army bulletin - sterilizing medical materiel

8/12/2019 Army Bulletin - Sterilizing Medical Materiel

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DEPARTMENT OF THE ARMY TECHNICAL BULLETIN

STERILIZING MEDICAL, SURGICAL, DENTAL, AND VETERINARY MATERIEL

Headquarters, Department of the Army, Washington, DC

2 May 1987

Approved for public release;distribution is unlimited.

Section I

Introduction

P u r p o s e . . . . . . . . . . . . . . . . . - . . . . . . . . . . . . . . . . .

R e f e r e n c e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

E x p l a n a t i o n o f a b b r e v i a t i o n s a n d t e r m s

Responsibilities . . . . , . . .

Section II

Processing of Supplies

C l e a n i n g a n d p a c k a g i n g .

S t e r i l i z i n g e q u i p m e n t . . . .

S t e r i l i z a t i o n p r o c e s s m o n i t o r i n g

E q u i p m e n t m o n i t o r i n g .

Storage and inventory control of sterilizedmateriel

Maintenance and repair. . . , . .

S o l u t i o n s . . . . . . . . . . . . . . . . . . . . . . , , , . . . , . . . ,

R e p r o c e s s i n g o f s i n g l e - u s e i t e m s .G l o s s a r y . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . ,

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Glossary

Section I Introduction

1. Purpose.This bulletin prescribes policies, responsibilities, andmethods for the sterilization process within the De-partment of the Army health care facilities. It coversprocessing, sterilizing, handling, and storing of medi-cal, surgical, dental, and veterinary materiel before,during, and after sterilization. The objective of this

bulletin is to achieve assurance of sterility and deliv-ery of sterile supplies to user areas of health care facil-ities. Sanitizers (formerly identified as sterilizers-boil-ing type), pasteurizers, and automated chemical disin-fection processors are not sterilizers; they will not beused for this purpose. The methodology for evaluationand selection of equipment and installation require-ment-s for sterile processing will not be covered in thisbulletin.

2. Referencesa. Requir ed publi cati ons.

(1) AR 40-66 (Medical Record and Quality Assur-ance Administration). Cited in paragraph 12.

(2) AR 25-400-2 (The Modern Army Recordkeeing System (MARKS)). Cited in paragraphs 7b8b(3), and 10.

(3) FM 8-38 (Centralized Materiel ServicelSection). Cited in paragraph 4b(4).b. Referenced f orm.

DA Form 4106 (Report of Unusual Occurrence).

3. Explanation of abbreviations and termsAbbreviations and special terms used in this bulleare explained in the glossary.

4. Responsibilitiesa. Commanders of medical treatment facilit

(MTFs), dental activities, and veterinary activities ensure compliance with policies stated in paragraphthrough 12.b. Supervisors of the sterilization process will

sure that personnel performing the sterilization ta

have-(1) Documented formal training.


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(2) Orientation.(3) On-the-job training.(4) Active participation in continuing education

or inservice programs. Specific guidelines for produral implementation are found in FM 8-38.

Section II Processing of Supplies

5. Cleaning and packaginga. Cleaning.

(1) Since a diminished bioburden increases the as-surance that an item will be sterilized, thorough clean-ing procedures are essential during the presterilizationprocessing.

(2) Cleaning procedures will be carried out in aproperly designed area of a centralized materiel serv-ices/section (CMS). This area will have a physical bar-rier separating it from all other areas of the depart-ment; it will be equipped for cleaning procedures. Fa-cilities that do not have a central processing depart-ment must designate an area for this function.b. Packaging.

(1) The function of a package containing a sterilemedical item is to assure that the contents are main-tained in a sterile condition until the package is inten-tionally opened; provisions must be made for the con-tents to be removed without contamination.

(2) Users must evaluate the many packaging ma-terials available and select those best suited to theirneeds. Packaging material of reuseable woven fabricsmust be laundered between uses. Factors to be consid-ered include-

(a) Suitability for the sterilization method used.The material must provide for adequate air removal

and sterilant penetration.(b) Adequacy of barrier to microorganisms or

their vehicles.(c) Resistance to tear or puncture.(d) Proven seal integrity.(e) Ease of aseptic presentation. The package

must be flexible and memory free.(f) Absence of toxic ingredients and nonfast

dyes.(g) Economy.

6.Sterilizing equipment

Saturated steam under pressure, dry heat, or gas willbe used within the Army Medical Department tosteri-lize supplies and equipment. These items are used inpatient care where sterility is essential. Saturatedsteam under pressure is the preferred method of steri-lization for all medical materiel except as indicated inparagraphs 9cand d or unless not recommended by themateriel manufacturer. The methods of sterilizationare steam, chemical, and dry heat.a. St eam.

(1) Users must have a basic understanding of theoperations of the types of sterilizers being used in the

facility.

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(2) Types of steam sterilizers include-(a) Gravity displacement, general purpose, a

hi-speed emergency.(b)Prevacuum.(c)Vacuum pulsing.

b. Chemical.

(1) Ethy lene oxi de CEO).(a) EO is the choice method for sterilization

heat-labile and moisture-sensitive medical items, splies, and equipment.

(b) Because of its toxic, potentially flammaand explosive nature, EO must be used with cautiUsers must have a basic understanding of EO systhardware and potential sources of EO release to environment. Efforts should be directed toward creasing atmospheric levels in the worker envirment and residual levels in sterilized devices. The est guidelines for the safe use of EO must be impmented.

(c) All EO sterilized items are to be aerated imechanical aerator. Manufacturers of medical devimust provide in writing the sterilization and aeratinstructions to be followed when their products are sterile, but are required to be EO sterilized in the faity prior to use.

(2) Formal dehyde. Sterilization by formaldehy

should be done with caution due to its toxic propertIt is not recommended as a primary method of sterzation.c. D r yheat. Dry heat may be used for the sterili

tion of anhydrous oils, greases, and powders.

7. Sterilization process monitoringa. Chemi cal monit ors.

(1) Chemical monitors are physical or chemical vices employed to monitor one or more sterilizatprocess parameters to detect failures in packagi

loading, andlor sterilizer function.(2) Since there are presently no official perfor

ance standards for chemical monitors available, usare advised of the following:

(a) Selection should be based on reliability, saty, efficacy, and cost effectiveness.

(b) Users will require manufacturers of cheical monitors to provide written instructions to intpret indicator results and safety and performancharacteristics of the sterilization process monitor.

(c) A chemical monitor will be considered an

junct to a sound biological monitor, not a replacem

for it.


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(3) A chemical monitor must be used with everypackage processed.b. Bi ol ogi cal t esti ng.

(1) The purpose of biological monitoring is todocument the effectiveness of specific sterilizationcycles under conditions of use.

(2) A biological test will be done a minimum ofonce weekly on dry heat sterilizers and on each type of

steam sterilizer. A biological test will be done. withevery EO load. When sterilizing solutions, a biologicaltest suitable for liquids must be done with every load.

(3) Bacillus stearothermophilus spores will beused to test steam sterilizers. Bacillus subtilis sporeswill be used to test dry heat and EO sterilizers.

(4) Laboratories that perform biological testingwill report any positive readings after 24, 48, and 72hours of incubation; they will submit a final writtenreport to the sterilizer user.

(5) Biological test results will be kept on file in theusing area for a minimum of 12 months. MTFs in-

spected by the J oint Commission on Accreditation ofHospitals (J CAH) will keep results from one inspection

to the next. (See AR 25-400-2.)c. Load control and expirat ion identi fi cati on.

(1) All supplies subjected to a sterilizing cycle willbear an identification load control number after com-pletion of the sterilization process. (Ink, pencil, orstamped information on woven wrapping material isnot recommended.) EO sterilized supplies will be iden-tified with the load control number after completion ofthe aeration cycle. The local control number will con-sist of seven digits as follows:

(a) The first two digits indicate the numericaldesignation of each sterilizer.

(b)The third, fourth, and fifth digits indicatethe calendar day of the year; for example, 001 through365 days.

(c) The sixth and seventh digits indicate thenumber of the sterilization cycle during the 24-hourperiod.

(2) All packages will be marked visibly with anexpiration date. (See para 9.)

(3) Color coding systems may be used only as anadjunct to the required expiration date and load con-

trol number.(4) A log book will be maintained with the follow-

ing information:(a) Load control number.(b) Expiration date.(c) Contents of load.(d) Operator.

8. Equipment monitoringa. Bow ie Di ck t ype test for prevacuum and vacuum

pulsi ng st eri l i zers. A Bowie Dick test will be run on

prevacuum and vacuum pulsing type steam sterilizers

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each day of use. This test will test steam penetrationby demonstrating the adequacy of air removal fromthe chamber and load, or the presence of an air leak.b. M echanical process control moni t ors.

(1) Mechanical process control monitors includetime/temperature recording devices and temper-ature/pressure gauges. These must be examined by thesterilizer operator at the beginning and end of each

sterilizer cycle. When time/temperature recorders areprovided, the operator must be sure that the recordingis marked with the date, load control number, andsterilizer identification. The operator must also ensurethat the device is functioning properly. Whentime/temperature recorders are not provided, theoperator will monitor the temperature/pressuregauges during the sterilization cycle to verify attain-ment of adequate temperature and duration of expo-sure.

(2) Before any materials are removed from thesterilizer, the sterilizer recording must be examined

and initialed to verify attainment of adequatetemperature and duration of exposure.

(3) Recordings -must be maintained in the usingarea with other sterilizer records for a minimum of 12months. MTFs inspected by the J CAH will keeprecordings from one inspection to the next. (See AR25-400-2.)

9. Storage and inventory control of sterilized ma-teriala. Shel f l i fe.The shelf life of sterilized items is

event-related and not time-related. It is dependent

upon the quality of the wrapper material, the storageconditions, the conditions during transport, and theamount of handling. Shelf-life is not simply a matterof sterility maintenance, but is also a function of mate-rials life and inventory control. However, for purposesof inventory control and inventory rotation, items willbe packaged and dated in the following manner:

(1) I tems transported from an environmentallycontrolled area, via covered or enclosed cart with asolid bottom shelf, to another environmentally con-trolled area with limited access and restricted traffic.

(a) Nonwoven, plastic, plastic/paper laminate

-6 months.(b) Papers and wovens-72 hours.(c) Papers and wovens, placed in hermetically

sealed or envelope-closure taped protective covers(after a sufficient cooling period following the steril-ization cycle)-6 months.

(d) Papers and wovens removed fromhermat-ically sealed or envelope-closure taped protectivecovers and not opened or contaminated-72 hours.

(e)Commercially prepared sterile items will beconsidered sterile unless the integrity of the packaginghas been compromised or the manufacturers expira-

tion date has been reached.

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(2) Items transported from an environmentallycontrolled area via open baskets, by hand, or opencarts with perforated bottom shelf, to areas with pooror inadequate environmental conditions for storageand which do not have restricted traffic will be her-matically sealed or have envelope-closure of all pack-aged items and be dated for 6 months. Items removedfrom plastic and not used will be reprocessed.

(3) All plastic used either as primary packagingmaterial or protective cover will meet medical gradeplastic specifications; for example, 2 to 3 mils.b. te e st orage.

(1) Sterile materials should be stored at least 8 to10 inches from the floor, at least 18 inches from theceiling, and at least 2 inches from outside walls.

(2) Items should be positioned so that packageditems are not crushed, bent, compressed, or punctured.

(3) Items must not be stored in any location wherethey can become wet.

(4) Items should be stored on designated shelving,

cabinets, or covered containers that are cleaned andmaintained in a dry condition.(5) Outside shipping containers and corrugated

cartons should not be used as containers in sterile stor-age areas.

(6) Open shelved storage may be used in an en-vironmentally controlled area with limited access and

restricted traffic. Closed shelf storage will be usedconditions for open shelf storage are not met.

10. Maintenance and repairPreventive maintenance and repair procedures mube outlined by the manufacturer of the sterilizer acarried out by a trained individual. Preventive mainnance and repair records must be maintained in acordance with AR 25-400-2.

11. SolutionsPreparation and sterilization of parenteral and irriging liquids by health care facilities are discourageHowever, there may be instances where solutions mube processed in the health care facilities; for exampin emergency and field situations. In such instancesquality assurance program must be implemented to asure sterility and nonpyrogenicity.

12. Reprocessing of single-use itemsSingle-use items will not be reprocessed andlor

sterilized in the health care facility unless the manfacturer provides specific written instructions fprocessing and reusing these items. Only in emergensituations can single-use items be reprocessed for ptient care use. This emergency situation must be wedocumented. Use DA Form 4106 (Report of UnusuOccurrence). (See AR 40-66).

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Glossary

Section. I Abbreviations

AOCarea of concentrationCMScentralized materiel service

E Oethylene oxide

J CAHJ oint Commission on Accreditation of Hospitals

MOSmilitary occupational specialtyMTFmedical treatment facility

Section II Terms

Bioburden(bioload, microbial load)The number of microorganisms with which an

object is contaminated.

BiologicalmonitorA calibration of microorganisms that has a high

resistance tothe mode of sterilization being moni-tored. It is in or on a carrier, put up in a package thatmaintains the integrity of the inoculated carrier, andis of convenience to the ultimate user. The biologicalmonitor shows that sterilization conditions have beenachieved. It is also known as a biological indicator orbiological spore test.

Closed storageContainers that are closed on all sides; for

example, cabinets with doors, case carts, or modularenclosed cabinets.

Centralized materiel service/sectionAn organizational element of the nursing depart-

ment in an MTF that is charged with the responsibilityof processing supplies and equipment used in the treat-ment and care of patients.

Chemical monitorsPhysical or chemical devices employed to monitor

one or more parameters in a sterilization process in or-der toassure that factors such as product packaging,

loading, and functioning of the equipment do not pre-vent sterilization.

DecontaminationThe destruction or removal of living organisms to

a safe level, but not necessarily to zero.

HermeticallyDescription of an airtight seal that prevents con-

taminants from entering the wrapped or packageditem.

Memory-freeDescriptive terminology used in wrapping or pack-

aging materiels to define the ease with which wrap-

pers or packages are opened and which do not reboundto the folded position.

Open storageContainers that are not closed on all sides; for

example, open shelves or cabinets without doors.

Protective coverA cover that provides protection from dust, dirt,

and moisture during the storage period.

Restricted access areas (limited traffic area)An isolated room or area dedicated to sterile sup-

ply storage that can be closed off from the main trafficcorridors. Access is limited to authorized personnel ap-propriately attired in protective garb; for example,scrub suit, cap, mask, and shoe covers.

Sterilization processA process that includes the collecting, receiving,

sorting, decontamination, cleaning, preparation, pack-aging, sterilizing, dating, storing, inventory and issueof reuseable items.

Trained personOne who has specialized knowledge, skills, and

training in all aspects of the sterilization process andhas one of the following MOS or AOC: MOS 91D91B 91C 35G or 35U or AOC 66E.User area

An area where sterile supplies are being used; forexample, ward, clinic, treatment area, or battalion aidstation.

Glossary 1


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Suggested improvements. The proponent agency ofthis bulletin is the Office of The Surgeon General.Users are invited to send comments and suggested im-provements on DA Form 2028 (RecommendedChanges to Publications and Blank Forms) directly to

HQDA (SGPS-CP-N), 5111 Leesburg Pike, FallsChurch, VA 22041-3258.

By Order of the Secretary of the Army:

Official:

J OHN A. WICKHAM, J R.General , Uni t ed Stat es Army

Chief of St aff

R.L. DILWORTH

Bri gadier General , Uni t ed St ates Army

The Adjut ant General

DISTRIBUTION:To be distributed in accordance with DA Form 2 34B R requirements for Sterilizer, Surgical Instrument an

Dressing, Model MS1018

U.S.tOUERNmENT P R I N T I N G OFFICE~198? 131 090:001


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PIN: 061275-000

army bulletin - sterilizing medical materiel

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