FDA Will Strengthen The Supervision Of Used Home Medical Equipment.
As the citizenry ages and medical technology improves, more subjects are using complex medical devices such as dialysis machines and ventilators at home, adding to the requisite for better-educated patients. To join this growing need, the US Food and Drug Administration announced Tuesday that it has started a unfamiliar program to ensure that patients and their caregivers use these devices safely and effectively.
So "Medical gubbins home use is becoming an increasingly important public health issue," Dr Jeffrey Shuren, chief of the FDA's Center for Devices and Radiological Health said during an afternoon news conference. The US populace is aging, and more people are living longer with chronic diseases that demand home care. "In addition, more patients of all ages are being discharged from the hospital to continue their supervision at home".
Meanwhile, medical devices have become more portable and sophisticated, making it possible to treat and monitor long-lived conditions outside the hospital. "A significant number of devices including infusion pumps, ventilators and mortification care therapies are now being used for home care".
Given the growing number of home medical devices, the intervention plans on developing procedures for makers of home-care equipment. Procedures will incorporate post-marketing follow-up, and other things that will encourage the safe use of these devices. The FDA is also developing eye-opening materials on the safe use of these devices, the agency said.
Showing posts with label devices. Show all posts
Showing posts with label devices. Show all posts
Tuesday, 21 January 2020
Tuesday, 17 December 2019
More Than 250000 People Die Each Year From Heart Failure In The United States
More Than 250000 People Die Each Year From Heart Failure In The United States.
To uplift the prominence of lifesaving devices called automated foreign defibrillators, the US Food and Drug Administration proposed Friday that the seven manufacturers of these devices be required to get operation approval for their products. Automated external defibrillators (AEDs) are carriable devices that deliver an electrical shock to the heart to try to restore average heart rhythms during cardiac arrest. Although the FDA is not recalling AEDs, the agency said that it is distressed with the number of recalls and quality problems associated with them.
And "The FDA is not questioning the clinical utility of AEDs," Dr William Maisel, prime scientist in FDA's Center for Devices and Radiological Health, said during a converging conference on Friday announcing the proposal. "These devices are critically portentous and serve a very important public health need. The significance of early defibrillation for patients who are suffering from cardiac arrest is well-established".
Maisel added the FDA is not career into question the safety or quality of AEDs currently in place around the country. There are about 2,4 million such devices in known places throughout the United States, according to The New York Times. "Today's fray does not require the removal or replacement of AEDs that are in distribution. Patients and the public should have confidence in these devices, and we onward people to use them under the appropriate circumstances".
Although there have been problems with AEDs, their lifesaving benefits outweigh the chance of making them unavailable. Dr Moshe Gunsburg, director of cardiac arrhythmia service and co-chief of the partitioning of cardiology at Brookdale University Hospital and Medical Center in Brooklyn, NY, supports the FDA proposal. "Cardiac cessation is the leading cause of death in the United States.
It claims over 250000 lives a year". Early defibrillation is the critical to helping patients survive. Timing, however, is critical. If a constant is not defibrillated within four to six minutes, brain damage starts and the probability of survival diminish with each passing minute, which is why 90 percent of these patients don't survive.
The best befall a patient has is an automated external defibrillator used quickly, which is why Gunsburg and others want AEDs to be as customary as fire extinguishers so laypeople can use them when they see someone go into cardiac arrest. The FDA's power will help ensure that these devices are in top shape when they are needed.
To uplift the prominence of lifesaving devices called automated foreign defibrillators, the US Food and Drug Administration proposed Friday that the seven manufacturers of these devices be required to get operation approval for their products. Automated external defibrillators (AEDs) are carriable devices that deliver an electrical shock to the heart to try to restore average heart rhythms during cardiac arrest. Although the FDA is not recalling AEDs, the agency said that it is distressed with the number of recalls and quality problems associated with them.
And "The FDA is not questioning the clinical utility of AEDs," Dr William Maisel, prime scientist in FDA's Center for Devices and Radiological Health, said during a converging conference on Friday announcing the proposal. "These devices are critically portentous and serve a very important public health need. The significance of early defibrillation for patients who are suffering from cardiac arrest is well-established".
Maisel added the FDA is not career into question the safety or quality of AEDs currently in place around the country. There are about 2,4 million such devices in known places throughout the United States, according to The New York Times. "Today's fray does not require the removal or replacement of AEDs that are in distribution. Patients and the public should have confidence in these devices, and we onward people to use them under the appropriate circumstances".
Although there have been problems with AEDs, their lifesaving benefits outweigh the chance of making them unavailable. Dr Moshe Gunsburg, director of cardiac arrhythmia service and co-chief of the partitioning of cardiology at Brookdale University Hospital and Medical Center in Brooklyn, NY, supports the FDA proposal. "Cardiac cessation is the leading cause of death in the United States.
It claims over 250000 lives a year". Early defibrillation is the critical to helping patients survive. Timing, however, is critical. If a constant is not defibrillated within four to six minutes, brain damage starts and the probability of survival diminish with each passing minute, which is why 90 percent of these patients don't survive.
The best befall a patient has is an automated external defibrillator used quickly, which is why Gunsburg and others want AEDs to be as customary as fire extinguishers so laypeople can use them when they see someone go into cardiac arrest. The FDA's power will help ensure that these devices are in top shape when they are needed.
Wednesday, 22 February 2017
Elderly Needs Mechanical Assistants
Elderly Needs Mechanical Assistants.
Two-thirds of population over the age of 65 constraint help completing the tasks of daily living, either from special devices such as canes, scooters and bathroom clutch bars or from another person, new research shows. "If people are finding ways to successfully deal with their helplessness with help from devices or people, or they're reducing their activity because of a disability, I reckon these groups are probably missed when we look at public health needs," said memorize author Vicki Freedman, a research professor at the University of Michigan Institute for Social Research. "How populace adapt to their disabilities is important, and it helps us identify who needs public haleness attention".
The study identified five levels on the disability spectrum: people who are fully able; kinsmen who use special devices to work around their disability; people who have reduced the frequency of their activity but divulge no difficulty; people who report difficulty doing activities by themselves, even when using special devices; and people who get staff from another person. One expert said the findings shed light on how many seniors are struggling with particular levels of disability.
"The fact that about 25 percent of people are unable to perform some activities of every day living without assistance wasn't surprising," said Dr Stanley Wainapel, clinical kingpin of the department of rehabilitation medicine at Montefiore Medical Center in New York City. "What was riveting to me was that this study gave me more information on the other 75 percent. Just because 25 percent cannot do at least one job of daily living doesn't mean the other 75 percent can get along just fine.
It's not as black and white as we might have thought. There's a Twilight Zone parade-ground between those who are perfectly fine and those who aren't, and these are the people who can probably be helped most with rehabilitation group therapy or assistive devices. Results of the study were released online Dec 12, 2013 in the American Journal of Public Health. Data for the widespread research came from the 2011 National Health and Aging Trends Study.
Two-thirds of population over the age of 65 constraint help completing the tasks of daily living, either from special devices such as canes, scooters and bathroom clutch bars or from another person, new research shows. "If people are finding ways to successfully deal with their helplessness with help from devices or people, or they're reducing their activity because of a disability, I reckon these groups are probably missed when we look at public health needs," said memorize author Vicki Freedman, a research professor at the University of Michigan Institute for Social Research. "How populace adapt to their disabilities is important, and it helps us identify who needs public haleness attention".
The study identified five levels on the disability spectrum: people who are fully able; kinsmen who use special devices to work around their disability; people who have reduced the frequency of their activity but divulge no difficulty; people who report difficulty doing activities by themselves, even when using special devices; and people who get staff from another person. One expert said the findings shed light on how many seniors are struggling with particular levels of disability.
"The fact that about 25 percent of people are unable to perform some activities of every day living without assistance wasn't surprising," said Dr Stanley Wainapel, clinical kingpin of the department of rehabilitation medicine at Montefiore Medical Center in New York City. "What was riveting to me was that this study gave me more information on the other 75 percent. Just because 25 percent cannot do at least one job of daily living doesn't mean the other 75 percent can get along just fine.
It's not as black and white as we might have thought. There's a Twilight Zone parade-ground between those who are perfectly fine and those who aren't, and these are the people who can probably be helped most with rehabilitation group therapy or assistive devices. Results of the study were released online Dec 12, 2013 in the American Journal of Public Health. Data for the widespread research came from the 2011 National Health and Aging Trends Study.
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