost-savings, we suggest the current practices of drug expiration dating be reconsidered,” Cantrell and his co-authors wrote in the conclusion.
Speaking with Medical Daily, Cantrell advised caution.
“My study didn’t convey anything about safety, I just looked at potency of active ingredients,” he said. Though an active ingredient may be as strong as the manufacturer originally intended, this does not mean the overall drug — a chemical jamboree, essentially — remains non-toxic, he explained. In fact, no scientific study has ever tested expired medications in human subjects and so he does not advocate using drugs past their due dates.
“I myself wouldn’t feel comfortable taking an outdated antibiotic, if you’re trying to kill a potentially life-threatening bug invading my system,” he said.

Drug Expiration Dates — Do They Mean Anything?

With a splitting headache you reach into your medicine cabinet for some aspirin only to find the stamped expiration date on the bottle has passed - two years ago. So, do you take it or don’t you? If you decide to take the aspirin will it be a fatal mistake or will you simply continue to suffer from the headache?
This is a dilemma many people face in some way or another. A column published inPyschopharmacology Today offers some advice.
It turns out that the expiration date on a drug does stand for something, but probably not what you think it does. Since a law was passed in 1979, drug manufacturers are required to stamp an expiration date on their products. This is the date at which the manufacturer can still guarantee the full potency and safety of the drug.
Most of what is known about drug expiration dates comes from a study conducted by the Food and Drug Administration at the request of the military. With a large and expensive stockpile of drugs, the military faced tossing out and replacing its drugs every few years. What they found from the study is 90% of more than 100 drugs, both prescription and over-the-counter, were perfectly good to use even 15 years after the expiration date.
So the expiration date doesn’t really indicate a point at which the medication is no longer effective or has become unsafe to use. Medical authorities state expired drugs are safe to take, even those that expired years ago. A rare exception to this may be tetracycline, but the report on this is controversial among researchers. It’s true the effectiveness of a drug may decrease over time, but much of the original potency still remains even a decade after the expiration date. Excluding nitroglycerin, insulin, and liquid antibiotics, most medications are as long-lasting as the ones tested by the military. Placing a medication in a cool place, such as a refrigerator, will help a drug remain potent for many years.
Is the expiration date a marketing ploy by drug manufacturers, to keep you restocking your medicine cabinet and their pockets regularly? You can look at it that way. Or you can also look at it this way: The expiration dates are very conservative to ensure you get everything you paid for. And, really, if a drug manufacturer had to do expiration-date testing for longer periods it would slow their ability to bring you new and improved formulations.
The next time you face the drug expiration date dilemma, consider what you’ve learned here. If the expiration date passed a few years ago and it’s important that your drug is absolutely 100% effective, you might want to consider buying a new bottle. And if you have any questions about the safety or effectiveness of any drug, ask your pharmacist. He or she is a great resource when it comes to getting more information about your medications.
November 2003 Update

Saturday, January 20, 2024

Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS". Cleared to Stop Gun and Knife Wounds in Arms and Legs

Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"

XSTAT detiene el sangrado potencialmente mortal de heridas no comprimibles en las uniones y las extremidades. Funciona inyectando esponjas pequeñas que se expanden rápidamente en la cavidad de una herida con un aplicador similar a una jeringa. Una vez dentro de la cavidad, las mini esponjas absorben sangre, se expanden hasta 10 veces su tamaño, tapan la herida y aplican presión hemostática.
Video

Así funciona XSTAT en Hemorragias de unión y extremidades y actúa en solo 15 segundos

XSTAT stops life-threatening bleeding from non-compressible junctional and extremity wounds. It works by injecting small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. Once inside the cavity, the mini sponges absorb blood, expand to 10x their size, pack the wound and apply hemostatic pressure.

MÁS LIBROS MEDICINA Y SALUD 


Dr. Ramon Reyes, MD


Les Esperamos en nuestro Grupo en TELEGRAM Soc. IberoAmericana de Emergencias


RevMedX just announced that the FDA has cleared its XSTAT 12 and XSTAT 30 devices for stopping severe bleeding from knife and gun-shot wounds in the arms or legs. The XSTAT devices are essentially large syringes that can be used to quickly push dozens of tablet-sized highly absorbent pieces of foam into a wound. Once the foam tablets are inside the wound, they quickly expand, blocking the blood from escaping and delivering pressure onto the wound from within. Each tablet contains a radiopaque marker so it can be easily found using X-ray fluoroscopy during surgery.
Previously, the XSTAT devices have been FDA approved for use in civilian and battlefield situations, but only to treat junctional wounds around the groin and shoulders. The new indication will help more wounds to be quickly treated, hopefully helping to prevent arm and leg loss and even death.
Here’s a quick demo of the XSTAT being used on a leg:

XSTAT detiene el sangrado potencialmente mortal de heridas no comprimibles en las uniones y las extremidades. Funciona inyectando esponjas pequeñas que se expanden rápidamente en la cavidad de una herida con un aplicador similar a una jeringa. Una vez dentro de la cavidad, las mini esponjas absorben sangre y se expanden hasta 10 veces su tamaño, taponando la herida y aplicando presión hemostática sin necesidad de aplicar presión manual externa. Este video demuestra el uso de XSTAT12 y XSTAT 30.

XSTAT para detener el sangrado severo en la pierna/ XSTAT for Stopping Severe Bleeding in the Leg 


XSTAT stops life-threatening bleeding from non-compressible junctional and extremity wounds. It works by injecting small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. Once inside the cavity, the mini sponges absorb blood and expand up to 10 times their size, packing the wound and applying hemostatic pressure without the need to apply external manual pressure. This video demonstrates the use of XSTAT12 and XSTAT 30.

WILSONVILLE, Ore., May 20, 2016 /Ireach PR Newswire/
For Immediate Release

RevMedx™ Announces First Field Use of  XSTAT®


XSTAT® is a first-in-kind hemostatic device for the treatment of gunshot and shrapnel wounds. XSTAT works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator. Each sponge contains an x-ray detectable marker. In the wound, the XSTAT sponges expand and swell to fill the wound cavity within 20 seconds of contact with blood. This creates a temporary barrier to blood flow and provides hemostatic pressure. 

“When a product is developed for use in the battlefield, it is generally intended to work in a worst­ case scenario where advanced care might not be immediately available,” said William Maisel, M.D., M.P.H., acting Director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “It is exciting to see this technology transition to help civilian first responders control some severe, life-­threatening bleeding while on the trauma scene.” 

Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"



Indications for Use:

XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.

XSTAT 30 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non- compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes

XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inguinal ligament; or tissues above the clavicle.


RevMedx, Inc. today announced that the XSTAT hemostatic device has been successfully deployed on a patient in a field setting.  The use of XSTAT on a soldier was the first documented clinical use of the product since its release. After failing to staunch severe bleeding in the patient using standard hemostatic technologies, a United States forward surgical team (FST) used XSTAT to achieve almost immediate hemostasis. 
Based on information released from the US Military, a coalition forces soldier was wounded in action with a gunshot wound to the left thigh.  The femoral artery and vein were transected and damage to the femur and soft tissue left a sizable cavity in the leg.  After a self-applied tourniquet stopped the bleeding, the patient was transferred to an FST for evaluation and treatment.  After proximal and distal control of the vessel was achieved, several hours were spent by the team trying to control residual bleeding from the bone and accessory vessels.  Throughout the course of the roughly 7-hour surgery, multiple attempts at using bone wax and cautery on the bleeding sites were unsuccessful and the patient received multiple units of blood and plasma.  Eventually, the FST team opted to use XSTAT and applied a single XSTAT device to the femoral cavity— resulting in nearly immediate hemostasis. The patient was stabilized and eventually transported to a definitive care facility. 
XSTAT is a first-in-kind hemostatic device for the treatment of severe bleeding in the axilla or groin area (known as junctional wounds). XSTAT works by injecting a group of small, rapidly-expanding sponges into a wound cavity using a syringe-like applicator.  In a wound, the sponges rapidly expand and exert hemostatic pressure.  Each sponge contains an x-ray detectable marker to confirm complete surgical removal when definitive surgery is performed. 

"The first-in-human experience with XSTAT is the culmination of tremendous effort on the part of both RevMedx and our military collaborators,” said Andrew Barofsky, president and CEO of RevMedx.  "We are pleased to see XSTAT play a critical role in saving a patient’s life and hope to see significant advancement toward further adoption of XSTAT as a standard of care for severe hemorrhage in pre-hospital settings” said Barofsky.

About RevMedx
Based in Wilsonville, Oregon, RevMedx is a privately held medical device company whose goal is to design, develop, and manufacture innovative medical products that save lives. Our product line includes XSTAT, XGAUZE, AIRWRAP, PARABELT, and TX Series Ratcheting Tourniquets.  Additional information about RevMedx and our products can be found at www.revmedx.com.

Media Contact:
Will Fox
VP Sales & Marketing
Phone: (503) 218-2172

LIFE-SAVING SYRINGE RECEIVES FDA APPROVAL



Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"
Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"


Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"



XSTAT gets the go-ahead for new battlefield tool

XStat, developed by RevMedx, has recently gained FDA approval. The new device functions as a temporary dressing for gunshot and shrapnel wounds, where a tourniquet cannot be used, such as injuries to the groin or armpit.

It has been designed for emergency battlefield situations, where  patients may be some way away from dedicated trauma theatres.  In many cases this is a life and death issue. In a study of soldiers who died between 2001 and 2009 of wounds that weren’t immediately fatal, exsanguinating hemorrhage or bleeding out, was the cause of death in an estimated 80 percent of cases.
The XStat device consists of a syringe-like applicator that contains 92 compressed, cellulose sponges which are coated with an absorbent material. Each tablet-sized sponge measures only 9.8mm in diameter and 4 to 5mm in height. The ultra-absorbent sponges areinjected directly into the wound and rapidly swell to fill the wound cavity, thus stemming blood loss. Designed to remain in place for up to four hours, each XSTAT sponge contains an x-ray detectable marker for speedy removal on hospitalization.
Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"


Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"


Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"


Xstat Instructional "SEALS A GUNSHOT WOUND IN 15 SECONDS"


Habilidades a aplicar segun nivel de competencias profesionales en el TECC by CTECC



Tactical Emergency Casualty Care (TECC) Guidelines for First Responders with a Duty to Act
Guías para Primeros Respondedores con Deber de Actuar “En Acto de Servicio”

(Fuerzas de Seguridad, Bomberos no SEM)

Enlace para descargar PDF Gratis http://emssolutionsint.blogspot.com/2017/09/curso-tecc-espana-28-septiembre-2017.html

FDA APPROVES SYRINGE-LIKE DEVICE FOR PLUGGING GUNSHOT WOUNDS


ORIGINALLY DESIGNED FOR THE MILITARY, THIS INJECTABLE SPONGE PACK COULD CHANGE THE WAY EMTS TREAT GUNSHOT VICTIMS.

The Food and Drug Administration has approved for civilian use a revolutionary device that can stop bleeding from a gunshot wound in less than a minute. On December 7, the agency gave the green light to deploy the XStat 30 to hospitals.
The simple invention is a syringe-like tool that injects tiny sponges into a wound to treat hemorrhaging. Originally developed with troops in Iraq and Afghanistan in mind, the XStat 30 could change the way gunshot victims are treated in the U.S.
The device is designed to plug bleeding from bullet and shrapnel injuries to the groin, armpits, and other areas where applying traditional tourniquets could be difficult.
"When a product is developed for use in the battlefield, it is generally intended to work in a worst-case scenario where advanced care might not be immediately available," said William Maisel of the FDA’s Center for Devices and Radiological Health. "It is exciting to see this technology transition to help civilian first responders control some severe, life-threatening bleeding while on the trauma scene."
The device is the brainchild of a small startup in suburban Portland, Oregon, called RevMedx, which primarily designs products for military personnel and emergency first responders. This past April, RevMedx shipped XStat devices to the military for the first time.
Over the long term, these devices and similar ones could reduce gun deaths in the United States. Data from the United States Army Institute of Surgical Research suggests 30% to 40% of civilian traumatic injury deaths are due to blood loss.
[Photo: XSTAT via RevMedx]

Information related: 




The Hartford Consensus III Compendium, September 2015. PHTLS B-Con Bleeding Control for the Injured




TACTICAL MEDICINE TACMED “Medicina Bona Locis Malis” tm. Good Medicine In Bad Places España by EMS Solutions International  http://emssolutionsint.blogspot.com.es/2017/09/tactical-medicine-tacmed-espana-by-ems.html 



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