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entitled 'Health-Care-Associated Infections in Hospitals: Number 
Associated with Medical Devices Unknown, but Experts Report Provider 
Practices as a Significant Factor' which was released on September 26, 
2008. 

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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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