April 26, 2006
Better heart device safety tracking needed: doctors
By Lisa Richwine
WASHINGTON (Reuters) - Makers of implanted heart devices
should track their performance more closely 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 aimed at identifying
problems sooner and increasing transparency.
"The recommendations are expected to improve patient
confidence in these devices and ensure these life-saving
technologies are safe, effective and available," said Dr. Anne
Curtis, the society's president.
The proposals were a response to concerns about how various
device makers handle problems such as a sudden stopping or
quick loss of battery power of devices, which shock the heart
back into a normal rhythm if dangerously abnormal beating
Boston Scientific Corp., which just bought ICD-maker
Guidant Corp., said it would adopt all the recommendations,
some of which already were implemented. Medtronic Inc. MDT.N
said it had similar practices in place.
Guidant has drawn particular criticism for failing to make
public for three years a potential problem with some ICDs.
Medtronic and St. Jude Medical Inc. also make ICDs, More
than 250,000 of the ICDs are expected to be implanted this year
An analysis by industry group AdvaMed found about 1 percent
of ICDs malfunctioned in 2005.
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 find potential problems and
recommend action, the group said. The FDA had previously
announced plans to seek guidance from outside experts.
Manufacturers should use a standard form to notify patients
directly of possible risks, the guidelines said. The term
"recall" should be avoided in safety alerts because it gives
the mistaken impression that the devices should automatically
be removed, they said.
Doctors should consider if 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 should return all malfunctioning devices to the
manufacturer for analysis, the guidelines said.
The FDA said it was exploring ways to improve its systems
for detecting rare problems.
Boston Scientific Chief Executive Jim Tobin said the new
proposals "will help ensure timely and transparent clinician
communication and patient safety. We clearly understand and
acknowledge our need to do better in this area."
Medtronic said most of the recommendations, such as use of
third-party experts, already were standard practice for the
St. Jude spokeswoman Kathleen Janasz said it was too early
to comment on specific recommendations. "We are open to
supporting changes that help improve patient healthcare and
represent good public policy," she said.
The Heart Rhythm Society said it would take comments on its
proposal through May 30.