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 In this section:

                Home Use Devices

Home Use Devices

                        Home Use Devices Initiative
          Unique Considerations in the Home
          Specific Devices for Home Use
          Frequently Asked Questions About Home Use Devices
          FDA's Role in Regulating Medical Devices
          FDA Activities:  Home Use Devices
          Additional Resources on Home Use Devices Home
          Medical Devices
          Products and Medical Procedures
          Home Health and Consumer Devices
          Home Use Devices
          Unique Considerations in the HomeHome Use Devices Unique Considerations in the Home
  
  	
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    PrintThe home care setting is a challenging environment. Because it is very different from the hospital setting, it often presents additional risks to patients and providers. This section outlines environmental considerations and potential safety hazards providers and patients should be alert to when using – or considering using – a medical device in the home setting.

Geographic Location

Where a person lives makes a difference in the type of home health care services they receive. For example, home health care providers and support staff may not be readily available in a rural setting, where it may also be difficult to obtain needed back-up supplies or equipment.

Different parts of the country experience power outages more frequently than others, especially during public emergencies like Hurricane Katrina. During these uncontrollable events, patients should have back-up plans and extra supplies when using certain medical devices. FDA provides information about how to handle medical devices during natural disasters and other emergency situations (see Medical Device and Hurricane Emergencies).

Age and Structure of a Home

A home’s age and structure can affect the quality of care, especially when using medical devices. For example, older homes may not have the electrical outlets needed for some medical devices. Older homes may also have smaller doorways, hallways, and rooms that do not accommodate large medical equipment. Smaller homes may not allow for wheelchairs to pass through the entranceway, forcing patients to use walkers, crutches, or canes instead.

Before a medical device goes home with a patient, check to see if the medical device is compatible with the patient’s home. FDA has developed a checklist with important questions to ask when considering home use medical devices (Home Healthcare Medical Devices: A Checklist) [PDF].

In-Home Environmental Hazards

Regardless of geographic location, home settings may present other environmental challenges for the use of medical devices. These challenges include the following:

Pets

	Pets may directly interfere with device operation. For example, they may chew through an electrical cord or play with an accessory, such as tubing. Pets may also contribute to unsanitary conditions where the medical device is used. They may walk over an area that is supposed to be clean, and pet fur/hair may find its way into a device.
	Unsanitary Conditions

	Unhealthy conditions may result from dirty surface areas, wet towels on the bathroom floor, dirty dishes, and open or scattered garbage. For example, trash that is not properly contained or removed may attract insects and rodents.

	The ability to manage medical waste properly and establish safe cleaning practices also requires attention. For instance, the improper disposal of sharps, such as needles, can lead to needlestick injuries in caregivers, patients, and household members. Each state or local government regulates the storage, transportation, and disposal of medical waste. Check with your local government to learn more.
	Children at Play

	Children may interfere with medical device operation. They may change the dial, settings, and on/off switches, twist tubing, adjust machine vents, or remove electrical cords from the outlet. They can also injure themselves while playing with devices they think are toys.
	Plumbing

	Clean, running water is critical to the use of a medical device in the home. Some medical devices and equipment, such as dialyzers or infusion pumps, require safe water during use, cleaning, and maintenance. Even if water is not required for a device to operate, it may be necessary for cleaning its accessories.
	Temperature Extremes

	Extreme heat and humidity can negatively affect a working device. Unusually high levels of heat and humidity may:

	Cause instruments to operate in unexpected or unusual ways;
		Reduce the expected life span of devices or totally destroy products;
		Cause laboratory substances used in chemical analysis to lose strength; or
		Compromise the cleanliness of packaged devices.For example, high humidity becomes a problem when a low flow of air causes moisture to build up on a medical device, resulting in a malfunction. Excess moisture may also cause mold to grow on a device.

Dust

	Carpets and drapes can hold allergen-containing dust. If dust gets into a medical device, it may affect the way it works.
	Fire Hazards

	Fire hazards are a concern when considering a home use medical device. Electrical problems with device equipment such as their potential to overheat or short–circuit may increase the likelihood for home fires. Home care patients who receive supplemental oxygen therapy are also at increased risk. Wherever there is a high concentration of oxygen gas, there is also an increased risk of fire initiated from electrical faults. Taking appropriate fire safety precautions is important.
	Tripping Hazards

	Too much clutter, loose carpeting, and slippery floor surfaces may cause people to fall. Patients who have trouble moving around without the use of a walker, crutch, or cane have a higher risk of falling when these hazards are present.
	Poor Lighting

	Poor lighting has been shown to result in injuries, especially from patient falls. Inadequate lighting can also make it more difficult for a patient or caregiver to see and operate a medical device.
	Background Noise

	There is a lot of noise in the home environment – from vacuum cleaners, televisions, telephones, to people arguing. Outside noise, such as trash pick-up trucks and emergency sirens, is also common. All loud noise can interfere with the ability to hear whether a medical device is operating correctly or whether an alarm has sounded.

                                                                                  Content current as of:
      01/24/2018
              
              
Regulated Product(s)
		 Medical DevicesHome Use Devices

          
                        Home Use Devices Initiative
          Unique Considerations in the Home
          Specific Devices for Home Use
          Frequently Asked Questions About Home Use Devices
          FDA's Role in Regulating Medical Devices
          FDA Activities:  Home Use Devices
          Additional Resources on Home Use Devices
 
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