Section: UTMB On-line Documentation Subject: Healthcare Epidemiology Policies and Procedures Topic: Cleaning and Reprocessing Patient Care Equipment and Medical Devices

1.5 - Policy 04.06.09 - Revised 1981 - Author

1.5 Cleaning and Reprocessing of Patient Care Equipment and Medical Devices

Purpose	To provide clean and sterile supplies for patient care. To define the responsibility for cleaning, disinfecting and sterilization of patient care equipment.
Audience	All those who reprocess patient care equipment.
Policy	All patient care equipment and medical devices will be cleaned and reprocessed according to these policies.
General Recommen-dations	All objects to be disinfected or sterilized should first be thoroughly cleaned to remove all organic matter (blood and tissue) and other residue. • All equipment used in patient care shall be kept clean and in proper working condition. • All medical equipment used for patient care must be cleaned and disinfected or sterilized before use on another patient. • A hospital grade disinfectant approved by the Department of Healthcare Epidemiology must be used to disinfect medical equipment.
Electrical Safety	• Excessive moisture on electrical components can cause equipment damage. Disinfectants and cleaners sprayed directly onto equipment may cause them to short circuit. This can also happen with excessively wet cleaning cloths. Manufacturers frequently recommend against certain types of cleaning such as steam cleaning, pressure washing, ultrasound, ethylene gas, radiation, and immersion. • Please refer to the manufacturer’s guidelines for the appropriate type of disinfectant and the best method of cleaning each piece of medical equipment. Or contact Environmental Services at (x25326) or Clinical Equipment Services at (x76143) if you need additional guidance on equipment cleaning technique.
Personnel Guidelines	• All personnel who clean or reprocess equipment should use appropriate protective barriers for the procedure being performed, (i.e., gowns, gloves, goggles, masks, etc.). This may vary according to the disinfectant used or the item being reprocessed.
Return of Equipment to CES	• Equipment belonging to CES will be returned from the patient care area to CES when the patient is discharged. • The CES technician will wash hands, don gloves and do a surface clean of the equipment. • After the surface clean the CES technician will remove the gloves and wash his/her hands. Then the equipment may be transported to the department.
Classification of Patient Care Equipment (Table 1)	- Critical Items Critical medical devices that enter normally sterile tissue or the vascular system should be sterilized before each use (refer to methods of sterilization and disinfection in this policy). - Semi-critical Items • Objects that come in contact with mucous membranes or skin that is not intact should be free of all microorganisms except for bacterial spores and are called semicritical medical devices. Intact mucous membranes are generally resistant to infection by common bacterial spores but susceptible to other organisms such as tubercle bacilli and viruses. Respiratory therapy and anesthesia equipment, endoscopes, and diaphragm fitting rings are included in this category. Semicritical items require high-level disinfection using wet pasteurization or chemical disinfectants. - Non-critical Items • Medical devices that come in contact with intact skin, but not mucous membranes only need cleaning or low-level disinfection.
Guidelines for High-Level Disinfection	• Disinfection is a process that eliminates pathogenic microorganisms on inanimate objects with the exception of bacterial spores. Chemical germicides used for disinfection should be registered with the Environmental Protection Agency (EPA). The following agents will be acceptable for disinfection provided that the manufacturer’s recommendations are followed. • Low Level: See Table 1 - Ethyl or isopropyl alcohol (70%-90%) - Phenolic genocidal detergent solution ▪ Phenolic germicidal detergent solutions must not be used for cleaning bassinets or incubators. - Iodophor germicidal detergent solution - Quaternary ammonium germicidal detergent solution ▪ For routine cleaning of most noncritical items, a quaternary ammonium germicidal detergent is available. Most of the noncritical items can be cleaned with this product between patients and when soiled. • Spills of blood and body fluids should be thoroughly wiped up using disposable absorbent material (i.e., paper towels) which are then discarded into the trash. Next, a hospital-grade disinfectant (quaternary ammonium solution) should be applied to the area contaminated by the spill. The area should then be thoroughly rinsed with tap water and dried (see policy: Universal Precautions). • High-Level: - Glutaraldehyde based formulation (2.5%) ▪ Glutaraldehyde is used most commonly as a high-level disinfectant for medical equipment, such as endoscopes, transducers, anesthesia and respiratory therapy equipment, and hemodialysis proportioning and dialysate delivery systems. All reprocessing using glutaraldehyde must be done away from patient care areas in a well-ventilated area. - Ortho-phthalaldehyde (OPA) ▪ OPA is a high level disinfectant used much like glutaraldehyde. It does not irritate the eyes and nasal passages, does not require exposure monitoring, has a barely perceptible odor and requires no activation. It will stain proteins grey and must be thoroughly rinsed to prevent discoloration of a patient’s skin or mucous membranes.
Guides for Sterilization (Table 1)	• Sterilization is the elimination or destruction of all forms of microbial life. - Sterilization may be accomplished in either of the following ways: - Stream sterilization - Plasma gas sterilization (Sterrad) - Peracetic Acid (Sterris) • Of all the methods available for sterilization, moist heat in the form of saturated steam under pressure is the most widely used and the most dependable. • Flash sterilization should only be used in carefully selected clinical situations (i.e. instrument needed for case falls or floor and no replacement instrument is available.) • Implantable medical devices will not be flash sterilized. • Gas plasma sterilization (radio frequencies are used to create hydrogen peroxide vapor). • Gas plasma is an acceptable method for sterilization. It requires no aeration time and the end products are not toxic. It cannot be used with cellulose or linen and cannot be used for very small lumens.
Urology Instruments	• Instruments that are used in Urology that enter the bladder must be sterile. • Instruments that enter the genital-urinary tract and must receive high-level disinfection must NOT use Cidex OPA. These instruments must be soaked in Cidex. • However, woven Filiforms and Followers must be soaked in Cidex OPA. They may NOT be soaked in Cidex.
Cleaning and Care of Surgical Instruments in the Operating Room	• Instruments will be kept free of all gross soil during surgical procedures by wiping the instruments with a sponge moistened with sterile water. • At the end of each case, all instruments must be wiped down and if the instruments have a channel (cannulated) they must be irrigated and brushed until all visible body fluids are removed. • At the end of each case, the instruments must be disassembled and with hinges opened and sprayed with an enzymatic solution. Channeled instrumentation must have enzymatic solution sprayed into cannulated openings. • At the end of each case, instruments are to be placed back in their original containers. • The instruments are to be sent to Sterile Processing immediately. The instruments should be placed on the dumb waiter (soiled room) and sent down as soon as it is free. • Once in sterile processing, the instruments will be inspected. If there are grossly soiled instruments, the Sterile Processing Manager will be notified, the tray will be tracked, and the OR team responsible for precleaning instruments will be reported to the Charge Nurse.
Cleaning and Care of Surgical Instruments in Sterile Processing	• All instruments that are grossly soiled will be soaked in water with enzymatic solution for five minutes and thoroughly brushed. • Each cannulated instrument if needed will be connected to an irrigation hose with the appropriate sizing and placed in the ultrasonic washer with an enzymatic solution. The cycle will run at 140 degrees F, for 8 minutes. All channels will then be brushed and flushed until fluid runs clear. The procedure will be repeated if needed. • The instruments will be placed in the Washer/Disinfector for final cleaning (refer to Getinge 8666AGS for specifications) prior to proceeding to Prep and Pack for inspection and assembly before sterilization. If any instruments remain soiled, they will be returned to the decontamination area for the cleaning process to be repeated.
Reprocessing Area	• Items that require sterilization should be processed in the Sterile Processing Department when feasible. Sterilization performed elsewhere must comply with the same guidelines as those used by the Sterile Processing Department. • Gross blood, fluid and tissue should not be allowed to dry on any reusable item (this makes for very difficult physical cleaning). Therefore, items should be transported to the decontamination area in a timely manner before reprocessing. • Reusable items shall be placed in a leak-proof bag or container prior to transport to the reprocessing area. • For those departments that perform high-level disinfection with chemicals, the area for reprocessing should be separated from the area where items are rinsed and stored. • Reprocessing should be performed away from patient care areas, and the area should be well-ventilated. The area must have sufficient air changes to prevent build up of vapor. Noxious levels of glutaraldehyde vapor are determined by detection badges worn by personnel working in the area. OPA requires no monitoring badges. Monitoring for concentrations of glutaraldehyde vapor is overseen by the Chemical Safety Committee. • Glutaraldehyde 2.5% and OPA solutions need to be labeled with name of the solution, date of activation/reconstitution, and date of expiration. The instruments must be fully immersed, hinged instruments opened instrument lumens filled with disinfectant and the cover closed. High-level disinfection requires a 20 minute soak time (see table) for glutaraldehyde and 12 minutes for OPA. • Glutaraldehyde 2.5% and OPA solutions must be monitored with a chemical test strip and results documented on a daily basis (or whenever the glutaraldehyde is used). • See Attachment for Soaking & Monitoring Instructions (Table 1). • For those departments who package their own items, physical barriers should separate the decontamination area from the packaging area. Decontamination and packaging should not be performed in patient care areas. • Non-critical items (i.e., beds, monitoring equipment, IV poles, etc.) may be cleaned in an area designated for dirty equipment or in non-patient care areas.
Packaging Supplies to be Sterilized	• Packaging must withstand the physical conditions of the sterilization process chosen for the device. • Packaging must allow for adequate air removal. • Packaging must be easily penetrated by the sterilant. • Packaging must allow adequate removal of the sterilant. • Packaging must be a reliable barrier to dust particles that carry microorganisms. • It must be possible to seal the packaging in such a way that tampering will be evident. • Packaging must adapt to the size and shape of the item to be packaged. • Packaging must resist tearing and puncturing under ordinary conditions of use. • Packaging must protect the package contents from physical damage. • Packaging must allow aseptic removal of the contents. • See SPD guidelines for packaging
Chemical Indicators For Sterilized Supplies	• External chemical indicators should be placed on the outside of the packaging material. They may be used as a form of closure for the package such as indicator tape. If the external chemical indicator does not demonstrate or show that the package has been in the autoclave, it should be reported to the manager/director of the Sterile Processing Department with the load control number and the item (s) should then be reprocessed and sterilized before use. • The appropriate internal chemical indicator should be placed in the center of the package in the center of the tray when sterilizing. If the internal chemical indicator does not indicate that the item has been sterilized, it should be reported with the load control number to the Manager/Director of the Sterile Processing Department and the item(s) should be reprocessed and sterilized before use.
Labeling	• The package must be labeled correctly and completely.The contents of the package must be identified before the package is opened. • The label information should include: - The expiration date - The identification of the sterilizer and cycle/lot number - A description of the contents if not visible - The technician’s initials • For tape-secured packages that are hand-labeled, felt-tip, indelible-ink markers may be used to record the necessary information on the tape. Do not write on the wrapper material. Indelible-ink is necessary so that the marking will not run or fade. Felt-tip indelible-ink markers may also be used on pouches. For paper/plastic pouches, the label must be on the clear/plastic side. Writing on the paper side may damage the material, and the ink may bleed through and contaminate the package contents. • All packages must be labeled prior to sterilization.
References	1. Mayhall, C.G. Hospital Epidemiology & Infection Control. Third Edition, 1473-1534; 2004.

Table 1

Soaking and Monitoring Glutaraldehyde and OPA

CIDEX Daily Quality Control Log

Month:____________					Location:_________________
Year:_____________					Tray No : ______________
PERFORM QUALITY CONTROL TEST PROCEDURE FOR CIDEX SOLUTION EACH DAY OF USE.
PERFORM POS/NEG QUALITY CONTROL TEST PROCEDURE FOR EACH NEW BOTTLE OF TEST STRIPS PRIOR TO USE.
WARNING: DO NOT USE CIDEX SOLUTION BEYOND ITS STATED REUSE LIFE OR IF QC FAILS.
	RECORD CORRECTIVE ACTION BELOW IN THE SPACE PROVIDED.
Date	Test Strip Lot #	New Bottle of Strips? (Y/N)	Test Strip QC (Pass/Fail/NA)	Solution Lot #	Date Solution Expires	Solution QC (Pass/Fail)	Initials
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
Corrective Action:
Date: Action:
Date: Action:
Date: Action:

QUALITY CONTROL PROCEDURE

FOR

CIDEX TEST STRIPS

PREPARATION OF CONTROL SOLUTIONS

Ø Use full strength CIDEX solution as a positive control.

Ø To prepare a negative control, dilute 1 part CIDEX solution with 1 part of water.

TESTING PROCEDURE

Ø Submerge 3 test strips in each freshly prepared solution for 1 second each.

Ø Remove.

Ø The 3 strips dipped in full strength positive control solution should exhibit a complete purple color on the indicating pad at 90 seconds.

Ø The 3 strips dipped in the diluted negative control solution should either remain completely blue or exhibit an incomplete color change to purple at 90 seconds.

Ø Refer to the color chart on the test strip bottle for interpretation of results.

TESTING FREQUENCY

Ø The testing of positive and negative controls should be performed on each newly opened bottle of CIDEX solution Test Strips.

Ø Testing of freshly prepared positive and negative controls should be performed only with test strips that have been properly stored or handled.

UNSATISFACTORY QC TEST PERFORMANCE

Ø If the results obtained from using positive and negative controls indicate the test strip is not functioning properly, discard the strips.

Ø Obtain new strips and repeat the test with positive and negative controls.

PROTOCOL FOR HIGH-LEVEL DISINFECTION

(CIDEX)

CIDEX CONTAINER

§ Label with chemical name.

§ Cover fluid at all times.

§ MSDS sheet for glutaraldehyde should be easily accessible.

§ Label container with activation date and expiration date and initial each time the chemical is changed.

TEST STRIPS

§ Date bottle of test strips (MM#32006) when opened (expiration 90 days).

§ CIDEX must be tested DAILY when medical instruments are reprocessed.

§ Dip test strip into solution for 1 second. Do not shake strip after removal.

§ Read the results of the chemical reaction 90 seconds after the test strip has been removed from the solution. Compare this color reaction to the color chart on the side of the test strip bottle.

§ Document the results of the test strip.

§ If the color of the test strip matches the “fail” panel on the color chart:

• Check the test strips expiration date. If the test strips are out of date, discard and retest with new strips.

• If test strips are in-date, discard solution, rinse out container, and refill with fresh solution. Retest new solution and document test results.

SOAKING IN CIDEX

§ CIDEX is a high-level disinfectant. Do not soak instruments in CIDEX prior to steam, gas, or plasma gas sterilization

§ Do not soak single-use disposables. They must be discarded after use.

§ All instruments that cut or biopsy must be sterilized (do not soak in CIDEX).

§ Instruments that are soaked in glutaraldehyde must be pre-washed in soap and water prior to high-level disinfection. ALL particulate matter must be removed (brushes and enzyme cleaners are available for this process)>

§ Instruments must be TOTALLY SUBMERGED in the solution.

§ Instruments must soak for 20 MINUTES (a timer should be used).

§ Instruments should be rinsed with clean water and allowed to air dry.

§ “Clean” instruments should be stored in a clean area (between two towels, in a bag, etc.), to avoid inadvertent contamination.

CIDEX/OPA SOLUTION

QUALITY CONTROL

LOG SHEET

Month:____________					Location:_________________
Year:_____________					Tray No : ______________
PERFORM QUALITY CONTROL TEST PROCEDURE FOR CIDEX SOLUTION EACH DAY OF USE.
PERFORM POS/NEG QUALITY CONTROL TEST PROCEDURE FOR EACH NEW BOTTLE OF TEST STRIPS PRIOR TO USE.
WARNING: DO NOT USE CIDEX SOLUTION BEYOND ITS STATED REUSE LIFE OR IF QC FAILS.
	RECORD CORRECTIVE ACTION BELOW IN THE SPACE PROVIDED.
Date	Test Strip Lot #	New Bottle of Strips? (Y/N)	Test Strip QC (Pass/Fail/NA)	Solution Lot #	Date Solution Expires	Solution QC (Pass/Fail)	Initials
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
Corrective Action:
Date: Action:
Date: Action:
Date: Action:

QUALITY CONTROL PROCEDURE

FOR

CIDEX OPA TEST STRIPS

PREPARATION OF CONTROL SOLUTIONS

Ø Use full strength CIDEX OPA Solution as a positive control.

Ø To prepare a negative control, dilute 1 part Cidex OPA Solution with 1 part of water.

TESTING PROCEDURE

Ø Submerge 3 test strips in each freshly prepared solution for 1 second each.

Ø Remove.

Ø The 3 strips dipped in full strength positive control solution should exhibit a complete purple color on the indicating pad at 90 seconds.

Ø The 3 strips dipped in the diluted negative control solution should either remain completely blue or exhibit an incomplete color change to purple at 90 seconds.

Ø Refer to the color chart on the test strip bottle for interpretation of results.

TESTING FREQUENCY

Ø The testing of positive and negative controls should be performed on each newly opened bottle of CIDEX OPA Solution Test Strips.

Ø Testing of freshly prepared positive and negative controls should be performed when test strips are improperly stored or handled.

UNSATISFACTORY QC TEST PERFORMANCE

Ø If the results obtained from using positive and negative controls indicate the test strip is not functioning properly, discard the strips.

Ø DO NOT USE STRIPS.

PROTOCOL FOR HIGH-LEVEL DISINFECTION

(CIDEX OPA)

CIDEX CONTAINER

♦ Label with chemical name (if not official Cidex container)

♦ Cover fluid at all times

♦ MSDS sheet for Cidex OPA should be easily accessible

♦ Label container with expiration date and initial each time the chemical is changed

TEST STRIPS

♦ Date bottle of test strips when opened (expiration 90 days).

♦ Cidex OPA must be tested DAILY when medical instruments are reprocessed.

♦ Dip test strip into solution for 1 second. Do not shake strip after removal.

♦ Read the results of the chemical reaction 90 seconds after the test strip has been removed from the solution. Compare this color reaction to the color chart on the side of the test strip bottle.

♦ Document the results of the test strip.

♦ If the color of the test strip matches the “fail” panel on the color chart:

♦ Check the test strips expiration date. If the test strips are out of date, discard and retest with new strips.

♦ If test strips are in-date, discard solution, rinse out container, and refill with fresh solution. Retest new solution and document test results.

SOAKING IN CIDEX OPA

♦ Cidex OPA is a high-level disinfectant. Do not soak instruments in Cidex OPA prior to steam, gas, or plasma gas sterilization.

♦ Do not soak single-use disposables. They must be discarded after use.

♦ All instruments that cut or biopsy must be sterilized (do not soak in Cidex OPA).

♦ Instruments that are soaked in Cidex OPA must be pre-washed in soap and water prior to high-level disinfection. ALL particulate matter must be removed (brushes and enzyme cleaners are available for this process).

♦ Instruments must be TOTALLY SUBMERGED in the solution.

♦ Instruments must soak for 12 minutes (a timer should be used) at room temperature.

♦ Instruments should be rinsed with clean water and allowed to air dry.

♦ “Clean” instruments should be stored in a clean area (between two towels, in a bag, etc.), to avoid inadvertent contamination.