33168 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices

†Currently, for minimally invasive and

laparoscopic procedures no differences in infection

control practices (preoperative, intraoperative, or

postoperative) have been identified.

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Draft Guideline for the Prevention of

Surgical Site Infection, 1998

AGENCY: Centers for Disease Control and

Prevention (CDC), Department of Health

and Human Services (DHHS).

ACTION: Notice.

SUMMARY: This notice is a request for

review of and comment on the Draft

Guideline for the Prevention of Surgical

Site Infection, 1998. The guideline

consists of two parts: Part 1. ‘‘Surgical

Site Infection, an Overview’’ and Part 2.

‘‘Recommendations for the Prevention

of Surgical Site Infections’’, and was

prepared by the Hospital Infection

Control Practices Advisory Committee

(HICPAC), the Hospital Infection

Program (HIP), the National Center for

Infectious Diseases (NCID), CDC.

DATES: Written comments on the draft

document must be received on or before

August 17, 1998.

ADDRESSES: Comments on this

document should be submitted in

writing to the CDC, Attention: SSI

Guideline Information Center, Mailstop

E–69, 1600 Clifton Road, N.E., Atlanta,

Georgia 30333. To order copies of the

Federal Register containing the

document, contact the U.S. Government

Printing Office, Order and Information

Desk, Washington, DC 20402–9329,

telephone (202) 512–1800. In addition,

the Federal Register containing this

draft document may be viewed and

photocopied at most libraries designated

as U.S. Government Depository

Libraries and at many other public and

academic libraries that receive the

Federal Register throughout the

country. Addresses and telephone

numbers of the U.S. Government

Depository Libraries are available by fax

by calling U.S. Fax Watch at (202) 512–

1716 and selecting option 5 from the

main menu. The Federal Register is also

available online at the Superintendent

of Documents home page at: http://

www.access.gpo.gov/suldocs, or the

Hospital Infection Program Home page

at: http://www.cdc.gov/ncidod/hip/

hip.htm

FOR FURTHER INFORMATION CONTACT: The

CDC Fax Information Center, telephone

(888) 232–3299 and order document

number 370160 or telephone (888) 232–

3228, then press 2, 2, 3, 2, 2, 1, 5 to go

directly to the guideline information.

SUPPLEMENTARY INFORMATION: This 2-

part document updates and replaces the

previously published CDC Guideline for

the Prevention of Surgical Wound

Infection. Part 1, ‘‘Surgical Site

Infection, an Overview’’ serves as the

background for the consensus

recommendations of the Hospital

Infection Control Practices Advisory

Committee (HICPAC) that are contained

in Part 2, ‘‘Recommendations for

Prevention of Surgical Site Infections’’.

HICPAC was established in 1991 to

provide advice and guidance to the

Secretary and the Assistant Secretary for

Health, DHHS; the Director, CDC, and

the Director, NCID regarding the

practice of hospital infection control

and strategies for surveillance,

prevention, and control of nosocomial

infections in U.S. hospitals. The

committee also advises CDC on periodic

updating of guidelines and other policy

statements regarding prevention of

nosocomial infections.

The Guideline for the Prevention of

Surgical Site Infection, 1998 is the third

in a series of CDC guidelines being

revised by HICPAC and NCID, CDC.

Dated: June 5, 1998.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

Executive Summary

This ‘‘Guideline for the Prevention of

Surgical Site Infection, 1998’’ represents

the third revision of the Centers for

Disease Control and Prevention’s (CDC)

recommendations for the prevention of

surgical site infection (SSI), formerly

called surgical wound infections. This

two-part guideline updates and replaces

previous guidelines.1 2

Part I, ‘‘Surgical Site Infection: An

Overview,’’ describes the epidemiology,

definitions, microbiology, pathogenesis,

and surveillance of SSIs. Part I also

discusses SSI prevention measures such

as antimicrobial prophylaxis, barrier

precautions, operating room

environment, sterilization practices, and

surgical technique.

Recommended strategies for the

prevention of SSIs are found in Part II,

‘‘Recommendations for the Prevention

of Surgical Site Infection.’’ These

recommendations represent the

consensus of the Hospital Infection

Control Practices Advisory Committee

(HICPAC). This 12-member committee

advises CDC on issues related to

surveillance, prevention, and control of

nosocomial infections in United States

hospitals.3 Whenever possible, the

recommendations in Part II are based on

data from well-designed scientific

studies. However, it must be kept in

mind that a limited number of studies

establish the validation of SSI risk

factors and SSI prevention measures. By

necessity, available studies have often

been conducted in narrowly defined

patient populations or for specific kinds

of operations, making generalization of

their findings to all specialties and types

of operations potentially problematic.

This is especially true regarding the

implementation of SSI prevention

measures. Finally, some of the infection

control practices routinely used by

surgical teams cannot be rigorously

studied for ethical or logistical reasons

(e.g., wearing vs. not wearing gloves or

masks). Thus, some of the

recommendations in Part II are based on

a strong theoretical rationale and

suggestive evidence in the absence of

confirmatory scientific knowledge.

This document does not specifically

address issues unique to burns, trauma,

transplant procedures, or transmission

of bloodborne pathogens from healthcare worker to patient. Neither does it

specifically cover minimally invasive †

(e.g., laparoscopic) procedures or

procedures performed by surgeons

outside of the operating room (e.g.,

endoscopic procedures). This document

does not cover invasive procedures not

performed by surgeons (e.g., cardiac

catheterization, or interventional

radiologic procedures). However, it is

likely that many of the prevention

strategies recommended in this

document could be applied or adapted

to prevent infections that complicate

these procedures. The document does

not recommend specific antiseptic

agents for patient preoperative skin

preparations or for health-care worker

hand/forearm antisepsis. Hospitals

should choose from the appropriate

products categorized by the Food and

Drug Administration (FDA).4 Finally,

this document is primarily intended for

use in acute-care hospitals by surgeons,

operating room nurses, infection control

professionals, anesthesiologists, hospital

epidemiologists, and other hospital

personnel responsible for the prevention

of nosocomial infections.

Part I. Surgical Site Infection (SSI): An

Overview

Introduction

Before the mid-19th century, surgical

patients commonly developed

postoperative ‘‘irritative fever,’’

followed by purulent drainage from

their incisions, overwhelming sepsis,

and often death. It was not until the late

1860s, after Joseph Lister had

introduced the principles of antisepsis,

that postoperative infectious morbidity
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices 33169

decreased substantially. Lister’s work

radically changed surgery from an

activity associated with infection and

death to a discipline that could

eliminate suffering and prolong life.

Currently, in the United States alone,

an estimated 27 million surgical

procedures are performed each year,

and nearly one-third of patients

undergoing these operations are ≥65

years of age.5 The CDC’s National

Nosocomial Infections Surveillance

(NNIS) system, established in 1970,

monitors reported trends in nosocomial

infections in U.S. acute-care hospitals.

Based on NNIS system reports, SSIs are

the second most frequently reported

nosocomial infection, accounting for

15% to 18% of all nosocomial infections

among hospitalized patients.6 During

1986–1996, hospitals conducting SSI

surveillance in the NNIS system

reported 15,523 SSIs following 593,344

operations. Among surgical patients,

SSIs were the most common nosocomial

infection, accounting for 38% of all

nosocomial infections. Of these SSIs,

67% were incisional and 33% organ/

space SSIs. Of the deaths among

surgical patients with an SSI, 77% were

related to the infection itself; the

majority (93%) were organ/space SSIs.

In 1980, Cruse showed that an SSI

increased a patient’s hospital stay by

about 10 days, and cost an additional

$2,000.7 8 1992 estimates suggested that

each SSI resulted in 7.3 additional

postoperative hospital days, adding

$3,152 in extra charges.9 Other studies

corroborate that increased length of

hospital stay and cost are associated

with SSIs.10 11 Deep (organ/space) SSIs,

as compared to superficial (incisional)

SSIs, are associated with an even greater

increase in hospital cost.12 13

In this document, SSIs refer to

infections of incisions that are closed

primarily (i.e., skin edges are reapproximated at the end of the

operation). SSIs are classified as

incisional SSIs or organ/space SSIs.

Incisional SSIs are further divided into

those involving only skin and

subcutaneous tissue (superficial

incisional SSI) and those involving

deeper soft tissues of the incision (deep

incisional SSI). Organ/space SSIs

involve any part of the anatomy (e.g.,

organs or spaces) other than incised

body wall layers opened or manipulated

during operations (Figure 1).

Standardized criteria have been

developed for defining superficial

incisional, deep incisional, and organ/

space SSIs are shown in Table 1. Table

2 lists specific sites used to differentiate

organ/space SSIs. For example, in a

patient who had an appendectomy and

subsequently developed a

subdiaphragmatic abscess, the infection

would be reported as an organ/space SSI

at the intra-abdominal specific site.

Failure to use objective criteria to define

SSIs has been shown to substantially

impact SSI rates.14 15 The CDC NNIS

definitions of SSIs have been applied

consistently by surveillance and

surgical personnel in many settings and

currently are a de facto national

standard.16 17

Advances in infection control

practices include improved operating

room ventilation, sterilization, barriers,

surgical technique, and availability of

antimicrobial prophylaxis. Despite these

activities, SSIs remain a substantial

cause of morbidity and mortality among

hospitalized patients. In part, this may

be explained by the fact that many

surgical patients today are of advanced

age and/or have a wide variety of

chronic, debilitating or

immunocompromising underlying

diseases. An increase in survival of lowbirth-weight infants (e.g., ≤1000 g) may

pose unique surgical challenges. There

also are increased numbers of implants

used and more organ transplants

performed. Other factors include

emergence of resistant pathogens,

increased numbers of contaminated and

dirty procedures (e.g., trauma-associated

gunshot wounds and motor vehicle

accidents). Thus, to reduce the risk of an

SSI, a systematic but realistic approach

must be applied with the awareness that

this risk is influenced by characteristics

of the hospital, surgical team, patient,

and operation.

Microbiology of SSIs

According to the NNIS system the

distribution of pathogens isolated from

SSIs has not changed markedly during

the last decade (Table 3).6 18 19

Staphylococcus aureus, coagulasenegative staphylococci, Enterococcus

spp., and Escherichia coli remain the

most frequently isolated pathogens.

However, SSIs are increasingly caused

by antimicrobial-resistant pathogens,

such as methicillin-resistant S. aureus

(MRSA), vancomycin-resistant

enterococcus, and gram negative

rods.20 21 In one 4-year study of 245

consecutive SSIs, 50% of all

staphylococcal isolates were MRSA,

11% were gentamicin-resistant E. coli,

and Klebsiella spp. demonstrated an

increased resistance to

aminoglycosides.22

The isolation of fungi from SSI,

particularly Candida albicans, also has

increased.23 From 1991–1995, among

patients at NNIS hospitals, the

incidence of fungal SSIs increased from

0.1 to 0.3 per 1000 discharges.23 The

increased proportion of SSIs caused by

resistant pathogens and Candida spp.

may reflect an increased severity of

illness of surgical patients, an increased

number of surgical patients who are

immunocompromised, and/or more

widespread use of prophylactic and

therapeutic antimicrobial agents.

Outbreaks or clusters of SSIs have

also been caused by unusual pathogens,

such as Rhizopus oryzae, Clostridium

perfringens, Rhodococcus bronchialis,

Legionella pneumophila and dumoffii,

and Pseudomonas multivorans. These

rare outbreaks have been traced to

contaminated adhesive dressings,24

elastic bandages,25 colonized health

care personnel,26 tap water,27 or

contaminated disinfection solution.28

When a cluster of SSIs is caused by an

unusual pathogen, a formal

epidemiologic investigation should be

conducted to determine the source of

infection.

Pathogenesis of SSI

Microbial contamination of the

surgical site is a necessary precursor of

SSI. The risk of SSI can be

conceptualized according to the

following relationship 29:

Dose of bacterial contamination

Resistance of the host rgical site infection × = virulence Risk of su

Quantitatively, it has been shown that

if a surgical site is contaminated with

>10 5 microorganisms per gram of tissue,

the risk of SSI is markedly increased,

whereas contamination with <10 5

microorganisms per gram of tissue

usually does not produce infection.30–32

The risk of SSI is increased when

foreign material, such as sutures,33

indwelling devices, or prostheses are

placed. For example, researchers have

shown that the insertion of foreign

material can decrease the infecting dose

of staphylococci from >10 6 to <10 3

microorganisms per gram of tissue.34–36

Organisms may contain or produce

substances or toxins that increase their

ability to invade a host, produce damage
33170 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices

within the host, or survive on or in

colonized or infected host tissue;

promoting the development of an

SSI.37–40 For example, endotoxin has

numerous effects as a component of the

outer membrane of gram negative

bacteria, such as a stimulator of

cytokine production, and as an initiator

of endogenous mediator pathways with

significant systemic effects (e.g.,

hypotension, fever).41 42 Some bacterial

surface components (notably

polysaccharide extracellular capsules)

inhibit phagocytosis.43 Some bacteria,

such as Clostridium spp., produce

powerful cytolytic exotoxins that

disrupt cell membranes or alter cellular

metabolism.32 44 Glycocalyx and the

more loosely associated component,

‘‘slime’’, are produced by a variety of

microorganisms, of particular

significance gram-positive bacteria, and

most notably coagulase negative

staphylococci.45–47 The glycocalyx

material slime develops into a biofilm

and can shield infecting bacteria from

phagocytosis, as well as inhibit the

action of antimicrobial agents.47

Glycocalyx biofilms have been

implicated as a significant contributor to

infection of surgically implanted

prostheses.47–52 Despite knowledge of

these and other virulence factors, in

most cases the mechanistic relationship

between their presence and SSI

development has not yet been fully

defined.

The primary reservoir for organisms

causing SSI is the patient’s endogenous

flora. Exogenous sources of SSI

pathogens include the operating room

environment, hospital personnel

(especially those in the operating

room),53–55 or seeding of the operative

site from a distant focus of

infection.56–60 Seeding from distant foci

is particularly important in patients

who have prostheses or other implants

placed during the operation since the

device provides a nidus for attachment

of the organism.61–66 The endogenous

flora causing SSIs vary according to the

specific body site.19 67–71 For example,

an SSI arising from the skin is

predominant due to gram-positive

organisms (e.g., staphylococci). SSIs

arising from the gastrointestinal system

are composed of a more mixed group of

organisms, including enteric, gramnegative bacilli (e.g., E. coli), anaerobes

(e.g., B. fragilis), and gram-positive

organisms (staphylococci and

enterococci). SSIs arising from the

genitourinary system are predominantly

due to gram-negative organisms (e.g., E.

coli, Klebsiella spp., and Pseudomonas),

and enterococci. The organisms causing

SSIs in the female reproductive system

include enteric, gram-negative bacilli;

enterococci; group B streptococci; and

anaerobes. Exogenous flora are

primarily gram-positive organisms (e.g.,

staphylococci and streptococci) and

other aerobes.19

Fungal pathogens rarely cause SSIs,

and their pathogenesis is not well

understood. Factors that increase the

risk of fungal infections in surgical

patients include (1) fungal colonization

of the upper gastrointestinal tract

following exposure to broad-spectrum

antimicrobials, (2) use of proton pump

inhibitors or histamine-2 blockers that

decrease stomach acidity and promote

growth of microorganisms, including

yeast, (3) disruption of the

gastrointestinal mucosal barrier, (4)

impaired host defenses,53 (5)

implantation of foreign bodies (e.g.,

prosthetic heart valves), and (6)

colonized operating room personnel

(e.g., fungal colonization of artificial

nails).72

Risk and Prevention of SSIs

The term ‘‘risk factor’’ has a particular

meaning in epidemiology and, in the

context of SSI pathophysiology and

prevention, strictly refers to a variable

that has a significant, independent

association with the development of

SSIs. Risk factors are identified by

multivariable analyses in epidemiologic

studies. Unfortunately, the term risk

factor often is used in the literature in

a broad sense to include patient or

operation features which, although

associated with SSI development, are

not themselves independent.73 The

literature cited in the sections that

follow includes both the strict and

broad definition of risk factor.

Recommendations given a category

ranking of IA are generally based on

studies using the strict definition.

SSI risk factors (Table 4) are valuable

in two ways: (1) they allow useful

stratification of operations, making

surveillance data more comprehensible,

and (2) preoperative knowledge of risk

factors may allow for targeted

prevention interventions. For example,

it is known that remote site infection is

an independent SSI risk factor in some

operations. If a patient has such an

infection, the surgical team may choose

to delay an elective operation until the

infection resolves.

An SSI prevention measure can be

defined as an action or set of actions

intentionally taken by caregivers to

reduce the risk of an SSI. Many such

techniques, to be described

subsequently, involve reducing the

opportunities for microbial

contamination of the patient’s tissues or

sterile surgical instruments. Other

techniques are adjunctive, such as using

antimicrobial prophylaxis or avoiding

unnecessary traumatic tissue dissection.

In general, SSI prevention measures

have been based on direct scientific

evidence, theoretical rationale, or

tradition. In the discussion that follows,

the foundation for each given

prevention measure will be described.

Optimum application of SSI prevention

measures requires that a variety of

patient and operation characteristics be

carefully considered.

In certain kinds of operations, patient

characteristics that may be associated

with an increased risk of an SSI include

coincident remote site infections (e.g.,

urinary tract, skin, or respiratory

tract),1 31 74–76 diabetes,77–80 cigarette

smoking,78 81–85 systemic steroid

use,77 80 86 obesity (> 20% ideal body

weight),78–80 87–90 extremes of age,85 91–95

and poor nutritional status.78 87 91 96–98

The contribution of diabetes to SSI

risk is controversial 77–79 91 99 because the

independent contribution of diabetes to

SSI risk has not typically been assessed

after controlling for potential

confounding factors. In one prospective

study of 130 pregnant women, no

correlation was found between SSI risk

and perioperative glycemic control, as

measured by glycosylated hemoglobin

(HgA1c) levels. However, the sample

size in the study was small and the use

of prophylactic antimicrobial agents was

not assessed. More recently, the

relationship between HgA1c levels and

SSI risk in coronary artery bypass graft

patients was assessed; a significant

relationship was found between

increasing levels of HbA1c and SSI

rates.100 Also, increased glucose levels

(>200 mg/dl) in the immediate

postoperative period (≤48 hours) were

associated with increased SSI risk.101 102

More studies are needed to assess the

efficacy of perioperative blood glucose

control as an adjunctive measure.

Nicotine use delays primary wound

healing and may increase the risk of

SSI.78 In a large prospective study,

current cigarette smoking was an

independent risk factor for sternal and/

or mediastinal SSI following cardiac

surgery.78 Other studies have

corroborated cigarette smoking as an

important SSI risk factor.81–85 The

limitation of these studies, however, is

that terms like ‘‘current cigarette

smoking’’ and ‘‘active smokers’’ are not

always accurately defined. To

appropriately determine the

contribution of tobacco use to SSI risk,

standardized definitions of smoking

history must be adopted and used in

studies designed to control for

confounding variables.
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices 33171

Patients who are receiving steroids or

other immunosuppressive drugs

preoperatively also may be predisposed

to developing SSI.77 80 In a study of

long-term steroid use in patients with

Crohn’s disease, SSI developed

significantly more often in patients

receiving preoperative steroids (12.5%)

than in patients without steroid use

(6.7%).86 In contrast, other investigators

have not found a relationship between

steroid use and SSI risk.103–105

There may be an increased risk of SSI

in patients who are malnourished, but

the exact relationship between

nutritional status and risk of SSI is

unclear. Low serum albumin (<3.5 g/dl)

has been shown to be associated with an

increased risk of SSI.78 96–98 More

precise definitions of malnutrition are

needed, along with prospective

observational studies, to resolve this

issue.

Prolonged preoperative hospital stay

is frequently suggested as a patient

characteristic associated with increased

SSI risk. However, length of

preoperative stay is likely a surrogate for

severity of illness and co-morbid

conditions requiring inpatient work-up

and /or therapy before the

operation.8 18 19 75 93 104 106 107

Preoperative Issues

Preoperative Antiseptic Showers

A preoperative antiseptic shower or

bath will decrease the patient’s skin

microbial colony count. In a study of

>700 patients who received

preoperative antiseptic showers,

chlorhexidine reduced bacterial colony

counts nine-fold (2.8 × 102 to 0.3), while

povidone-iodine or triclocarbanmedicated soap reduced colony counts

by 1.3 and 1.9-fold, respectively.108 A

smaller uncontrolled study corroborated

these findings.109 Despite the fact that

preoperative showers reduce the skin’s

microbial colony counts, it has not

definitively been shown to reduce SSI

rates.110–112

Preoperative Shaving/Hair Removal

Preoperative shaving of the surgical

site the night before an operation is

associated with a significantly higher

SSI risk. This risk is greater than that

accompanying the use of depilatory

agents or no hair removal.8 113–115 In one

study, SSI rates were 5.6% in patients

who had hair removed by razor-shave

compared to a 0.6% rate among those

who had hair removed by depilatory or

had no hair removal.113 The increased

SSI risk associated with shaving has

been attributed to microscopic cuts in

the skin that later serve as foci for

infection. Shaving immediately before

the operation compared to shaving

within 24 hours or > 24 hours

preoperatively is associated with

decreased SSI rates (3.1% vs. 7.1% and

20% respectively).113 Clipping hair

immediately before an operation is also

associated with a lower risk of SSI than

shaving or clipping the night before an

operation (SSI rates immediately before

= 1.8% vs night before = 4.0%).116–119

Although the use of depilatories is

associated with a lower SSI risk than

shaving or clipping,113 114 depilatories

sometimes produce hypersensitivity

reactions.113 Other studies show that

preoperative hair removal is associated

with increased SSI rates and suggest

that no hair be removed.93 120 121

Patient Skin Preparation in the

Operating Room

Several antiseptic agents are available

for preoperative preparation of skin at

the incision site (Table 5). The

iodophors (e.g., povidone-iodine),

alcohol-containing products, and

chlorhexidine gluconate are the most

commonly used agents.18 31 122 No

studies have adequately assessed the

comparative effects of these

preoperative skin antiseptics on SSI risk

in well-controlled procedure-specific

studies.

Alcohol is defined by the Food and

Drug Administration as having one of

the following active ingredients: ethyl

alcohol 60–95% by volume in an

aqueous solution, or isopropyl alcohol

503–91.3% by volume in an aqueous

solution.4 In this document, -propyl

alcohol is included in the definition of

alcohol. Alcohol is readily available,

inexpensive, and remains the most

effective and rapid acting skin

antiseptic.123 Aqueous 70%–92%

alcohol solutions have germicidal

activity against bacteria, fungi, and

viruses, but spores can be

resistant.123 124 One potential

disadvantage of the use of alcohol in the

operating room is its flammability.123–125

Both chlorhexidine gluconate and

iodophors have broad spectra of

antimicrobial activity.18 31 124 126 In some

comparisons of the two antiseptics,

chlorhexidine gluconate achieved

greater reduction in skin microflora than

did povidone-iodine and also had

greater residual activity after a single

application.127–129 Further,

chlorhexidine gluconate is not

inactivated by blood or serum

proteins.18 123 130 131 Iodophors may be

inactivated by blood or serum proteins,

but exert a bacteriostatic effect as long

as they are present on the skin.18 125

Before the skin preparation of a

patient is initiated, the skin should be

free of gross contamination (i.e., dirt,

soil, or any other debris).132 The patients

skin is prepped by applying an

antiseptic preparation in concentric

circles, beginning in the area of the

proposed incision. The prepped area

should be large enough to extend the

incision or create new incisions or drain

sites, if necessary.1 124 133 The

application of the skin preparation may

need to be modified, depending on the

condition of the skin (e.g., burns) or

location of the incision site (e.g., face).

Some modifications of the

preoperative skin preparation process

include: (1) removing, drying, or wiping

off the skin prep antiseptic agent after

application, (2) using an antisepticimpregnated adhesive drape, (3)

painting the skin with an antiseptic in

lieu of the traditional scrub, or (4) using

a ‘‘clean’’ versus a ‘‘sterile’’ surgical skin

prep kit. None of these modifications

adds to further reductions in bacterial

colony counts at the surgical site or

reduces SSI risk.134 ¥137

Preoperative Hand/Forearm Antisepsis

Members of the surgical team

universally wash their hands and

forearms by performing a traditional

procedure known as scrubbing (or the

surgical scrub) immediately before

donning sterile gowns and gloves.

Ideally, the optimum antiseptic agent

should have a broad spectrum of

activity, be fast-acting, and have a

persistent effect.1 138 139 Antiseptic

agents commercially available in the

United States contain alcohol,

chlorhexidine, iodine/iodophors, parachloro-meta-xylenol, or triclosan (Table

5).18 123 124 140 141 Alcohol is considered

the ‘‘gold standard’’ for surgical hand

preparation in several European

countries.142–145 Alcohol-containing

preps have been used less frequently in

the United States than in Europe,

possibly because of concerns about

flammability and skin irritation.

Povidone-iodine and chlorhexidine

gluconate are the current agents of

choice for most U.S. surgical team

members.124 However, when 7.5%

povidone-iodine or 4% chlorhexidine

gluconate was compared to alcoholic

chlorhexidine (60% isopropanol and

0.5% chlorhexidine gluconate in 70%

isopropanol), alcoholic chlorhexidine

was found to have greater residual

antimicrobial activity.138 146 No agent is

ideal for every situation, and a major

factor aside from the efficacy of any

product is its acceptability by operating

room personnel after repeated usage.

Unfortunately, most studies evaluating

surgical scrub antiseptics have focused

on measuring hand bacterial colony

counts. No clinical trials have evaluated
33172 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices

the impact of scrub agent choice on SSI

risk.141 147–151

Factors other than the choice of

antiseptic agent influence the

effectiveness of the surgical scrub.

Scrubbing technique, the duration of the

scrub, the condition of the hands, or the

techniques used for drying and gloving

are examples of such factors. The ideal

duration of scrubbing is unknown.

Recent studies suggest that scrub times

of 3–5 minutes are as effective as the

traditional 10-minute scrub in reducing

hand bacterial colony counts.152 153

A surgical team member who wears

artificial nails may have increased hand

bacterial and fungal colonization even

after performing an adequate hand

scrub.154 155 Hand carriage of gramnegative organisms has been shown to

be greater among wearers of artificial

nails than among non-wearers.155 An

outbreak of Serratia marcescens SSIs in

cardiovascular surgery patients was

found to be associated with a surgical

nurse who wore artificial nails.72 Long

nails, artificial or natural, may be

associated with tears in gloves.31 124 154

The influence on SSI risk of operating

room team members wearing nail polish

or jewelry has not been adequately

studied.140 154 156–158

Antimicrobial Prophylaxis

Well-designed, randomized clinical

trials have demonstrated the benefit of

antimicrobial prophylaxis in certain

kinds of operations.12 70 159–195

Prophylaxis should not be confused

with therapy. Prophylaxis is the

administration of an antimicrobial agent

for operations where minimal microbial

contamination of the surgical site is

expected (i.e., clean or cleancontaminated operations, Table 6).47

Therapy is the administration of an

antimicrobial agent in operations where

substantial microbial contamination

already has occurred (i.e., contaminated

or dirty operations).47 196 197 For

prophylaxis to be maximally effective,

an appropriate agent must be

administered at the correct time to

ensure microbiocidal tissue levels

before the incision is made, be

maintained at adequate levels for the

duration of the operation, and not be

continued postoperatively.69–71 198–200

There is no evidence that antimicrobial

agents given after incision closure have

prophylactic effect on bacterial

contamination acquired before incision

closure.47 Also, use of antimicrobial

prophylaxis beyond the intraoperative

period may increase the risk of toxicity

and the development of antimicrobialresistant organisms.47 71 201

Antimicrobial prophylaxis is reserved

for clean and clean-contaminated

operations. The purpose of

antimicrobial prophylaxis in clean

operations in which prostheses, grafts,

or implants are placed in the patient is

to prevent the attachment of organisms

to the device since the device can serve

as a nidus for infection.47 69 197 202 203 In

clean operations in which no implant or

device is placed, there is controversy

regarding the use of antimicrobial

prophylaxis. Because the risk of

developing an SSI following clean

operations is generally low,87 the risk of

infection versus the risk of prophylaxis

must be considered. The purpose of

using antimicrobial prophylaxis in

clean-contaminated operations is

primarily to reduce the number of

mucosal-associated organisms.71 202

A prophylactic antimicrobial agent

should be chosen based on its efficacy

against the SSI pathogens expected as

contaminants for a particular operation.

Table 6 lists clean and cleancontaminated operations and the most

frequently isolated SSI pathogens. The

most commonly used agents are

cephalosporins, particularly first and

second generation cephalosporins.202

Vancomycin should not be used

routinely as a prophylactic

agent 69 70 197 204 However, at

institutions with high numbers of

infections due to (MRSA) or methicillinresistant Staphylococcus epidermidis,

vancomycin has been recommended as

a prophylactic agent in major operations

involving implantation of prosthetic

materials or devices (e.g., cardiac,

vascular and orthopedic

operations).69 204 205

Intravenous administration of the

prophylactic antimicrobial agent is the

most commonly used route. The

intravenous route produces adequate

serum and tissue concentrations in a

relatively short period of time.202 A

major exception to using the

intravenous route is with operations

involving the gastrointestinal tract,

mainly colorectal

operations.71 181 182 184 202 206¥213 In these

operations, the antimicrobial agent is

administered orally to reduce

endogenous flora in the gastrointestinal

tract .

Timing and duration of prophylaxis

are very important issues. The objective

is to administer the antimicrobial agent

before the operation starts to assure

adequate microbiocidal tissue levels

before the skin incision is made. A

large, prospective study of antimicrobial

prophylaxis in surgical patients

undergoing elective clean and cleancontaminated operations showed that

when prophylaxis was given 0–2 hours

before incision, the SSI rate was 0.59%

(10/1708). If given earlier or later, the

SSI rate increased (3.8 % [14/369] and

3.3% [16/488], respectively).214 For a

cesarean section, the prophylactic agent

is given immediately after umbilical

cord clamping to prevent the infant

from being exposed to the agent.69 70

In modern surgical practice, the

optimum strategy for most commonly

used agents (first and second generation

cephalosporins) entails infusion of the

preoperative dose approximately 30

minutes before skin incision and

administration of additional doses

approximately every 2 hours

intraoperatively.18 69 71 197 202 203

Because an elective operation can be

unexpectedly delayed, the practice of

administering prophylactic agents ‘‘on

call’’ to the operating room is not

recommended.70 215 Appropriate timing

of prophylaxis may be enhanced by

administering the agent as close as

possible to the time of anesthetic

induction. In general, the duration of an

operation will dictate the necessity

infusing one or more additional doses of

the prophylactic agent to maintain

appropriate tissue levels (i.e., for

operations whose duration exceeds the

estimated serum half-life). Other reasons

for additional intraoperative dosing

include operations with major

intraoperative blood loss or operations

on morbidly obese

patients.47 69 71 201 203 216¥218

Intraoperative Issues

Operating Room Environment

Air/Ventilation

Operating room air may contain

microbial-laden dust, lint, skin

squames, or respiratory droplets. The

microbial level in operating room air is

directly proportional to the number of

people moving about in the room.219

Therefore, efforts should be made to

minimize personnel traffic during

operations. Outbreaks of SSIs caused by

group A beta-hemolytic streptococci

have been traced to airborne

transmission of the organism from

colonized operating room personnel to

patients.220¥223 In these outbreaks, the

strain causing the outbreak was

recovered from the air in the operating

room,220 221 224 or on settle plates in a

room in which the human carrier

exercised.221¥223

Operating rooms should be

maintained at positive pressure with

respect to corridors and adjacent

areas.225 Positive pressure prevents air

flow from less clean areas into clean

areas. All ventilation or air conditioning

systems in hospitals, including those in

operating rooms, should have two filter

beds in series with the efficiency of

filter bed one ‘‘30% and filter bed two
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices 33173

†† According to the FDA, an implantable device

is a ‘‘device that is placed into a surgically or

naturally formed cavity of the human body if it is

intended to remain there for a period of 30 days or

more’’.245

2’’ 90%.226 Conventional operating

room ventilation systems produce a

minimum of about 15 air changes of

filtered air per hour. Three (20%) of

these air changes/hour must be fresh

air.226 227 Air should be introduced at

the ceiling and exhausted near the

floor.227 228 Recommended ventilation

parameters for operating rooms have

been published by the American

Institute of Architects, and the U.S.

Department of Health and Human

Service (Table 7).226

Laminar air flow is designed to move

particle-free air (called ‘‘ultraclean air’’)

over the aseptic operating field at a

uniform velocity (0.3 to 0.5 μm/sec),

sweeping away particles in its path.

This air flow can be directed vertically

or horizontally, and recirculated air is

usually passed through a high efficiency

particulate air (HEPA) filter.229 230

HEPA filters, commonly used in

hospitals, remove particles 0.3μm in

diameter with an efficiency of

99.97%.74 227 229 231 Ultraviolet (UV)

light has been used as an infection

control measure to reduce SSI risk.

However, neither laminar flow nor UV

light has been conclusively shown to

decrease overall SSI risk.87 225 232¥237

Environmental Surfaces

Environmental surfaces in U.S.

operating rooms (e.g., tables, floors,

walls, ceilings, lights, and the like) are

rarely implicated as the sources of

pathogens important in the

development of SSIs. Nevertheless, it is

important to perform routine cleaning of

environmental surfaces to reestablish a

clean environment after each

operation.31 154 227 229 There are no data

to support routine disinfecting of

environmental surfaces or equipment

between operations in the absence of

contamination or visible soiling. When

visible soiling of surfaces or equipment

occurs during an operation, an

Environmental Protection Agency

(EPA)-approved hospital disinfectant

should be used to decontaminate the

affected areas before the next

operation.31 154 227 229 238¥240 This is in

keeping with the Occupational Safety

and Health Administration (OSHA)

requirement that all equipment and

environmental surfaces be cleaned and

decontaminated after contact with blood

or other potentially infectious

materials.240 Wet-vacuuming with an

EPA-approved hospital disinfectant is

performed routinely after the last

operation of the day or night. Care

should be taken to insure that medical

equipment is covered and that solutions

used for cleaning and disinfecting do

not contact sterile devices or equipment.

There are no data to support special

cleaning procedures or closing an

operating room after a contaminated or

dirty operation has been

performed.227 228

Tacky mats placed outside the

entrance to an operating room/suite

have not been shown to reduce the

number of organisms on shoes or

stretcher wheels, nor do they reduce the

risk of SSI.1 18 219 228

Microbiologic Sampling

Because there are no standards or

acceptable parameters for comparison of

microbial levels for ambient air or

environmental surfaces in the operating

room, routine microbiologic sampling

cannot be justified. Such environmental

sampling should only be performed as

part of an epidemiologic investigation.

Conventional Sterilization of Surgical

Instruments

Inadequate sterilization of surgical

instruments has resulted in SSI

outbreaks.229 241 242 Surgical

instruments can be sterilized by steam

under pressure, by dry heat, by ethylene

oxide, or other approved methods. The

importance of monitoring the quality of

sterilization procedures has been

established.1 31 154 226 Microbial

monitoring of steam autoclaves

performance is necessary and can be

accomplished by use of a biological

indicator.154 239 243 Detailed

recommendations for sterilization of

surgical instruments have been

published.154 239 244 245

Flash Sterilization of Surgical

Instruments

The Association for the Advancement

of Medical Instruments (AAMI) defines

flash sterilization as ‘‘the process

designated for the steam sterilization of

patient care items for immediate

use’’.245 During any operation, the need

for emergency sterilization of equipment

may arise (e.g., to reprocess an

inadvertently dropped instrument).

Flash sterilization is intended to be used

for emergent sterilization of surgical

instruments and other items and is

never used for reasons of convenience

such as an alternative to purchasing

additional instrument sets and as a

general time-saver. Some of the reasons

that flash sterilization has not been

recommended as a routine sterilization

method include lack of timely biologic

indicators to monitor performance,

absence of protective packaging

following sterilization, possible

contamination during transportation to

the operating rooms, and use of minimal

cycle parameters (i.e., time,

temperature, pressure).243 The AAMI

has published sterilization cycle

parameters for flash sterilization (Table

8).

Until studies are performed to

demonstrate that routine flashing for

purposes other than emergencies does

not increase SSI risk, flash sterilization

should be restricted to its intended

purpose. Also, flash sterilization is not

recommended for implantable devices††

because of the potential for serious

infections.239 244–246

Surgical Attire and Drapes

In this section the term ‘‘surgical

attire’’ refers to scrub suits, caps/hoods,

shoe covers, masks, gloves, and gowns.

Although experimental data show that

live microorganisms are shed from hair,

exposed skin, and mucous membranes

of operating room personnel,126 247–252

few controlled clinical studies have

evaluated the relationship between the

use of surgical attire and the risk of SSI.

Nevertheless, the use of barriers seems

prudent to minimize exposure of a

patient to the skin, mucous membranes,

or hair of surgical team members and

operating room personnel, and to

protect operating room personnel from

bloodborne pathogens (e.g., human

immunodeficiency virus and hepatitis

virus).

Scrub Suits

Hospital personnel, especially

operating room nurses, surgeons, and

anesthesiologists, often wear a uniform

throughout the day that consists of

pants and top/shirt and is called a

‘‘scrub suit.’’ Procedures for laundering,

wearing, covering, and changing scrub

suits vary greatly. In some facilities,

scrub suits are laundered only by the

hospital, while in others, scrub suits

also may be laundered at the health-care

worker’s home. Although, there are no

well-controlled studies evaluating SSIs

risk among hospital-versus homelaundered scrub suits,253 the

Association of Operating Room Nurses

(AORN) recommend scrub suits only be

laundered in an approved and

monitored laundry facility.154 Some

facilities require that scrub suits be

worn only in operating room suites,

while others allow the wearing of cover

gowns over scrub suits when personnel

leave the operating room suites. AORN

recommends changing scrub suits when

they are visibly soiled.154 OSHA

requires that ‘‘if a garment(s) is

penetrated by blood or other potentially

infectious materials, the garment(s) shall
33174 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices

be removed immediately or as soon as

feasible.’’ 240

Masks

Data regarding the possible effect of

using surgical masks on SSI risk are

limited. However, there is a strong

theoretical rationale for wearing surgical

masks during all operations. Some

studies have evaluated the efficacy of

surgical masks in reducing SSI risk and

have raised issues regarding cost vs

benefit.254–258 Although surgical masks

are effective at filtering out some

bacteria, they may not completely

prevent passage of organisms around the

sides and edges of the mask.250, 259, 260

Nevertheless, masks protect the surgical

team from inadvertent exposures to

blood (i.e., splashes) and other body

fluids. OSHA requires that masks in

combination with eye protection

devices, such as goggles or glasses with

solid shields, or chin-length face shields

be worn whenever splashes, spray,

spatter, or droplets of blood or other

potentially infectious material may be

generated and eye, nose, or mouth

contamination can be reasonably

anticipated.240

Surgical Caps/Hoods and Shoe Covers

Surgical caps/hoods are inexpensive

and reduce the shedding of hair and

scalp organisms. Rarely, SSI outbreaks

have been traced to organisms isolated

from the hair or scalp (S. aureus and

Group A Streptococcus),248 261 even

when caps were worn by personnel

during the operation and in the

operating suites.

The use of shoe covers has never been

shown to decrease SSI risk or decrease

floor bacterial counts.262 263 Shoe covers

may protect a health care worker from

exposures to blood and other body

fluids during an operation. OSHA

stipulates that surgical caps or hoods

and/or shoe covers or boots shall be

worn in instances when gross

contamination can reasonably be

anticipated (e.g., autopsies, orthopaedic

surgery).240

Sterile Gloves

There is a strong theoretical rationale

for the use of sterile gloves by all

members of the surgical team. Sterile

gloves are worn to minimize

transmission of microorganisms from

the hands of operating room personnel

to patient’s and to prevent

contamination of personnel hands with

blood and body fluids. If the integrity of

a glove is compromised (e.g., punctured)

it should be changed as promptly as

safety permits.240 264–266 Double gloving

(i.e., wearing two pairs of gloves) has

been shown to reduce bloodborne

pathogen contamination of surgical

team members’ hands.267–270 Sterile

gloves are put on after donning sterile

gowns.

Gowns and Drapes

Both sterile surgical gowns and

drapes are used to create an aseptic

barrier between the surgical site incision

and possible sources of bacteria. Gowns

are worn by operating room personnel

and drapes are laid over the patient.

There are limited data to substantiate

the impact of surgical gowns and drapes

on reducing SSI risk. The wide variation

in the products studied and the study

designs make available data difficult to

evaluate.251 271–275

Gowns and drapes are classified as

disposable (single use) or reusable

(multiple use). Regardless of the

material used to manufacture gowns and

drapes, these items should be

impermeable to liquids and

viruses 276 277 and effective when wet.1

In general, only gowns reinforced with

films, coatings, or membranes appear to

meet standards developed by the

American Society for Testing and

Material (ASTM).276–278 However, the

gowns that do meet these standards

‘‘liquid proof’’ gowns may be

uncomfortable because they also inhibit

the evaporation of sweat and heat loss

from the wearer’s body. These factors

should be considered when selecting

gowns.278

Practice of Anesthesiology

Anesthesiologists and nurse

anesthetists perform invasive

procedures (e.g., placement of

intravascular devices, endotracheal

intubation, administering intravenous

solutions) and work in close proximity

to sterile surgical fields, thus it is

imperative that they strictly adhere to

recommended infection control

practices.154 279–281 Breaks in aseptic

technique,282 including use of common

syringes,283 284 contaminated infusion

pumps,282 285–287 and the assembly of

equipment in advance of

procedures,283 288 have been associated

with SSI outbreaks. Although a barrier

(i.e., sterile drape) is placed between the

anesthesiologist’s work area and the

surgical field, SSIs have occurred in

which the source of the pathogen was

the anesthesiologist or a member of the

anesthesia team (e.g., anesthesia

technician).289–293 Continued efforts

must be undertaken to educate and

reinforce the importance of good

infection control practices in preventing

SSIs, not only to surgeons and operating

room nurses but to all members of the

surgical team.282 294

Hypothermia in surgical patients,

defined as a core body temperature

below 36°C, may result from general

anesthesia, exposure to cold, or

intentional cooling such as, in cardiac

procedures to protect the myocardium

or central nervous systems.295–297 In one

study of patients undergoing colorectal

operations hypothermia was associated

with an increased risk of SSI.298

However, since any alteration in normal

homeostasis alters normal host

responses, more studies are needed to

establish a relationship between

hypothermia and SSI risk.

Surgical Technique

Excellent surgical technique can

reduce SSI risk. Maintaining effective

hemostasis while preserving adequate

blood supply, gently handling tissues,

avoiding inadvertent entries into a

viscus, removing devitalized (e.g.,

necrotic or charred) tissues, using drains

and suture material appropriately,

eradicating dead space, and appropriate

post-operative incision management are

widely believed to reduce the risk of

SSI.18 19 31 32 299 300

Any foreign body, including suture

material or drains, may promote

inflammation at the surgical site 87 and

may increase the probability of infection

for some levels of tissue contamination.

There are two types of suture material:

absorbable and non-absorbable. There is

extensive literature comparing different

types of suture material and their

presumed relationships to SSI

risk.301–310 In general, monofilament

sutures appear to have the lowest

infection-promoting effects.3 18 31 87

While appropriate decisions regarding

drain placement are beyond the scope of

this document, general points should be

briefly noted. Drains placed through an

operative incision increase SSI risk.67

Many researchers suggest placing drains

through a separate incision distant from

the operating incision.67 197 311 It appears

that SSI risk decreases when closed

suction drains are used in comparison

to open drains. 312 313 Closed suction

drains are useful in evacuating

postoperative hematomas, seromas, and

purulent material. Also, the timing of

drain removal is important; bacterial

colonization of drains tracts may

increase as the duration of drainage

increases.314

Postoperative Issues

Postoperative Incision Care

Whether the incision is closed

primarily (i.e., the skin edges are reapproximated at the end of the

operation), left open to be closed later,

or left open to heal by secondary
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices 33175

intention determines the details of

postoperative incision care.

When a surgical incision is closed

primarily, as most are, the surgeon has

determined that it is relatively free of

microbial contamination (i.e., clean or

clean-contaminated). The primarily

closed incision is covered with a sterile

dressing for 24–48 hours until the

incision edges are sealed.315 316 Beyond

48 hours, it is unclear whether an

incision must be covered by a dressing

or whether showering or bathing is

detrimental.

When a surgical incision is left open

for a few days before it is closed

(delayed primary closure), a surgeon has

determined that it is likely to be

contaminated, or that the patient’s

condition prevents primary closure (e.g.,

edema at the site). At the end of the

operation, such an incision is packed

with a sterile dressing (usually moist)

and is inspected daily during dressing

changes until the decision is made to

close it. When a surgical incision is left

open to heal by secondary intention, it

is also packed with sterile moist gauze

and covered with a sterile dressing. For

wounds healing by secondary intention,

there is no consensus on the benefit of

using sterile technique (i.e., using sterile

gloves and dressings) vs clean technique

during dressing changes. The American

College of Surgeons, CDC, and others

have described changing dressings with

sterile gloves and equipment.31 317–320

However, a pilot study of 30 patients

examined the difference between sterile

vs clean technique for dressing changes

of surgical incisions left open. No

difference was found in SSI rates and

the clean technique was less expensive.

However, larger studies are needed to

confirm these preliminary findings.321

Discharge Planning: Care of the

Surgical Site

Today, many patients are discharged

soon after their operation, with surgical

incisions in the early process of

healing.322 There are no set, specific

protocols for home incision care, and

much of what is done at home by the

patient, family, or home care agency has

to be individualized for each patient.

The intent of discharge planning is to

maintain integrity of the healing

incision, educate the patient about the

signs and symptoms of infection, and

inform the patient about whom to

contact to report any problems. Written

instructions and repeated

demonstrations may help reinforce

consistency in following verbal

directions. It is the responsibility of the

surgeon, nurse, discharge planners, and

home health agencies to educate the

patient and family in a uniform,

concise, and coordinated fashion.

SSI Surveillance

Surveillance of SSI with feedback of

appropriate data to surgeons has been

shown to be an important component of

strategies to reduce SSI risk.8, 323, 324 A

successful surveillance program

includes epidemiologically sound

infection definitions (Tables 1 and 2),

effective surveillance methods, and

stratification of SSI rates according to

risk factors associated with SSI

development.17

SSI Risk Stratification

Concepts

From the factors found to be

associated with SSI, three categories of

variables have emerged as good

predictors: (1) those that estimate the

intrinsic degree of microbial

contamination of the surgical site, (2)

those that measure the duration of an

operation, and (3) those that serve as

markers for host susceptibility.17 The

probability of developing an SSI

depends upon the interaction of these

variables in a given patient.

A widely accepted scheme for

classifying the degree of intrinsic

microbial contamination of a surgical

site was developed by the 1964 National

Academy of Sciences/National Research

Council cooperative research study and

modified in 1982 by CDC for use in SSI

surveillance (Table 9).2, 87 In this

scheme, a member of the surgical team

classifies the patient’s wound at the

completion of the operation. Because of

its ease and wide availability, the

surgical wound classification has been

used to predict the risk of SSI.8, 87, 325–330

Some researchers have suggested that

surgeons compare clean wound SSI

rates with those of other surgeons.8, 323

However, two CDC efforts—the Study

on the Efficacy of Nosocomial Infection

Control (SENIC) Project and the NNIS

system—incorporated other predictor

variables into SSI risk indices. These

showed that even within the category of

clean wounds, the risk of SSI varied

from 1.1% to 15.8% and from 1.0% to

5.4%, respectively.328,331 In addition,

sometimes the incision is neither

classified at the time of surgery nor

assigned by a member of the surgical

team, calling into question the

reliability of the classification.

Therefore, reporting SSI rates stratified

by wound class alone is not

recommended.

Data on 10 variables collected in the

SENIC Project were analyzed by using

logistic regression modeling to develop

a simple additive SSI risk index.331 Four

of these were found to be independently

associated with the risk of SSI: (1) an

abdominal operation, (2) an operation

lasting >2 hours, (3) a surgical site with

a wound classification of either

contaminated or dirty/infected, and (4)

an operation performed on a patient

having ≥3 discharge diagnoses. Each of

these equally weighted factors

contributes a point when present, such

that the risk index values range from 0

to 4. By using these factors, the SENIC

index was able to predict the risk of SSI

twice as well as the traditional wound

classification scheme alone.

The NNIS risk index is operation

specific and applied to prospectively

collected surveillance data. The index

can range from 0 to 3 points and is

defined by three independent and

equally weighted variables. A surgical

patient scores one point when any of the

following are present: (1) American

Society of Anesthesiologists (ASA) class

is ≥3 (Table 10), (2) wound classification

is either contaminated or dirty/infected,

and (3) operation lasts >T hours, where

T is the approximate 75th percentile of

the duration of the specific operation

being performed.328 The ASA class

replaced discharge diagnoses of the

SENIC risk index as a proxy for the

patient’s underlying severity of illness

(host susceptibility) 332 333 and is readily

available in the chart during the

patient’s hospital stay (Table 10). Unlike

SENIC’s constant 2 hour cut-point for

duration of operation, the operationspecific cut-points used in the NNIS risk

index have been shown to increase

discriminatory power.328

Issues

Adjustment for variables known to

confound rate estimates is critical if

valid comparisons of SSI rates are to be

made between surgeons or hospitals.334

Risk stratification, as described above,

has proven useful for this purpose, but

relies on the ability of surveillance

personnel to consistently and correctly

find and record the data. For the three

variables used in the NNIS risk index,

only one study has focused on how

accurately any of them are recorded.

Cardo et al. found that surgical team

members’ accuracy in assessing wound

classification for general and trauma

surgery was 88% (95% CI: 82%–

94%).335 However, there are sufficient

ambiguities in the wound class

definitions themselves to warrant

concern about the reproducibility of

Cardo’s results. The accuracy of

recording the duration of operation (i.e.,

time from skin incision to skin closure)

and the ASA class has not been studied.

In an unpublished report from the NNIS

system, there was some evidence that
33176 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices

over-reporting of high ASA class existed

in some hospitals (Emori TG, personal

communication). Further validation of

how well the risk index variables are

recorded is needed.

Additionally, NNIS data show that the

NNIS risk index does not adequately

discriminate the risk of SSI for all types

of operations.336 337 It seems likely that

a combination of risk factors specific to

patients undergoing an operation will be

more predictive. A few studies have

been performed to develop procedurespecific risk indices 338–342 and the NNIS

system continues research in this area.

SSI Surveillance Methods

SSI surveillance methods used in both

the SENIC Project and the NNIS system

were designed for monitoring inpatients

at acute-care hospitals. Over the past

decade, the shift from inpatient to

outpatient surgical care (also called

ambulatory or day surgery) has been

dramatic. It has been estimated that

75% of all operations in the United

States will be performed in outpatient

settings by the year 2000.343 While it

may be appropriate to use common

definitions of SSI for inpatients and

outpatients, 344 the types of operations

monitored, the risk factors assessed, and

the case-finding methods used may

differ. New predictor variables may

emerge from analyses of SSIs among

outpatient surgery patients, which may

lead to different ways of estimating SSI

risk in this population.

Deciding upon which operations to

monitor should be done jointly by

surgeons and infection control

personnel. Rarely do hospitals have the

resources to monitor all surgical

patients all the time, nor is that level of

surveillance intensity probably

necessary for certain low-risk

procedures. Instead, hospitals should

target surveillance efforts towards highrisk procedures.345

Inpatient SSI Surveillance

Two methods, alone or together, have

been used to identify inpatients with

SSIs: (1) direct observation of the

surgical site by the surgeon, trained

nurse surveyor, or infection control

personnel 8 90 323 326 346–350 and (2)

indirect detection by infection control

personnel through review of laboratory

reports, patient records, and discussions

with primary care

providers.7 77 323 326 329 346 348 351–357 The

surgical literature suggests that direct

observation of surgical sites is the most

accurate method to detect SSIs,

although sensitivity data are

lacking.8 323 326 347 348 Much of the SSI

data reported in the infection control

literature have relied on indirect casefinding methods,328 331 352 355 356 358–360

but some studies of direct methods also

have been conducted.90, 346 Some

studies use both methods of

detection.77 325 346 354 357 361 A study that

focused solely on the sensitivity and

specificity of SSIs detected by indirect

methods found a sensitivity of 83.8%

(95% CI: 75.7%–91.9%) and a

specificity of 99.8% (95% CI: 99%–

100%).346 Another study showed that

chart review triggered by a computergenerated report of antibiotic orders for

post-cesarean section patients had a

sensitivity of 89% for detecting

endometritis.362 It is recommended that

hospitals use direct, indirect, or a

combination of both methods for

detecting SSI in postoperative

inpatients.

Indirect SSI detection can readily be

performed by infection control

personnel during surveillance rounds.

The work includes gathering

demographic, infection, surgical, and

laboratory data on patients who have

undergone operations of interest to the

investigator.224 These data can be

obtained from patients’ medical records,

including microbiology and

histopathology laboratory data and

radiology reports, and records from the

operating room. Pharmacy records may

be useful if data on prophylactic

antimicrobial use are to be collected.

Additionally, hospital admissions,

emergency room, and clinic visit

records are sources of data for those

postdischarge surgical patients who readmitted or seek follow-up care.

The optimum frequency of casefinding by either method is unknown

and varies from daily to ≤3 times per

week, continuing until the patient is

discharged from the hospital. Because

duration of hospitalization is now so

short, postdischarge SSI surveillance

has become increasingly important to

obtain accurate SSI rates (see

‘‘Postdischarge SSI Surveillance’’

section).

To calculate meaningful SSI rates,

data must be collected on all patients

undergoing the operations of interest

(i.e., the population at risk). In the NNIS

system, because one of its purposes is to

develop strategies for risk stratification,

the following data are collected on all

surgical patients surveyed: operation

date; NNIS operative procedure

category; 363 surgeon identifier; patient

identifier, age, and sex; duration of

operation; wound class; general

anesthesia; ASA class; emergency;

trauma; multiple procedures;

endoscopic approach; and discharge

date.224 With the exception of discharge

date, these data can be obtained

manually from operating room logs or

be electronically downloaded into

surveillance software, thereby

substantially reducing manual

transcription and data entry errors.224

Depending on the needs for riskstratified SSI rates by infection control,

surgery, and quality assurance, not all

data elements may be pertinent for

every type of operation. At minimum,

however, variables found to be

predictive of increased SSI risk should

be collected (see ‘‘SSI Risk

Stratification’’ section).

Postdischarge SSI Surveillance

Between 12% and 84% of SSIs are

detected after patients are discharged

from the hospital. 91 259 326 358 364–383 At

least two investigators have shown that

most SSIs become evident within 21

days after operation.360 376 Since the

length of postoperative hospitalization

continues to decrease, true estimates of

SSI risk will only be possible by

performing a combination of inpatient

and postdischarge surveillance.

Postdischarge surveillance methods

have been used with varying degrees of

success for different procedures and

among hospitals and include (1) direct

examination of patients’ wounds during

follow-up visits to either surgery clinics

or physicians’

offices,323 326 329 360 365 369 370 376 381 384 385

(2) review of medical records of

surgery clinic patients,329, 360, 368 (3)

questionnaire administration to patients

by mail or telephone,364 366 367 370

371 374 375 377 378 384 386 388 or

(4) questionnaire administration to

surgeons by mail or telephone.91 358 360

366 368 372 373 375 377 379 380 384 One study

found that patients have difficulty

assessing their own wounds for

infection (52% specificity, 26% positive

predictive value),389 suggesting that data

obtained by patient questionnaire may

inaccurately represent actual SSI rates.

Recently, Sands et al. performed a

computerized search of three data

bases—ambulatory encounter records

for diagnostic, testing, and treatment

codes; pharmacy records for specific

antimicrobial prescriptions; and

administrative records for

rehospitalizations and emergency room

visits. The purpose of the search was to

determine which best identified SSIs.375

These researchers found that pharmacy

records indicating a patient had

received antimicrobial agents commonly

used to treat soft tissue infections had

the highest sensitivity (50%) and

positive predictive value (19%).

As integrated health information

systems expand, tracking surgical

patients through the course of their care

may become more feasible, practical,

and effective. Until then, there is no
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices 33177

consensus on which postdischarge

surveillance methods are the most

sensitive, specific, and practical.

Infection control and surgery personnel

must choose from a variety of methods

to find those that work for their unique

mix of operations, personnel resources,

and data needs.

Outpatient SSI Surveillance

Both direct and indirect methods have

been used to detect SSIs that complicate

outpatient operations. One study used

home visits by district health nurses

combined with a questionnaire

completed by the surgeon at the

patient’s 2-week postoperative clinic

visit to identify SSIs in an 8-year study

of operations for hernia and varicose

veins.390 While ascertainment was very

high, essentially 100%, this method is

impractical for widespread

implementation. High response rates

have been obtained from questionnaires

mailed to surgeons (72%–

>90%).372 373 375 384 391 393 Response rates

from telephone questionnaires

administered to patients were more

variable (38%,386 81%,388 and 85%384),

and response rates from questionnaires

mailed to patients were quite low

(15% 384 and 33%375). At this time, no

single detection method can be

recommended. Available resources and

data needs determine which method(s)

should be used and which operations

should be monitored. It is recommended

that the CDC NNIS definitions of SSI

(Tables 1 and 2) be used without

modification in the outpatient setting.

Guideline Evaluation Process

Users of the HICPAC guidelines

determine their value. To help assess

that value, HICPAC is developing an

evaluation tool to learn how guidelines

meet user expectations, and how and

when these guidelines are disseminated

and implemented.

Part II—Recommendations for the

Prevention of Surgical Site Infections

(SSIs)

Introduction

As in previous CDC guidelines, each

recommendation is categorized on the

basis of existing scientific data,

theoretical rationale, applicability, and

possible economic impact. However, the

previous CDC system for categorizing

recommendations has been modified to

include a designation of those

recommendations that are required by

federal regulations. The document does

not recommend specific antiseptic

agents for patient preoperative skin

preparations or for health-care worker

hand/forearm antisepsis. Hospitals

should choose from the appropriate

products categorized by the Food and

Drug Administration (FDA).4

Category IA. Strongly recommended

for all hospitals and strongly supported

by well-designed experimental or

epidemiological studies.

Category IB. Strongly recommended

for all hospitals and viewed as effective

by experts in the field and a consensus

of Hospital Infection Control Practices

Advisory Committee (HICPAC), based

on strong rationale and suggestive

evidence, even though definitive

scientific studies may not have been

done.

Category II. Suggested for

implementation in many hospitals.

Recommendations may be supported by

suggestive clinical or epidemiological

studies, a strong theoretical rationale, or

definitive studies applicable to some,

but not all hospitals.

No recommendation; unresolved

issue. Practices for which insufficient

evidence or no consensus regarding

efficacy exists.

Recommendations

1. Preoperative preparation of the

patient

a. Adequately control serum blood

glucose level in all diabetic patients

before elective operation and maintain

blood glucose level <200 mg/dl during

the operation and in the immediate

postoperative period (48

hours).77–79 100–102 Category IB

b. Always encourage tobacco

cessation. At minimum, instruct

patients to abstain for at least 30 days

before elective operation from smoking

cigarettes, cigars, pipes or any other

form of tobacco consumption (e.g.,

chewing/dipping).78 81 83–85 Category IB

c. No recommendation to taper or

discontinue steroid use (when

medically permissible) before elective

operation.77 80 86 103–105 Unresolved issue

d. Consider delaying an elective

operation in a severely malnourished

patient. A good predictor of nutritional

status is serum albumin.78 96–98 Category

II

e. Attempt weight reduction in obese

patients before elective

operation.78 79 89 90 Category II

f. Identify and treat all infections

remote to the surgical site before

elective operation.31 74–76 Do not perform

elective operations in patients with

remote site infections. Category IA

g. Keep preoperative hospital stay as

short as possible.18 75 93 104 106 Category

IA

h. Prescribe preoperative showers/

baths with an antiseptic agent the night

before and the morning of the

operation.108 109 Category IB

i. Do not remove hair preoperatively

unless the hair at or around the incision

site will interfere with the

operation.8 93 113 114 120 121 Category IA

j. If hair is removed, it should be

removed immediately before the

operation using electric clippers rather

than razors or depilatories.115 117 119

Category IA

k. Thoroughly wash and clean at and

around the incision site to remove gross

contamination before performing

antiseptic skin preparation.154 Category

IB

l. Use an acceptable antiseptic agent

for skin preparation, such as alcohol

(usually 70%–92%), chlorhexidine (4%,

2%, or 0.5% in alcohol base), or iodine/

iodophors (usually 10% aqueous with

1% iodine or formulation with 7.5%)

(Table 5).123 124 Category IB

m. Apply preoperative antiseptic skin

preparation in concentric circles moving

out toward the periphery. The prepped

area must be large enough to extend the

incision or create new incisions or drain

sites, if necessary.31 124 154 Category IB

2. Preoperative Hand/Forearm

Antisepsis

All members of the surgical team:

a. Keep nails short and do not wear

artificial nails.31 72 124 154 155 Category IB

b. No recommendation on wearing

nail polish. Unresolved Issue

c. Do not wear hand/arm jewelry.

Category II

d. Perform a preoperative surgical

scrub that includes hands and forearms

up to the elbows before the sterile field,

sterile instruments, or the patient’s

prepped skin is touched. Category IB

e. Clean underneath each fingernail

prior to performing the surgical

scrub.31 140 154 Category IB

f. Perform the surgical scrub for a

duration of 3–5 minutes 124 152 153 with

an appropriate antiseptic (see Table

5).123 124–140 Category IB

g. After performing the surgical scrub,

keep hands up and away from the body

(elbows in flexed position) so that water

runs from the tips of the fingers toward

the elbows. Dry hands with a sterile

towel and don a sterile gown and

gloves.154 Category IB

3. Antimicrobial Prophylaxis

a. Select a prophylactic antimicrobial

agent based on its efficacy against the

most common pathogens causing SSI for

a specific operation (Table 6). Category

IA

b. Administer the antimicrobial

prophylactic agent by the intravenous

route except for colorectal operations.202

In colorectal operations the

antimicrobial agent is administered

orally, or a combination of oral and

intravenous route is used. Category IA
33178 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices

*Federal regulation—Occupational Safety and

Health Administration

c. Administer the antimicrobial agent

before the operation starts to assure

adequate microbiocidal tissue levels

before the skin incision is made, ideally

antimicrobial prophylaxis should be

administered within 30 minutes before,

but not longer than 2 hours before, the

initial incision.69 71 202 203 214 Category

IA

d. For cesarean section, administer

prophylaxis immediately after the

umbilical cord is clamped.69 70 Category

IA

e. Administer prophylactic

antimicrobial agent as close as possible

to the time of induction of anesthesia.

Category II

f. Do not extend prophylaxis

postoperatively.47 71 199 ¥201 Category IB

g. Consider additional intraoperative

doses under the following

circumstances: (1) operations whose

duration exceeds the estimated serum

half-life of the agent, (2) operations with

major intraoperative blood loss, and (3)

operations on morbidly obese

patients.47 69 71 201 203 216 ¥218 Category IB

h. Do not routinely use vancomycin

for prophylaxis.204 205 Category IB

4. Intraoperative Issues

4–1. Operating Room Environment

A. Ventilation

a. Maintain positive-pressure

ventilation in the operating room with

respect to the corridors and adjacent

areas.226 Category IB

b. Maintain a minimum of 15 air

changes per hour, of which at least 3

should be fresh air.226 Category IB

c. Filter all air, recirculated and fresh,

through the appropriate filters per the

American Institute of Architects

recommendations.226 Category IB

d. Introduce all air at the ceiling and

exhaust near the floor.227 228 Category IB

e. No recommendation for the use of

laminar flow ventilation or ultraviolet

lights in the operating room to prevent

SSI.87 225 232 ¥237 Unresolved issue

f. Keep operating room doors closed

except as needed for passage of

equipment, personnel, and the

patient.219 Category IB

g. Limit the number of personnel

entering the operating room to necessary

personnel.219 Category IB

B. Cleaning and Disinfection of

Environmental Surfaces

a. No recommendation on disinfecting

operating rooms between operations in

the absence of visible soiling of surfaces

or equipment. Unresolved issue

b. When visible soiling or

contamination, with blood or other body

fluids, of surfaces or equipment occurs

during an operation, use an EPAapproved hospital disinfectant to clean

the affected areas before the next

operation.31 154 227 ¥229 238 ¥240 Category

IB*

c. Wet vacuum the operating room

floor after the last operation of the day

or night with an EPA-approved hospital

disinfectant.154 Category IB

d. Do not perform special cleaning or

disinfection of operating rooms after

contaminated or dirty operations.227 228

Category IA

e. Do not use tacky mats at the

entrance to the operating room suite for

infection control; this is not proven to

decrease SSI risk.1 18 219 228 Category 1A

C. Microbiologic Sampling

Do not perform routine environmental

sampling of the operating room. Perform

microbiologic sampling of operating

room environmental surfaces or air only

as part of an epidemiologic

investigation. Category IB

D. Sterilization of Surgical Instruments

a. Sterilize all surgical instruments

according to published

guidelines.154 226 239 245 Category IB

b. Perform flash sterilization only in

emergency situations.239 244 ¥246

Category IB

c. Do not use flash sterilization for

routine reprocessing of surgical

instruments. Category IB

4–2. Surgical Attire and Drapes

a. No recommendations on how or

where to launder scrub suits, on

restricting use of scrub suits to the

operating suite or for covering scrub

suits when out of the operating

suite.154 277 Unresolved issue

b. Change scrub suits when visibly

soiled, contaminated and/or penetrated

by blood or other potentially infectious

materials.154 240 Category IB *

c. Wear a surgical mask that fully

covers the mouth and nose when

entering the operating room if sterile

instruments are exposed, or if an

operation is about to begin or already

under way. Wear the mask throughout

the entire operation.154 240 Category IB *

d. Wear a cap or hood to fully cover

hair on the head and face when entering

the operating room suite.154 240 248 261

Category IB *

e. Do not wear shoe covers for the

prevention of SSI.262 263 Category IA

f. Wear shoe covers when gross

contamination can reasonable be

anticipated.240 Category II *

g. The surgical team must wear sterile

gloves, which are put on after donning

a sterile gown.240 264–266 Category IB *

h. Use materials for surgical gowns

and drapes that are effective barriers

when wet.1 154 169 277 Category IB

4–3. Practice of Anesthesiology

Anesthesia team members must

adhere to recommended infection

control practices during

operations.154 279–281 Category IA

4–4. Surgical Technique

a. Handle tissue gently, maintain

effective hemostasis, minimize

devitalized tissue and foreign bodies

(i.e., sutures, charred tissues, necrotic

debris), and eradicate dead space at the

surgical site.18 19 31 32 Category IB

b. Use delayed primary closure or

leave incision open to close by

secondary intention, if the surgical site

is heavily contaminated (e.g., Class III

and Class IV). Category IB

c. If drainage is deemed necessary,

use a closed suction drain. Place the

drain through a separate incision, rather

than the main surgical incision. Remove

the drain as soon as possible.312 313

Category IB

5. Postoperative Surgical Incision Care

a. Protect an incision closed primarily

with a sterile dressing for 24–48 hours

postoperatively. Also ensure that the

dressing remains dry and that it is not

removed bathing.315 316 Category IA

b. No recommendation on whether or

not to cover an incision closed primarily

beyond 48 hours, nor on the appropriate

time to shower/bathe with an uncovered

incision. Unresolved Issue

c. Wash hands with an antiseptic

agent before and after dressing changes,

or any contact with the surgical site.

Category IA

d. For incisions left open

postoperatively, no recommendation for

dressing changes using a sterile

technique vs. clean technique.

Unresolved Issue

e. Educate the patient and family

using a coordinated team approach on

how to perform proper incision care,

identify signs and symptoms of

infection, and where to report any signs

and symptoms of infection. Category II

6. Surveillance

a. Use CDC definitions of SSI 16

without modification for identifying SSI

among surgical inpatients and

outpatients. Category IB

b. For inpatient case-finding, use

direct prospective observation, indirect

prospective detection, or a combination

of both direct and indirect methods for

the duration of the patient’s

hospitalization, and include a method of

postdischarge surveillance that

accommodates available resources and

data needs. Category IB
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices 33179

c. For outpatient case-finding, use a

method that accommodates available

resources and data needs. Category IB

d. For each patient undergoing an

operation chosen for surveillance,

record those variables shown to be

associated with increased SSI risk (e.g.,

surgical wound class, ASA class, and

duration of operation). Category IB

e. Upon completion of the operation,

a surgical team member assigns the

surgical wound classification. Category

IB

f. Periodically calculate operationspecific SSI rates stratified by variables

shown to be predictive of SSI risk.

Category IB

g. Report appropriately stratified,

operation-specific SSI rates to surgical

team members. The optimum frequency

and format for such rate computations

will be determined by stratified caseload sizes and the objectives of local,

continuous, quality improvement

initiatives. Category IB

h. No recommendation to make

available to the infection control

committee coded surgeon-specific data.

Unresolved issue

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BILLING CODE 4163–18–C
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TABLE 1.—CRITERIA FOR DEFINING SURGICAL SITE INFECTION (SSI).16

SUPERFICIAL INCISIONAL SSI

Infection occurs within 30 days after the operation and infection involves only skin or subcutaneous tissue of the incision and at least one of the

following:

1. Purulent drainage, with or without laboratory confirmation, from the superficial incision.

2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.

3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative.

4. Diagnosis of superficial incisional SSI by the surgeon or attending physician.

Do not report the following conditions as SSI:

1. Stitch abscess (minimal inflammation and discharge confined to the points of suture penetration).

2. Infection of an episiotomy or newborn circumcision site.3

3. Infected burn wound.3

4. Incisional SSI that extends into the fascial and muscle layers (see deep incisional SSI).

DEEP INCISIONAL SSI

Infection occurs within 30 days after the operation if no implant 4 is left in place or within 1 year if implant is in place and the infection appears

to be related to the operation and

Infection involves deep soft tissues (e.g., fascial and muscle layers) of the incision and at least one of the following:

1. Purulent drainage from the deep incision but not from the organ/space component of the surgical site.

2. A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs

or symptoms: fever (>38°C), localized pain, or tenderness, unless site is culture negative.

3. An abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by

histopathologic or radiologic examination.

4. Diagnosis of a deep incisional SSI by a surgeon or attending physician.

Notes:

1. Report infection that involves both superficial and deep incision sites as deep incisional SSI.

2. Report an organ/space SSI that drains through the incision as a deep incisional SSI.

ORGAN/SPACE SSI

Infection occurs within 30 days after the operation if no implant is left in place or within 1 year if implant is in place and the infection appears to

be related to the operation and

Infection involves any part of the anatomy (e.g., organs or spaces), other than the incision, that was opened or manipulated during the operative

procedure and at least one of the following:

1. Purulent drainage from a drain that is placed through a stab wound 5 into the organ/space.

2. Organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space.

3. An abscess or other evidence of infection involving the organ/space that is found on direct examination, during reoperation, or by

histopathologic or radiologic examination.

4. Diagnosis of an organ/space SSI by a surgeon or attending physician.

3Specific criteria are used for infected episiotomy and circumcision sites and burn wounds.

4 NNIS definition—A nonhuman-derived implantable foreign body (e.g., prosthetic heart valve, nonhuman vascular graft, mechanical heart, or

hip prosthesis) that is permanently placed in a patient during surgery. 5 If the area around a stab wound becomes infected, it is not an SSI1. It is considered a skin or soft tissue infection, depending on its depth.

TABLE 2.—SPECIFIC SITES OF ORGAN/

SPACE SURGICAL SITE INFECTION 16

Arterial or venous infection

Breast abscess or mastitis

Disc space

Ear, mastoid

Endocarditis

Endometritis

Eye, other than conjunctivitis

Gastrointestinal tract

TABLE 2.—SPECIFIC SITES OF ORGAN/

SPACE SURGICAL SITE

INFECTION 16—Continued

Intraabdominal, not specified elsewhere

Intracranial, brain abscess or dura

Joint or bursa

Mediastinitis

Meningitis or ventriculitis

Myocarditis or pericarditis

Oral cavity (mouth, tongue, or gums)

Osteomyelitis

TABLE 2.—SPECIFIC SITES OF ORGAN/

SPACE SURGICAL SITE

INFECTION 16—Continued

Other infections of the lower respiratory tract

(e.g., abscess or empyema)

Other male or female reproductive tract

Sinusitis

Spinal abscess without meningitis

Upper respiratory tract, pharyngitis

Vaginal cuff

TABLE 3.—DISTRIBUTION OF PATHOGENS ISOLATED * FROM SURGICAL SITE INFECTIONS, NATIONAL NOSOCOMIAL

INFECTIONS SURVEILLANCE SYSTEM, 1986–1996.6 18 19

Percent of isolates

1986–1989 1990–1996

Pathogen ........................................................................................................................ (N=16,727) (N=17,671)

Staphylococcus aureus .................................................................................................. 17 20

Coagulase-negative staphylococci ................................................................................ 12 14

Escherichia coli .............................................................................................................. 10 8

Enterococcus spp. ......................................................................................................... 8 12
33190 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices

TABLE 3.—DISTRIBUTION OF PATHOGENS ISOLATED * FROM SURGICAL SITE INFECTIONS, NATIONAL NOSOCOMIAL

INFECTIONS SURVEILLANCE SYSTEM, 1986–1996.6 18 19—Continued

Percent of isolates

1986–1989 1990–1996

Pseudomonas aeruginosa ............................................................................................. 8 8

Enterobacter spp. .......................................................................................................... 8 7

Proteus mirabilis ............................................................................................................ 4 3

Klebsiella pneumoniae ................................................................................................... 3 3

Other Streptococcus spp. .............................................................................................. 3 3

Candida albicans ........................................................................................................... 2 3

Group D streptococci ..................................................................................................... 2

Other gram-positive aerobes ......................................................................................... 2

Bacteroides fragilis ........................................................................................................ 2

*Pathogens representing less than 2% of isolates are excluded.

TABLE 4.—FACTORS THAT INFLUENCE

SURGICAL SITE INFECTION RISK

INTRINSIC—Patient-Related Risk Factors

Age

Nutritional status

Diabetes

Smoking

Obesity

Remote infections

Endogenous mucosal microorganisms

Altered immune response

Preoperative stay—severity of illness

EXTRINSIC—Operation-Related Risk Factors

TABLE 4.—FACTORS THAT INFLUENCE

SURGICAL SITE INFECTION RISK—

Continued

Duration of surgical scrub

Skin antisepsis

Preoperative shaving

Preoperative skin prep

Surgical attire

Sterile draping

Duration of operation

Antimicrobial prophylaxis

Ventilation

Sterilization of instruments

TABLE 4.—FACTORS THAT INFLUENCE

SURGICAL SITE INFECTION RISK—

Continued

Wound class

Foreign material

Surgical drains

Exogenous microorganisms

Surgical technique

Poor hemostasis

Failure to obliterate dead space

Tissue trauma

This table has been adopted from references.17 and 29

TABLE 5.—MECHANISM AND SPECTRUM OF ACTIVITY FOR COMMONLY USED ANTISEPTICS FOR PREOPERATIVE SKIN

PREPARATION AND SURGICAL SCRUBS.123

Agent Mechanism of action

Grampositive

bacteria *

Gramnegative

bacteria *

Mycobacterium

tuberculosis * Fungi* Virus * Rapidity of action

Residual

activity * Toxicity

Alcohol ................. Denature proteins E E G G G Most rapid ........ None ...... Drying, volatile.

Chlorhexidine ....... Disrupt cell wall ... E G P F G Intermediate ..... E ............ Ototoxicity, Keratitis.

Iodine/Iodophors .. Oxidation/substitution by free

iodine.

E G G G G Intermediate ..... Minimal .. Absorption from

skin with possible toxicity,

skin irritation.

**PCMX ............... Disrupt cell wall ... G F F F F Intermediate ..... Good ...... More data needed.

Triclosan .............. Disrupt cell wall ... G G† G P U Intermediate ..... E ............ More data needed.

**Para-chloro-meta-xylenol

† Good except for Pseudomonas

*E—excellent. G—good. F—fair. P—poor. U—unknown.

TABLE 6.—OPERATIONS, LIKELY SURGICAL SITE INFECTION PATHOGENS, AND REFERENCES REGARDING USAGE OF

ANTIMICROBIAL PROPHYLAXIS

Operations Likely pathogens

Clean—Class I Endogenous and Exogenous

Placement of all grafts, prostheses, or implants 47 69 197 202 203 ............... S. aureus, S. epidermidis.

Cardiac 190 192–194 205 .................................................................................. S. aureus, S. epidermidis.

Neurosurgery 170–174 394 395 ........................................................................

If approach through nasopharynx or transphenoid sinus are Class II.

S. aureus, S. epidermidis.

Ophthalmology 396 397 ...............................................................................

—Limited data.

—However, commonly used in procedures such as anterior segment

resection, vitrectomy, and scleral buckles.

S. aureus; S. epidermidis; streptococci; enteric, gram-negative bacilli.
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices 33191

TABLE 6.—OPERATIONS, LIKELY SURGICAL SITE INFECTION PATHOGENS, AND REFERENCES REGARDING USAGE OF

ANTIMICROBIAL PROPHYLAXIS—Continued

Operations Likely pathogens

Orthopedic 57 69 175–180 398–404 .....................................................................

—Total joint replacement.

—Closed fractures/use of nails, bone plates, other internal fixation

devices.

—Functional repair without implant/device.

—Trauma

S. aureus, S. epidermidis.

Pulmonary (noncardiac thoracic) 188 191 405 406 .........................................

—Thoracic (lobectomy, pneumonectomy, wedge resection, other

non-cardiac mediastinal procedures)

—Closed tube thoracostomy

S. aureus; S. epidermidis; Streptococcus pneumoniae; enteric, gramnegative bacilli.

Vascular 69 189 197 205 407 408 ...................................................................... S. aureus, S. epidermidis.

Clean—Contaminated—Class II*

Appendectomy 185 409 410 ............................................................................ Enteric, gram-negative bacilli, anaerobes.

Biliary (cholecystectomy) 186 187 411–416 .....................................................

—For high risk (e.g., age >65, jaundice, acute cholecystitis,

choledocholithiasis, or prior biliary surgery) and low-risk patients.

Enteric, gram-negative bacilli, anaerobes.

Colorectal ..................................................................................................

—Oral.71 181 182 184 202 206–213

—Oral and IV.184 211 417–419

Enteric, gram-negative bacilli, anaerobes.

Gastroduodenal 183 184 420–422 .................................................................... Enteric, gram-negative bacilli, enterococci.

Head and neck (major procedures with incision through oral or pharyngeal mucosa 423–426.S. aureus, streptococci, oral anaerobes (e.g., peptostreptococci).

Obstetric and gynecologic 159–168 203 364 ....................................................

—Cesarean section.

Low risk and high risk (high risk = prolonged rupture of membranes, no

prenatal care, multiple vaginal examines, emergency cesarean, frequent invasive monitoring).

—Hysterectomy.

Vaginal and abdominal

Enteric, gram-negative bacilli; enterococci; group B streptococci;

anaerobes.

Urology—prostate 68 69 198 203 .....................................................................

May not be beneficial if urine is sterile.

Escherichia coli, Klebsiella spp. Pseudomonas.

Exploratory laparotomy. ............................................................................

Penetrating abdominal trauma.193 338 339 427 428

Aerobic coliforms Bacteroides fragilis and other anaerobes.

*Staphylococci will cause a certain amount of infections in all procedures.

TABLE 7.—DEPARTMENT OF HEALTH AND HUMAN SERVICES’ PARAMETERS FOR OPERATING ROOM VENTILATION,

AMERICAN INSTITUTE OF ARCHITECTS, 1996.226

Normal temperature .................................................................................. 68–73°F depending on normal ambient temperatures.

Relative humidity ...................................................................................... 30%–60%.

Air movement ............................................................................................ Out ‘‘clean to less clean’’ areas.

Air Changes .............................................................................................. Minimum 15 total air changes per hour.

Minimum 3 air changes of outdoor air per hour.

TABLE 8.—ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTS FLASH STERILIZATION CYCLE

PARAMETERS.245

Gravity-displacement cycles Minimum exposure time and temperature

Porous and nonporous items ................................................................... Nonporous items—3 min at 132°C (270°F)

Nonporous and porous items—10 min at 132°C (270°F)

Prevacuum cycles Minimum exposure time and temperature

Porous and nonporous items ................................................................... Nonporous items (270°F)—3 min at 132°C

Nonporous and porous items (270°F)—4 min at 132°C
33192 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 / Notices

TABLE 9.—SURGICAL WOUND

CLASSIFICATION.1 2

Class I/Clean: An uninfected operative

wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered. In addition, clean wounds are primarily closed and, if necessary, drained

with closed drainage. Operative incisional

wounds that follow nonpenetrating (blunt)

trauma should be included in this category

if they meet the criteria.

Class II/Clean-Contaminated: An operative

wound in which the respiratory, alimentary,

genital, or urinary tracts are entered under

controlled conditions and without unusual

contamination. Specifically, operations involving the biliary tract, appendix, vagina,

and oropharynx are included in this category, provided no evidence of infection or

major break in technique is encountered.

Class III/Contaminated: Open, fresh, accidental wounds. In addition, operations with

major breaks in sterile technique (e.g.,

open cardiac massage) or gross spillage

from the gastrointestinal tract, and incisions in which acute, nonpurulent inflammation is encountered are included in this

category.

Class IV/Dirty-Infected: Old traumatic wounds

with retained devitalized tissue and those

that involve existing clinical infection or

perforated viscera. This definition suggests

that the organisms causing postoperative

infection were present in the operative field

before the operation.

TABLE 10.—AMERICAN SOCIETY OF

ANESTHESIOLOGISTS’ (ASA) PHYSICAL STATUS CLASSIFICATION

Code Patient’s preoperative physical

status

1 ............. Normally healthy patient.

2 ............. Patient with mild systemic disease.

3 ............. Patient with severe systemic disease that is not incapacitating.

4 ............. Patient with an incapacitating

systemic disease that is a constant threat to life.

5 ............. Moribund patient who is not expected to survive for 24 hours

with or without operation.

[FR Doc. 98–15551 Filed 6–16–98; 8:45 am]

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