Contemporary Clinical Trials 32 (2011) 307–308
Contents lists available at ScienceDirect
Contemporary Clinical Trials
j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / c o n c l i n t r i a l
Editorial letter
Post-marketing device safety surveillance
Recalls of several commonly used implantable medical
devices after US Food and Drug Administration (FDA)
approval have led to increasing scrutiny of the tools and
techniques employed for assuring post-marketing medical
device safety. [1–4] The most established surveillance
methods rely on a mix of mandatory and voluntary adverse
event reporting systems, such as the MedSun system, Med-
Watch and the “Adverse Event Reporting System”. However,
these systems are limited by their inability to assess accurate
event rates due to event under-reporting and a lack of
information regarding the total number of devices implanted.
[5–7] Other more recent mechanisms for monitoring the
safety of devices, including mandated post-approval clinical
registries, have been implemented to address the need to
detect long term adverse events and device performance in
high risk patient populations and to address gaps in
knowledge regarding treatment efficacy and safety beyond
the populations studied in randomized clinical trials. [7]
Although such registries may be mandated as a condition of
approval, the lack of industry incentives and FDA enforce-
ment capacity have resulted in a low execution rates for much
of the last decade. [7]
In response to the growing need for additional surveillance
capacity, the FDA announced the Sentinel Initiative in 2008
which was designed to access the capabilities of multiple
existing data systems including electronic health record
systems and large medical claims databases to detect safety
signals and to confirm signals suggested by other sources.[8]
These initiatives have thus far focused primarily on pharmaco-
surveillance rather than medical device surveillance. Moreover,
studying post-market device safety surveillance is complicated
by the lack of uniform standards for documentation of specific
medical devices as compared with medications, as well as
unique challenges related to the interactions between medical
devices and concurrent medications taken by the patient, and
operator learning curve effects that might influence subsequent
outcomes related to the device.
However, there are emerging opportunities to prospec-
tively monitor the safety of medical devices through disease
specific and device specific clinical registries. Such registries
may be voluntary in nature or mandated at the municipal,
state or federal level. These outcomes registries can provide a
1551-7144/$ – see front matter © 2011 Elsevier Inc. All rights reserved.
doi:10.1016/j.cct.2011.02.002
granular and rich dataset that may be suitable for prospective
device safety surveillance [9]. Examples of such clinical
registry programs include the National Cardiovascular Data
Registry, the Society of Thoracic Surgeons national database,
the Veterans Health Administration Cardiovascular Assess-
ment, the Reporting and Tracking database and many others.
The effective use of these databases within the larger FDA
effort will require robust observational cohort statistical
methods as well as advances in data de-identification, sharing,
and aggregation in order to achieve the vision building an
effective national safety surveillance system. Automated
processing and analysis of the resulting large heterogeneous
healthcare data will be important, and interpretation of
potential safety signals by a well-trained scientist workforce
will also be crucial. Such a collaborative approach is much
needed in this era of expanding newer device developments to
ensure patient safety.
References
[1] Steinbrook R. The controversy over Guidant's implantable defibrillators.
N Engl J Med Jul 21 2005;353(3):221–4.
[2] Hauser RG, Kallinen LM, Almquist AK, Gornick CC, Katsiyiannis WT. Early
failure of a small-diameter high-voltage implantable cardioverter-
defibrillator lead. Heart Rhythm Jul 2007;4(7):892–6.
[3] Hanley JA, McNeil BJ. The meaning and use of the area under a receiver
operating characteristic (ROC) curve. Radiology Apr 1982;143(1):29–36.
[4] Newcombe RG. Two-sided confidence intervals for the single proportion:
comparison of seven methods. Stat Med Apr 30 1998;17(8):857–72.
[5] Kessler DA. Introducing MEDWatch. A new approach to reporting
medication and device adverse effects and product problems. JAMA Jun
2 1993;269(21):2765–8.
[6] Mehran R, Leon MB, Feigal DA, et al. Post-market approval surveillance: a
call for a more integrated and comprehensive approach. Circulation Jun
29 2004;109(25):3073–7.
[7] O'Shea JC, Kramer JM, Califf RM, Peterson ED. Part I: Identifying holes in
the safety net. Am Heart J Jun 2004;147(6):977–84.
[8] Spanos C, Poolla K. Multivariate Control and Model-Based SPC (Lecture
15). EE290H F03 Lectures; 2003.
[9] Welke KF, Ferguson Jr TB, Coombs LP, et al. Validity of the Society of
Thoracic Surgeons National Adult Cardiac Surgery Database. Ann Thorac
Surg 2004 Apr;77(4):1137–9.
Venkatesan D. Vidi
Cardiovascular Division, Brigham and Women's Hospital,
Harvard Medical School, Boston, MA, United States
308 Editorial letter
Michael E. Matheny
GRECC and Center for Health Services Research,
Tennessee Valley Health System, Veterans Administration,
Nashville, TN, United States
Division of General Internal Medicine and Public Health,
Vanderbilt University Medical Center, Nashville,
TN, United States
Department of Biomedical Informatics,
Vanderbilt University Medical Center, Nashville, TN,
United States
Frederic S. Resnic
Cardiovascular Division, Brigham and Women's Hospital,
Harvard Medical School, Boston, MA, United States
Corresponding author at: Cardiovascular Division,
Brigham and Women's Hospital, 75 Francis St.,
Boston MA 02115, United States. Tel.: +1 857 307 1992.
E-mail address: fresnic@partners.org.
26 January 2011