ALZAIEM ALAZHARI UNIVERSITY FACULTY OF POST-GRADUATE STUDIES FACULTY OF RADIOLOGICAL SCIENCES AND MEDICAL IMAGING MEDICAL DIAGNOSTIC ULTRASOUND

(MS.C) BATCH(9)-SMESTER(1) INFECTION CONTROL IN ULTRASOUND: BARRIER PROTECTION FOR TRANSDUCERS IN GENERAL AND ENDOCAVITARY SCANNING PRESENTED BY STUDENTS OF GROUP (4) SUPERVISOR: Dr: AHMED ABDELRAHEEM 11th.MARCH.2013

PRESENTED BY: HAFSA MOHAMED HAMED MUSA TARIQ ALNOUR SLMAN ALNOUR SHAMSALDEEN ALTAHEIR AWADALSEED NIHAL AHMED ADAM HAMZA AMAL ALLAHGABO HASABALLAH SAMYA ABDELGAUOM IBRAHIM

INTRODUCTION
Infection is a potential area of safety concern in a diagnostic ultrasound. Patient safety includes the right of patient not to be placed at increased risk for infection while under the sonographers care. (1)

INTRODUCTION(cont..)
To accomplish this the sonographer should practice good infection control techniques, these include good hand washing, using appropriate barriers, and appropriate cleaning, disinfection, and where necessary sterilization of equipment. (1)

INTRODUCTION(cont..)
Hands should always be washed between patients. Transducers should be cleaned and disinfected. Endcavitary transducers (endovaginal, endorectal, etc) should be disinfected according to manufactures and department protocols. (1)

Endocavitary Ultrasound Risks

The risk of transmitting infections on instruments and equipment is related to the presence or absence and burden of infectious agents (number and virulence), the type of procedure (e.g. invasive versus non-invasive) and the body site where the instrument is used (e.g. submucosal invasion versus intact skin).

Endocavitary Ultrasound Risks(cont..)

The Spaulding classification system suggests that contact sites for instruments may be classified as critical, semicritical or noncritical and that instruments should be classified accordingly. (5)

Endocavitary Ultrasound Risks(cont..)

The endocavitary ultrasound examination is a common diagnostic procedure performed for both inpatients and outpatients. Transvaginal ultrasound examinations are routinely used for follow-up examinations of pregnant women or for diagnostic purposes. Transrectal ultrasound used for scanning the prostate, rectal biopsies and endoanal sphincter. (11)

Endocavitary Ultrasound Risks(cont..)

Endocavitary ultrasound scanning can cause cross-infection with organisms transmitted by blood and by genital or rectal secretions, such as the human immunodeficiency virus, hepatitis B virus, hepatitis C virus, cytomegalovirus, Neisseria gonorrhea, Chlamydia trachomatis, and Trichomonas vaginalis. (9,10,11)

Endocavitary Ultrasound Risks(cont..)

Outbreaks of Pseudomonas aeruginosa infection associated with the use of contaminated transrectal ultrasound equipment have occurred recently. (9,10,11) International guidelines recommend strict hygiene procedures that include the use of a probe cover (condom or sheath) and chemical high-level disinfection immediately after each examination. (11)

Endocavitary Ultrasound Risks(cont..)

According to the guidelines, systematic use of a probe cover is considered insufficient to prevent endocavitary ultrasound probes from becoming contaminated with microbes because the probe cover frequently becomes perforated during transrectal and transvaginal ultrasound examinations. Perforation usually occurs in 1%9% of cases and, in 1 study, occurred in 81% of cases.(11)

Transmitted organism

Table(1): common transmitted organisms(4)

Infection control

General Measure
Every patient must be regarded as a potential source of infection and appropriate precautions should be taken to prevent crossinfection between patient and operator. These are known as Universal Precautions and are promoted as an essential part of all health care institutions. (5)

General Measure(cont..)
Standard precautions that should be undertaken as part of every examination include: Washing of hands both before and after direct patient contact. Use of personal protective equipment where appropriate. Maintenance of clean and/or disinfected patient equipment (as required). Maintenance of a clean working environment Correct disposal of waste.(5)

Probe Covers
A simple method of maintaining sterility is to cover the probe and cable with sterile sheath, this the most common approach when ultrasound is used in the operating room. (1)

Probe Covers(cont..)
The most preferred option is using a cover that is at least 38 microns thick. This may include condoms, specific probe covers, surgical drapes, or surgical gloves. At the end of the procedure, using a gloved hand, the disposable cover should be removed and discarded, taking care not to contaminate the surface of the instrument. (5)

Probe Covers(cont..)
Although the use of a disposable cover reduces the level of risk of transmission of infection or contamination, covers can be perforated or contain small, unrecognized defects. (3,5)

Figure(1): ultrasound probe cover (14)

Figure(2): ultrasound keyboard cover

(13)

Cleaning
Cleaning is the removal of soil, and hence the reduction in numbers of microorganisms from the surface. Cleaning can be achieved by washing with soap and water or wiping with 70% alcohol. It is an essential first step prior to sterilization or disinfection. Cleaning is appropriate for low risk or non critical procedures, e.g. transducers used for normal transabdominal scanning. (7)

Cleaning(cont..)
Cleaning is an essential prerequisite for all effective disinfection processes because organic residue may prevent the disinfectant from contacting the item being processed and may also bind and inactivate chemical disinfectants. (7) Utilizing running water, all the gel should be removed from the transducer. A free-rinsing, mild alkali is preferred over neutral detergents. Use a small, soft brush to clean any crevices or angles. (5)

Cleaning(cont..)
The current Australian standard outlines that standard household-type detergents and soaps are not a recommended cleaner due to their high foaming properties which increases the residue left behind and decreases the effectiveness of the clean. The transducer must be thoroughly cleaned and then dried with a soft, disposable towel. (5)

Disinfection

Disinfection
Disinfection is the inactivation of vegetative bacteria, viruses, and fungi but not necessarily of bacterial spores, ie, the selective removal of microbial organisms. It is required for medium risk or semi-critical medical instruments including those used in contact with intact mucous membranes, e.g. vaginal transducer. (1)

Disinfection(cont..)
Cleaning is an essential part of the disinfection process. However, high level disinfection, with a chemical agent is necessary for further statistical reduction in the number of infective agents on the transducer. (5)

Classes of Disinfection
High-Level Disinfection - Destruction/removal of all microorganisms except bacterial spores. Mid-Level Disinfection - Inactivation of MB Tuberculosis, bacteria, most viruses and most fungi and some bacterial spores. Low-Level Disinfection - Destruction of most bacteria, some viruses and some fungi. not necessarily inactivate MB Tuberculosis or bacterial spores. (8)

Disinfection; Chemical Agents

All chemical agents utilized must be Therapeutic Goods Administration (TGA) approved for use as a high level disinfectant on medical devices. (5)

TGA has published a list of approved chemical agents that can be used as high level disinfectants in processing reusable medical devices. That list can be consulted to find agents that may be useful for probe disinfection. It includes;

Chemical Agents (cont.. )

a. 2.4-3.2% glutaraldehyde products:- ( "Cidex," "Metricide," or "Procide") They are cold disinfectants which have broad spectrum of activity with rapid microbiocidal action, and are non-corrosive to most materials, including metals and rubber. Soak the transducer in the glutaraldehyde solution for twenty minutes, rinse under running tap water then dry. (5)

Chemical Agents (cont.. )

b. Ortho-phthalaldehyde 0.55%: ( Cidex OPA) It has a broad spectrum of activity with rapid microbiocidal effects and is non-corrosive metals and rubber, so is a satisfactory preparation . Soak the transducer in the solution for a minimum of ten minutes at twenty degrees Celsius (20) or higher, followed by rinsing under copious amounts of running tap water before drying. (5)

Chemical Agents (cont.. )

c. Hydrogen peroxide: An approved automated system utilizing hydrogen peroxide can be utilized. No rinsing is required at the completion of the cycle . (5)

Chemical Agents (cont.. )

Although most ultrasound manufacturers recommend use of 2% glutaraldehyde for highlevel disinfection of contaminated transvaginal transducers, this agent has been questioned because it might shorten the life of the transducer and might have toxic effects on the gametes and embryos.(8)

Chemical Agents (cont.. )

An alternative procedure for disinfecting the vaginal transducer involves the mechanical removal of the gel from the transducer, cleaning the transducer in soap and water, wiping the transducer with 70% alcohol or soaking it for 2 minutes in 500 ppm chlorine, and rinsing with tap water and air drying.(8)

Important points to REMEMBER

Chemical disinfectants are potentially toxic or irritant (skin, eye, and especially respiratory tract irritation), and many require adequate precautions such as proper ventilation, personal protective devices (gloves, face/eye protection, etc.) and thorough rinsing before reuse of the probe. (5)

REMEMBER
Ultrasound transducers are heat sensitive items and as such will need to be disinfected using low-temperature chemical sterilizing agents or systems. The ability of chemical disinfectants to effectively inactivate contaminating infectious agents depends on a number of factors, including the initial number of agents present, temperature, pH and concentration.(5)

REMEMBER
The transducer must not be left in the chemical agent for longer than the recommended time due to the possibility of damage. This means that the soaking period should be timed. Post-disinfection rinsing with sterile water is recommended, as the use of tap water can reintroduce pseudomonas to the disinfected medical device. (5)

REMEMBER
Efficacy must be checked regularly (with the appropriate chemical test strip indicators) to ensure a minimal effective concentration, as recommended by the manufacturer. (5) ALLWAYS FOLLOW MANUFACTURER INSTRUCTIONS. THE

Sterilization
Sterilization is the complete destruction of microorganisms, ie, the complete elimination of all forms of microbial life including spores and viruses. It is required for high-risk or critical medical procedures involving penetration of skin, membranes or other tissues, e.g. oocyte harvesting or chorionic villous sampling (1)

Sterilization(cont..)
Sterilization is generally achieved by autoclaving (steam under pressure), a process that must never be used with ultrasound transducers since they are heat sensitive, so alternative like ethylene oxide (gas) sterilization can be used. (1)

ULTRASOUND GEL: USE, HANDILING AND STORAGE

Ultrasound Gel
There are two types of ultrasound gel: A. sterile gel. B. non-sterile gel A. Sterile ultrasound Gel: Contains a bacteriostatic agent that was added during the manufacturing process and labeled as sterile. Once a container of sterile ultrasound gel is opened, it is no longer considered sterile. (6)

Ultrasound Gel(cont..)
Sterile gel used with the following procedures: I. Invasive procedures in which a device is passed through tissue, such as needle aspiration or needle biopsy. II. Procedures performed on mucous membranes such as esophageal, gastric and transvaginal ultrasound procedures without biopsy.

Ultrasound Gel(cont..)
iii. Procedures involving neonates. iv. Procedures involving sterile body site , any invasive procedures using ultrasound guided biopsy and non intact skin. (6)

Ultrasound Gel(cont..)
B. Non-sterile ultrasound gel: Does not contain a bacteriostatic agent and labeled as nonsterile.

Use open containers of ultrasound gel only for low risk procedures on intact skin and for low risk patients. (6)

Ultrasound Gel Containers

Single use containers are recommended versus refillable multidose bottles. If single use containers are not used, the following guidelines are recommended for reusable bottles: a. Prior to refilling, ensure that the ultrasound gel large bulk container has not passed the expiration date.

Ultrasound Gel Containers(cont..)

b. If reusable bottles are used, they must be washed in hot soapy water or a hospital-grade disinfectant, rinsed thoroughly and dried prior to refilling. Dried, caked gel must be thoroughly removed from the neck of the bottle and inside of bottle lid. Only completely intact bottles may be reused. c. Bottles should not be topped off.

Ultrasound Gel Containers(cont..)

d. Bottles should be filled using a dispensing device that has been attached to the large bulk container, NOT by inserting the tip of the reusable into the large bulk container to aspirate the contents. When refilling the bottle, don't touch the opening of either container with your hands or allow your hands to touch other environmental surfaces.

Ultrasound Gel Containers(cont..)

e. Bottles should be refilled as close as possible to the time of use. f. When opening a new ultrasound gel bottle, or a newly refilled bottle, date the bottle when opened and discard unused ultrasound gel after 30 days.

Ultrasound Gel Containers(cont..)

g. Tips of the bottles or dispensing nozzles must NOT come in direct contact with a patient, another staff member, medical equipment, other instrumentation or the environment. h. Wipe the tip of the dispensing nozzle with a 70% isopropyl alcohol swab and wipe the outside of the ultrasound gel bottle with a Sani-Cloth disposable cloth between patients.

Ultrasound Gel Containers(cont..)

i. If the patient is in any of the Contact, Airborne, or Droplet Transmission-based precautions, utilize a single dose packet of ultrasound gel to prevent possible contamination of the entire bottle of ultrasound gel. j. To eliminate the need for refilling ultrasound gel bottles, the use of prefilled 8 ounce bottles is acceptable. The bottles will need to be dated when opened and discarded after 30 days. (6)

Ultrasound Gel Warmers

As warm ultrasound gel provides patient comfort, it is also the perfect temperature to promote the growth of bacteria. a. Warm the ultrasound gel only when needed. b. Do not store the bottles of ultrasound gel in the warmer throughout the day.

Ultrasound Gel Warmers(cont..)

c. Ultrasound gel warmers should be cleaned weekly with Sani-Cloth Plus disposable cloth and allowed to air dry. If the warmer becomes soiled, it should be cleaned immediately with Sani -Cloth Plus disposable cloth.(6)

Storage of Ultrasound Gel

a. Bulk packages and prefilled bottles of ultrasound gel should be stored is an area that is dry, and protected from potential sources of contamination, such as dust, moisture, insects, rodents. b. If evidence of potential contamination is present, or if the package integrity has been breached, the ultrasound gel must be discarded. (6)

INFECTION CONTROL GUIDELINES IN NON-INVASIVE AND INVASIVE ULTRASOUND EQUIPMENTS

Non-invasive Ultrasound Equipment

All practitioners must disinfect their hands immediately before and after each patient contact. After every examination, all gel must be removed from the probe then it and the keyboard must be cleaned with detergent wipe and then with a compatible disinfectant (e,g: Tspray).

Non-invasive Ultrasound Equipment

(cont..)

After contact with a known/suspected infected patient, all other areas of the machine should also be cleaned with a detergent wipe and then with a compatible disinfectant(e,g: 70% alcohol wipe). The probe holder and gel containers must be cleaned with detergent at the beginning and end of each day, and whenever visibly soiled.

Non-invasive Ultrasound Equipment

(cont..)

All other areas of the ultrasound machine must be cleaned detergent at least once a week, and kept free from visible soiling and dust at all times.

The use of a gel containing antibacterial properties is recommended. (4)

Invasive Ultrasound Equipment

All practitioners must wear disposable latex gloves during the examination and wash their hands immediately after each patient contact. All probes must be covered with a new sheath and a new elastic band used (if applicable)prior to each use.

Invasive Ultrasound Equipment(cont..)

After every examination, the sheath and elastic band must be disposed of as clinical waste and the probe cleaned with a detergent wipe and then a compatible disinfectant.

The keyboard must be cleaned with a detergent wipe after each examination.

Invasive Ultrasound Equipment(cont..)

After contact with a known/suspected infected patient , all other areas of the machine must also be cleaned with detergent wipe and then a compatible disinfectant(e,g: 70% alcohol wipe). The probe holder and gel containers must be cleaned with detergent at the beginning and end of each day, and whenever visibly soiled.

Invasive Ultrasound Equipment(cont..)

All other areas of the ultrasound machine must be cleaned with detergent at least once a week, and kept free from visible soiling and dust at all times.

The use of a gel containing antibacterial properties is recommended. (4)

Choose appropriate covers for head in use Remove cover and dispose in yellow bag

Any evidence of cover damage or cover not used

Scan patient
Wipe scanhead with white paper towel Wipe twice with clinwipe

Wear gloves and apron, wash in warm soapy water, clean cervices dry with white paper towel

Immerse in Tristel for 5 minutes to ensure sterilization

Rinse under cold running water(care with electrical wire). Dry with white paper towel

Dry air Ready for use

Ready for use

Figure(3): decontamination of ultrasound transducers(12)

References
1. Devin Dean physics, first edition, module 4, The Burwin institute of diagnostic medical ultrasound ;Lunenburg, Canada, p(87). 2. College of Physicians & Surgeons of Alberta, Diagnostic Imaging Standards and Guidelines,2008, D1: http://www.ualberta.ca/~lel/pdf_files/Diagnostic %20Imaging_Standards%20&%20Guidelines%2 0(April%20%202008).pdf .

References(cont..)
3. Storment JM, Monga M and Blanco JD. Ineffectiveness of Latex Condoms in Preventing contamination of the Transvaginal Ultrasound Head.Southern Medical Journal 1997:p90;206-8. 4. British Journal of infection control: http://www.tristel.com/wpcontent/uploads/2012/07/Case-Study-Aninvestigation-of-the-microbiological-contaminationof-ultrasound-equipment-Jun-2006.pdf .

References(cont..)
5. Australian society of ultrasound in medicine: http://www.asum.com.au/newsite/files/docum ents/policies/PS/B2_policy.pdf . 6. Creighton medical assoication: http://cmait.creighton.edu/cmapolicy/Infectio n%20Control/I20%20Ultrasound%20Gel%20Use,%20Handl ing,%20and%20Storage.pdf .

References(cont..)
7. Muscarella LF. Are all sterilization processes alike? AORN Journal 1998: p67: 96670, 9736. 8. Center for disease control: http://www.cdc.gov/hicpac/Disinfection_Sterilizatio n/3_1deLaparoArthro.html#2 . 9. Paz A, Bauer H, Potasman I. Multiresistant Pseudomonas aeruginosa outbreak associated with contaminated transrectal ultrasound. J Hospital Infect 2001; p49(2):148149.

References(cont..)
10. Gillespie JL, Arnold KE, Noble-Wang J, et al. Outbreak of Pseudomonas aeruginosa infections after transrectal ultrasound-guided prostate biopsy. Urology 2007; p69(5):912914. 11. Guillaume Kac, MD and others, Evaluation of Ultraviolet C for Disinfection of Endocavitary Ultrasound Transducers Persistently Contaminated despite Probe Coversinfection control and hospital epidemiology february 2010, vol. 31, no. 2 http://www.ccih.med.br/m/aluno/mod/biblioteca_virt ual/revistas_2010/infection_control_hospital_epide miology/fevereiro/165.pdf .

References(cont..)
12. British Medical Ultrasound Society: http://www.abpharma.com.eg/images/pdf/c ase_studies/Bmus%20NewPgs%203739.pdf . 13. https://www.venefitprocedure.com/accesso ryguide.aspx#!prettyPhoto/9/. 14. http://rsna2006.rsna.org/rsna2006/V2006/e xhibitor_list/displayEx.cvn?exbID=626 .