Transcript Safety Alerts and Recalls on Heart Devices : ICDs & Pacemakers

Safety Alerts and Recalls on Heart Devices :
ICDs & Pacemakers.
Presevter:
09-11-2001
Emanuel
CIS 763
PRESENTATION BC/CUNY
Objective
To present an overview on the
topic of hardware and software
errors in the safety alerts and
recalls of pacemakers and ICDs.
ICDs & PACEMAKERS – WHAT ARE THEY?
An ICD (implantable cardioverter defibrillator) looks much
like a pacemaker. It is "implanted", or put in your body
surgically.
Whereas pacemakers can speed up a slow heart rate, ICD
therapy generally slows down a fast heart rate.
It is like a small computer that runs on a battery.
Or, ICDs are high-tech devices that contain sophisticated
detection algorithms and tiered therapy options.
The ICD system consists of an ICD , one or two leads , and a
programmer .
A typical ICD is often four to five ounces in weight, less than
two inches wide and a half-inch thin.
The device is roughly the size of four to five silver dollars
stacked on top of one another.
St. Jude
Medical
 PACEMAKER
Guidant
Medtronic
Biotronik
ICD 
The term "pacemaker" is used for a small, batteryoperated device that helps the heart beat in a regular
rhythm.
Some are permanent (internal) and some are temporary
(external). It can replace a defective natural pacemaker
or blocked pathway.
Programmers
A programmer enables a
physician to evaluate an
ICD's performance and
change its settings noninvasively.
PR-3500
Programmer
For example:
St. Jude Medical CRMD's proprietary
software enhances ICD function, offering
comprehensive diagnostic capabilities.
It uses a Pentium-processor-based
programmer .
WHY I MIGHT NEED AN ICD?
Normally, your heart has a natural pacemaker
that helps your heart beat steadily.
You may need an ICD if you have had, or are at
high risk of having, certain heart rhythm
problems.
SOURCE: http://familydoctor.org/handouts/270.html
ARE ICDs USED WIDELY?
Japan Airlines Purchases 130 Automated
External Defibrillators From Cardiac
ScienceAirline to Outfit All International
Flights With AEDs
SOURCE: PRNewswire 9-30-2001
About 900,000 people in the USA, including
Vice President Cheney, wear pacemakers or
ICDs1
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT Medtronic Implantable Cardioverter Defibrillators: a)
Medtronic Micro Jewel II Implantable Cardioverter Defibrillator,
Model 7223CX; b) GEM DR Model 7271 Implantable Cardioverter
Defibrillator. Recall #Z-261/262-0.
CODE All serial numbers of the Model 7223CX; Serial Numbers
PIM200002R through PIM302777R and PIM400352R, PIM400968R,
and PIM400969R of the Model 7271 Defibrillators.
MANUFACTURER Medtronic Med Rel, Inc., Humaco, Puerto Rico;
Medtronic, B.V., Kerkrade, European Service and Technology
Center, The Netherlands; Medtronic, Switzerland Manufacturing
Operations, Tolochenaz, Switzerland.
RECALLED BY Medtronic, Inc., Minneapolis, Minnesota, by letter
dated August 1999 for the Model 7223CX Defibrillators and by
letter dated December 1999 for the Model 7271 Defibrillators.
Devices having capacitor charge times above a certain level are
being reprogrammed. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 28,000 units were distributed.
REASON Some of the devices have extended charge times for the
high- voltage capacitors used to store the charge for cardioversion
and defibrillation therapies.
ANY STUDIES………YES !
CASE 1:
Krannert Institute of Cardiology Case..
A 70-year-old patient experience an acute
dizziness, and was found to have a loss of
ventricular output due to an internal software
problem. This was corrected by software
programming via the programmer.
Comment
Although this article was written to exemplify
the potential ability of correcting new
generation ICD software problems noninvasively, it does not minimize the importance
of a life-threatening software failure.
CASE 2:
Brigham and Women Hospital’s Study…
Context Unanticipated pacemaker and ICD generator
malfunctions sometimes warrant recall by the US Food
and Drug Administration (FDA).
Objectives To determine pacemaker and ICD generator
advisory rates in the United States, to identify trends in
these rates, and to examine their clinical and financial
implications.
Design and Setting Analysis of weekly FDA
Enforcement Reports issued between January 1990
and December 2000.
Recalls and safety alerts involving lead malfunctions
were not included.
Main Outcome Measures Number of pacemakers and
ICD generators in the United States subject to FDA
recall or safety alert in 1990-2000
Results of Study
1. During the study period, 52 advisories,
involving 408 500 pacemakers and 114 645
ICDs were issued.
2. Hardware malfunctions and computer errors
accounted for 95% of device recalls
3. Implantable cardioverter-defibrillators were
recalled more frequently than pacemakers.
4. Between 1995 and 2000, the annual advisory
rate increased for both pacemakers
5. An estimated 1.3 million device checks and
analyses and 36 187 device replacements
resulted from the advisories and cost
approximately $870 million.
COMMENTS & RECOMMENDATIONS
Nearly 20% of pacemaker wearers could not live without one
Hardware problems and computer programming errors were
the most common basis for recalling both pacemakers and
implantable defibrillators.
"Some (flaws) are potentially life-threatening and require
device replacement," says William H. Maisel, MD, MPH of
BWH of Harvard Medial School.
Kim Eagle of the University of Michigan Medical Center said
in an accompanying editorial that routine recalls are not
unexpected "in a free-market society that highly rewards
profit and attends to safety primarily through its violation."
Eagle called for:
•A longer testing period for pacemakers.
•Closer regulation of the testing process.
•The creation of a better "device tracking system"
involving "more parties than industry alone."
By studying devices that fail, researchers might learn how to
improve their reliability.
Source: USATODAY Healthscience News August 14, 2001
CONCLUSION
Pacemaker and ICD recalls and safety
alerts occur frequently, affect many
patients, and appear to be increasing in
number and rate.
Improve the methodology of reporting
these flaws.
Remedy for these failures should be
improved hardware/software
engineering methods.
SOURCES…
Coppess MA, Miller JM, el. Software error resulting in
malfunction of an implantable
Cardioverterdefibrillator. J Cardiovasc
Electrophysiol 1999 Jun;10(6):871-3
Maisel WH, el. Recalls and safety alerts involving
pacemakers and implantablecardioverterdefibrillator generators. JAMA. 2001 Aug
15;286(7):843-4
Kaczmarek RG, Beaulieu MD, Kessler LG. Medical
device tracking: results of a case study of the
implantable cardioverterdefibrillator. Am J Cardiol
2000 Mar 1;85(5):588-92
Eagle KA. Safety alerts involving device therapy for
arrhythmias. JAMA. 2001 Aug 15;286(7):843-4.
The End !