Page 168 - Assurance of Sterility for Sensitive Combination Products and Materials

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large proportion of preventable medical injuries and deaths throughout the
world. Adverse events have been estimated to affect 3%–16% of all hospital-
ized patients and more than half of such events are considered preventable
[15–18]. In addition over half of these events occur during surgery [19, 20].
SSI remains one of the most common causes of serious surgical compli-
cations. Due to poor systemization, proven measures, e.g., prophylactic use
of antibiotics, are used inconsistently. Improving surgical safety is a complex
problem that requires numerous steps to implement even basic procedures.
As a result of their findings in 2009, WHO created the Safe Surgery Saves
Lives campaign. The program consists of 10 essential objectives for safe sur-
gery. One of these objectives is the team that will consistently use methods
known to minimize the risk for SSI.

6.5.1.1 CDC SSI guideline 1999
In 1999, CDC first introduced its “Guideline for Surgical Site Infection
[21]” Part II of this guideline provided recommendations for the prevention
of SSI. This document represented the consensus opinion of the Hospital
Infection Control Practices Advisory committee (HICPAC). A new draft
guidance on the prevention of SSIs was submitted to the Federal Register
on January 29, 2014. Until the new guidance is approved the 1999 version
remains in effect. Since the guideline’s inception many improvements in
infection control practices have been made including: improved operating
room ventilation, more effective sterilization methods, increased barriers,
better surgical techniques, and increased availability of antimicrobials. Even
with these advances SSI remains a significant cause of patient morbidity and
mortality, frequently resulting in prolonged hospitalization. SSIs are among
the most common HAI accounting for 31% of all HAIs [22]. Approximately
3% of SSIs result in mortality and 75% of SSI-associated deaths are directly
attributable to the SSI [23].

6.5.2 Behavior
There are several infection control practices that directly involve the be-
havior of the people who perform these tasks. Health-care workers must
pay close attention to how they perform the following tasks: hand hygiene,
isolation precautions, surgical hand scrub, wearing of personal protective
attire, and aseptic technique.

6.5.2.1 Isolation precautions
Isolation precautions are used to help stop the spread of germs from one
person to another. The goal is to protect patients, their families, visitors, and