Health-Care-Associated Infections in Hospitals
Number Associated with Medical Devices Unknown, but Experts Report Provider Practices as a Significant Factor Gao ID: GAO-08-1091R September 26, 2008Health-care-associated infections (HAI) in hospitals can be expensive to treat and, according to the Department of Health and Human Services' (HHS) Centers for Disease Control and Prevention (CDC), HAIs are estimated to be one of the top 10 causes of death in the United States. HAIs can be caused by bacteria or viruses, which may be introduced to a patient through the use of a device used to treat them, such as a needle or tube to deliver medicine, fluids, or blood. Common HAIs that are often associated with the use of medical devices are urinary tract infections (UTI), surgical site infections (SSI), pneumonia, and bloodstream infections (BSI). A number of federal agencies within HHS, including CDC and the Agency for Healthcare Research and Quality (AHRQ), currently collect HAI-related data for a variety of purposes. Nearly half of the states also require public reporting of hospital HAI rates, according to a summary report of these state laws. The Food and Drug Administration Amendments Act of 2007 requires us to conduct work on HAIs in hospitals associated with medical devices. The act defines these infections as those that are acquired while an individual is a patient at a hospital and were neither present nor incubating prior to the patient's receiving services in the hospital. Specifically, the act requires us to report on the number of HAIs in hospitals attributable to new and reused medical devices and on the causes of such infections. As agreed with the committees of jurisdiction, in this report we examine two questions: (1) What is known from available federal and state data about the number of HAIs in hospitals associated with the use of medical devices? (2) What factors affect the occurrence of HAIs in hospitals associated with the use of medical devices?
In summary, multiple federal programs and states collect data on HAIs in hospitals, but none of the data sources we identified provide a national estimate of the number of all HAIs in hospitals associated with medical devices. At the federal level, three HHS agencies, AHRQ, CDC, and CMS, specifically collect or have collected HAI-related data in databases maintained by separate programs, such as CDC's National Healthcare Safety Network (NHSN) program and CMS's Medicare Patient Safety Monitoring System (MPSMS). However, limitations in the scope and collection methods for these databases preclude them from developing a national estimate of HAIs in hospitals associated with medical devices. For example, CDC's NHSN data are not drawn from a representative sample of hospitals nationwide. Similarly, the infection rates included in the MPSMS are based on the experiences of a representative sample of Medicare fee-for-service beneficiaries and are not representative of the experiences of other Medicare or non-Medicare patients. Also, because the HAI-related information in two of these federal databases is gleaned from patient discharge and other medical records, the quality of the data is dependent on the accuracy with which the information was documented. Finally, although a Consumers Union summary report indicates that nearly half of the states mandate public reporting of hospital HAI rates, a number of factors limit the generalizability and usefulness of the state-reported rates. Improper patient examination and treatment practices by health care professionals, such as the improper insertion of urinary catheters, are the most significant factor affecting the occurrence of HAIs in hospitals associated with medical devices, according to most medical experts we interviewed. Certain in-hospital sterilization techniques and improper handling of sterilized medical devices were also commonly identified as significant causes of such infections, as was the inherent risk of using medical devices, which can introduce bacteria into the body. Our review of medical literature corroborated many of the risk factors cited by the experts and identified additional factors. For example, patient characteristics such as old age, diabetes, or compromised immune systems were frequently cited in the literature as risk factors. In terms of preventing HAIs, improved hygiene, such as appropriate hand-washing, and the use of barrier precautions, such as caps and gloves, were commonly identified strategies.
GAO-08-1091R, Health-Care-Associated Infections in Hospitals: Number Associated with Medical Devices Unknown, but Experts Report Provider Practices as a Significant Factor
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September 26, 2008:
The Honorable Edward M. Kennedy:
Chairman:
The Honorable Michael B. Enzi:
Ranking Member:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable John D. Dingell:
Chairman:
The Honorable Joe Barton:
Ranking Member:
Committee on Energy and Commerce:
House of Representatives:
Subject: Health-Care-Associated Infections in Hospitals: Number
Associated with Medical Devices Unknown, but Experts Report Provider
Practices as a Significant Factor:
Health-care-associated infections (HAI) in hospitals can be expensive
to treat and, according to the Department of Health and Human Services'
(HHS) Centers for Disease Control and Prevention (CDC), HAIs are
estimated to be one of the top 10 causes of death in the United States.
HAIs can be caused by bacteria or viruses, which may be introduced to a
patient through the use of a device used to treat them, such as a
needle or tube to deliver medicine, fluids, or blood. Common HAIs that
are often associated with the use of medical devices are urinary tract
infections (UTI), surgical site infections (SSI), pneumonia, and
bloodstream infections (BSI). A number of federal agencies within HHS,
including CDC and the Agency for Healthcare Research and Quality
(AHRQ), currently collect HAI-related data for a variety of purposes.
Nearly half of the states also require public reporting of hospital HAI
rates, according to a summary report of these state laws.[Footnote 1]
The Food and Drug Administration Amendments Act of 2007[Footnote 2]
requires us to conduct work on HAIs in hospitals associated with
medical devices.[Footnote 3] The act defines these infections as those
that are acquired while an individual is a patient at a hospital and
were neither present nor incubating prior to the patient's receiving
services in the hospital. Specifically, the act requires us to report
on the number of HAIs in hospitals attributable to new and reused
medical devices and on the causes of such infections. As agreed with
the committees of jurisdiction, in this report we examine two
questions: (1) What is known from available federal and state data
about the number of HAIs in hospitals associated with the use of
medical devices? (2) What factors affect the occurrence of HAIs in
hospitals associated with the use of medical devices?
To obtain information about the number of HAIs in hospitals associated
with the use of medical devices, we identified available federal data
sources at four HHS agencies--AHRQ, CDC, the Centers for Medicare &
Medicaid Services (CMS), and the Food and Drug Administration (FDA)--
and reviewed a summary report of available state data sources.[Footnote
4] We interviewed relevant officials responsible for these federal data
sets to determine the extent to which they included information
specifically on HAIs in hospitals associated with the use of medical
devices, how these data were collected, and whether the data were
nationally representative. To identify the factors affecting the
occurrence of HAIs in hospitals associated with the use of medical
devices, we conducted a literature review and interviewed infection
control experts. For the literature review, we identified 38 relevant
articles from nearly 200 peer-reviewed scientific studies and medical
literature published since 2000 and examined them to determine the
significant risk factors and how these factors varied for different
HAIs in hospitals. In addition, on the basis of our literature review
and recommendations from officials at several federal agencies,
professional associations, and advocacy groups, we identified 11
experts to interview about factors that affect the occurrence of HAIs
in hospitals. When interviewing these experts, we asked them to
identify causes of HAIs in hospitals from among those listed in the
mandate and to identify any additional known causes.[Footnote 5] We
further relied on the literature review and these interviews to
identify related prevention strategies. We conducted this performance
audit from March 2008 through August 2008, in accordance with generally
accepted government auditing standards. Those standards require that we
plan and perform the audit to obtain sufficient, appropriate evidence
to provide a reasonable basis for our findings and conclusions based on
our audit objectives. We believe that the evidence obtained provides a
reasonable basis for our findings and conclusions based on our audit
objectives.
In summary, multiple federal programs and states collect data on HAIs
in hospitals, but none of the data sources we identified provide a
national estimate of the number of all HAIs in hospitals associated
with medical devices. At the federal level, three HHS agencies, AHRQ,
CDC, and CMS, specifically collect or have collected HAI-related data
in databases maintained by separate programs, such as CDC's National
Healthcare Safety Network (NHSN) program and CMS's Medicare Patient
Safety Monitoring System (MPSMS). However, limitations in the scope and
collection methods for these databases preclude them from developing a
national estimate of HAIs in hospitals associated with medical devices.
For example, CDC's NHSN data are not drawn from a representative sample
of hospitals nationwide. Similarly, the infection rates included in the
MPSMS are based on the experiences of a representative sample of
Medicare fee-for-service beneficiaries and are not representative of
the experiences of other Medicare or non-Medicare patients. Also,
because the HAI-related information in two of these federal databases
is gleaned from patient discharge and other medical records, the
quality of the data is dependent on the accuracy with which the
information was documented. Finally, although a Consumers Union summary
report indicates that nearly half of the states mandate public
reporting of hospital HAI rates, a number of factors limit the
generalizability and usefulness of the state-reported rates.
Improper patient examination and treatment practices by health care
professionals, such as the improper insertion of urinary catheters, are
the most significant factor affecting the occurrence of HAIs in
hospitals associated with medical devices, according to most medical
experts we interviewed. Certain in-hospital sterilization techniques
and improper handling of sterilized medical devices were also commonly
identified as significant causes of such infections, as was the
inherent risk of using medical devices, which can introduce bacteria
into the body. Our review of medical literature corroborated many of
the risk factors cited by the experts and identified additional
factors. For example, patient characteristics such as old age,
diabetes, or compromised immune systems were frequently cited in the
literature as risk factors. In terms of preventing HAIs, improved
hygiene, such as appropriate hand-washing, and the use of barrier
precautions, such as caps and gloves, were commonly identified
strategies.
In commenting on a draft of this report, HHS suggested that the report
would be enhanced by providing a more detailed discussion of HAIs
caused by reusable medical devices but acknowledged the difficulties in
doing so. HHS also provided technical comments, which we incorporated
as appropriate. HHS's comments are reprinted in the enclosure.
Background:
Within HHS, three agencies currently collect or have collected data on
HAIs in hospitals associated with medical devices in databases
maintained by separate programs: AHRQ's Healthcare Cost and Utilization
Project (HCUP), CDC's NHSN, and CMS's MPSMS.[Footnote 6] In addition,
FDA's Manufacturer and User Facility Device Experience Database (MAUDE)
collects reports of deaths or serious injuries related to the use of
medical devices, a small number of which may involve HAIs. In addition
to the data collection efforts of these federal agencies, nearly half
of the states require public reporting of HAI rates.
Among the federal agencies, CDC's NHSN collects information from
hospitals that voluntarily report data on five HAIs associated with
medical devices: central-line-associated bloodstream infections
(CLABSI), ventilator-associated pneumonia (VAP), catheter-related UTIs,
SSIs, and postprocedure pneumonia.[Footnote 7] In its 2006 annual
report, NHSN calculated national rates for three of these HAIs--CLABSI,
VAP, and catheter-related UTI--and reported the rates by hospital unit,
including various types of intensive care units (e.g., burn, surgical,
medical).[Footnote 8] For example, NHSN reported a rate of 2.9 CLABSIs
per 1,000 central line days in medical intensive care units.[Footnote
9] CMS's MPSMS includes information on the rates of HAIs in hospitals
associated with three medical devices, including catheter-related UTIs,
catheter-related bloodstream infections, and VAP. To calculate these
rates, a CMS contractor extracted information from the medical records
of a representative sample of certain fee-for-service Medicare
beneficiaries. AHRQ's HCUP database collects discharge data from all
the community hospitals in 39 participating states. The states
voluntarily report these data, which include information on the number
of infections associated with certain medical devices, including CLABSI
and catheter-associated UTI.[Footnote 10] Collected data are
categorized either as the principal condition or complication a patient
had during his or her hospitalization or as one of several conditions
or complications. Finally, FDA's MAUDE includes reported incidents of
serious injuries and deaths that medical devices have or may have
caused or contributed to, which manufacturers, importers, and user
facilities are required to report to FDA.[Footnote 11] MAUDE also
includes reports of adverse events voluntarily submitted to
FDA.[Footnote 12]
Available Federal and State Data Do Not Provide a National Estimate of
HAIs in Hospitals Associated with Medical Devices:
Although multiple federal agencies and states collect data on HAIs in
hospitals, limitations in the scope of the information they collect in
their databases or their collection methods have precluded the
development of national estimates of all HAIs in hospitals associated
with medical devices. Among the federal data sources, CDC's NHSN
database provides the most clinically detailed information about HAIs
in hospitals, and its procedures for identifying patients with these
HAIs draw on the wider range of clinical information available while
patients are still in the hospital, as opposed to retrospective reviews
of patient medical records after discharge. However, the utility of its
data in developing a nationwide estimate has been limited for at least
two reasons, specifically its limited scope and its use of a
nonrepresentative sample. For example, the NHSN does not collect
information on all HAIs in hospitals associated with medical devices;
however, in its 2006 annual report, it calculated national rates by
hospital unit for three such HAIs--CLABSI, VAP, and catheter-related
UTI.[Footnote 13] In addition, the sample of hospitals used in the 2006
annual report was not necessarily representative of hospitals
nationwide, as a random sample would be. The sample included 211
hospitals, which voluntarily submitted data to NHSN. Further, hospitals
that reported to NHSN may vary in the scope of their data collection
efforts. For example, hospitals can collect data on different
infections and monitor HAIs in different units within their
hospitals.[Footnote 14],[Footnote 15]
In addition, limitations in the scope and collection methods for CMS's
MPSMS and AHRQ's HCUP databases have precluded the use of their data in
developing a national estimate of HAIs in hospitals associated with
medical devices. For example, in 2006 MPSMS reported rates of infection
for three HAIs in hospitals: 5.35 percent of reviewed medical charts
showed evidence of catheter-related UTIs, 2.80 percent showed evidence
of catheter-related bloodstream infections, and 9.02 percent showed
evidence of VAP infections. However, these rates were based on the
experiences of a representative sample of Medicare fee-for-service
beneficiaries and did not include other Medicare or non-Medicare
patients. Further, because MPSMS data were extracted from medical
records, the quality of the data depended on the accuracy with which
the patient information was documented, according to a CMS official.
Similarly, AHRQ's HCUP database relies on patient discharge records to
collect information on the number of HAIs in hospitals associated with
certain medical devices, including CLABSI and UTI. For example, data
from 2006 showed an estimated 45,879 instances of catheter-associated
UTI as one of several complications or conditions patients experienced
and an estimated 21,123 instances as the principal complication or
reason for admission. However, differences in how hospital staff assign
discharge codes may result in inconsistent reporting of HAIs. Further,
prior to 2008, the HCUP database did not include information about
whether an infection was present on admission. As a result, the number
of HAIs in the hospital could have been overstated in previous years as
it may have included patients who were infected prior to their hospital
stay, according to an AHRQ official. Finally, although a small portion
of the incidents reported to FDA's MAUDE database may involve HAIs in
hospitals, the principal purpose of the database is to identify devices
whose safety and effectiveness warrant closer scrutiny and not to
determine the frequency of HAIs in hospitals.
Over 20 states mandate public reporting of hospital HAI rates,
according to Consumers Union, and variation exists in the types of data
they require hospitals to report.[Footnote 16] For example, Missouri
requires hospitals to report data on CLABSI, SSI, and VAP, while as of
July 2008, Washington requires hospitals to collect data only on
CLABSI. Because of the variation among state reporting requirements,
data from individual states cannot be generalized, thereby limiting the
usefulness of state data in determining a national estimate of HAIs in
hospitals associated with medical devices.
Patient Examination and Treatment Practices Cited as the Most
Significant Factor Affecting the Occurrence of HAIs in Hospitals:
The most significant factor affecting the occurrence of multiple types
of HAIs in hospitals from among possible causes listed in the mandate
is health care professionals' improper patient examination and
treatment practices, according to the experts we interviewed. All 11
experts we interviewed identified health care professionals' improper
patient examination and treatment practices as a factor, with 7 of the
11 medical experts identifying it as one of the most significant
factors affecting the occurrence of HAIs in hospitals associated with
medical devices. As a specific example of such practices, experts cited
the improper insertion and maintenance of medical devices such as
urinary catheters and central lines. In addition, about half of the
medical experts identified certain in-hospital sterilization processes
and improper handling of sterilized devices as potential causes of such
infections. Specifically, the experts cited the inadequate preparation
of a device for sterilization and the improper storage of sterile
devices, which may result in their contamination, as examples of
potential causes. Although the use of reprocessed single-use devices is
on the list of potential causes included in the mandate, none of the
experts we interviewed cited the use of reprocessed single-use devices
as a factor contributing to HAIs in hospitals[Footnote 17]. Beyond the
list of potential causes included in the mandate, the medical experts
we interviewed referred to other risk factors for developing HAIs in
hospitals. For example, 8 of the 11 experts identified the intrinsic
risk of using medical devices, including the inability to completely
disinfect the area where a device is inserted, as a factor affecting
the occurrence of HAIs in hospitals.
Our literature review largely corroborated many of the risk factors
cited by the experts and identified additional risk factors. For
example, similar to the examples cited above, a number of articles
identified health care professionals' improper patient examination and
treatment practices and handling of sterilized medical devices as
causes of HAIs in hospitals. In addition, half of the articles we
reviewed referred to the inherent risk of using medical devices, which
can introduce bacteria into the body. The increased risk of infection
based on patient characteristics such as old age, diabetes, or
compromised immune systems was also cited in more than one-third of the
reviewed articles. Other risk factors cited in articles were specific
to certain HAIs in hospitals. For example, risk factors specific to
CLABSI included the design of the device, such as the materials a
catheter is made from and the location on a patient's body where a
catheter is inserted, and risk factors specific to VAP included the
prolonged duration of mechanical ventilation.
The medical experts and literature highlighted a variety of strategies
to prevent the occurrence of HAIs in hospitals associated with the use
of medical devices. Three specific prevention strategies--barrier
precautions, such as caps, gowns, and gloves; general hygiene measures,
such as appropriate hand washing technique; and the use of
antimicrobial-coated or antimicrobial-impregnated devices--were the
strategies most frequently identified through our expert interviews and
our literature review. Other strategies, such as the use of
disinfectants, particularly chlorhexidine gluconate, and reducing
unnecessary use of medical devices, were also often identified.
Finally, bundling prevention strategies, a practice whereby a number of
prevention strategies are implemented together, was identified as an
additional strategy to prevent the occurrence of HAIs in hospitals. For
example, some of the bundled prevention strategies for VAP cited in the
literature included elements related to bed elevation and oral hygiene.
Although a number of effective prevention strategies exist, the need
for evidence-based research on effective prevention techniques for HAIs
in hospitals associated with medical devices was identified by several
medical experts and studies. In addition, to help reduce HAIs in
hospitals, we previously recommended that HHS identify priorities among
effective evidence-based practices for infection control and
prevention.[Footnote 18]
Agency Comments and Our Evaluation:
In its written comments, HHS stated that the report correctly points
out the extent of surveillance conducted for single-use, disposable
devices, such as urinary catheters. HHS also said a limitation is that
the report combines single-use devices and reusable devices and that
the report would be improved by clarifying the distinction between
these types of devices. HHS further suggested that the report would be
enhanced by including a more detailed discussion of HAIs caused by
reusable medical devices. However, HHS acknowledged, and we agree, that
very little is known about infections caused by reusable devices.
Therefore, it was not feasible to discuss reusable devices separately
because no data sources focused on or explicitly included these
devices. Nevertheless, HHS's point is important in that it highlights
another area in which knowledge is lacking about medical devices and
HAIs.
HHS also provided technical comments, which we incorporated as
appropriate. HHS's comments are reprinted in the enclosure.
- - - --:
We are sending copies of this report to the Secretary of Health and
Human Services. We will also make copies available to others on
request. In addition, the report will be available at no charge on
GAO's Web site at [hyperlink, http://www.gao.gov].
If you or your staffs have any questions about this report, please
contact me at (202) 512-7114 or bascettac@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this report. Key contributors to this report were
Susan Anthony, Assistant Director; Lisa Motley; Roseanne Price; Sari B.
Shuman; and Stephen Ulrich.
Signed by:
Cynthia A. Bascetta:
Director, Health Care:
[End of section]
Enclosure: Comments from the Department of Health and Human Services:
Department Of Health & Human Services Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
Cynthia Bascetta:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street N.W.:
Washington, DC 20548:
Dear Ms. Bascetta:
Enclosed are comments on the U.S. Government Accountability Office's
(GAO) report entitled: "Health-Care-Associated Infections in Hospitals:
Number Associated with Medical Devices Unknown, but Experts Report
Provider Practices as a Significant Factor" (GAO 08-1091R).
The Department appreciates the opportunity to review this report before
its publication.
Sincerely,
Signed by:
Vincent J. Ventimiglia, Jr.:
Assistant Secretary for Legislation:
Attachment:
Comments Of The Department Of Health And Human Services (HHS) On The
U.S. Government Accountability Office's (GAO) Draft Report Entitled:
Health-Care-Associated Infections In Hospitals" (GAO-08-1091R)
General Comments:
Thank you for the opportunity to review and comment on the GAO report,
Health-Care- Associated Infections in Hospitals: Number Associated with
Medical Devices Unknown, but Experts Report Provider Practices as a
Significant Factor (GAO-08-1091R).
Single Use Versus Reusable Devises A limitation of this report is that
it combines, and hence equates, two very different types of medical
devices. The report focuses on infections due to urinary catheters,
vascular catheters and ventilators, and is correct in pointing out that
there is quite a bit of surveillance conducted for these types of
infections. However, the report does not point out that these devices
are exclusively single use, disposable devices (in the case of the
ventilator, the portions that contact the patient are single use and
disposed or between patients) that are left in patients for prolonged
periods of time. These devices are very different from other devices
such as colonoscopes and surgical instruments that are used for time
limited procedures (i.e. they are not left in patients for long periods
of time), re- used on multiple patients and are cleaned and disinfected
between uses.
We believe the report would be improved by providing more clarity on
the different types of devices and discussing each type separately. In
addition, the top paragraph on page 2 makes a distinction between "new
and used medical devices." We suggest considering instead explaining
the difference between disposable, single use devices and reusable
devices.
Identification of Infections from Reusable Devices:
Much is known about both the numbers of, and risk factors for,
infections associated with the disposable devices and we would agree
that there are surveillance systems in place that do provide some
estimates about how often these occur. However, very little is known
about infections caused by the reusable devices. The report highlights
the availability of the FDA's MAUDE system, but points out various
limitations in the ability of this system to provide information on
healthcare associated infections. To these, we would add the important
fact that often times healthcare providers do not know when a
particular infection is associated with a device and thus would be
unable to report this information through a surveillance system.
Special investigative efforts are often needed to associate a HAI with
a particular reusable device. Public health officials at state and
federal levels have been involved in investigations of outbreaks of
healthcare associated infections of unknown etiology which turned out
to be caused by contaminated, reusable medical devices. These
infections were not reported as device-associated infections, because
the etiology was not known until after the investigation occurred.
Published investigations have shown that these types of infections can
be due not only to problems with the handling, cleaning and
disinfection of the devices, as is mentioned in the report, but also to
defects in the devices themselves.
We believe that the report would be enhanced by including a more
detailed discussion of the issues of infections caused by reusable
medical devices. It should be noted that investigations of these
infections have led to a variety of improvements, not just in the
handling, cleaning and disinfection devices in healthcare, but also in
device design. The investigation of these types of device-associated
infections remains an important part of improving the overall safety of
medical devices.
[End of section]
Footnotes:
[1] Consumers Union, "State Hospital Infection Disclosure Laws,"
available at [hyperlink,
http://www.stophospitalinfections.org/learn.html] (accessed July 30,
2008).
[2] Pub. L. No. 110-85, § 229, 121 Stat. 823, 858.
[3] The act uses the term nosocomial infections instead of HAIs.
However, for consistency with our previous work, we use the term HAIs
in hospitals. See GAO, Health-Care-Associated Infections in Hospitals:
Leadership Needed from HHS to Prioritize Prevention Practices and
Improve Data on These Infections, GAO-08-283 (Washington, D.C.: Mar.
31, 2008).
[4] Consumers Union, "State Hospital Infection Disclosure Laws,"
available at http://www.stophospitalinfections.org/learn.html (accessed
July 30, 2008).
[5] The Food and Drug Administration Amendments Act of 2007 included
the following possible causes: reprocessed single-use devices, handling
of sterilized medical devices, in-hospital sterilization of medical
devices, health care professionals' practices for patient examination
and treatment, hospital-based policies and procedures for infection
control and prevention, hospital-based practices for handling of
medical waste, and other causes.
[6] For additional information regarding these three databases and
their limitations, see GAO-08-283. According to a CMS official, data on
HAIs in hospitals associated with medical devices were collected from
2002 through 2007.
[7] Hospitals submit data to the NHSN database using a uniform set of
definitions.
[8] According to a CDC official, the agency will update these HAI rates
in NHSN's 2007 annual report, which the agency plans to publish at the
end of 2008, based on data submitted by 621 hospitals. The increased
participation is largely due to recent state mandates that require
hospitals to report HAI data to NHSN. For example, although hospitals
may continue to join NHSN voluntarily, 89 percent of the facilities
that joined NHSN in 2007 and 2008 were in states that required
participation through a mandate.
[9] Jonathan R. Edwards et al., "National Healthcare Safety Network
(NHSN) Report, Data Summary for 2006, issued June 2007," American
Journal of Infection Control, vol. 35, 290-301 (2007). The rate of 2.9
CLABSIs per 1,000 central line days was calculated by dividing the
aggregate number of reported instances of CLABSI (489) by the total
number of days central lines were used (170,719) for all hospitals
reporting such data, and multiplying this number by 1,000.
[10] HCUP encompasses a set of related databases, one of which is the
Nationwide Inpatient Sample (NIS). NIS contains data from 5 million to
8 million hospital stays from about 1,000 hospitals. According to an
AHRQ official, NIS approximates a 20-percent stratified sample of U.S.
community hospitals drawn from the participating states, which
represent 90 percent of hospital discharges across the United States.
[11] Manufacturers and importers are also required to report device
malfunctions to FDA.
[12] Medical device user facilities, manufacturers, importers, and
distributors must all maintain records of adverse events.
[13] Edwards et al., "National Healthcare Safety Network (NHSN) Report,
Data Summary for 2006, issued June 2007." NHSN reports national rates
for other HAIs, including SSI and postprocedure pneumonia. However, SSI
and postprocedure pneumonia rates were not calculated for the 2006
annual report due to insufficient data, but will be reported in NHSN's
2007 annual report, according to a CDC official.
[14] Despite these limitations, data from the National Nosocomial
Infections Surveillance System--the predecessor to NHSN--were used,
along with data from CDC's National Hospital Discharge Survey and the
American Hospital Association Survey, to calculate the 2002 nationwide
estimate of 1.7 million HAIs in hospitals. CDC officials estimated that
over half of these infections were associated with the use of certain
medical devices. CDC has no specific plans to update this number using
a comparable methodology; however, the agency is exploring the
feasibility of developing a national estimate of HAIs in the future
using an alternative methodology that has been successful in other
countries, according to a CDC official.
[15] Despite this flexibility, voluntary participation in NHSN involves
fulfilling a number of requirements, including submitting a monthly
reporting plan, adhering to the NHSN reporting protocol, and using NHSN
surveillance methods.
[16] Consumers Union, "State Hospital Infection Disclosure Laws,"
available at [hyperlink,
http://www.stophospitalinfections.org/learn.html] (accessed July 30,
2008).
[17] Further, one of our recent reports found that available data,
while limited, did not indicate that reprocessed single-use medical
devices present elevated health risks to patients. See Reprocessed
Single-Use Medical Devices: FDA Oversight Has Increased, and Available
Information Does Not Indicate That Use Presents an Elevated Health
Risk, GAO-08-147 (Washington, D.C.: Jan. 31, 2008).
[18] GAO-08-283, 41.
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