8
Sterilization == it has a role Ann M. Cahill, RN, MS in The main objective of the nursing staff in any operating room should be pro- viding quality nursing care to each in- dividual patient. This quality nursing care is administered by the application of the knowledge, principles and ex- pertise of the staff educated in each person’s specific clinical fields. The patient in surgery has the right to expect competence from those who are most qualified to carry out this specialized component of nursing care - the operating room nursing staff. The professional competence demon- strated in operating rooms today is the result of a gradual development of tech- nics and principles. This evolution of -__ Ann M . Cahill, RN, MS, is operating room clinical instructor at the Massachusetts General Hospital School of Nursing, where she received her nurse’s training and was previously employed as staff nurse head nurse, and OR supervisor. Miss Cahill was awarded her bachelor’s and mas- ter’s degrees at Boston College, Chestnut Hill, Mass, and was employed as a staff nurse at the Stanfard- Law Hospital in Son Francisco. This article was adapted from a speech made by Miss Cahill at the May 15-16 Parauro!ogical Seminar in Philadelphia. quality care technic now ensures each and every patient a sterile and safe environment while he is undergoing surgery. Foremost in this evolution of modern surgical technic is the broad spectrum of sterilization. How wonderful it would be if we could toss a pill in water, use instant sprays on instruments or immerse them in some magical formula to render an article sterile and ready for use. With the technological advances being developed in our scientific laboratories -developed at such a pace that it is almost humanly impossible to remain current - instant sprays or immersion fluids may be a reality in the “Exotic Eighties.” For us in these “Unsettled Seventies” however, we must utilize the methods available here and now. It is important that we are in agree- ment in our use of terminology. One might say, “What is an Irish Catholic ‘girl’ from Boston doing writing on steri- lization?” It is all in the definition of the term - the word sterilization. In our connotation of the term, the universally accepted definition of steri- October 1970 73

Sterilization–it has a role in quality care

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Sterilization ==

it has a role

Ann M . Cahill, RN, MS

in

The main objective of the nursing staff in any operating room should be pro- viding quality nursing care to each in- dividual patient. This quality nursing care is administered by the application of the knowledge, principles and ex- pertise of the staff educated in each person’s specific clinical fields.

The patient in surgery has the right to expect competence from those who are most qualified to carry out this specialized component of nursing care - the operating room nursing staff.

The professional competence demon- strated in operating rooms today is the result of a gradual development of tech- nics and principles. This evolution of

-__

Ann M . Cahill, RN, MS, is operating room clinical instructor at the Massachusetts General Hospital School of Nursing, where she received her nurse’s training and was previously employed as staff nurse head nurse, and OR supervisor.

Miss Cahill was awarded her bachelor’s and mas- ter’s degrees at Boston College, Chestnut Hill, Mass, and was employed as a staff nurse at the Stanfard- Law Hospital in Son Francisco.

This article was adapted from a speech made by Miss Cahill at the May 15-16 Parauro!ogical Seminar in Philadelphia.

quality care

technic now ensures each and every patient a sterile and safe environment while he is undergoing surgery.

Foremost in this evolution of modern surgical technic is the broad spectrum of sterilization. How wonderful it would be if we could toss a pill in water, use instant sprays on instruments or immerse them in some magical formula to render an article sterile and ready for use.

With the technological advances being developed in our scientific laboratories -developed at such a pace that it is almost humanly impossible to remain current - instant sprays or immersion fluids may be a reality in the “Exotic Eighties.” For us in these “Unsettled Seventies” however, we must utilize the methods available here and now.

It is important that we are in agree- ment in our use of terminology. One might say, “What is an Irish Catholic ‘girl’ from Boston doing writing on steri- lization?” It is all in the definition of the term - the word sterilization.

In our connotation of the term, the universally accepted definition of steri-

October 1970 73

lization is the process by which all organisms - pathogenic and nonpatho- genic, including spores - are destroyed. It is an absolute term. (To use that “old clich6” there is no instance of an article being “just a little bit sterile” - just as one cannot be “a little bit preg- nant.”) An article either is sterile or it is not.

We must also be clear in our definition of the term disinfectant as opposed to antispetic to eliminate any confusion. Spaulding’ defines disinfection as “A process which destroys most, but not all forms of microorganisms.” (This differs from the term sterilization where total destruction of all microorganisms is guaranteed. Those not killed are some bacterial spores, hepatitis virus. )

Disinfectants are stronger solutions because there need be no contact with living tissue; they are used on inanimate objects - instruments and furniture.

Antiseptics are weaker solutions because of danger of injury to tissue; they are used on animate objects-the human body.

Chemical disinfection is a more ac- ceptable term than chemical sterilization. Chemical disinfection, as we use the term, refers to disinfection of inanimate objects with a disinfectant.

Now that we have defined the basic terminology - let us concern ourselves with the selection of a method of steri- lization. In selecting any method of sterilization our major concerns are the organisms to be destroyed, the items to be sterilized and the availability of the sterilizing process.

Out first consideration is the organism to be destroyed. Microorganisms are di- vided into four main groups: bacteria, viruses, fungi (yeast and molds), and animal parasites ( protoza and worms). The bacteria and the viruses are the

Table 1

Most important bacteria and viruses in the operating room

Bacteria

Coagulase-positive staphylococci (Staphylococcus aureusl Ercherichio coli, and other coliform bacilli such as Aerobacfer Pseudomonos aeruginasa (pyocyaneus) Group A beta hemolytic streptococci ffiemolytic strep) Mycobacferium tuberculosis Proteus species * Closteridium tetani

Clostridium perfringens (welchii) * Low frequency but very dangerous. The viruses are also listed for the next few years much more will be known about their destruction.

Viruses

Serum hepatitis virus (SH) Infectious hepatitis virus (IH) Enteroviruses (polio, ECHO, Coxsackie) Common cold viruses Influenza virus Adenoviruser Primary atypical pneumonia PPLO** (not a virus, but included anyway) .t PleuroPneumonia-Like Organism

74 AORN Journal

Fig 1

Pictured are several different material types, many requiring unique sterilizaton technics: 1) plastic irri- gating tubing; 2) ureteral catheter (disposable); 3) telescope; 4) bakelite sheath; 5) electrical connec- tions; 6) catheter adapter; 7) woven piliforms; 8) ure- teral catheter (steam autoclaved); and 91 plastic

tubing (steam autoclaved).

two groups causing major problems in operating room asepsis.

Most important bacteria and viruses in an operating room are shown in Table 1 which was originally published in the AORN JOURNAL, March-April, 1963.

The main action of heat or chemical sterilization on the organism to be de- stroyed is either the coagulation or de- naturing of the protein substance in the cellular structure; or the alternation of the pH level, thus rendering the struc- ture nonfunctional for cell metabolism. A few genera of bacteria have special properties which make them highly re- sistant to destruction: 1) the large amount of waxy material in the Myco- bacterium tuberculosis; 2 ) spore-form- ing properties in the Clostridia group; these can be listed on one hand, yet must be destroyed to guarantee setrility.

The unique properties of these par- ticular organisms must influence our se- lection of an effective sterilization method. If we are to have effective methods of sterilization, we must ensure the destruction of the most resistant properties of these organisms.

By the same token, the composition of the type of material to be sterilized also determines the selection of a method of sterilization. Metals, cloths, plastics, fibers, synthetics, lenses, delicate instru- ments, cement, mountings, light cords - all are affected by the method chosen (Fig. 1).

The importance of knowing the com- position of items to be sterilized cannot be overemphasized.

For example, differentiation should be established between plastics which will dissolve due to extremes of temperature; linens whicli will char and burn due to overexposure to high temperatures; lenses which will fog from moist heat sterilization; and cement mountings on light bulbs which will dissolve in cer- tain chemicals - specifically alcohol,

Some instruments are corroded by improper sterilization; many light cords have a lessened life span due to heat sterilization; and, lamps may be de- stroyed by extremes of temperature.

Our third major concern is the avail- ability of the sterilizing process. In se- lecting a process of sterilization, we must consider these factors: 1) sim- plicity, 2 ) safety; and 3) surety.

By simpiicity we mean the selection of the easiest, and the most economical (for we are all concerned with cost) method of sterilization for the particular item.

By safety we mean safety for the pa- tient - that there will be left on the in- strument no residue harmful to tissue; and safety for the practitioner - that it is a method he is able to use without harm to himself or to those with whom he works.

By surety we mean that he determines with reasonable certitude that destruc- tion of all organisms will be accom- plished by the method of sterilization he has selected.

October 1970 75

Keeping these factors in mind, we will now discuss three methods of steri- lization. Any other methods are less ac- ceptable and should be employed only when none of these three methods is available.

The three methods of sterilization are: 1) physical - moist heat sterilization, steam under pressure - “autoclave;” 2) chemical - gas - ethylene oxide; and 3) chemical - liquid - 2% activated gluteraldehyde.

The first method of sterilization is steam under pressure. One might say “Why even mention steam sterilization?”

It is still the simplest, the safest, the surest and the least expensive method of sterilization and sometimes we lose sight of this fact.

All instruments autoclaved for open surgical procedures are sterilized by this method. Many simple items are pack- aged individually, then autoclaved and kept available for use,

Linen and wrapped goods are steri- lized using the conventional autoclaves. Goods are sterilized at a temperature of 250 F for 30 minutes, with sufficient time allocated after the sterilizing cycle for drying the load. This is 10 to 30 minutes depending on package size.

The newer type of sterilizer known as the “high vacuum sterilizer” can be and is being used by many hospitals. The entire sterilization cycle takes 30 minutes. This 30 minutes includes re- moval of air, warming time, sterilization time (275 F for a shorter period of time), vacuum time, and drying time.

It is accepted procedure that un- wrapped goods can be “flash” autoclaved for a given period of time at 270 F; the time to be determined by the specific hospital. Most hospitals “flash instru- ments for 3 minutes or 7 minutes. (We, at the hospital in which I work, use 5 minutes and 12 minutes. We have dis-

cusssed changing the time but it takes us a little while to make major changes.) Regardless of the method used, the main guidelines of steam sterilization to re- member are:

1. Time, moisture and temperature (TMT) are the factors in moist heat sterilization. Pressure is needed only to raise the temperature of the steam.

2. To ensure the sterility of any in- strument being “flash” autoclaved, the instrument must be placed in a kit pan during the sterilizing cycle to ensure steam contact with all surfaces of the instrument.

3. Tests paks for determination of sterilization should be included in each load. These test packs can be purchased commercially or made up by ones own bacteriology department. Usually a non- pathogenic spore-forming organism such as Bacillus stearothermophilus is used.

4. The items wrapped, whether large or small, should be packaged to ensure adequate permeation by steam, and the safe opening of the package by an un- sterile person with maintenance of ste- rility. “Cater-corner” wrapping of small articles ensures adequate packaging of an item as well as easy and safe open- ing by the unsterile circulator. Large cuffs on linen bundles, also ensures in opening maintenance of sterility.

5. All wrapped goods should be dated with expiration dates.

6. John J. Perkins3 states that all hinged instruments should be opened for sterilization.

7. Operational directions of the steri- lizers should be understood by all staff members concerned with the running of the autoclaves. Operating room per- sonnel should never be hesitant to ques- tion directions which seem unclear.

Chemical sterilization, with which we, as urological nurses, are more concerned, has changed drastically and effectively

76 AOAN Journal

in the past ten years. This is due to two new sterilizing agents: 1) ethlene oxide gas; and 2) 2% activated gluteraldehyde.

For years urologists as well as gen- eral surgeons have been seeking a chem- ical solution which is economical, non- corrosive, nonirritating, free from resi- due, stable, bacteriocidal, fungicidal, sporicidal and viricidal. The answer to this question seems to be activated gluteraldehyde. It fulfills all require- ments mentioned, with the possible ex- ception of the last - viricidal.

The effect of chemicals on the hepa- titus virus is not known and cannot be determined until a susceptible experi- mental animal can be found. There is no evidence to support the theory that the hepatitis virus is more resistant to chemical disinfectants than spore-form- ing organisms. Thus, what is effective against spores can be assumed to be effective against hepatitis virus.

Many factors do influence the effec- tiveness of any chemical agent:

1. Cleanliness - The instruments should be meticulously cleansed to elimi- nate organic material and residue, then rinsed and dried to prevent dilution of solution or alteration of the pH of a solution.

2. Type and number of organisms- For the purpose of chemical disinfection, bacteria fall into three types: a ) ordi- nary, vegetative bacteria (staphylo- cocci) ; b ) Mycobacterium tuberculosis; and c ) spores.

3. Time requirements - An adequate span of time must be provided to en- sure that all generations of bacteria have been destroyed.

4. Agent strength and concentration -These must be low in strength yet have “cidal” (bacteriocidal, fungicidal, sporicidal, viricidal ) properties.

5. Environment aspects - Heat can speed the chemical action.

6. Use of containers - Containers should be lined to prevent damage to instruments. Containers should be cov- ered to prevent evaporation of solution and to prevent dust particles from set- tling on the surface of the solution.

7 . Rinsing of instruments - Rinsing of chemical solution from instruments at the end of the sterilizing cycle elimi- nates any question of remaining resi- due which will be injurious to tissue.

Of all the chemical disinfectants avail- able today Litsky4 recommends one and only one chemical disinfectant for in- struments - 2% activiated gluteralde- hyde.

Two percent activated gluteraldehyde is a solution which is both tuberculoci- dal and sporicidal. Aqueous solutions of gluteraldehyde are mildly acid in re- action. In their acid state they are non- sporicidal. Buffered with a suitable alka- linating agent (0.3%) sodium bicarbon- ate, they become antimicrobially active.

The alkalinating agent raises the pH level from 7.5 to 8.5 which results in its germicidal effect on all microorgan- isms. The solution of 2% activated glu- teraldehyde retains its efficacy for a two- week time span. This solution has consistently demonstrated its ability to destroy vegetative bacteria, fungi, Myco- bacterium tuberculosis, and some viruses within 10 minutes; and spores in 10 hours.

The odor is not unpleasant; the solu- tion retains its activity in the presence of organic protein and in relatively low concentrations. Two percent activated gluteraldehyde has no deleterious effect on lenses or cement mountings and does not interfere with electrical conductivity. Plastics and rubber goods can be im- mersed in activated gluteraldehyde and will remain unaffected. It is one of the few nonalcoholic solutions which will kill the tubercle bacillus properly. A

October .I970 77

Table 2 Evaluation of germicides

(Bacteria only)

LIQUIDS GENERAL

USEFULNESS AS EFFECTIVENESS

AGAINST

Mercurial compounds

Phenolic derivatives

Chlorine, inorganic

Alcohol, ethyl & isopropyl

Formolin, aqueous

Cationic detergents ("Quats")

Glutaraldehyde, activated

Combinations:

Formaldehyde-alcohol

Iodine-alcohol

Iodine-detergents (iodophors)

Chlorine-phenolic (hexachlorophene)

GASES

Ethylene oxide

Beta propiolactone

disinfec-

147'04% concentration.

70%-90% concentration.

tonts

None

-

Good

Goodl

GoodZ

Fair

Good

Good

Good3

Fair

Good

Fair

Special

Special

anti- septics

Poor

-

Poor

Fair

Good2

None

Good

None

None

Very good

Good

Good

None

None

TBC spores - - None

Good

Fair1

Very good2

Good3

None

Good

Very good3

Very good

Good"

None

Good

Good

None

Poor

Fair1

None

Fair3

None

Good

OTHER PROPERTIES

Static only; inactivated by organic matter; bland.

Bad odor; irritating; not inocti- voted by organic matter or soap.

Inactivated by organic matter; cor- rosive.

Volatile; strong concentrotion re- quired; rapidly cidal; not inacti- vated by soap.

Toxic; irritating fumes.

Neutralized by soap; relatively nontoxic; odorless, absorbed by gauze and fabrics.

Low protein coagulability; aque- ous solution useful for lens in- struments and rubber articles; unstable; corrodes metal on 24 hours' exposure.

Good3 Toxic; irritating fumes; volatile.

None Stains fabrics.

Poor4 Staining temporary; relatively non- toxic; corrosive.

None Slow acting; not neutralized by soap; HzO insoluble; alcohol sol- uble; inactivated by organic mat- ter.

Good Poisonous; expensive; penetrating.

Very Vesicant; carcinogenic; expensive; good unstable.

5%-8% formaldehyde (1240% formalin)

450 or more ppm available 12

78 AORN Journal

comparison of different chemical agents demonstrates without question that 2% activated gluteraldehyde is the chemical disinfectant of choice1 (Table 2 ) .

The third method of sterilization is ethylene oxide sterilization. One of the greatest contributions to effective sterili- zation in the operating room in the last ten years is the utilization of ethylene oxide gas as a sterilizing agent.

Ethylene oxide sterilization has made possible the sterilization of delicate arti- cles and synthetic products that hereto- fore challenged the ingenuity of the operating room nurse. The methodology of its use has been simplified to enable operating rooms to run these sterilizers safely and effectively.

Sterilization by ethylene oxide is essentially a function of concentration, exposure time, and temperature. Humid- ity is an important adjunct to sterilizing by gas- as it is a well known fact that moist bacteria are easier to kill than dried bacteria. For sterilization purposes, concentrations of 450 mgm per 1 cu ft are required.

Temperature is important because it affects the efficiency of the sterilizing action of ethylene oxide. The higher

Fig 2

the temperature, the lesser exposure time needed. The recommended time for goods sterilized at room temperature is 12 hours. As the temperature increases the time span lessens.

Ethylene oxide is highly penetrative and will diffuse through most commonly used packaging materials. Items proper- ly wrapped and sealed, then sterilized by ethylene oxide gas are considered sterile indefinitely, provided specific recommendations are met.

One of the many factors-an impor- tant one - involved in the sterilization of materials by ethylene oxide is the rate at which ethylene oxide dissipates from these materials following the sterilization cycle, and the quantity of ethylene oxide gas retained on ma- terials.

The range of surfaces from smooth nonporous metaI surfaces to rough, por- ous fibers must be considered. Ade- quate aeration time must be provided to ensure that all residue has dissi- pated from the sterilized article. It is equally important that test-pack con- trols be run on each load. Circulation of the load into general use should be deferred until the negative culture

A steam sterilizer was converted to a gas sterilizer for experimental work.

October 1970 79

Fig 3

An ethylene oxide sterilizer i s used for gas sterilization by Massachusetts General Hospital Pharmacy.

report has been returned by the bac- teriology department.

Since many types of materials have to be “quarantined for at least 48 hours, this should present no major problems. I thought you might be interested in two of the ethylene oxide sterilizers at the Massachusetts General Hospital. Fig 2, “our Rube Goldberg,” was used when experimental work was being carried out; Fig 3 is the present model being used for sterilization in our pharmacy.

Although the subject of sterilization is not new to the majority of OR nurses, there is much that has not yet been covered. What has been said does reaf-

firm, however, the principles of steriliza- tion set as prototypes by professional practitioners concerned with high stand- ards of practice in operating rooms.

If operating room nursing is a science, and I believe it is, then our actions must be based on scientific principles, not instinct or intuition. The principles of sterilization discussed here are aU based on tested and proved scientific data.

If these tenets of sterilization are practiced by all members of the oper- ating room staff, each patient undergoing surgery will be assured of the high level of competence which is his right. 0

REFERENCES

1. Spaulding, John J.: Principles and application 3. Perkins, John J.: Principles and methods of sterilization in health sciences, ed 2; Springfield, 111:

4. Litsky, Bertha Y., regional workshop, AORN of

of chemical disinfection, AORN, 1 :36-46 (May-June) 1963. Charles C. Thomas 1969.

2. Spoulding, John J.: Principles of microbiology as applied to OR nursing, AORN, 1:49-57 March- April) 1963.

Rhode Island, spring 1970.

80 AORN Journal