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Doctor insights on: Medical Device Safety

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Dr. Arthur Balin
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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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). ...Read more

Dr. Arthur Balin
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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Are paper medical records more secure than electronic health records?

Usually 7 years: Paper charts- 7 years. This may differ by state. Advantage of emr is they can be preserved for ever. Paper charts may not be as secure as electronic charts if proper precautions are taken. ...Read more

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Electronic health records allow sharing with insurance companies, right?

Electronic health records allow sharing with insurance companies, right?

Yes, but...: ...Guess what? Insurance companies can also look at your paper records too. Built into the contracts they sign with doctors, insurance companies can "audit" a physician to look at their clinical notes. This is to prevent overbilling or incorrectly billing. So your insurance company already has access to all of your medical records. An ehr would make it easier to share those records. ...Read more

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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? ...Read more

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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. ...Read more

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Medical records. Is there any way to obtain my medical records?

Medical records. Is there any way to obtain my medical records?

Each : Each doctor's office or hospital has different policies regarding this matter, however your medical records should be made available to you in a timely fashion. Most facilities merely require a signed authorization, usually to be signed in person. If the records are in another state they may have another method for obtaining them. Remember you have a right as a patient to have access to your medical records. This includes all labs, x-rays, and clinic notes. Another method of obtaining medical records would be to have your current primary provider request to have your records released to them, which also requires your signature, this tends to be a little quicker in most case. Good luck! ...Read more

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Will medical care change with the implementation of electronic health records?

Will  medical care change with the implementation of electronic health records?

It will benefit you: Some health workers don't like electronic records, but they benefit patients. You can get electronic copies of your records. Is a law, and your right, although they can charge for this. http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/medicalrecords.html. Electronic records also can remind doctors to do things that need to get done. ...Read more

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Are personal health records services or products regulated by accredited organization or gov?

Are personal health records services or products regulated by accredited organization or gov?

Some laws govern: In recent years, the government has passed laws that set rules for protecting personal health information. I'm sure the laws apply to people and businesses that handle personal health information, regardless of whether or not a person or business is labeled a "personal health records service". ...Read more

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Medical uses for alum?

Medical uses for alum?

Multiple Purposes: Alum is regularly employed as an astringent to shrink tissues and reduce the discharge of bodily fluids, as a styptic to contract organic tissues and stop or reduce hemorrhage and bleeding, and as an emetic agent to induce vomiting when someone has ingested poison. It is also often used to enhance certain vaccines and to prevent or treat infections. ...Read more

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Who owns personal medical records?

Who owns personal medical records?

Personal medical rec: You as patient have right and access to a full copy. ...Read more

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Do hospitals look at an employee's medical record when hiring them? Are medical records confidential?

Do hospitals look at an employee's medical record when hiring them? Are medical records confidential?

Medical records are: confidential. Without your permission they cannot look at your medical records. If an employer requires drug testing they need to let their employees know the policy as well. ...Read more

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Can I get my own medical records under federal laws protecting consumers?

Can I get my own medical records under federal laws protecting consumers?

Yes. : Hipaa regulations allow you to request your personal medical records from your provider, considering you are not a minor. Some providers may charge a per page or per x-ray fee, or if digital records, a per disk fee. ...Read more

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Dr. Andrew Ho Dr. Ho
5 doctors agreed:
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Are there any safety measures built into fibromyalgia drug trials?

Dr. Andrew Ho Dr. Ho
5 doctors agreed:
Are there any safety measures built into fibromyalgia drug trials?

Many measures: One of main reasons to conduct drug trials is to assess the safety of new drugs. Compared to clinical practice, drug trials tend to be much more comprehensive in terms of laboratory tests and frequency of followup. Of course, not all drug trials are equal. If you are thinking of volunteering for a trial, you should ask the study doctor specific questions about safety measures. ...Read more

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Can you use oxygen intended for welding for medical purposes?

Can you use oxygen intended for welding for medical purposes?

NO: Oxygen is a drug, and a toxic one at that. For billions of years oxygen was toxic to life. Evolution first led to tolerance of oxygen before it led to adaptation to use oxygen to burn energy. Too much oxygen is still toxic. It should not be used without explicit instructions from your doctor. ...Read more

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Does fda publish information on drug safety?

All the time: Yes, all the time. So does the cdc, the nih, and even the dea. Plus the manufacturers themselves are fairly exacting in their discussion of safety and side effects. ...Read more

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Any reviews for contraceptive marina or skyla devices?

Any reviews for contraceptive  marina or skyla devices?

Great options: The intrauterine device is a small t shape item placed inside the uterus. There are 3 approved iuds in the us. Mirena (levonorgestrel) can last up to 5 years and contains a small amount of Progesterone giving you the benefit of light or no periods. Skyla is a smaller 3 yr version of mirena (levonorgestrel). Paragard lasts 10 years and is hormone free. All are safe, highly effective, well tolerated & popular options. ...Read more

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Purchase home INR monitoring device without doctor's prescription, is this bad?

Purchase home INR monitoring device without doctor's prescription, is this bad?

Help is good: Who is going to prescribe and help you adjust the dose of your anticoagulant medication? Your doctor is your partner in this: why not include him/her? ...Read more

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Can you buy child safety proof containers for cleaning supplies?

Can you buy child safety proof containers for cleaning supplies?

Child proofing : Yes. You can also buy locks to put on the cabinet you keep them in. Most stores that carry baby products, have a child proofing section. ...Read more

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What impacts doctors decision to start electronic health records implementation?

What  impacts doctors decision to start electronic health records implementation?

Govt regulation: Emr is being introduced in a phased manner- cms guidelines. All hospitals and offices are to implement electronic records. There are so many technical difficulties with these programs, but they are getting better. As of now, most doctors have not embraced them as well. ...Read more

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