FDA Steps Up Oversight of Home Medical Devices

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.