Bringing medical technology into the home involves safety issues and following the correct procedures in using or operating medical devices. Today, healthcare is requiring a number of medical devices, including dialysis equipment to treat kidney failure, infusion pumps, intravenous therapy devices, ventilators, wound therapy care therapies along with telemedicine technologies and wireless monitoring devices to be used in the home.
In April 2010, FDA’s Center for Devices and Radiological Health published a document to launch their “Medical Device Home Use Initiative”. Currently, the FDA does not have a clear regulatory pathway for devices intended for home use that describes the unique factors that manufacturers need to take into consideration when designing, testing, and labeling such products.
The use of medical devices includes all permanently and temporarily implanted devices and any type of equipment that a person may need to recover. The term “home use” extends beyond the home to encompass all environments in which a person plans to use their medical device in day-to-day life.
The use of medical devices presents some challenges. Many devices are still too complex for a layperson to use safely and effectively without training. In many cases, home care recipients may be using devices designed for use by trained healthcare professionals in an acute care facility and not by lay caregivers in a non-clinical setting.
Sometimes individuals who receive or provide care in the home use older medical devices which often come with minimal or no labeling or instructions for use. In such cases, the home healthcare provider must develop their own basic instructions for use.
Another concern is that home care recipients may not be able to choose the devices that are provided to them and therefore may not receive devices that are optimal to meet their individual needs.
In addition, although the internet offers care recipients more control over their equipment purchases, it also means that the quality of devices and associated materials and services provided by internet-based device distributors can vary.
Lastly, unlike the clinical setting, the home is an uncontrolled environment with space limitations, there may be children and/or pets in the home, electromagnetic interference, sanitation issues, clutter in the home, high levels of noise, while poor air quality, temperature, and humidity may also affect device performance.
The new FDA home use guidance document that FDA intends to develop will:
• Establish the guidelines for manufacturers of home use devices. FDA will develop a guidance document recommending actions that manufacturers should take to receive FDA approval or clearance on devices intended to be used in the home
• Create an online labeling repository for medical devices that have been approved or cleared for home use and are available to the public. FDA is launching a ten month pilot program beginning in summer 2010 where manufacturers of devices labeled for home use may voluntarily submit their labeling electronically to FDA
• Partner with home health accrediting bodies to support the safe use of devices. To do this, the agency is partnering with two major accrediting bodies to include the Community Health Accreditation Program and the Joint Commission with the goal to strengthen home health agency accreditation criteria relating to medical device safe use practices
• Enhance post market oversight and continue to strengthen the HomeNet arm of the Medical Product Surveillance Network (MedSun). This network is an adverse reporting program that includes more than 350 healthcare facilities nationwide
• Work to increase public awareness and education. To help do this, FDA is launching an new Home Use Devices web site featuring information on using medical devices in the home and the strategies needed to reduce the risks associate with home use
On May 24th, FDA will be holding a public workshop entitled “Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device Technology Migrating Into the Home.” The purpose for the workshop is to solicit information from healthcare providers, academics, human factors experts, medical device manufacturers, distributors, professional societies, patient advocacy groups, patients, caregivers to talk about the challenges surrounding the use of devices in the home. The workshop will be held at the Hilton Hotel in Silver Spring Maryland.
For more information, email Mary Brady, Center for Devices and Radiological Health at Mary.Brady@fda.gov.