April 26, 2006
Int’l group wants better heart device safety tracking
By Lisa Richwine
WASHINGTON (Reuters) - Makers of implanted heart devices
should track their performance better and ask independent
experts to evaluate their safety, an international doctors'
group proposed on Wednesday.
Regulators also should improve surveillance of potential
problems with implanted cardioverter defibrillators (ICDs) and
pacemakers on the market and use simple language to explain
concerns, the Heart Rhythm Society said in draft guidelines.
The group, which represents more than 4,200 specialists in
78 countries, said its suggestions were designed to help
identify potential problems sooner and increase transparency
about malfunction rates.
"The recommendations are expected to improve patient
confidence in these devices and ensure these life-saving
technologies are safe, effective and available to people who
need them," Dr. Anne Curtis, president of the society, told
The proposals were a response to concerns about the
handling of problems such as sudden stopping or quick loss of
battery power with devices from various makers. Guidant Corp.,
now a part of Boston Scientific Corp., in particular drew
criticism for failing to make public for three years a
potential problem with some ICDs.
Medtronic Inc. and St. Jude Medical Inc. also make ICDs,
which shock the heart back into a normal rhythm if dangerously
abnormal beating occurs. More than 250,000 of the devices are
expected to be implanted this year worldwide.
Problems are rare but can occur with any of the products,
To identify abnormal devices earlier, manufacturers should
expand use of wireless and remote monitoring technologies that
can track the implants daily, the guidelines said.
The makers and the U.S. Food and Drug Administration should
ask independent experts to help identify potential problems and
recommend action, the group said. Manufacturers should use a
standard form to notify patients directly of possible risks.
The guidelines urged elimination of the term "recall" in
safety alerts, saying it gives the mistaken impression that the
implanted devices should automatically be removed.
When deciding how to respond to a warning, doctors should
consider whether replacing a device is more risky than leaving
it in, they added.
"It is not in most patients' best interest to change out a
device that might have a rare possibility of a malfunction,"
Doctors also should return all malfunctioning devices to
the manufacturer for analysis, the guidelines said.
Most of the recommendations already are in use at
Medtronic, the company said in a statement.
"Medtronic has routinely used outside medical advisers and
other third-party experts to provide product quality, safety
and reliability assessments. We welcome these types of
activities becoming standard practice for the entire industry,"
Stephen Mahle, Medtronic's president of cardiac rhythm disease
The Heart Rhythm Society said it would take comments on the
proposed guidelines through May 30.