Frequently Asked Questions About Home Use Devices
FDA is responsible for regulating companies that manufacture, repackage, re-label, and import medical devices sold in the United States. This is accomplished through scientific review of premarket data submitted by a medical device manufacturer to establish a device’s safety and efficacy and then once on the market, monitoring medical device adverse event reports to detect and correct device-related problems in a timely manner.
It is important to note because the FDA’s scope of work is to regulate the medical device industry, the FDA cannot and does not recommend specific medical devices for use in any setting. Review the instructions for use for a device you plan to use in the home before deciding on the one best for a particular patient population.
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There are many risks to consider when caring for a patient who requires a medical device in their home environment, especially in rural areas. It is important to consider:
- What the device needs to operate safely and effectively,
(for example: electricity, running water, computer connections, back up supplies)
- Power sources and outlets, (for example: are they compatible with one another?)
- Patient capabilities
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Home Use devices are often sold to patients who have a prescription for that given device at hospitals or at pharmacies. Medical devices are also cleared or approved for sale directly to the consumer and these are called Over-The-Counter (OTC) products. Medical devices are also available at many online retailers. If you buy a home use device online, make sure you are buying from a reliable source. Also check the store’s return policy and customer support statement before you place an order.
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Make sure you have phone numbers for your homecare agency, doctor, or the device manufacturer to call if your device is not working properly. You should also report the problem to your doctor, to the manufacturer of your medical device and to FDA through the MedWatch Reporting Program.
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Each state has laws and regulations that determine who can write a prescription for a medical device in that state. FDA defers to the states on determining who can write a valid prescription.
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Not all medical devices require a prescription; however, many medical devices do require a prescription (for example, contact lenses).
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If you do not have the instructions, contact your healthcare provider.
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You may report a problem by phone, fax, online or mail:
- Phone: 1-800-332-1088
- Fax: 1-800-FDA-0178
- MedWatch Online
- Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane Rockville, MD 20852-9787
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Follow the manufacturer’s instructions. If you do not have the instructions, contact your healthcare provider.
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Dispose of your medical device according to the manufacturer’s instructions. You may also wish to contact your pharmacist, nearest hospital, solid waste company, or state or local government for additional information about proper disposal.
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