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Compliance In Focus
Posted by John Lehmann on Mon, Dec 17, 2012

3 Steps FDA’s Taken for Home Use of Medical Devices

3 Steps for Home Use of Medical DevicesWhat exactly is a Home Use Device? FDA’s website defines this as “a medical device intended for users in any environment outside of professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes. Typically the following standards are met:

  • A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
  • A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

FDA recently pushed some major steps forward to push the use of devices at home. According to a recent update to the website, these efforts include:

  1. Issuing a draft guidance for manufacturers recommending actions they should take to receive FDA approval or clearance of devices intended to be used in the home.
    This draft guidance is intended to assist manufacturers in designing device for at home use that has easy to understand instructions and clear labels.  This draft guidance will hopefully reduce the errors that occur with at home use.
  2. Developing a labeling repository for medical devices that have been approved or cleared for home use.
    FDA initiated a labeling repository pilot, which provided manufacturers of devices labeled for home use with the opportunity to voluntarily and electronically submit their labeling to FDA.
  3. Increasing public awareness
    FDA has partnered with many organizations which will further provide collaboration to provide home care recipients, consumers, caregivers, and health care professionals with the information they need.

 Achieving safe, effective at home use of medical devices can be a challenge. This environment is quite difference then a hospital or clinic setting.  Beyond the obstacles of at home use, daily maintenance must also be considered.

How will a patient adequately clean their device at home? Where will patients dispose of hazardous waste, like needles or tubing? How can we ensure homes are compatible with the medical device?

These are questions FDA has been considering and answers can be found on their website, “Frequently Asked Questions About Home Use Devices”. With the push for greater use of at home medical devices you can be sure we’ll be seeing some additional questions and answers added to this page.

What you do think about the Home Use Device Initiative? Share your thoughts or questions below.

Photo Credit: tachyondecay

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Topics: Draft Guidance, Home Use of Medical Devices, FDA


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