Better Health Care with Quality Medical Devices:
FDA on the Cutting Edge of Device Technology
More than 20,000 firms worldwide produce over
80,000 brands and models of medical devices for the U.S.
market, ranging from contact lenses and blood sugar monitors
to implanted hip joints and heart valves. The FDA's Center
for Devices and Radiological Health (CDRH) makes sure
that new medical devices are safe and effective before
they are marketed. Many of these devices are the first of
a kind, such as a robotic arm that can operate a variety
of surgical tools with tremendous precision. Other high-tech
devices are designed to prevent, diagnose or treat cancer,
heart disease, impaired vision and hearing, and other health
problems. The center also monitors devices throughout the
product life cycle, including a nationwide postmarket surveillance
system. And it assures that radiation-emitting products,
such as microwave ovens, TV sets, cell phones, and laser
products meet radiation safety standards.
The size of the CDRH workload is reflected
in its performance statistics for 2001: 3,507 new products
received marketing clearance, including 29 devices representing
breakthrough technologies; 1,098 ongoing device trials were
monitored; and 216 new clinical studies to test the safety
and effectiveness of experimental devices in humans were
approved.
Although its workload is rapidly increasing,
CDRH has streamlined its processes and reduced the average
review time for novel and high-risk medical devices, which
offer the greatest potential health benefits to patients.
Between 1995 and 2000, approval times for these products
declined from 26 months to 12 months.
In the near future, CDRH will be challenged
to resolve complex issues connected with emerging technological
and demographic developments, including:
- Diagnosis and treatment options related to the human
genome project
- Radiation safety issues, including those associated
with new medical imaging technologies
- Breakthrough devices using artificial intelligence,
nanotechnology and robotics
- Special needs of our aging population for
prosthetics, cardiac interventions, and home health
care.
For more information, please call CDRH
at 301-827-7975.
Advances in Medical Device Technology
CDRH's approvals in 2001 included numerous
state-of-the-art medical devices, such as:
- the first implanted pacemaker that includes a tiny
transmitter that automatically transmits data on the
patient's heart condition to the physician
- a vest-like device for patients who cannot have an
implanted defibrillator and are at risk of dying from
heart attack; the device senses heart malfunction and
automatically delivers an electrical shock to restore
normal heart rhythm
- a wristwatch-like device for diabetics that automatically
checks the wearer's glucose level every 20 minutes and
sounds an alarm if it is dangerously high
- an inflatable device that is surgically placed around
the upper stomach of greatly overweight patients who
cannot lose weight by dieting and are at serious risk
for weight-associated serious diseases, such as hypertension;
the device limits their food consumption and creates
an earlier feeling of fullness
- a swallowable capsule with tiny camera that snaps
pictures as it moves through the small intestine; the
device helps detect bleeding and other abnormalities
that are reachable by endoscope.
