WASHINGTON — As more complex medical products migrate to the home and more patients receive continuing treatment at home, the U.S. Food and Drug Administration will establish guidelines for manufacturers, develop safe-use education for users and boost post-market oversight, officials said April 20.
Under its Medical Device Home Use initiative, the FDA will zero in on negative pressure wound therapy devices, home infusion, ventilators, dialysis machines and the like to ensure safe use for patients and caregivers, according to Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health.
"Using complex medical devices at home carries unique challenges," Shuren said. "Caregivers may lack sufficient training, product instructions may be inadequate or overly technical and the home environment itself may pose environmental or safety hazards that can affect the product's functioning."
Currently, Shuren said, the FDA does not have a clear regulatory path for devices intended for home use that describes the unique factors manufacturers should take into consideration when designing, testing and labeling such products. He told reporters that pets, sanitation issues and even electromagnetic interference from home wireless networks could affect the function of a medical device.
From 1997 through 2009, the FDA received more than 19,000 reports of adverse events in the home, according to an agency white paper. To guard against such safety problems, the FDA will:
- develop recommendations for approval or clearance of these devices, including testing with home caregivers and patients.
- exercise its authority to require that certain devices are labeled that they have not been cleared for use in the home.
- enhance post-market surveillance to identify and address adverse events in the home.
The FDA also announced a 10-month pilot program in which manufacturers of devices labeled for the home can voluntarily submit their labeling electronically to the agency for posting in a central repository on its website. That will make it easier for home care patients and caregivers to locate information about their device, officials said. The program is expected to begin this summer, with more information available in the Federal Register in coming weeks, according to the agency.
In addition, the FDA is partnering with the Community Health Accreditation Program and the Joint Commission to strengthen accreditation criteria that relate to medical device safe-use practices for the home.
"Although accreditation programs for home health agencies already exist, they generally focus on the practitioner's ability to provide care to patients, rather than also assessing the practitioner's ability to properly use devices in the home or to train lay caregivers and care recipients on the safe use of these technologies," the FDA explained.
The agency is also seeking better information about home medical device problems, so it is strengthening the HomeNet survey arm of its Medical Product Surveillance Network. For example, a survey to collect information about safety concerns regarding NPWT devices in the home is currently being conducted.
Shuren told reporters that on Monday, the agency sent letters to NPWT manufacturers stating that they must begin testing their devices specifically for use in the home and labeling them if the device is not suitable for home use.
The agency said it expects that increased post-market surveillance will also "help identify situations in which devices not intended to be used outside of a health care facility are being used in the home." In their premarket submissions, manufacturers may be required to include labeling for home use or a statement in the label that indicates the device is not suitable for home use.
The FDA initiative doesn't focus only on manufacturers. The agency is also offering education to patients via a new Home Uses Device website that includes ways to reduce safety risks and downloadable checklists on such topics as infusion therapy and blood glucose meters.
By launching the multi-faceted initiative, the FDA is hoping to prevent safety problems even as the use of sophisticated medical devices in the home spirals upward. In its white paper, the FDA acknowledged the great value of home care, noting that it "can provide significant benefits to patients, in terms of both quality of life and cost of care.
"Because care recipients expect to be able to stay independent, mobile and active, the term 'home use' extends beyond the home, per se, to encompass all environments in which a person plans to use his or her medical device in day-to-day life," the FDA document said. "The device must be capable of safely accommodating the many needs of the person using it."
The FDA is asking for input from manufacturers. A public workshop will be held May 24 "to discuss steps manufacturers can take to design and test devices for use in the home and to develop user-friendly instructions for home care recipients and caregivers."
For more information, see the FDA's Medical Device Home Use Initiative white paper.