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Doctor insights on: Medical Device Safety

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Dr. Mark Pack
4 doctors shared insights

Medical Device Safety (Overview)

Medical device safety is monitored by the FDA, and focuses on tracking and reporting adverse events and problems relating to medical devices. It regulates the proper use of various devices to ensure the safety of patients.


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Where can we find fire safety device for someone confined to bed?

Where can we find fire safety device for someone confined to bed?

Fire department: Call your local fire department. They should have some great ideas and information.

Dr. Mark Pack
4 doctors shared insights

Medical Device Safety (Overview)

Medical device safety is monitored by the FDA, and focuses on tracking and reporting adverse events and problems relating to medical devices. It regulates the proper use of various devices to ensure the safety of patients.


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Fire safety bed device for a quadriplegic?

Fire safety bed device for a quadriplegic?

Good question!: I have tried to find answers for this, to no avail. Suggestions from our spinal cord injury rehab center include 1. Have a way to call 911 from your bed 2. A companion dog who is trained to drag you to safety until help arrives, 3. Smoke and heat detectors through a home alarm service, who will send emergency personnel if they go off, and 4. A heat-triggered automatic sprinkler system.

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If I use Cranial electrotherapy stimulation device everyday,for 30 years, could I damage my health? Has medicine proven long-term safety of CES?

If I use Cranial electrotherapy stimulation device everyday,for 30 years, could I damage my health? Has medicine proven long-term safety of CES?

CES: I use Cranial Electrotherapy Stimulation regularly with many of my patients. It was used as early as 1963 for sleep and was approved by FDA in 1976. The literature I have read does not report long-term safety problems. It is helpful in about 90% of cases and overall is a safe treatment.

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Are hair growth/regrowth laser devices such as the HairMax laser combs harmful to use or do they pose any safety/health risks?

Are hair growth/regrowth laser devices such as the HairMax laser combs harmful to use or do they pose any safety/health risks?

Hair laser device: Are hair growth/regrowth laser devices such as the HairMax laser combs harmful to use or do they pose any safety/health risks? ANS: These devices are not generally tested properly to answer your questions. They do not need to be approved by the FDA. So you have no way of knowing if they are effective, safer or harmful. Beware of testimonials as they are not science. Go to PUBMED and search to see.

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Whats a rotable medical device?

Rotable: I never heard of it before. Have you tried looking that up? Are you sure you have the right spelling?

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Is a nightguard a medical device?

Is a nightguard a medical device?

Dental device: Night-guard is typically recommended by dentists. While wearing in your teeth at night to keep your teeth from grinding. It helps to preserve enamel of your teeth from abrasion as result of grinding during sleep. It is also recommended for TMJ disorder due to excessive night grinding or bruxism.

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How can you operate medical devices if the electricity fails?

How can you operate medical devices if the electricity fails?

You mostly cannot: Many of the things we are accustomed to using in medicine require electrical input and will stop operating when the power stops. Most hospitals and many clinics have back up electrical generators for this circumstance. This is not different than all of society, dependent upon technology usually run with electrons.

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What consumer medical devices are available in healthy senior lifestyles?

What consumer medical devices are available in healthy senior lifestyles?

Many & hard to rank: There are many and their value to you varies with your focus. There are the usual one to monitor your blood pressure, weight, caloric intake. You can measure sleep patterns, exercise level, heart rate, and others. If you need it, there are devices to measure your blood sugar, the effect of anti-clotting medications, and some urine values. The field is growing . See startup reflexwireless.Com.

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What is a clinical medical device trial and how is it conducted?

What is a clinical medical device trial and how is it conducted?

Research on people: This is a clinical trial to test a new device in humans. The device could be a new kind of metal rod for back surgery, an Insulin pump, etc. The device must be reasonably safe and the research must be approved by a board dedicated to ensure patient safety (irb). The device is used and compared to similar devices that have been in use. It can take many years to get results.

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What type of medical test and device can detect the number of boys a girl has done sex with and is it do the test?

What type of medical test and device can detect the number of boys a girl has done sex with and is it do the test?

There is no test...: AND why should there be?Honest communication & trust are a great thing in a relationship.If you don't have that then maybe moving forward to sexual intercourse isn't the best idea anyway.Are you honest about the number of sexual partners you have had? Does the # really matter?If there is a # that will change the feelings you have for your partner...I'd think more about if it's a real relationship

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Does fda test medical devices?

Does fda test medical devices?

Yes but not directly: The fda requires approval for marketing of devices that monitor, treat, or diagnose medical problems. They do not directly test the devices but have approved third party companies that can verify the function and accuracy of devices and may require clinical trial data or some types of devices (ie. Those used to diagnose, monitor or treat serious conditions).

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Are their any medical tests or devices in usa that can tell the number of boys a girl has done sex with?

Are their any medical tests or devices in usa that can tell the number of boys a girl has done sex with?

Yes: There is one "test". You just ask the person (but be sure you have a reason to ask). A girl can ask a guy how many people he has had sex with. Likewise, a guy can ask a girl how many people she has had sex with. This "test" has better accuracy when guys are being asked, because there is more negative stigma for a girl to have had several sex partners. To be fair, stigma should also apply to guys.

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If is there a website that can provide abbreviated versions of medical guidelines (disease specific), how often would you use it many times healthcare professionals use the internet or their mobile devices for quick references on drugs and disease states.

If is there a website that can provide abbreviated versions of medical guidelines (disease specific), how often would you use it many times healthcare professionals use the internet or their mobile devices for quick references on drugs and disease states.

In : In my opinion as an emergency physician, i think that would be a very valuable contribution. I would personally love to have an app like that for rapid reference. In general, i would estimate that a physician would pay $5 for an app.

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Do medical devices need to be approved by the fda? Who regulates these devices such as an inversion table for example? How can I be sure they're safe?

Do medical devices need to be approved by the fda? Who regulates these devices such as an inversion table for example? How can I be sure they're safe?

Not a Medical device: Yes, actual medical devices are regulated by the fda, but i doubt an inversion table is marketed to treat anything. Most manufacturers go out of their way to be sure to state the it is not intended to treat a medical condition. So you are left with reviews and comments by other users. If the device is truly unsafe and it injures someone, they will be sued for it.

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I have a Fisher Wallace FDA-approved medical device for cranial electrotherapy stimulation. Is it a safe & *possibly* effective treatment for anxiety?

I have a Fisher Wallace FDA-approved medical device for cranial electrotherapy stimulation. Is it a safe & *possibly* effective treatment for anxiety?

Read what you can: Talk to anyone who's tried it. Since you already have it - the $ is not an issue - Ask about liability coverage for possible injury or other risk. Then, if all says "go". give it a try. But only after asking hard ?'s of the mfg. Confidence is important - so gain it if deserved. Good luck. Be careful. Best wishes. http://tinyurl.com/kagr35p http://tinyurl.com/ckkqlv8 http://tinyurl.com/nz24vgc

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What is the medical device used by optometrists to visualize the optic nerve called?

What is the medical device used by optometrists to visualize the optic nerve called?

Several devices: Several devices are used to evaluate optic nerves. The most common is the biomicroscope, or slit lamp, that is also used to examine the other parts of the eye.

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I have a very low hematocrit and I work in a medical device they don't want my blood for testing cause my blood is like a water it leaks on the membrane and goes to the channel of our products.. I'm worried but I don't know what to do..?

I have a very low hematocrit and I work in a medical device they don't want my blood for testing cause my blood is like a water it leaks on the membrane  and goes to the channel of our products.. I'm worried but I don't know what to do..?

See your doctor: I don't really know what you are describing. But if you have a really low hematocrit, the least of your problems are difficulty using your blood in testing your products. This means you are anemic and you need to find out why and fix it. See your doctor.

Dr. Cornelia Franz
2,007 doctors shared insights

Safety (Definition)

Safety is a topic that includes recommendations for making the home and outdoor environments safe, especially for kids. This topic includes ideas on childproofing cabinets, keeping dangerous items locked up, ensuring balconies and stairs are safe, covering wiring and outlets, fencing off pools, staying away from cars, watching ...Read more