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162 Assurance of sterility for sensitive combination products and materials

6.6 Conclusion
The incidence of HAIs is strongly correlated with the activities in HCFs.
Terminally sterilized and aseptically processed single-use products have
proved effective at limiting this risk as a source of HAI. Although indus-
try still needs to continue to be diligent in its control, the main driver of
HAIs is the activities that occur in health-care facilities. Medical device
and pharmaceutical manufacturers have the luxury of being able to tightly
control incoming materials, environment, equipment, processes, and per-
sonnel manufacturing the product. This enables the processes to be highly
predictable and repeatable. In contrast, the processes occurring at the HCF
are inherently variable and often must be performed quickly. Each patient’s
microflora, health, and treatment is different. The treatment process as well
as the environment is inherently more difficult to control. The net result is
that risk to the patient is driven predominately by the more variable pro-
cesses in the hospital.
In this chapter, we discussed HAIs, what causes them, how medical de-
vices are implicated in them and steps that can be taken to prevent an HAI.
Transmission of HAIs is a very complex process that is difficult to control.
However, it is important that HCFs take all steps possible to minimize the
possibility of an infection to the patient, visitor, or HCW.

References
[1] Antibiotic Resistance Threats in the United States, Center for Disease Control and
Prevention, 2013. US Department of Health and Human Services.
[2] WHO, Health care-associated infections FACT SHEET, Downloaded May 14, 2016.
www.who.int/gpsc/country_work/gpsc_ccisc_fact_sheet_en.pdf.
[3] Centers for Disease Control and Prevention, Immediate Need for Healthcare Facili-
ties to review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical
Devices. Health Alert Network, issued September 11, 2015. Available online at http://
emergency.cdc.gov/han/han00382.asp.
[4] CDC/NHSN Surveillance Definition of Healthcare-Associated Infection and Criteria
for Specific Types of Infections in the Acute Care Setting, HAI Definitions, January
2013. https://www.cdph.ca.gov/programs/hai/Documents/Slide-Set-20-Infection-
Definitions-NHSN-2013.pdf.
[5] HAI Estimates Occurring in US Acute Care Hospitals, HAI data and statistics, CDC,
Centers for Disease Control and Prevention, 2011. Available at 222.cdc.gov/hai/sur-
veillance.
[6] Hospital Survey on Patient Safety Culture, User comparative database report, Agency
for Healthcare Research and Quality 2016 (2016). page 20.
[7] Background to Clean Care Is Safer Care. WHO. www.whco.int/gpsc/background/en/
Accessed 19 June 2016.
[8] Healthcare-associated Infections (HAI) Progress Report. CDC 2016. www.cdc.gov/
hai/sureillance/progress report/ Accessed May 14, 2016.