The Center
for Devices and Radiological Health (CDRH) of the Food and Drug Administration
(FDA) is mandated to regulate medical devices; however, the regulatory
authority alone is inadequate to assure that devices are safe and
effective when used in the home environment. CDRH also receives reports
of adverse events that happen with medical devices and more of these
reports are coming from the home environment. This is due in part
to more device use in the home which in turn is associated with improvements
in technology, changes in the practice of medicine, shifting reimbursement
patterns, and patients’ desire to receive care in the home.
Because the devices are not usually cleared or approved for home use,
user problems are becoming more prevalent. This can be from poor device
design, defective components, an inappropriate environment for device
use, and inadequate information for proper device use.
CDRH
wants to decrease the number of problems that occur in the home environment;
however this is very complex. To be successful, the government agencies
involved in home care need to collaborate with relevant stakeholders:
manufacturers, distributors, health care professionals, health care
organizations, accrediting bodies, and human factors experts.
The purpose
of this conference is to bring together these stakeholders to identify
the problems with a safe migration into the home, identify the barriers
to change, and discuss meaningful technology and other actions that
will promote the safe use of devices in this environment.
Sessions
will follow a technology, government, or clinical tract for specific
device groups. Sessions will also highlight how the devices are getting
into the home, what barriers there are in the environment for safe
operation, and what barriers there are with the caregiver or patient
while using the device.
REGISTER
NOW!
FDA
has applied for approval as a provider of continuing education programs
in the clinical laboratory sciences by the ASCLS P.A.C.E. Program. This
application would cover continuing education credits for pharmacists,
laboratory technicians, and respiratory therapists. The FDA is also
in the process of applying for continuing education credits for nurses
and physicians.
