001127 1004457 hatsis surgical assisting

March 2011 ASCRS/ASOADiana Hatsis, RN, BSN, COT

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Diana Hatsis, RN, BSN, COTSenior Clinical Research Associate

Chiltern InternationalBoynton Beach, FL

March2011 ASCRS/ASOA Diana Hatsis, R.N., BSN, C.O.T.

ASCRS/ASOA 2011San Diego, CA

Speaker Disclosure:

March2011 ASCRS/ASOA Diana Hatsis, RN, BSN, COT

I do not have financial interest in the subject I am presenting at this program.

I will not be discussing the use of any unapproved devices in my presentation.

GOALS

enhance a surgeon’s ability to perform his or her surgical case

Prevent infection

Shorten the patient’s recovery time


Create a surgical environment free of microorganisms and contamination.

**Keep our patients safe**

Act as a second set of eyes and hands for the surgeon


Universal Precautions


http://www.nhj.k12.in.us/teachers/sbaker/UP.htm

Universal Precautions:

A manual of mandatory policies and Standard Operating ProceduresStandard Operating Procedures

(SOPs) containing a description of each policy/task should be located

centrally and within easy reach.



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All patients should be treated as if they have a potential blood-borne disease that can infect the health care worker

All body fluids should be considered to be highly contagious sources

Items not considered contagious unless contaminated with blood/body fluids are: tears, nasal secretions, feces, saliva, urine/vomitus ,sputum and sweat



In demanding circumstances, when dealing with potentially harmful infections use ethyl or i l l h l f h d hiisopropyl alcohol for hand washing

Formulations containing ChlorhexidinePovidone or Hexachlorophene are also effective in preventing the spread of infections


How different items of surgical attire protect both the health care provider & the patient

Masks:Protect the patient from

microorganisms expelled from the operating room personnel during talking

Caps:

Protect the patient from microorganisms in hair and skin shed from the personnel during talking,

coughing, sneezing or breathing.

Protect healthcare providers from microorganisms and possible toxins released from the plume during the vaporization of corneal tissue.

health care worker’s head.

Eye ware:

Protect the healthcare provider from splashing of blood/body fluid

March 2011 ASCRS/ASOA Diana Hatsis, RN, BSN, COT

Patient Care Issues:Pre-op Nursing Care: Documentation

Prior to surgery it is important to check that all necessary t ti f d I C bt i d t i dtesting was performed, I.C. obtained, consents signed, and physicians notes re: I.C. and assessment/diagnosis with relation to the surgical procedure are clear and filed in the patient’s record.


Patient Care Issues:Pre-op Nursing Care: Patient Instruction Explain post-operative care prior to surgery. Afterwards

they may be sedated and not understand medication and t i ti i trestrictions regiment.

Obtain a history (and physical if ordered by the MD) and discuss chronic illnesses, current medications and allergies.

BP / P / Respirations (if required by MD)

Offer pre-op sedation (follow State Nurse Practice Act)


Patient Care Issues:

Pre-op Nursing Care: The Prep Have patient spell last name, recheck allergies and have

patient verbally verify treatment to be performed and onpatient verbally verify treatment to be performed and on what eye(s).

Mark Location (eye to be operated on) Instill topical anesthetic prior to prepping. Use only one

prep/swab per eye.



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Patient Care Issues:Pre-op Nursing Care: The Prep Use medial to lateral wipes from center to edges and

be sure not to re-wipe an area.

When an iodophor solution is used to prepare the skin before a surgical procedure, it should remain on the skin for 2 minutes and the excess should be wiped off with sterile gauze. (DO NOT soak!)

Be absolutely sure the solution has dried before beginning procedure. Wet prep solution can actually be a fire hazard for the patient!


Medical AsepsisClean technique- reduces the number of microorganisms and prevents the transmission of disease processes from one person or place to another.

Sterile technique –renders areas and objects maximally free from microorganisms.


Surgical Asepsis


Recommended Practicesfor Cleaning and SterilizingIntraocular Surgical Instruments

A special THANK YOU for the handout provided with permission from:

The American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Registered Nurses


Steps to Proper Sterilization:

Step 1: DecontaminationUse a solution of 0.5% chlorine to render the

instruments free of microorganisms.Contaminated heat-sensitive instruments can be

soaked in Glutaraldehyde and must remain submerged for at least 30 minutes.

Step 2: CleaningRemove organic material and residuals to reduce

the number of bacteria and endosporespresent.


Steps to Proper Sterilization:

Step 3: Sterilization

Ensures that instruments and other items are free of bacteria, viruses, fungi and parasites, including bacterial endospores.



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Methods of SterilizationCommonly Used in Ophthalmology

Autoclave (steam)

Dry Heat (electric oven)

Cold or Chemical (gas/liquid)


Steps of Steam Sterilization:

A.) Clean & decontaminate items to be sterilized.

B.) Open all instruments, especially those with jointed, sliding or multiple parts (e.g. hemostats), so that the steam can reach all surfaces on the instrument. All items should be separated to avoid damage during sterilization.


Steps of Steam Sterilization:

C.) Single wrapping helps to insure the safety of the instrument when wrapping is necessary. (M l i l hi(Metal against metal causes scratching, dulling and pitting of instruments)

D.) Follow manufacturer’s instruction, as each autoclave has specific directions.


Principles of Asepsis During Surgery


All materials in contact with the eye and used within the sterile field must be sterile.

Principle ISterile drapes should always be

used to establish a sterile field

When using or dispensing a sterile item or eye drop personnel must be assured that the item is sterile and will remain sterile until used.

Operating room personnel should check the package integrity, the expiration dates, and the appearance of the sterilizing indicator tape and the biological spore test.


Only the top surface of the surgical table is considered sterile. This excludes a one inch border around the edge.

Even when a sterile drape extends over the sides of the table, the sides are never considered sterile.

Any item that extends beyond the sterile boundary is considered unsterile and can not be brought back on to the sterile fieldback on to the sterile field.



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Scrubbed persons function within a sterile field

Principle II

Handwashing,

Gowning and Gloving


Performing the Surgical ScrubStep 1 –

Remove all jewelry on hands and wrists Remove all jewelry on hands and wrists.

Artificial nails should not be worn in the O.R.

Nail polish, if worn at all, should not be cracked or flaking and must be changed weekly

March 2011 ASCRS/ASOA Diana Hatsis, RN, BSN, COT

Performing the Surgical Scrub(Cont.)

Step 2 -

Adjust the water to a warm temperature paying close attention to careful hand washingclose attention to careful hand washing including the wrist area.

Use an anti-microbial soap or an alcohol hand rub solution. Rub hands together until dry.


Performing the Surgical Scrub(Cont.)

March2011 ASCRS/ASO Diana Hatsis, RN, BSN, COT

http://www.ttsh.com.sg/csi/

Gowning & Gloving: Gowns are considered sterile only in these

areas: Front from axillary line to waist

Sl 3 i h b h lb Sleeves to 3 inches above the elbow

Refer to the Association of Surgical Technologists’ handout for correct donning procedures or (even better) attend a workshop

(http://www.ast.org/pdf/Standards_of_Practice/RSOP_Gowning_Gloving.pdf - online, 2/11/2011)


Gowning:


http://www.tpub.com/content/medical/14295/img/14295_109_1.jpg


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Sterile Gloves:

In order to prevent the spread of infection sterile surgical gloves, h ld b d i

Sterile gloves protect the patient from microorganisms on the health care workers handsshould be worn during

all procedures in which there may be contact with blood or body fluids.

health care workers hands and protects the operating room personnel from infectious microorganisms in the client’s blood, tissue or body fluids.


Gloving:


http://research.uiowa.edu/animal/esasept.htm

Contamination of sterile gloves occurs when: The outside of a sterile glove is touched with

an ungloved hand.

Y t h thi th t i t il You touch anything that is non-sterile.

Your glove becomes torn or punctured.

A gloved hand drops below waist level.


When your glove becomes contaminated:

Stop whatever activity you are performing.

Step away from the sterile field.

Remove the contaminated glove.

If the hand is contaminated with blood or other bodily fluid, perform a surgical scrub and re-glove.



To Maintain a Safe Environment

Limit the number of people who enter these areas.

Require that all personnel who enter the surgical area wear clean scrubs, masks, caps and shoe covers.

Air condition the room and utilize HEPA filters and/or ionizer to eliminate particulate matter.



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To Maintain a Safe Environment (Cont.)

Before a new patient enters the room, clean and disinfect all surfaces that mayclean and disinfect all surfaces that may have been contaminated during the last procedure. For example: the microscope, mayo tray and the patient chair.


To Maintain a Safe Environment (Cont.)

Items above the level of the draped client are considered sterile.

Anything that drops below waist level isAnything that drops below waist level is considered unsterile.

If a sterile field crosses under anything that is not sterile the field is considered contaminated.



http://www.cafepress.com/+i_scrub_surgical_tech_throw_pillow,231165925

Principle IIIAll items within a sterile field should be sterile

• After opening a sterile package or bottle, the edges and cap are considered contaminated. The sterility of the bottle contents can not be assured if the cap is


of the bottle contents can not be assured if the cap is replaced on the bottle.

• It is very important to use good judgment based on the principles of aseptic technique when rendering an item sterile.

• An easy saying to remember is,”when in doubt…throw it out!”

To Maintain the Sterile Field

• Do not place sterile items near windows or doors.

• Place only sterile items within the sterile field.

• Do not contaminate sterile items when opening, dispensing or administering themdispensing or administering them.

• Recognize that the edges of a package containing a sterile object are not sterile.

• Remember that when the sterile field is penetrated by water, cut or torn it is considered not sterile.

• Be cognizant of the sterile field at all times and move around the area in a way that maintains sterility.


Items of doubtful sterility must be considered unsterile.

The state of sterility is an absolute; items are either sterile or unsterile.

The instrument that is dropped anywhere outside of the sterile environment is considered not sterile.



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Preparation of sterile setups hours before use and the covering of a sterile table with sterile sheets is not acceptable.

If sterile setups are covered or left unguarded they could be contaminated and should be regarded as unsterile.


Surgical AssistingCorrect Patient, Correct Procedure,

Correct Location Position the patient for optimal comfort Position the patient for optimal comfort

Wedge for under knees

Conforming “bead” pillow

Be sure patient is straight on the chair Shoulders in line with hips and feet

Be sure that the surgical eye is clearly marked


Surgical Assisting

Have instruments laid out in the order of use if possible

K t it i t f b i Keep wet items on a moisture proof barrier away from dry instruments

Hand off instruments to the surgeon in the position to be used

Bending & Reshaping should be prohibited


Surgical Assisting

WATCH SHARP TIPS AND BLADES!!!!

Be aware of the location of the surgeon’s h d ll t f thands as well as your own to ensure safety

Surgeons are usually looking through loupes or a microscope and rely on you to place the instrument properly in their hand without having to grope for it

March2011 ASCRS/ASOADiana Hatsis, RN, BSN, COT

Surgical Assisting

When an instrument is handed back dirty, immediately use an instrument wipe to clean away debris This will prevent malfunctionaway debris. This will prevent malfunction and clogging of instruments

Instruments which are not to be used again should be set to one side of tray so as not to contaminate other sterile items.


Surgical Assisting• All used needles and sharps should be

disposed of in a thick walled puncture proof container.

• Do NOT recap needles to avoid needle stick


• Do NOT recap needles to avoid needle stick injuries.

• Treat all non-disposables as extremely hazardous and if used without safe practices can infect the next patient to undergo a procedure


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Ophthalmic Surgical Issues:

• Toxic Anterior Segment Syndrome (TASS) is an acute sterile postoperative, usually pain-free, inflammatory reaction in which a noninfectious substance enters the anterior segment and induces toxic damage to the intraocular tissues.


• Endophthalmitis is an infectious condition of the internal eye in which the primary signs are decreased vision, vitritis, and the development of a hypopyon. Patients usually complain of pain. Other symptoms include erythema and edema. Primary causes are bacterial or fungal infection or may also result from trauma.

Ophthalmic Surgical Issues• TASS outbreaks should be reported to state and local health departments. Assistance with investigating outbreaks can be obtained from CDC’s Division of Healthcare Quality Promotion at telephone, 800-893-0485.


Healthcare Quality Promotion at telephone, 800 893 0485.

• TASS outbreaks that are caused by a specific product should be reported to the Food and Drug Administration’s MedWatch Program: at telephone, (800) FDA-1088; website, http://www.fda.gov/medwatch/report.htm.

Periodic Review of Universal Precautions Standard Operating Procedures (SOPs) and infection control surveillance reports helps to enhance everyone’s sterile technique.


Always be conscientious about maintaining sterility. Think of it like this: What if this patient was YOUR MOM ???


Thank You!!!


Diana Hatsis, RN, BSN, [email protected]

Toxic anterior segment syndrome (TASS) is an acute inflammation of the anteriorchamber, or segment, of the eye following cataract surgery. A variety of substanceshave been implicated as causes of TASS. These substances can be divided intoextraocular substances that inadvertently enter the anterior chamber during or aftersurgery (topical anti-septic agents,1,2 talc from surgical gloves,3,4 topical ophthalmicointment5), products that are introduced into the anterior chamber as a part of thesurgical procedure (anesthetic agents,6,7 preservatives,8-11 inappropriately reconstitut-ed intraocular preparations,12 mitomycin-C,13 intraocular lens14), and irritants on thesurfaces of intraocular surgical instruments that have accumulated as a conse-quence of inadequate or inappropriate instrument cleaning (denatured ophthalmicviscosurgical devices [OVDs] [Sutphin JE, Papadinus TJ. IOVS 1989; 30:165ARVO Abstract 8],15 detergents,16 heat stable endotoxin from overgrowth of gram-negative bacilli in water baths of ultrasonic cleaners,17,18 degradation of brass-con-taining surgical instruments from plasma gas sterilization,19 and impurities of auto-clave steam20).

Whereas opportunities exist to prevent TASS resulting from extraocularly orintraocularly applied products by product withdrawals, product communicationsand compounding alerts, preventing TASS by appropriate management of intraocu-lar surgical instruments is a challenge that must be repeated with each cycle ofcleaning and sterilization of cataract surgical instruments at every cataract surgicalfacility. In fact, this challenge is not always satisfactorily addressed, resulting insingle-facility outbreaks of TASS that frequently subside when the cleaning andsterilization steps are improved (N. Mamalis, MD, H. Edelhauser, PhD, personalcommunication, September 2006). Careful review of a number of facilities report-ing cases of TASS to the Intermountain Ocular Research Center at the Universityof Utah in the spring of 2006 identified many opportunities to lower the risk forTASS through improving the steps of the cleaning process and sterilization.21

The goal of these recommended practices for cleaning and sterilizing intraocularsurgical instruments is to prevent single-facility outbreaks of TASS related to con-taminated or degraded instruments. It is also hoped that the availability of recom-mended practices could facilitate the identification of causes of TASS and resolu-tion of single-facility outbreaks of TASS when they occur. The recommendationshave been written to be generic enough to enable appropriate application at allfacilities performing cataract surgery, recognizing that differences in proceduresand activities exist between surgical facilities.

The recommended practices are derived largely from existing, evidence-based gen-eral recommendations for cleaning and sterilizing all surgical instruments,22-24 fromevidence derived from published reports of single-facility outbreaks of TASS,3,4,15-20

and from directions for management of equipment provided by manufacturers. Thechallenge of preventing TASS is multifaceted. Relevant factors include the minuteamounts of irritants needed to cause clinically significant postoperative inflamma-tion of the anterior chamber, the frequency with which cataract surgery is per-formed on a daily basis across the country, the variety of instruments used, and the

Ad Hoc Task Force MembersWalter C. Hellinger, MD

Laura P. Bacalis, RN, BSN, CIC

Henry F. Edelhauser, PhD

Nick Mamalis, MD

Bernard Milstein, MD,

Samuel Masket, MD

Kandon Kamae, MD

Barbara Ann Harmer, RN, BSN, MHA

Julie Burlew-Quartey, RN, CNOR, CRNO

Sue Clouser, RN, MSN, CRNO

Linda Timmons, RN

Ramona Conner, RN, MSN, CNOR

Arjun Srinivasan, MD

Lynne Sehulster, PhD

Everette T. Beers, PhD

Chris Danford

Ned Luce

Patrick J. McCormick, PhD

Robert Shimizu, PhD

Mark Steen

Prepared February 16, 2007, by theAmerican Society of Cataract andRefractive Surgery Ad Hoc Task Force onCleaning and Sterilization of IntraocularInstruments.

Guidance provided by theAssociation of periOperativeRegistered Nurses, the Associationfor Professionals in InfectionControl and Epidemiology, the Society for HealthcareEpidemiology of America, theCenters for Disease Control andPrevention, and the U.S. Food and Drug Administration

SPECIALREPORT

Recommended Practices for Cleaning and Sterilizing Intraocular Surgical InstrumentsFrom the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Registered Nurses

ASCRSASORN

various requirements for cleaning different types of instru-ments. Consequently, these recommendations for cleaningand sterilization were developed by representatives of pro-fessional societies for cataract surgeons, ophthalmic andoperating room nurses, and infection control, in collabora-tion with manufacturers of intraocular cataract surgicalinstruments. Guidance was also provided by the Centers forDisease Control and Prevention and the U.S. Food and DrugAdministration.

These recommended practices are not intended to addressall requirements for sterilization and quality assurance of thesterilization process. They should be used in conjunctionwith current consensus guidelines from the Association forthe Advancement of Medical Instrumentation, the AmericanSociety of Ophthalmic Registered Nurses, and theAssociation of periOperative Registered Nurses.22-24,30 Therecommendations are believed to be relevant for instrumentsused in all intraocular surgical procedures, most of whichare cataract surgical procedures; therefore, to expedite con-sistent and optimal instrument management, the recommen-dations are intended to apply to all intraocular surgicalinstruments. When recommendations for instrument man-agement include cleaning without disinfection prior to steril-ization, unsterilized instruments should be considered con-taminated and therefore unsafe for handling unless appropri-ate barriers and precautions are used (eg, gloves and separa-tion from environments in which disinfected items are han-dled).

The recommendations are divided into 2 sections. The firstestablishes general principles of cleaning and sterilizationthat must be addressed to prevent TASS. The second pro-vides specific recommendations for cleaning and sterilizingintraocular surgical instruments.

General Principles of Cleaning andSterilizing Intraocular Surgical Instruments

The instruments should be kept moist until the cleaningprocess begins to avoid drying of debris and OVD.23,25,26

All debris inclusive of OVD should be removed.15,25,27

Quality and volume of water should be used as specified bymanufacturer's directions for use (DFU) for suspension ofdetergents and for cleaning and rinsing instruments.22,23,28 TheDFU for many intraocular instruments require or recom-mend sterile distilled or sterile deionized water for mostcleaning steps. Sterile distilled or sterile deionized water isrequired for final rinsing.25

Follow detergent and instrument manufacturers' DFU toensure proper use of the detergent and to ensure compatabil-ity with the instruments.22,23,28

Rinsing should remove all cleaning agents as well as alldebris loosened during the cleaning process.25,26,29

The method of sterilization applied to instruments should beapproved by both the manufacturer of the sterilizer and themanufacturer of the surgical instruments. Sterilizers shouldbe maintained in accordance with the manufacturer's recom-mendations.22-24

Procedures for instrument cleaning and sterilization shouldbe developed and written for each healthcare facility.22,23

Adequate time should be provided to allow completion ofall steps of cleaning and sterilization.22,23

Staff training, competency validation, and periodic perform-ance review should be implemented for each healthcarefacility.22,23,30

Recommendations for Cleaning and SterilizingIntraocular Surgical Instruments

1. Adequate time for thorough cleaning and sterilization ofinstrumentation should be established.a. Rigorous adherence to recommended procedures for

cleaning and sterilizing surgical instruments shouldnever be circumvented to save time or money.30,31

b. Inventory of instruments should be sufficient to meetsurgical volumes and to provide adequate time forcompletion of cleaning and sterilization.22,23

c. Flash sterilization is designed to manage unanticipat-ed, urgent needs for instruments. Flash sterilizationshould not be used to save time or as a substitute forsufficient instrument inventory.22

2. For each piece of equipment, the manufacturer'sDFU pertaining to cleaning and sterilization should befollowed.22-24

3. Ophthalmic viscosurgical device solution, which can dryand harden within minutes, should not be allowed to dryon the instruments.25

a. Instruments should be wiped with a dampened lint-free cloth and flushed and/or immersed in sterilewater in the operating room (OR) immediately fol-lowing use, in strict accordance with manufacturer'sDFU for each instrument.23,24 Sterile water baths usedfor cleaning or soaking soiled instruments should bekept in areas removed from the operative field andremoved from sites that maintain instruments neededto complete the surgical procedure.

b. The DFU for some reused cannulated instrumentspecify the solution, volumes, and frequency forflushing of each lumen. Flushing should be complet-ed as specified in the OR or in the decontaminationarea.23,24

Special Task Force Report

4. Whether they are used, instruments opened for a proce-dure should be transported from the OR in a closed con-tainer to the decontamination area, where cleaningshould be completed immediately.23,24

5. Disposable cannulas and tubing should be used when-ever possible, and they should be discarded after each use. These devices are sold without a DFU forcleaning, and thorough cleaning is difficult to achieveand validate.25

6. Devices labeled for single use only should not bereused; single-use devices do not include instructionsfor reuse or reprocessing. The FDA actively regulatesthird-party and hospital reprocessors of single-usedevices according to FDA guidance.32

7. To avoid contamination with bioburden and cleaningchemicals, intraocular instruments should be cleaned separately from nonophthalmologic surgical instruments.

8. The importance of enzymatic detergents for cleaningsoiled intraocular instruments has not been established.Inappropriate use and incomplete rinsing ofenzymatic detergents have been associated with out-breaks of TASS.16 If the DFU does not prohibit the useof a detergent and if a detergent is used a. Care should be taken to ensure instructions for

proper dilution, outdate, and disposal are followed.The cleaning solution should be mixed with measuredamounts of water and detergent (ie, not mixed withestimated volumes), according to the detergent'sDFU.23,24,28

b. Following cleaning with detergents, with or without the use of an ultrasonic cleaner, instruments should be thoroughly rinsed with copious volumes of water toensure removal of all detergent. If rinse volumes arespecified by the detergent manufacturer's DFU or bythe equipment manufacturer's DFU, they should beconsidered minimum volumes. Use of tap water forrinsing and for removal of detergent should be compati-ble with the manufacturer's DFU for the detergent andfor the equipment. The final rinse should be with steriledistilled or sterile eionized water.25,29,30

9. If an ultrasonic cleaner is useda. Ensure that gross soil has been removed prior to

placement in the ultrasonic cleaner. b. Check the manufacturer's DFU of instruments to

identify instruments that should not be subjected toultrasonic cleaning.

c. An ultrasonic unit designated for cleaning medicalinstruments should be used.24

d. Validation of functioning, degassing, and preventivemaintenance should be performed as recommended inthe ultrasonic cleaner's DFU.23,24

e. Ultrasonic machines must be emptied, cleaned, disin-fected, rinsed, and dried at least daily and preferablyafter each use.17,18,33 Unless specified otherwise by themanufacturer, cleaning should be performed with anEPA-registered, facility-approved disinfectant and fol-lowed by sterile or tap water rinse sufficient to fullyremove the cleaning agent. If not contraindicated bythe ultrasonic cleaner's manufacturer, final rinse with70% to 90% ethyl or isopropyl alcohol is recommend-ed when feasible and unassociated with risk for fire.The machine should be dried completely with a lint-free cloth.34-36

f. Refilling should occur immediately prior to use.

10. Manual cleaning processesa. Brushes should be designed for cleaning medical

instruments.24

b. Cleaning tools such as syringes and brushes should bediscarded after each use. If brushes are reused, theyshould be designed for reuse and they should becleaned and high-level disinfected or sterilized, prefer-ably after each use, or at least once daily.24,34

c. Cleaning solutions should be discarded after eachuse.24

d. When flushing is used as part of a cleaning technique,the effluent should be discharged into a sink or sepa-rate basin so the fluid is not reused. Discharge of theeffluent should be completed to minimize splash andaerosolization.

11. Rinsinga. Follow the manufacturer's DFU for selecting the

appropriate type of rinse water for equipment. b. Unless otherwise specified by the manufacturer's

DFU, sterile distilled or sterile deionized water shouldbe used for the final rinse of instruments.25

c. Rinsing should provide flow of water through and/orover instruments, with effluent discarded as it is usedso only debris-free water is used for rinsing.

d. Agitation in a basin of water should not be used as afinal rinse.

12. Following thorough rinsing, instruments with lumens should be dried with forced or compressed air. a. Compressed air should be filtered and free of oil

and water.b. Instruments with lumens should be fully dried.23

13. Specific instruments: phacoemulsifier handpiece, irrigator/aspirator, irrigator/aspirator tips, and insertersa. Flush phacoemulsifier handpiece with balanced saline

solution prior to removing from the operative field.b. Wipe each instrument with a lint-free cloth and place

immediately in a bath of sterile water. Remove fromthe operative field and remove from sites thatmaintain instruments needed for completion of the

surgical procedure, in strict accordance with the man-ufacturer's DFU for each piece of equipment. Toavoid introduction of water or reintroduction of grosssoil to the operative field, the sterile water bathshould be clearly separated from the operative field.23

c. Clean and flush each item in accordance with themanufacturer's DFU and verify removal of all debrisinclusive of OVD.23

d. Inspect irrigator/aspirator tips, preferably undermagnification, before sterilization.23,25

14. If reusable woven materials are used for draping thesterile field, to absorb condensate in steam-sterilizedinstrument trays or to wipe instruments, they should belaundered and rinsed thoroughly between each use toeliminate surgical compounds, debris, and cleaningagents.a. Inadequate rinsing of high pH detergents used in

institutional laundering can leave chemical residuesthat could be transferred to intraocular instruments.30

Laundry procedures should be reviewed and moni-tored to ensure delivery of residue-free, reused wovenmaterials; otherwise disposable, chemical, and lint-free materials should be used.

b. All woven materials used in intraocular surgery orinstrument management should be lint free.

15. Cleanliness and integrity of instruments should beverified.23,24

a. Instruments should be visually inspected for debrisand damage, preferably under magnification, immedi-ately after cleaning and before packaging for sterili-zation to ensure removal of visible debris.24,25,30,37

b. Additional or repeated cleaning and rinsing steps maybe required on a case-by-case basis to ensure removalof all debris and OVD.

c. Surgeons should examine instruments under themicroscope prior to each use and reject any instru-ment that shows signs of residual debris or defects.38

16. Sterilization a. The method for sterilizing intraocular surgical instru-

ments should be in accordance with the DFU of theinstruments and with the DFU of the sterilizermanufacturer.22,24

b. Steam sterilization should be completed in accor-dance with published guidelines.22,24

c. Glutaraldehyde is not recommended for sterilizingintraocular instruments because of the toxicity of glu-taraldehyde residues resulting from inadequate rins-ing or contamination during post-sterilization han-dling. Other low temperature methods of sterilizationshould not be used unless the ophthalmic instrumentmanufacturer and the sterilizer manufacturer havevalidated the method for the specific instruments withrespect to efficacy of sterilization, potential ocular

toxicity (eg, from oxidation of metals) and instrumentfunctionality.19

d. Verification of sterilizer function should be complet-ed at least weekly, preferably daily, in accordancewith the sterilizer manufacturer's instructions for useand with published guidelines, and documented in thefacility log.22,24

e. Measures should be taken to ensure that preventivemaintenance, cleaning, and inspection of sterilizersare performed on a scheduled basis, according to thesterilizer manufacturer's written instructions.22,24 Allpreventive maintenance should be documented.

f. Maintenance of boilers, of the water filtration sys-tems, and of the quality of water supplying the steam-sterilizing system should be verified at least yearly.Healthcare organizations may find consultation withcompanies specializing in boiler maintenance andwater quality helpful.20,22,24

17. Administrative controls should be implemented.a. Policies and procedures regarding cleaning and steril-

izing intraocular surgical instruments should be writ-ten, reviewed periodically (at least annually), andkept readily available within the practice setting.22,23

b. A sufficient number of instrument sets, phacoemulsi-fier handpieces, irrigator/aspirators, and insertersshould be purchased to allow adequate time forcleaning and sterilizing between procedures.

c. Personnel involved in handling and cleaning and/orsterilizing intraocular surgical instruments should i. Be educated about TASS and its causes at hire and

updated regularly thereafter.25

ii. Receive initial education, training, and validationof competency in the cleaning, inspection, prepa-ration, packaging, sterilization, storage, and distri-bution of all intraocular surgical instruments.Education, training, and validation of competencyshould be updated at least annually and prior tointroduction of any new devices or procedures.22,23

iii. Be educated and trained in cleaning and steriliza-tion procedures as well as related tasks (eg, equip-ment operation, preventive maintenance) via aformal, standardized training program adminis-tered by qualified personnel.22,23

iv. Undergo competency validations by direct obser-vation of performance, using a competencychecklist to ensure uniform evaluation of allpersonnel.22,23

d. Records of instrument use, of medication use, and ofsterilization should be maintained in accordance withfacility policy.22,24,25 Complete and detailed records willaid in the investigation of any occurrence of TASS.

e. A surveillance system for detecting TASS should beimplemented. Cases of TASS should prompt re-evalu-ation of cleaning and sterilization procedures.21

REFERENCES

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2. Phinney RB, Mondino BJ, Hofbauer JD, et al. Corneal edemarelated to accidental Hibiclens exposure. Am J Ophthalmol 1988;106:210-215

3. Cox MJ, Woods JA, Newman S, Edlich RF. Toxic effects of surgi-cal glove powders on the eye. J Long-Term Eff Med Implants1996; 6:219-226

4. Bene C, Kranias G. Possible intraocular lens contamination bysurgical glove powder. Ophthalmic Surg 1986; 17:290-291

5. Werner L, Sher JH, Taylor JR, et al. Toxic anterior segment syn-drome and possible association with ointment in the anteriorchamber following cataract surgery. J Cataract Refract Surg 2006;32:227-235

6. Guzey M, Satici A, Dogan Z, Karadede S. The effects of bupiva-caine and lidocaine on the corneal endothelium when applied intothe anterior chamber at the concentrations supplied commercially.Ophthalmologica. 2002; 216:113-117

7. Anderson NJ, Nath R, Anderson CJ, Edelhauser HF. Comparisonof preservative-free bupivacaine vs lidocaine for intracameralanesthesia: a randomized clinical trial and in vitro analysis. Am JOphthalmol 1999; 127:393-402

8. Liu H, Routley I, Teichmann KD. Toxic endothelial cell destruc-tion from intraocular benzalkonium chloride. J Cataract RefractSurg 2001; 27:1746-1750

9. Eleftheriadis H, Cheong M, Sandeman S, et al. Corneal toxicitysecondary to inadvertent use of benzalkonium chloride preservedviscoelastic material in cataract surgery. Br J Ophthalmol 2002;86:299-305

10. Hull DS, Chemotti MT, Edelhauser HF, et al. Effect of epinephrineon the corneal endothelium. Am J Ophthalmol 1975; 79:245-250

11. Jumper JM, McCauley MB, Equi RA, et al. Corneal toxicity ofintraocular hyaluronidase. J Ocul Pharmacol Ther 2002; 18:89-97

12. Holley GP, Alam A, Kiri A, Edelhauser HF. Effect of indocyaninegreen intraocular stain on human and rabbit corneal endothelialstructure and viability; an in vitro study. J Cataract Refract Surg2002; 28:1027-1033

13. Fukuchi T, Hayakawa Y, Hara H, Abe H. Corneal endothelial dam-age after trabeculectomy with mitomycin C in two patients withglaucoma with cornea guttata. Cornea 2002; 21:300-304

14. Jehan FS, Mamalis N, Spencer TS, et al. Postoperative sterileendophthalmitis (TASS) associated with the MemoryLens. JCataract Refract Surg 2000; 26:1773-1777

15. Kim JH. Intraocular inflammation of denatured viscoelastic sub-stance in cases of cataract extraction and lens implantation. JCataract Refract Surg 1987; 13:537-542

16. Breebaart AC, Nuyts RMMA, Pels E, et al. Toxic endothelial celldestruction of the cornea after routine extracapsular cataract sur-gery. Arch Ophthalmol 1990; 108:1121-1125

17. Richburg FA, Reidy JJ, Apple DJ, Olson RJ. Sterile hypopyon sec-ondary to ultrasonic cleaning solution. J Cataract Refract Surg1986; 12:248-251

18. Kreisler KR, Martin SS, Young CW, et al. Postoperative inflamma-tion following cataract extraction caused by bacterial contamina-tion of the cleaning bath detergent. J Cataract Refract Surg 1992;18:106-110

19. Duffy RE, Brown SE, Caldwell KL, et al. An epidemic of cornealdestruction caused by plasma gas sterilization; the ToxicEndothelial Cell Destruction Syndrome Investigative Team. ArchOphthalmol 2000; 118:1167-1176

20. Hellinger WC, Hasan SA, Bacalis LP, et al. Outbreak of toxic ante-rior segment syndrome following cataract surgery associated withimpurities in autoclave steam moisture. Infect Control HospEpidemiol 2006; 27:294-298

21. Toxic Anterior Segment Syndrome (TASS) Outbreak Final Report -September 22, 2006 [online]. Available at:http://www.ascrs.org/press_releases/Final-TASS-Report.cfm.Accessed February 15, 2007

22. AORN. Recommended practices for sterilization in the periopera-tive practice setting. In: Association of Operating Room Nurses.Standards, Recommended Practices & Guidelines. Denver, CO,AORN, 2007; 673-687.

23. AORN. Recommended practices for cleaning and caring for surgi-cal instrumentation and powered equipment. In: Association ofOperating Room Nurses. Standards, Recommended Practices &Guidelines. Denver, CO, AORN, 2006; 555-563

24. Association for the Advancement of Medical Instrumentation.Comprehensive Guide to Steam Sterilization and SterilityAssurance in Health Care Facilities. ANSI/AAMI ST79:2006

25. Mamalis N, Edelhauser HF, Dawson DG, et al. Toxic anterior seg-ment syndrome. J Cataract Refract Surg 2006; 32:324-333

26. Parikh CH, Edelhauser HF. Ocular surgical pharmacology: cornealendothelial safety and toxicity. Curr Opin Ophthalmol 2003;14:178-185

27. Rutala WA. Disinfection and sterilization of patient-care items.Infect Control Hosp Epidemiol 1996; 17:377-384

28. AORN. Recommended practices for the evaluation and selection ofproducts and medical devices used in perioperative practice setting.AORN J 1998; 67:270-272

29. Parikh C, Sippy BD, Martin DF, Edelhauser HF. Effects of enzy-matic sterilization detergents on the corneal endothelium. ArchOphthalmol 2002; 120:165-172

30. Burlew J. Care and Handling of Ophthalmic MicrosurgicalInstruments, 2nd ed. San Francisco, CA, American Society ofOphthalmic Registered Nurses, 2006

31. AORN. Explications for perioperative nursing. In: Association ofOperating Room Nurses. Standards, Recommended Practices, &Guidelines. Denver, CO, AORN, 2006; 167-197

Copyright 2007 by the American Society of Cataract and Refractive Surgery and the American Society of OphthalmicAdministrators. All rights reserved. Printed in the United States of American. None of the contents may be reproduced,stored in a retrieval system (currently available or developed in the future), or transmitted in any form or by any means(electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of the publisher.

Special Task Force Report

The mission of the American Society of Cataract and Refractive Surgery is to advance theart and science of ophthalmic surgery and the knowledge and skills of ophthalmic surgeons.It does so by providing clinical and practice management education and by working withpatients, government, and the medical community to promote the quality of eyecare.

American Society of Cataract and Refractive Surgery, 4000 Legato Road, Suite 700, Fairfax, VA 22033703-591-2220 • [email protected] • www.ascrs.org

AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY

ASCRS

32. Guidance for Industry and for FDA Staff. Enforcement Prioritiesfor Single-Use Devices Reprocessed by Third Parties andHospitals [online]. Available at:http://www.fda.gov/cdrh/comp/guidance/1168.pdf. AccessedFebruary 15, 2007

33. Miller CH, Riggen SD, Sheldrake MA, Neeb JM. Presence ofmicroorganisms in used ultrasonic cleaning solutions. Am J Dent1993; 6:27-31

34. American Society for Gastrointestinal Endoscopy. Multi-societyguideline for reprocessing flexible gastrointestinal endoscopes.Gastrointest Endosc 2003; 58:1-8

35. Standards of Infection Control in Reprocessing of FlexibleGastrointestinal Endoscopes [online]. Available at:http://www.sgna.org/Resources/guidelines/guideline3.cfm. Accessed February 15, 2007

36. Guideline for Environmental Infection Control in Health-CareFacilities, Recommendations of the CDC and the HospitalInfection Control Practice Advisory Committee, 2003 [online].Available at: http://www.cdc.gov/ncidod/dhqp/gl_environinfec-tion.html. Accessed February 15, 2007

37. Dinakaran S, Kayarkar VV. Debris on processed ophthalmicinstruments: a cause for concern. Eye 2002; 16:281-284

38. Beran RF. Cleaning of ophthalmic diamond scalpels. J RefractCorneal Surg 1994; 10:582-586

Task Force MembersWalter C. Hellinger, MDMayo Clinic JacksonvilleJacksonville, FL

Laura P. Bacalis, RN, BSN, CICAssociation for Professionals inInfection Control and EpidemiologyJacksonville, FL

Henry F. Edelhauser, PhD, TASS Task Force Co-ChairEmory University Eye CenterAtlanta, GA

Nick Mamalis, MD, TASS Task Force Co-ChairMoran Eye Center, University of UtahSalt Lake City, UT

Bernard Milstein, MD, Chair, ASCRSComprehensive OphthalmologyClinical CommitteeGalveston, TX

Samuel Masket, MD, ASCRS PresidentCentury City, CA

Kandon Kamae, MDMoran Eye Center, University of UtahSalt Lake City, UT

Barbara Ann Harmer, RN, BSN, MHAAmerican Society of Ophthalmic Registered NursesVero Beach, FL

Julie Burlew-Quartey, RN, CNOR, CRNOAmerican Society of OphthalmicRegistered NursesPalo Alto, California

Sue Clouser, RN, MSN, CRNOAmerican Society of OphthalmicRegistered NursesPlano, Texas

Linda Timmons, RNAmerican Society of OphthalmicRegistered NursesMiami, FL

Ramona Conner, RN, MSN, CNORAssociation of periOperativeRegistered Nurses Standards and RecommendedPractices Center for NursingPractice, Denver, CO

Arjun Srinivasan, MDDivision of Healthcare Quality Promotion Centers for Disease Control and Prevention , Atlanta, GA

Lynne Sehulster, PhDDivision of Healthcare Quality Promotion Centers for Disease Control and Prevention , Atlanta, GA

Everette T. Beers, Ph.D. Food and Drug AdministrationBethesda, MD

Chris DanfordAlcon Labs, Inc.Fort Worth, TX

Ned LuceBausch & Lomb, Inc.Rochester, NY

Patrick J. McCormick, Ph.D.Bausch & Lomb, Inc.Rochester, NY

Robert Shimizu, Ph.D.Advanced Medical OpticsSanta Ana, CA

Mark SteenAdvanced Medical OpticsSanta Ana, CA

Recommended Standards of Practice for Gowning and Gloving

Introduction The following Recommended Standards of Practice were researched and authored by the AST Education and Professional Standards Committee and have been approved by the AST Board of Directors. They are effective October 20, 2008. AST developed the Recommended Standards of Practice to support health care facilities in the reinforcement of best practices as related to gowning and gloving in the perioperative setting. The purpose of the Recommended Standards is to provide an outline that surgical team members can used to develop and implement polices and procedures for gowning and gloving. The Recommended Standards is presented with the understanding that it is the responsibility of the health care facility to develop, approve, and establish policies and procedures for gowning and gloving according to established health care facility protocols. Rationale The following are Recommended Standards of Practice related to gowning and gloving in the perioperative setting. Gowning and gloving is part of the daily routine of the CST and CFA in the O.R. As required by Standard Precautions, sterile gowns and gloves are worn to prevent the migration of microbes from the skin and scrub attire of the sterile team member to the sterile field. Additionally, sterile attire prevents blood and body fluids from contaminating the team member. Lastly, t sterile attire aids in preventing surgical site infections (SSI) by allowing team members to work within the sterile field handling sterile Below is a reminder to surgical personnel: Additionally, the O.R. professional’s skin, especially the hands, may not be an intact barrier to viral penetration on any given day. Allergic rashes, shearing injuries from suture tying, and weekend sports or other activities may cause unapparent breaks in the skin. Personal protective equipment should be chosen with these factors in mind. The inability to identify all patients infected with bloodborne pathogens reinforces the need for effective protection with all patients. All surgical team members should be involved in the process of developing and implementing health care facility policies and procedures for gowning and gloving. Standard of Practice I All sterile surgical team members are required to don a sterile surgical gown prior to entering the sterile field to aid in preventing surgical site infection (SSI).

1. Gowns are required to be worn according to Standard Precautions to provide a barrier between the patient and sterile surgical team member to reduce microbial and body fluid contamination of the surgical wound. Additionally, the gown protects the team member from the patient’s blood and body fluids.24

2. Gowns are sterile in the front from mid-chest level to the level of the sterile field or waist level.

A. If a surgical team member requires a standing platform, it should be positioned prior to the team member taking position at the sterile field. The team member should avoid changing levels, eg stepping down to take a new position at the sterile field.

B. If the surgeon is seated for the surgical procedure, the entire surgical team should be seated and remain seated for the entire procedure, avoiding changing levels.

3. The gowns are sterile from two inches above the elbow to the cuff seam. The axillary region is not considered a sterile area.

4. The back of the gown is not considered sterile, because it cannot be observed by the sterile team member.

5. The sterile gown package for the CST in the first scrub role should be opened on a flat, separate surface, such as the Mayo stand. The gown should not be opened onto the sterile back table, and the CST should not obtain the gown from the back table in order to avoid contaminating the sterile field, eg water dripping from the hands and/or arms or inadvertently touching a sterile item.

A. A CST, CFA or other surgical personnel who have performed a surgical scrub who enter the O.R. when the procedure is in process should gown and glove from a flat, separate surface, such as the prep table. The gown should not be opened onto the sterile back table or any other sterile surface, and the individual should not obtain the gown from the back table or sterile surface in order to avoid contaminating the sterile field, eg water dripping from the hands and/or arms, or inadvertently touching a sterile item.

6. Gowns must be properly sterilized in accordance with the recommendations of the Association for the Advancement of Medical Instrumentation (AAMI) and American National Standards Institute (ANSI).

A. Methods of sterilization for gowns, include but are not limited to, radiation, steam, and ethylene oxide.

B. Single-use gowns that are included in the sterile back table pack or were opened and included in the sterile set-up, but not used, should not be re-sterilized.

7. When reusable woven gowns are used, manufacturer’s instructions should be consulted in regard to the care and reprocessing of the gowns.

8. Disposable and non-disposable contaminated gowns should be properly contained at the end of the surgical procedure. The gowns should be placed in impervious bags that are labeled with the biohazard symbol.

A. Gowns should be removed prior to the removal of the gloves. Standard of Practice II A compromise in the integrity of the microbial barrier results in contamination.

1. Gowns must be free of holes, punctures and tears. A. Gowns should be resistant to punctures and tears to prevent microbial

contamination of the sterile field and prevent SSI.

Standard of Practice III Gown selection should be made according to the surgical procedure and the anticipated level of exposure to blood and body fluids.

1. Gowns should be resistant to blood and body fluid penetration. A. Intraoperatively patient body fluids and irrigating solutions come into

contact with gowns. B. Gowns should be impervious and fluid-resistant to prevent strike-through

contamination from microorganisms.4 Prevention of strike-through contamination reduces the risk of SSI.

2. The gown product selection process should include evaluation of the performance qualities listed below as recommended by AAMI and ANSI/AAMI.17,18

A. Microbial and fluid resistance B. Resistance to tears and punctures C. Comfort; fit loosely and comfortably to prevent excess heat build up. D. Durability, particularly related to repeated sterilization of non-disposable

materials E. Gowns, in particular gowns composed of reusable woven material, are free

of toxic substances, such as dyes and laundry detergent residues. F. Flammability resistance G. Lint free

3. Gowns, both disposable and non-disposable, are manufactured in styles that vary in the level of reinforcement, thus affecting the extent of fluid resistance.13

A. It is the ethical responsibility of the surgical team to contribute to controlling the costs of the surgical procedure. The choice of gown should be based upon the procedure to be performed and the anticipated level of exposure to blood and body fluids.15,23 For example, exposure to blood and body fluids is minimal when a blepharoplasty is performed; therefore, a routine gown with the least reinforcement and thus less expensive will provide adequate protection. However, a high degree of exposure to blood and body fluids will occur during a total hip arthroplasty, thus requiring a gown with maximum reinforcement. The Stull and Pournoor (1998) article is a good source to consult; the tables in the article match procedures to level of exposure to blood and body fluids in order to better determine and select the gown to be used.20

4. It is recommended when a health care facility is in the process of selecting gown materials that the AAMI Technical Information Report Selection of Surgical Gowns and Drapes in Health Care Facilities, No. 11-1994 be used as a primary guide.17

Standard of Practice IV Gowns should be lint free as well as free of toxic substances.

1. Lint is recognized as a vector for causing SSI. Additionally, airborne lint serves as a medium for transport of microbes.

A. Lint-free gowns minimize airborne contamination and spreading of particles into the surgical wound.

2. Gowns should be free of toxic substances. A. Gowns should be free of toxic substances such as dyes. Reusable gowns

should also be free of laundry detergent residues. B. These substances could cause the surgical team member or patient to

experience a negative reaction, ranging from mild skin rash to anaphylaxis.

Standard of Practice V Gowns should be flame resistant.

A. Manufacturers of gowns should follow the standards for surgical gowns as established by the Consumer Product Safety Commission (CPSC) and National Fire Protection Agency (NFPA). The manufacturer should provide data concerning the gowns in order for the end user to evaluate the efficacy of the product. The surgical team should refer to the following standards when evaluating gowns:

• NFPA: NFPA No. 702-1980 Standard for Classification of the Flammability of Wearing Apparel. In 1987, the NFPA removed this from their list of current standards, but it is still used as a reference by manufacturers, FDA, and AAMI as one of the standards to be used for evaluating the safety and performance characteristics of gowns. This standard established four classes for rating gowns by two factors: ignition and flame spread. Class 1, relatively slow burn, is the most relevant for surgical team members.

• CPSC: 16 CFR Part 1610, Standard for the Flammability of Clothing Textiles. Through this standard, the CPSC is responsible for the regulation of gowns. When evaluating a gown, the surgical team members should confirm that the manufacturers information includes the statement The Basic Fabric Meets the Class 1 Flammability Requirements for CPSC 16 CFR Part 1610.

2. Gowns should resist ignition from sources, such as lasers, fiberoptics, and electrosurgery within the sterile field.

A. Surgery personnel should wear flame-resistant gowns when performing laser surgery.

B. Surgery personnel should still exercise caution when wearing any type of gown, including flame-resistant gowns. Gown material is composed of natural and/or synthetic fibers that could be flammable. If the three components of the fire triangle, fuel, ignition, and oxygen, are present, the possibility of a fire exists.

3. Health care facilities should establish policies and procedures for fire prevention. A. All HCWs should complete annual competencies on fire safety.

Standard of Practice VI The surgical team members should evaluate gowns based upon specific factors and characteristics.

1. When evaluating gowns the surgical team members should evaluate the information as provided by the American Society for Testing and Materials (ASTM).

A. ASTM developed two tests, F1670 and F1671 for assessing the fluid and microbial barriers of surgical non-woven and woven fabrics.17,18

B. The manufacturer should provide the information as related to the results of these tests when the surgical team members are evaluating gowns.

C. AAMI and the U. S. Food and Drug Administration both confirm that the ASTM tests are the definitive tests for assessing the fluid and microbial barriers of surgical fabrics.

Standard of Practice VII Gowns made of reusable woven fabric should have the same barrier characteristics as single-use non-woven disposable fabrics.

1. The thread count and chemical treatments establish barrier properties of the woven fabric.

A. It is recommended that woven fabrics with a thread count of 270 to 280 be used as sterile gowns.

B. It is recommended that woven fabrics treated with chemicals to increase the barrier properties be used as sterile gowns.

2. A system should be established for monitoring the number of times a woven fabric gown undergoes reprocessing.9

A. Repeated laundering and sterilization of woven fabrics decreases the barrier effectiveness.

B. The number of uses, launderings, and sterilization should be recorded in order to monitor the woven fabrics effectiveness as a barrier. Woven fabrics with a high-thread count should be considered a non-effective barrier after approximately 75 reprocessings.

3. Reusable gowns must be visually inspected prior to sterilization. A. For small holes or thin, stretched areas of fabric, a patch of the same type

of draping material may be applied. The patches should be heat-sealed to the gown; stitching the patch must never be allowed as a method for repairing a drape.

Standard of Practice VIII Surgical team members should be involved in the selection process of gowns to be used in the O.R.

1. Surgical team members should be involved in the evaluation of gowns that are being considered for use in the O.R.

A. It is highly recommended that the team members refer to the AAMI document Technical Information Report TIR No. 11-1994 during the evaluation process.17

B. It is also recommended that team members refer to the ANSI/AAMI document Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Healthcare Facilities during the evaluation process.18

C. It is recommended the team members evaluate a variety of manufactures gowns including reviewing the manufacturer’s documentation in order to determine they are meeting ANSI/AAMI standards for performance.

D. Manufacturers should be requested to provide information that verifies the gowns fabric provides the appropriate barrier against microorganisms and fluids, is resistant to tears and punctures, and is flammable resistant.

Standard of Practice IX All sterile surgical team members are required to don sterile gloves prior to entering the sterile field to aid in preventing SSI.

1. Gloves are required to be worn according to Standard Precautions to provide a barrier between the patient and sterile surgical team member to reduce microbial and body fluid contamination of the surgical wound. Additionally the gloves protect the team member from the patient’s blood and body fluids.

2. Gloves must be worn in order for the team member to handle sterile supplies, equipment and instruments, and touch tissue.

3. The closed gloving method is the recommended method for donning the gloves.3 A. The closed gloving method is best practice for preventing contamination

when gloving since the fingers, hands and wrists are not exposed. B. When performing the closed gloved method the fingers and hands should

not extend into the cuff until the gloves are being pulled on. 4. If a glove becomes contaminated, the situation should be immediately addressed

by implementing one of the following methods. The methods reflect best practice as well as routine practice through the application of the principles of aseptic technique in order to prevent the patient from acquiring a SSI.

A. Circulator, wearing non-sterile gloves, removes the contaminated glove touching only the glove and not the gown. The circulator should not include the cuff of the gown by pulling it over the team member’s hand since the cuff is not considered sterile. A member of the sterile team should then re-glove the person, eg, assisted gloving.

B. If a member of the sterile team cannot perform assisted gloving the team member with the contaminated glove should remove the gown and gloves, and re-gown and re-glove using the closed gloving method.

C. If the above methods cannot be implemented and in order to prevent the patient from acquiring an SSI, the team member with the contaminated glove should perform self gloving using the open glove technique.

D. When necessary if the above methods cannot be implemented, the team member should don a sterile glove over the contaminated glove using the open gloving technique. When time permits one of the other methods stated above should be performed.

5. Contaminated gloves should be properly contained at the end of the surgical procedure.

A. Gloves are removed after the gown is removed. B. The gloves should be placed in impervious bags that are identified by the

biohazard symbol. The gloves should not be thrown or “sling-shot” into the container; this can cause blood or body fluids to be splattered on the

floor, walls and/or O.R. furniture, as well as cause exposure to the eyes of the other team members.7

C. Hand washing should be performed after removing the gloves. Standard of Practice X The primary factors for glove selection are thickness, strength and durability.

1. Glove material differs in chemical composition, strength, thickness and durability. 16

A. The team members should evaluate gloves based upon specific factors and characteristics.

B. The glove product selection process should include reviewing the information provided by the American Society of Testing Materials (ASTM) for the glove material in order to allow the surgical team members to make an informed choice or choices.

C. Information that should be requested and obtained from the glove manufacturer includes technical data, infection control data, and failure rate data pertaining to testing the glove material under simulated use conditions.

2. Gloves should be resistant to blood and body fluid penetration. A. Intraoperatively patient body fluids and irrigating solutions come into

contact with gloves. The gloves should be impervious and fluid-resistant to prevent the wearer being contaminated by microorganisms.

3. Gloves made of natural rubber latex or synthetic non-latex is the glove materials of choice when the potential exists for exposure to blood and body fluids.

A. Synthetic non-latex gloves are comparable to natural latex rubber gloves in barrier performance, comfort, and tactile sensitivity.

4. Synthetic non-latex gloves offer an alternative to the natural rubber latex sensitive health care worker. Examples of synthetic non-latex materials include butyl, neoprene, nitrile and styrene. Refer to the AST standard on latex allergy for additional information.

5. Vinyl gloves are not recommended for use by the team members. A. The barrier properties of vinyl gloves are inferior to natural rubber latex

and synthetic non-latex gloves. 2,10,16 B. Vinyl gloves quickly degrade with use and have a high failure rate in

simulated use conditions.16 Standard of Practice XI Double gloving is recommended for all surgical procedures.

1. The literature review of the results of five major studies reveals the following8,12,14,21,22:

A. There is no difference in the number of perforations between a single pair of gloves and the outer glove when the individual is double gloved.

B. The number of perforations to the innermost glove when an individual is double gloved is significantly reduced.

C. There is no difference in the number of perforations to the innermost glove when double gloving as compared to wearing a single pair of orthopedic gloves.

D. When wearing a colored glove as the innermost when double gloving it is considerably easier to detect perforations to the outer glove. However, it does not increase the detection of perforations of the innermost glove.

E. Glove liners worn between the two gloves when double gloving significantly reduces the number of perforations to the innermost glove.

F. Wearing an outer cloth glove over the inner glove versus standard double gloving significantly reduces the number of perforations to the innermost glove.

G. There is no difference in the number of perforations to the innermost glove when wearing steel weave gloves as the outer glove as compared to standard double gloving.

2. The following recommendations are made based upon the literature review. A. Members of the sterile surgical team should double glove for added protection and consequently to reduce the risk of exposure to patient

blood and body fluids. Additionally, if a sharp accident occurs the amount of blood and body fluid is reduced by being wiped or stripped off the sharp as it passes through the first glove thus reducing the risk of exposure to the wearer as the sharp passes through the innermost glove.

B. The CDC supports double gloving as a routine practice for all invasive procedures.4 The Berguer and Heller article published in the Journal of the American College of Surgeons supports routine double gloving based upon the results of studies.1

C. The team members should wear a colored glove as the innermost glove. During orthopedic procedures, in particular those procedures that involve handling bone, the team members should consider wearing a glove liner between two pairs of gloves or wearing a cloth outer glove over the inner standard glove. However, it is recommended the team members take into consideration that the wearing of steal weave outer gloves does not reduce the number of perforations to the innermost glove as compared to standard double gloving.

D. The team members should remove the outer glove prior to applying the sterile dressing.7

Competency Statements

Competency Statements Measurable Criteria 1. The CST and CFA are knowledgeable of the importance of reducing microbial contamination through the use of sterile gowns and gloves to reduce the risk of SSI. 2. The CST and CFA are knowledgeable of the need to prevent strike-through

1. Educational standards as established by the Core Curriculum for Surgical Technology and Core Curriculum for Surgical Assisting. 5,6 2. The subject of gowning and gloving is included in the didactic studies as a student

contamination to protect themselves and the patient from microbial contamination. 3. The CST and CFA are knowledgeable of the gowning and gloving procedures and have the skills for properly performing the procedures in an aseptic manner. 4. The CST and CFA are knowledgeable of the need to implement cost-effective measures in the selection and use of gowns and gloves without compromising the care of the patient. 5. The CST and CFA are knowledgeable of the fire hazards in the health care facility and measures that are implemented to reduce the risks.

as well as the principles of aseptic technique. 3. Students demonstrate knowledge of gowning and gloving procedures in the lab/mock O.R. setting and during clinical rotation. 4. As practitioners, CSTs and CFAs perform gowning and gloving procedures. 5. CSTs and CFAs complete continuing education to remain current in the principles and practice of aseptic techniques including annual review of the policies of the health care facility.

References 1. Berguer R, Heller PJ. (2004). Preventing sharps injuries in the operating room. J

Am Coll Surg. 199, 462-467.

2. Burt S. What you need to know about latex allergy. Nurse Manager. (1999). 30(8), 20-25.

3. Caruthers B, Junge T, Long JB, Price BD. Surgical case management. In: KB

Frey, T Ross, eds. Surgical Technology for the Surgical Technologist: A Positive Care Approach, 3rd ed. Clifton Park, NY: Delmar Cengage Learning; 2008: 304-376.

4. Centers for Disease Control and Prevention. Guideline for prevention of surgical

site infection.1999. Available at: http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/SSI.pdf. Accessed February 4, 2008.

5. Core Curriculum for Surgical Assisting. 2nd ed. Littleton, CO: Association of

Surgical Technologists; 2006.

6. Core Curriculum for Surgical Technology. 5th ed. Littleton, CO: Association of Surgical Technologists; 2002.

7. Davis MS. Advanced Precautions for Today’s O.R. 2nd ed. Atlanta, GA:

Sweinbinder Publications; 2001.

8. Duron JJ, Keilani K, Elian NG. (1996). Efficacy of double gloving with a

coloured inner pair for immediate detection of operative glove perforations. Eur J Surg, 162(12), 941-944.

9. Healthcare Laundry Accreditation Council. (2006). Accreditation standards for

processing reusable textiles for use in healthcare facilities. Available at: http://www.hlacnet.org/HLAC_Standards_042006.pdf . Accessed April 11, 2008.

10. Korniewicz DM, Laughon BE, Butz A, Larson E. (1989). Integrity of vinyl and

latex procedure gloves. Nursing Research, 38(3), 144-146.

11. Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. (PB70 2003) American National Standards Institute/Association for the Advancement of Medical Instrumentation. Arlington, VA; 2003.

12. Louis SS, Steinberg EL, Gruen OA, Bartlett CS, Helfet DL. (1998). Outer gloves

in orthopaedic procedures: A polyester/stainless steel wire weave glove liner compared with latex. J Orthop Trauma, 12(2), 101-105.

13. McCullough EA. (1993). Methods for determining the barrier efficacy of surgical

gowns. Am J Infect Control, 21(6), 368-374.

14. Murta EF, Silva CS, Jứnior OR. (2003). Frequency of glove perforation and the protective effect of double gloves in gynecological surgery. Arch Gynecol Obstet, 268(2), 82-84.

15. Occupational and Safety Health Administration. US Department of Labor.

Bloodborne pathogens 1910.1030. Available at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051. Accessed February 28, 2008.

16. Rego A, Roley L. (1999). In-use barrier integrity of gloves: Latex and nitrile

superior to vinyl. Am J Infect Control, 27(5), 405-410.

17. Selection of surgical gowns and drapes in health care facilities. AAMI Technical Information Report TIR No. 11-1994. Association for the Advancement of Medical Instrumentation. Arlington, VA; 1994.

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