Sterilization Nusing Procedue

8/13/2019 Sterilization Nusing Procedue

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Administrative Protocol Page 1 of 5

FSC & JDH OR / CSSIR / Sterile Processing Unit Practice Manuals

John Dempsey Hospital Dept. of Nursing

PROCEDURE FOR: Sterilization

unit17/comb/sterilization

POLICY: 1. Items to be sterilized should be cleaned, decontaminated,sterilized, and stored in a controlled environment, per the

Procedure for: Care of Surgical Instruments and Powered

Equipment in the Perioperative Setting, this policy, and

with the device manufacturer's written instructions. More

detailed reference may also be made to the AORN Recommended

Practices for Sterilization and the Association for the

Advancement of Medical Instrumentation (AAMI) Standards and

Recommendations for Sterilization in Health Care Facilities.

2. Items to be sterilized will be packaged in systems(indicators, containers, etc.) that are approved for the

specific type of sterilization used. Medical-grade, all-

paper pouches will be used for organization of items withinsets; combination paper/plastic peel pouches will not be

used for this purpose.

3. The sterilizer manufacturer's written instructions for use,monitoring, and maintenance of each specific sterilizer will

be followed during use.

4. Load configuration and placement of items inside thesterilizers will comply with the sterilizer manufacturer's

recommendations and/or accepted guidelines from AAMI and

AORN.

5. Saturated steam under pressure should be used to sterilizeheat- and moisture-stable items unless otherwise indicated

by the device manufacturer:

a. manufacturers' written instructions for operating steam

sterilizers and for items sterilized should be followed;

certain types of equipment and implants (eg, some

pneumatically powered instruments; specialty orthopedic,

neurosurgery, trauma instruments) may require prolonged

exposure times or drying times;

b. following steam sterilization, the contents of the

sterilizer should be removed from the chamber and left

untouched for a period of at least 30 minutes;

c. warm or hot items should not be placed on cool or cold

surfaces;


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d. sterilized packages or containers that have formed

condensate should be considered unsterile and none of the

contents used;

e. steam sterilization integrators will be used internally

and indicators used externally for all sterilized items.

Rapid-action biological spore-test indicators will be used

in all loads processed in CSS/IR and for all loads

containing implants when processed in steam autoclaves in

the surgical suites.

6. Use of flash sterilization should be kept to a minimum:a. flash sterilization should be used only when there is

insufficient time to process by the preferred wrapped orcontainer method.

b. items that are flash sterilized should be noted on the

Flash Sterilization Log to guide purchase of additional

inventory;

c. packaging and wrapping (eg, textiles, paper/plastic

pouches, nonwoven wrappers) should not be used in flash

sterilization cycles

d. a rapid-action biological spore-test indicator must be

run for a minimum of 10 minutes with any implant that is

flash sterilized; each flash sterilization cycle should be

monitored to verify that parameters required for

sterilization have been met and the results are acceptable.

Label indicator with last name of patient for whom the

implant has been flash sterilized for traceability.

e. users should adhere to aseptic technique for flash-

sterilized items during transport to the point of use;

f. it is strongly preferred that a rigid sterilization

containers designed and intended for flash-sterilizationcycles be used; CSS/IR / Sterile Processing is responsible

for routine cleaning of rigid sterilization containers and

nursing is responsible for inspecting containers prior to

use;

g. nursing is responsible for documenting patient and device

information on the Flash Log; CSS/IR / Sterile Processing is


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responsible for maintaining documentation of sterilizer

cycle information.

7. Ethylene oxide (EO) sterilization that is appropriate forheat- and moisture-sensitive surgical items when indicated

by the device manufacturer will be performed only at the JDH

CSS/IR site.

a. Research Safety is responsible for monitoring air in the

enclosed sterilizer location and maintaining records of

same;

b. manufacturers recommendations will be followed for

preparation, exposure, and aeration of items sterilized.

8. Low-temperature hydrogen peroxide gas plasma sterilizationmethods (Sterrad) will be used for moisture-sensitive and

heat-sensitive items and when indicated by the device

manufacturer:

a. Items to be gas-plasma sterilized should clean and dry

and packaged in pouches designed for this sterilization

method;

b. only trays designed and validated for use with low-

temperature hydrogen peroxide gas plasma sterilization

should be used.

9.All loaned instrumentation and equipment that must besterilized will be handled according to the procedure for:

Loaned Instrumentation and Equipment: Inventory and

Processing.

10. Sterilized materials should be packaged, labeled, andstored in a manner to ensure sterility, and each item should

be marked with the sterilization date. Shelf life is to be

considered event-related unless the manufacturer requires /

recommends use of an expiration date.

11. Transportation of sterile items should be controlled:a. sterile items should be transported in covered or

enclosed carts; items transported outside the perioperative

are should be transported in carts with closed bottoms;


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b. items that are processed in either the JDH or FSC sterile

processing areas may be used in either locations operating

rooms (ORs) without resterilization at the alternate site as

long as transportation between sites maintains sterility,

preferably by use of the transport bins maintained for this

purpose.

12. As part of overall quality monitoring, all OR gravitydisplacement autoclaves will undergo daily biological

monitoring prior to patient care use and per manufacturer

recommendations. CSS/IR staff will perform testing of all

autoclaves during normal weekday mornings; OR staff will

perform testing on weekends and holidays for any autoclave

that will be used.

13. All sterilizer failures and corrective actions will bedocumented and reported to Infection Control and the

Director of Perioperative Services or his/her designee.

Load inventory records / flash sterilization log of the

affected autoclave will be reviewed and the attending

surgeon(s) will be notified if patient exposure occurred.

14. Sterilization records and logs shall be maintained byCSS/IR / Sterile Processing for 5 years.

PROCEDURE FOR: Use of Biological Indicator in Gravity Steam Sterilization

EQUIPMENT 3M Attest 1291 Rapid Readout Biological Indicator (BI) for

270F/132C gravity steam cycles:

Rapid readout BI system monitors the effectiveness of the gravity steam

sterilization process with results in one hour. System consists of:

a. biological indicators, consisting of a Geobacillus

stearothermophilus spore strip, sealed glass ampule with growth

medium and dual indicator system, blue color-coded cap with hole

for sterilant penetration, hydrophobic filter as a bacterial

barrier, and chemical indicator on the label that changes from

rose to brown when processed;

b. dual function fluorescent auto-reader/incubator, which runs a

140F/60C.;and

c. log book

Action Points of Emphasis

1. Label control start of day BI withC and place in incubator, crush

1. Apositive control / unprocessed BI anda test BI from the same lot and


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vial in crusher well, and place in

incubator.

manufacturing date must be incubated

daily. Incubation of the positive

control gives the benefit of a visual

color change by providing a positive

fluorescent result (red light +).

2. Place test pack in the center of thechamber and run for a 10-minute

exposure cycle.

2. Retrieve test pack, remove BI vial,crush vial in crusher well to join

the growth media with the processed

spore strip, and place in auto-reader

for 1 hour.

2. Automatic readings are taken until a re

or green light goes on. (Incubation of

the positive control gives the benefit

of a visual color change).

Processed indicator results are not

valid until the positive control reads

fluorescent positive (red light +),

which indicates a positive result or

sterilization failure.

3.At the end of the incubation time, ifa negative indicator result is

detected, the rapid read instruments

green light (-) will illuminate

indicating an acceptable

sterilization process. A red light

(+) will illuminate and an alarm will

sound (if the sound feature is turned

on), as soon as a positive indicator

result is detected.

4. Record testing results information inlog book and discard BIs in

biohazardous waste or sharps

receptacle.

5. Negative results (green): indicates an

acceptable sterilization process

6. Follow instructions above and labelwith patient information any BI

included in a flash-cycle load that

contains implants.

6. Complete Flash Sterilization Log entry

and check auto-reader for results of

rapid read out to confirm negative

results.

7. Report immediately all positive testresults (red) for further

investigation and/or action, per


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policy.

APPROVAL: Nursing Standards Committee

EFFECTIVE DATE: 10/03

REVISION DATE: 11/11

Sterilization Nusing Procedue

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