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GUIDELINES FOR HYGIENIC TESTING

THE PREVENTION OF INFECTIONS DURING PSYCHOPHYSIOLOGICAL RESEARCH

OCTOBER 2004

Contents:

Preface

Guidelines for the prevention of infections during psychophysiological research

Literature

5 Annex 4A: Working safely with chemical substances

1 Annex 4B: Working with CidexTM disinfectant

2 Annex 4C: Washing and caring for your hands

3 Annex 4D: Overview of relevant telephone numbers and e-mail addresses

A. PREFACE

For a number of years, physiological and non-physiological research in the Faculty of Psychology has been performed in the same building. Not only is this the result of the (former) department of psychophysiology relocating from the Jan Swammerdam Institute to the Psychological Laboratory, other programme groups and ‘sections’ are also using physiological research methods to an increasing degree.

The fact that this form of research is different from other psychological research is often expressed in telling remarks made by subjects who participate in a psychophysiological experiment: ‘Gosh, it looks like a hospital here…’ This kind of conclusion is correct to the extent psychophysiological research quite often features procedures that are medical in character: applying electrodes, taking blood or saliva samples, measuring blood pressure, etc.

Unfortunately the comment is not always correct when it comes to the hygienic aspects of the test room and/or the various procedures. This is probably due to the fact that, on the one hand, physiological and other types of research are performed so close to each other and, on the other hand, the chances of infection are zero because the work is done with ‘healthy’ subjects. Additionally, there may be a lack of knowledge and/or skills in the field of hygienic testing.

Even though it is definitely true that the chances of infection during psychophysiological experiments are smaller than in most medical ‘settings’, a number of arguments can still be made in favour of paying more attention to a hygienic test method:

1) Physiological research usually includes procedures that lead to direct physical contact between the Subject (S) and the Experimenter (E).

2) Instruments are often used that come into direct contact with the S (blunt or sharp needles, electrodes, etc.).

3) The research is generally performed in the same room(s) for all Ss and is done by the same E using the same set of instruments.

From these three points it can basically be concluded that relatively harmless infections such as influenza and the common cold can spread relatively easily from the S to the E and from the E to all Ss. However, this is not essentially different to other psychological research. It only changes when we consider that:

4) For some procedures bodily fluids (blood, saliva, etc.) are deliberately removed from the S, whilst this may occur accidentally during other procedures (e.g. due to skin damage).

This point implies that for physiological research there is a risk that participants (both Ss and E) come into contact with other people’s bodily fluids, either by direct contact or by contact via instruments (in the broadest sense of the word). It should therefore be clear that the transfer of dangerous infections such as Hepatitis B or HIV cannot be deemed impossible in advance. Finally, the following should also be noted:

5) Much physiological research involves the use of chemicals (alcohol, collodion, acetone, CidexR OPA, etc.), almost all of which are volatile, usually stupefying and/or toxic and sometimes corrosive.

6) All aspects of the research (recruitment of subjects, preparation, the research itself, the procedures and discussions after the research) must be planned in such a way that the mental well-being of the subjects is not put at risk. As said before, physiological research evokes associations with hospitals for many people, which can make an S nervous. If the S is ‘treated’ in a clean room and sees that the E is working hygienically this will definitely contribute to his/her confidence in the whole operation. However, there are also situations (e.g. research involving children) in which it is desirable to avoid a ‘hospital atmosphere’ as much as possible for the mental well-being of the S.

In the following a number of recommendations are given with regard to the procedure used for psychophysiological research. The recommendations are based on guidelines for healthcare from the Health Council of the Ministry of Public Health and Environmental Hygiene (1977) and the ‘Centers of Disease Control’ of the ‘U.S. Dept. of Health and Human Services (1987), among others. Furthermore, they almost exactly match the recommendations in the report by the ‘SPR ad-hoc committee on the prevention of disease transmission’ entitled: ‘Guidelines for reducing the risk of disease transmission in the psychophysiology laboratory’ (Putnam, Johnson & Roth, 1992). We have tried to find a compromise between, on the one hand, the strict requirements that apply to healthcare and, on the other hand, the current practice of psychophysiological research. The guidelines for psychophysiological research that arise from this compensate for the lack of knowledge in the field of hygienic testing mentioned above. However, if it is to have any chance of success, a change of attitude among all the people involved will also be required. If one or two people continue working under the assumption ‘that it’s all probably not such a big deal’, the implementation of the guidelines – even when observed by the majority – will be pointless.

Winni Hofman

Amsterdam, January 2001

Original version: July 1995.

Revised versions:

June 1998, December 1999, Guido Band

October 2004, Martin Elton

B. GUIDELINES FOR THE PREVENTION OF INFECTIONS DURING PSYCHOPHYSIOLOGICAL RESEARCH

1. General information

1.1 Within the laboratory[1] the following guidelines apply to:

a. all rooms used for psychophysiological research

b. all people involved in psychophysiological research

c. all people present in rooms intended for psychophysiological research (researchers, students, technical staff, cleaners, etc.)

1.2 A number of guidelines serve as recommendations (indicated by R). Other guidelines serve as prescriptions (indicated by P). These must be observed without exception. People should not observe some instructions and ignore others: remember that other people also use the same rooms or equipment!

1.3 Work on the basis of the assumption that all subjects and experimenters could be infected.

1.4 If the research involves a reasonable chance of blood/blood contact, a hepatitis vaccination is recommended (R).

1.5 In supervisor-student situations the supervisor will always have ultimate responsibility for safety and hygiene. He/she should therefore ensure that the student is aware of and familiar with the guidelines described here, and should also ascertain that they are actually observed.

1.6 There is a Committee for Research Hygiene with the following duties:

a. Keeping these guidelines up to date.

b. Providing advice on central laboratory facilities.

c. Assessing the practical feasibility of the recommendations made.

d. Making students and staff aware of the guidelines.

e. Providing additional recommendations/information, also to individual researchers.

f. Monitoring compliance with the guidelines.

2. People

2.1 Postpone the research if the Experimenter or Subject has the flu, a severe cold or any other serious infection. (see arguments 1, 2 and 3) (R)

2.2 Perhaps superfluously: make sure that your general physical and clothing hygiene is good during the research period. (R)

2.3 Always wear (disposable) gloves during the following physiological procedures:

a. cleaning/scrubbing of the skin of the Subject (P)

b. applying electrodes to cleaned/scrubbed skin (P)

c. removing electrodes (P)

d. all procedures relating to blood, sperm or vaginal fluid (P)

e. working with disinfectants (P)

f. if the S or E has clearly visible wounds or skin irritation (P).

• It is recommended to wear gloves for every physiological procedure.

• As stated above (argument 4), there is almost always a chance of (accidental) blood/blood contact.

• Use new gloves for each Subject and dispose of old ones immediately after use.

• Before taking off the glove, take hold of the cuff and ‘peel’ it from your hand in a single movement. The glove will then automatically turn inside out. Never remove a glove by the fingers; this is to prevent touching ‘contaminated’ surfaces.

• Always wash your hands immediately after removing the gloves.

2.4. The easiest procedure for disinfection is washing your hands.[2] You must do this (regardless of whether gloves are used or not!):

a. prior to physiological procedures (P)

b. after physiological procedures (P)

c. after going to the toilet (P)

d. after sneezing, coughing or blowing your nose (use paper tissues!) (R)

e. after accidental contact with blood or other bodily fluids (P)

Gloves can be damaged. You should therefore always wash your hands, both before putting them on and immediately after taking them off.

2.5. No rings should preferably be worn during research: (R)

• they make it more difficult to wash your hands and

• they increase the risk of the gloves becoming damaged

2.6. Nails should preferably be kept short during the research period: (R)

• in connection with washing your hands and keeping them clean, and

• to prevent the gloves from becoming damaged

3. Instruments

3.1 Ready equipment as much as possible in advance, so that the number of cabinets, door-knobs, bottles and jars to be touched during the physiological procedures is kept to a minimum. (R)

3.2 Use disposable materials as much as possible and dispose of them (after single use) in containers intended for this (R):

a. Yellow waste container

location: waste freezer box[3] in general research room.

type of waste: used needles

b. White chemicals drum

location: worktop in general research room

type of waste: used CidexR OPA (general: organic substances with low halogen content)

replacement: full drums can be exchanged for empty ones at the Central Warehouse (building B, B03).

c. Waste-paper baskets

location: in every room

type of waste: other waste (coffee cups, writing paper, etc.)

replacement: by the cleaning staff

• Biomedical waste can be collected first in a cardboard collection tray and later placed in the B1 waste container together with the connection tray.

• Never use reusable towels or cloths, etc., use disposables instead; damp locations are very good feeding grounds for bacteria.

3.3 Reusable instruments must be disinfected/sterilised for each S. (R)

• Reusable needles (both blunt and sharp) can be sterilised by means of hot-air sterilisation, not with CidexR OPA 8.

• Instruments intended for invasive procedures must be sterilised; other instruments can be disinfected.

• Collect the material to be disinfected in a cardboard collection tray or a reusable ‘container’ specially intended for the purpose. Throw the collection tray in the B1 waste container after use (see 3.2). A reusable container must be disinfected together with the instruments.

• Thoroughly clean the instruments with warm water and soap before disinfecting. Use (household) gloves for this and a brush, which is to be stored separately or disinfected.

• Where available, follow the disinfection recommendations of the manufacturer. Otherwise:

• Disinfect it by immersing it in activated CidexR OPA solution for 10 minutes (see Annex B).[4]

• It is also possible to disinfect heat-resistant equipment in the hot-air oven (1 hour at 180°C, heat-up time not included).

3.4 When beds are used for the research:

• use cotton blankets, as these can be easily washed (for each Subject) (90°C), just like the other bedlinen.

• Use clean bedlinen for each Subject (blanket as well!).

• Place a washable tick or plastic cover over pillows and mattresses, and clean them for each Subject.

3.5 Any towels, face-cloths, etc. intended for use by the Subject must be replaced for each Subject.

4. Research rooms

4.1 For the physiological procedures/preparations (applying electrodes, taking blood/saliva samples, centrifuging, disinfecting, pipetting, etc.), use one general research room assigned for this purpose as much as possible[5]. (R)

• In this way any danger of infection will remain limited to a single room, which can be cleaned and disinfected accordingly.

4.2. If certain procedures must be performed in a location different to the room described under point 4.1 (e.g. the test set-up), this must only be done in the subjects section of the research unit. The researcher in question must ensure that the lab coordinator is aware of the types of procedures that are performed in the room and any precautionary measures that should be taken by other users (colleagues, technical staff, etc.). This also applies to research performed outside of the laboratory. (P)

4.3. Rooms in which physiological procedures are performed must not be used for preparing meals or consuming food. (P)

4.4. Rooms in which physiological procedures are performed must be cleaned every day (e.g. with a bleach solution). (R) This includes:

• wiping the floor

• wiping the furniture and other horizontal surfaces with a damp cloth.

4.5. In rooms where physiological procedures are performed the following must be checked every day:

• whether the paper towel roll should be replaced

• whether the soap dispenser should be refilled

• whether the waste-paper basket(s) should be emptied.

4.6. Rooms in which physiological procedures are performed must be well ventilated.

4.7 Smoking is prohibited in all the rooms in the basement. (P)

• Volatile and other flammable substances are used.

• These are public areas, which are subject to national regulations.

• Some subjects are non-smokers.

5. Procedures

5.1. Invasive procedures (such as taking blood samples) may only be performed by qualified staff. (P)

5.2. When working with organic substances or chemicals, the work surface must be covered in absorbing paper. (P)

5.3. Prior to using a piece of equipment or substance (centrifuge, hot-air oven, CidexR OPA, etc.) every researcher must familiarise himself/herself with the correct use, safety measures and cleaning instructions for the piece of equipment or substance in question by consulting the user manual. (P)

C. LITERATURE

1. Advies inzake herziene richtlijnen ter preventie en bestrijding van ziekenhuisinfecties (Recommendation regarding renewed guidelines for preventing and combating hospital infections). Ministry of Public Health and Environmental Hygiene, The Hague (1977).

2. Recommendations for the prevention of HIV transmission in health-care settings. Centers for Disease Control (1987). Morbidity and Mortality Weekly Report, 36, (suppl 2S), 1s–18s.

3. Update: Universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings. Centers for Disease Control (1988). Morbidity and Mortality Weekly Report, 37, 377–388.

4. Extracts from ‘Electrode maintenance and infection control in the EEG laboratory’ [A.M.Grass & E.R.Grass]. In: Regan, D. Human brain electrophysiology. New York: Elsevier (1989).

5. CidexR OPA information brochure. Johnson & Johnson Medical BV

6. CIDEX™ approval certificate, Ministry of Welfare, Health and Culture (1991).

7. Putnam, L.E., Johnson, R.Jr. & Roth, W.T. (1992) Guidelines for reducing the risk of disease transmission in the psychophysiology laboratory. (SPR ad hoc committee report). Psychophysiology, 29 (2), 127-141.

ANNEX 4A: WORKING SAFELY WITH CHEMICAL SUBSTANCES

Chemical substances are considered to be all substances that are used during physiological research: alcohol, acetone, electrode paste, CidexR OPA, collodion, etc.

1 Make sure that all bottles, jars, dishes, etc. are clearly and accurately labelled.

2 Always check the label before using a substance,

• especially to make sure that the correct substance is being used, but also

• to establish whether certain precautionary measures have to be taken (read the user instructions or information leaflet where necessary[6]).

3 Bottles, jars, dishes and Cidex containers must be kept closed as much as possible to prevent drying-out, evaporation.

• this is because of economic and health aspects,

• furthermore, many fumes directly affect the eyes, which is naturally highly undesirable in connection with visual tasks, etc.

4 Never smell bottles, etc. directly; always wave some of the fumes towards your nose when smelling is necessary.

5 Always make sure that the room is well ventilated.

6 Never use a bottle or jar for substances other than those stated on the label.

7 When substances come into contact with the skin, immediately rinse with lots of water for safety reasons.

8 When substances accidentally come into contact with the eyes, immediately rinse thoroughly with water. Never rub your eyes! Bend the plastic hose on the tap upwards and use it as an ‘eye shower’. Where required, an eye rinsing bottle is present in the storage cabinet in K16. Always use the cold tap and control the water supply with your free hand. Rinse both eyes one after the other and pause after a while to protect the eyes from hypothermia. Notify a doctor where required (first-aid hotline: 6228, psychology reception).

9 For cases of poisoning, please contact:

• OLVG: 020 - 5999111 (ask for the hospital pharmacy)

• National Poisoning Centre: 030 - 2748888

10 Never smoke in rooms where work is performed with chemical substances and be careful with open fire.

• Most substances that are used for psychophysiological research are (highly) flammable.

11 Never flush chemicals down the sink, but collect them in a chemicals drum intended for the substance type in question (see 3.2). The colour of the drum indicates which class of chemicals may be poured into the drum. Information about the colour coding of chemicals drums can be requested from the H&S and Environmental Service of UvA (extension 6201). The drums themselves can be obtained from the Central Warehouse (building B, B03), which also takes care of replacing full drums.

12 Always transport chemicals in a well-sealed container that has a clear label.

ANNEX 4B. WORKING WITH CIDEXR OPA DISINFECTANTS

The following is a summary of an information brochure published by Johnson & Johnson Medical BV and is in accordance with Annex I to the approval certificate of the substance Cidex by the Ministry of Welfare, Health and Culture dated 04-02-1991. For specific questions, please contact:

Johnson & Johnson Medical BV

Hospital Products Division

Postbus 188

3800 AD Amersfoort

Tel: 0800-0225566 (free)

Tel: 033-4500500

For CidexR OPA instructions for use, please consult the wall chart in the labelling room or read the instructions for use on any bottle. For more information, please contact psychology technical support or visit . The description of CidexR OPA (as of 18-10-2004) is stated below.

Cidex® OPA

ortho-Phthalaldehyde Solution

High-level disinfectant

Active Ingredient

ortho-Phthalaldehyde . . . . . . . . . . . . . . . .0.55%

Inert Ingredients . . . . . . . . . . . . . . . . . . . .99.45%

Dipotassium hydrogen phosphate

Potassium dihydrogen phosphate

Benzotriazole

Citric acid

D&C Green Dye #5

N-(hydroxyethyl)-ethylenediaminetriacetic acid (HEDTA)

Total . . . . . . . . . . . . . . . . . . . . . . . . . . .100.00%

Does not require activation before use.

INSTRUCTIONS FOR USE

Intended Use: CIDEX® OPA Solution is a high level disinfectant for reprocessing heat-sensitive medical devices when used according to the Directions for Use. CIDEX OPA Solution is intended for use in manual (bucket and tray) systems made from polypropylene, acrylonitrile-butadienestyrene (ABS), polyethylene, glass-filled polypropylene and/or polycarbonate plastics. CIDEX OPA Solution may also be used in automated endoscope reprocessors according to the manufacturer’s instructions and should be monitored with CIDEX® OPA Solution Test Strips. See DIRECTIONS FOR USE – Reusage for Disinfection.

Medical devices reprocessed in CIDEX OPA Solution must first be cleaned according to a validated cleaning protocol or Standard, such as the ASTMF 1518 “US Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera.”

Indications for Use: CIDEX OPASolution is a high level disinfectant for reprocessing heat-sensitive medical devices, for which sterilization is not suitable, and when used according to the Directions for Use.

Manual Processing: High Level Disinfectant at a minimum of 20°C (68°F). CIDEX OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX OPA Solution Test Strips, with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days.

Automatic Endoscope Reprocessors that can be set to a minimum of 25°C: High level disinfectant at a minimum of 25°C (77°F). CIDEX OPA Solution is a high level disinfectant when used or reused in a legally marketed automatic endoscope reprocessor (that can be set to a minimum of 25°C) according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX OPA Solution Test Strips, with an immersion time of at least 5 minutes for a reuse period not to exceed 14 days.

Note: If your AER cannot be set to a minimum of 25°C please follow the time and temperature stated in Indications for Use, Manual Processing.

Minimum Effective Concentration (MEC): 0.3%.

Reuse Period for Disinfection: CIDEX OPA Solution has demonstrated disinfection efficacy in the presence of 5% organic soil contamination and microbiological burden during reuse. CIDEX OPA Solution may be reused for up to a maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the Directions for Use. DO NOT rely solely on days in use. Concentration of this product during its reuse life must be verified by the CIDEX OPA Solution Test Strip prior to each use to determine that the concentration of ortho-phthalaldehyde is above the MEC of 0.3%. The product must be discarded after 14 days, even if the CIDEX OPA Solution Test Strip indicates a concentration above the MEC.

General Information on Selection and Use of Germicides for Medical Device Reprocessing: Choose a germicide with the level of antimicrobial activity that is appropriate for the reusable device. Follow the reusable device labelling and standard institutional practices. In the absence of complete instructions, use the following process: First, for patient-contacting devices, determine whether the reusable device to be reprocessed is a critical or semi-critical device. Critical device: Presents a high risk of infection if not sterile. Routinely penetrates the skin or mucous membranes during use or are otherwise used in normally sterile tissue of the body. Semi-critical device: Makes contact with mucous membranes but does not ordinarily penetrate normally sterile areas of the body. Second, determine if sterilisation or high level disinfection is required. Critical device (e.g., cardiac catheters, scalpels, surgical instruments): Sterilisation is required. Semi-critical reusable device (e.g., endoscopes): Sterilisation is required whenever feasible; where not feasible, high level disinfection is the minimum acceptable process. Third, select a germicide that is labelled for the appropriate germicidal level and is compatible with the reusable device. Follow directions for the germicide.

Microbicidal Activity: The following table indicates the spectrum of activity as demonstrated by testing of CIDEX OPA Solution using prescribed test methods.

MICROORGANISM

VEGETATIVE ORGANISMS

Staphylococcus aureus

Salmonella choleraesuis

Pseudomonas aeruginosa

Mycobacterium bovis

FUNGI

Trichophyton mentagrophytes

VIRUSES

NON-ENVELOPED

Poliovirus Type 1

Rhinovirus Type 42

Adenovirus Type 2

Vaccinia (Wyeth)

Coxsackievirus Type B-3

ENVELOPED

Coronavirus

Cytomegalovirus

Influenza Virus [Hong Kong]

HIV-1

Herpes simplex Types 1,2

To qualify CIDEX OPA Solution as a high level disinfectant, the reused solution passed the AOAC Sporicidal Activity Test in 32 hours at 20°C and in 32 hours at 25°C.

Material Compatibility: CIDEX OPA Solution has been tested and found to be compatible with the materials shown below.

METALS1 PLASTICS5

Aluminum Polymethylmethacrylate (Acrylic)

Anodized aluminum2 Nylon

Brass Polyethylene terephthalate

Carbon steel (Polyester)

Chrome plated brass2 Polystyrene

Chrome plated steel2 Polyvinylchloride (PVC)6

Copper Acrylonitrile/butadiene/styrene (ABS)

Nickel plated brass2 Polysulfone

Nickel silver alloy2 Polycarbonate7

Stainless steel3 Polyethylene

Titanium Polypropylene

Tungsten carbide2 Acetal

Vanadium steel4 PTFE

Polyamide

ELASTOMERS5

Polychloroprene (Neoprene)

Kraton G

Polyurethane

Silicone rubber6

Natural Rubber Latex

ADHESIVES5

Cyanoacrylate8

EPO-TEK 301 Epoxy8

EPO-TEK 353 Epoxy

1. Exposed to 31 days (744 hours) of continuous contact with CIDEX OPA Solution with no effect unless otherwise noted.

2. Shows signs of surface discoloration at 7 days or greater.

3. Most grades tested show no effect. Others may exhibit slight discoloration at 7 days or greater. Stainless steel 440 shows rust at 14 days immersion.

4. Treated with 500 cycles of CIDEX OPA Solution. Surface breakdown noted after 150 cycles (25 hour total contact).

5. Exposed 7 days of continuous contact with CIDEX OPA Solution with no effect unless otherwise noted.

6. Some grades or applications exhibit discoloration.

7. Some sonic welded parts may exhibit crazing.

8. Some loss in shear strength but no signs of severe degradation.

Olympus, Pentax, and Fujinon endoscopes are compatible with CIDEX OPA Solution. If questions arise regarding the compatibility of a device with CIDEX OPA Solution, contact the device manufacturer.

Cleaning Agent Compatibility: CIDEX OPA Solution is compatible with enzymatic detergents which are mild in pH, low foaming, and easily rinsed from equipment (e.g., ENZOL® Enzymatic Detergent). Detergents that are either highly acidic or alkaline are not recommended as cleaning agents.

CONTRAINDICATIONS

1. CIDEX OPA Solution should not be used to process any urological instrumentation used to treat patients with a history of bladder cancer. In rare instances CIDEX OPA Solution has been associated with anaphylaxis-like reactions in bladder cancer patients undergoing repeated cystoscopies.

2. CIDEX OPA Solution should not be utilized to process instrumentation for patients with known sensitivity to CIDEX OPA Solution or any of its components.

3. CIDEX OPA Solution should not be used to sterilise heat sensitive medical devices. When sterilisation by a biologically monitorable process is not feasible, high level disinfection of rigid endoscopes is recommended by the Centers for Disease Control and Prevention (CDC) and the Association for Professionals in Infection Control and Epidemiology (APIC).

WARNINGS

1. May elicit an allergic reaction. Possible allergic reactions have been reported in rare instances. In the majority of these instances health care workers were not using the product in a well-ventilated room or not wearing proper personal protective equipment. (See PRECAUTIONS).

2. Avoid contact with eyes, skin, or clothing. (See PRECAUTIONS – for important information on how to protect eyes, skin and clothing.) Direct contact with eyes may cause irritation. Direct contact with skin may cause temporary staining. Repeated skin contact may cause skin sensitisation. In case of eye contact, immediately flush eyes with large quantities of water for at least 15 minutes (See Appendix 4A, point 8). Seek medical attention. In case of skin contact, immediately wash with water. Refer to the MSDS for additional information. Do not form sprays, mists or aerosols of this product.

3. Avoid contamination of food. Ingestion may cause irritation or chemical burns of the mouth, throat, esophagus and stomach. If swallowed, DO NOT INDUCE VOMITING. Drink large quantities of water and call a physician immediately. Probable mucosal damage from oral exposure may contraindicate the use of gastric lavage.

4. Avoid exposure to ortho-phthalaldehyde vapours, as they may be irritating to the respiratory tract and eyes. May cause a stinging sensation in the nose and throat, discharge, coughing, chest discomfort and tightness, difficulty with breathing, wheezing, tightening of throat, urticaria (hives), rash, loss of smell, tingling of mouth or lips, dry mouth or headache. May aggravate a pre-existing asthma or bronchitis condition. In case of adverse reactions from inhaling vapours, get some fresh air. If breathing is difficult, oxygen may be given by qualified personnel. If symptoms persist, seek medical attention.

5. The use of CIDEX OPA Solution with semi-critical devices must be part of a validated rinsing procedure as provided by the device manufacturer. See DIRECTIONS FOR USE Rinsing Instructions – for important information on rinsing.

6. ALWAYS follow the Directions For Use Rinsing Instructions (Part B) and the SPECIAL INSTRUCTIONS for transesophageal echocardiography (TEE) probes in Part C EXACTLY or residues of CIDEX OPA Solution may remain on the device. Failure to follow rinsing instructions exactly has resulted in reports of chemical burns, irritation, and staining of the mouth, throat, esophagus and stomach.

PRECAUTIONS

Follow OSHA Bloodborne Pathogens Universal Precautions when handling and cleaning soiled devices.

1. When disinfecting devices, use gloves of appropriate type and length, eye protection and fluid-resistant gowns. When using latex rubber gloves, the user should double glove and/or change single gloves frequently, e.g., after 12 minutes of exposure. For those individuals who are sensitive to latex or other components in latex gloves, 100% synthetic copolymer gloves, nitrile rubber gloves, or butyl rubber gloves may be used. Note: Contact with CIDEX OPA Solution may stain exposed skin or clothing.

2. Use CIDEX OPA Solution in a well-ventilated area and in closed containers with tight-fitting lids. If adequate ventilation is not provided by the existing air conditioning system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb orthophthalaldehyde from the air.

3. Contaminated reusable devices MUST BE THOROUGHLY CLEANED prior to disinfection, since residual contamination with soil or lubricants will decrease the effectiveness of the germicide.

4. The user MUST adhere to the Directions for Use, as deviation from the Directions for Use may affect the safety and effectiveness of the germicide.

5. Do not use CIDEX OPA Solution on medical devices that are intended for use in a sterile area of the body (e.g. cataract surgical instruments).

6. The reusable device manufacturer should provide the user with a validated reprocessing procedure for that device using CIDEX OPA Solution.

7. The use of CIDEX OPA Solution in automated endoscope reprocessors must be part of a validated reprocessing procedure. The contact conditions must be 25°C for 5 minutes. (See note following the Indications for Use section).

8. Use CIDEX OPASolution Test Strips to detect ortho-phthalaldehyde concentration before each cycle to detect the MEC. Follow the Directions For Use provided with the CIDEX OPA Solution Test Strips.

DIRECTIONS FOR USE

Cleaning/Decontamination: Blood, other bodily fluids, and lubricants must be thoroughly cleaned from the surfaces and lumens of medical devices before reprocessing in the disinfectant. Blood and other bodily fluids should be disposed of according to all applicable regulations for infectious waste disposal.

Refer to the reusable device manufacturer’s labelling for instructions on disassembly, decontamination, cleaning and leak testing of their equipment.

Before immersion in CIDEX OPA Solution, thoroughly clean devices, including all lumens, using a cleaning protocol or standard, such as the ASTM F 1518 “Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera”. Thoroughly rinse and rough dry all surfaces and lumens of cleaned devices.

Usage: NO ACTIVATION IS REQUIRED.

Record the date the container was opened on the container label, or in a log book. After opening, the solution remaining in the container may be stored for up to 75 days (providing the 75 days does not extend past the expiration date on the container) until used. Record the date the solution was poured out of the original container into a secondary container in a log book (separate from the one mentioned above), or on a label affixed to the secondary container. The solution in the secondary container can be used for a period up to 14 days. The product must be discarded after 14 days even if the CIDEX OPA Solution Test Strip indicates a concentration above the MEC.

A.High Level Disinfection

1. Manual Processing: Immerse device completely, filling all lumens and eliminating air pockets, in CIDEX OPA Solution for a minimum of 12 minutes at 20°C (68°F) or higher to destroy all pathogenic microorganisms. Remove device from the solution and rinse thoroughly following the rinsing instructions below.

2.Automatic Endoscope Reprocessor that can be set to a minimum of 25°C (See note following the Indications for Use section): High Level Disinfectant at a minimum of 25°C (77°F). For use in a legally marketed AER (that can be set to a minimum of 25°C) with a minimum immersion time of 5 minutes. As with all high level disinfectants, it is critical that temperature is monitored when using CIDEX OPA Solution in an AER at 25°C. See section D. 1 ‘Monitoring of Germicide’.

B.Rinsing Instructions

1. RINSING PROCEDURE

a) Manual Processing:

• Following removal from CIDEX OPA Solution, thoroughly rinse the medical device by immersing it completely in a large volume (e.g. 2 gallons) of water. Use sterile water unless potable water is acceptable. See item 2 or 3 below.

• Keep the device totally immersed for a minimum of 1 minute in duration, unless a longer time is specified by the reusable device manufacturer.

• Manually flush all lumens with large volumes (not less than 100 mL) of rinse water unless otherwise noted by the device manufacturer.

• Remove the device and discard the rinse water. Always use fresh volumes of water for each rinse. Do not reuse the water for rinsing or any other purpose.

• Repeat the procedure TWO (2) additional times, for a total of THREE (3) RINSES, with large volumes of fresh water to remove CIDEX OPA Solution residues. Residues may cause serious side effects. SEE WARNINGS. THREE (3) SEPARATE, LARGE VOLUME WATER IMMERSION RINSES ARE REQUIRED.

• Refer to the reusable medical device manufacturer’s labelling for additional rinsing instructions.

b) Automated Processing:

• Select a rinse cycle on an automatic endoscope reprocessor that has been validated for use with this product.

• Ensure that the automated rinse cycle selected will thoroughly rinse the medical device including all lumens with large volumes of sterile or potable water equivalent to the reusable device manufacturer’s recommendations.

• Verify that each rinse is a minimum of 1 minute in duration unless the reusable device manufacturer specifies a longer time. Ensure that a fresh volume of water is used for each rinse. Do not reuse the water for rinsing or any other purpose.

• Refer to the reusable device manufacturer’s labelling for additional rinsing instructions.

2. STERILE WATER RINSE: The following devices should be rinsed with sterile water, using sterile technique when rinsing and handling: Devices intended for use in normally sterile areas of the body. Devices intended for use in known immunocompromised patients, or potentially immunocompromised patients based on institutional procedures (e.g., high-risk population served). When practical, bronchoscopes, due to a risk of contamination from potable water supply. Although micro organisms in this type of water system are not normally pathogenic in patients with healthy immune systems, AIDS patients or other immunocompromised individuals may be placed at high risk of infection by these opportunistic micro organisms.

3. POTABLE WATER RINSE: For all other devices, a sterile water rinse is recommended when practical. Otherwise, potable tap water rinse is acceptable. When using potable water for rinsing, the user should be aware of the increased risk of recontaminating the device or medical equipment with micro organisms which may be present in potable water supplies.

Water treatment systems, such as softeners or deionizers, may add micro organisms to the treated water to the extent that microbial content of the water at the point of use could exceed that of the pretreated drinking water. To ensure proper water quality, adherence to maintenance of the water treatment system(s) is recommended.

The use of a bacterial retentive (0.2 micron) filter system may eliminate or greatly reduce the amount of these waterborne bacteria from the potable water source. Contact the manufacturer of the filter or UV system for instructions on preventative maintenance and periodic replacement of the filter to avoid colonisation or formation of biofilms in the filter.

A device that is not completely dried provides an ideal situation for rapid colonisation of bacteria. As these waterborne bacteria are highly resistant to drying, rapid drying will avoid possible colonisation but may not result in a device free from these bacteria. A final rinse using a 70% isopropyl alcohol solution can be used to speed the drying process and reduce the numbers of any organism present as a result of rinsing with potable water.

C. Special Instructions for Transesophageal Echocardiography (TEE) probe reprocessing: As with all devices, carefully follow all probe manufacturer recommendations such as use of a sterile protective sheath when performing TEE. Soaking for a minimum of 12 minutes in CIDEX OPA Solution is required for high level disinfection (HLD). Excessive soaking of the probes (e.g., longer than an hour) during HLD and/or not rinsing three times with a fresh quantity of water each time as described in Part B may result in residual CIDEX OPA Solution remaining on the device, the use of which may cause staining, irritation or chemical burns of the mouth, throat, oesophagus and stomach.

D. Reusage for Disinfection: CIDEX OPA Solution has demonstrated efficacy in the presence of organic soil contamination and microbiological burden during reuse. The ortho-phthalaldehyde concentration of CIDEX OPA Solution during its use-life must be verified by the CIDEX OPA Solution Test Strips prior to each use, to determine that the MEC of 0.3% is present. CIDEX OPA Solution may be used and reused within the limitations indicated above for up to a maximum of 14 days. CIDEX OPA Solution must be discarded after 14 days, even if the CIDEX OPA Solution Test Strip indicates a concentration above the MEC.

1. MONITORING OF GERMICIDE: During reuse, it is recommended that the CIDEX OPA Solution be tested with CIDEX OPA Solution Test Strips prior to each use. This is to ensure that the Minimum Effective Concentration (MEC) of ortho-phthalaldehyde is present.

During the usage of CIDEX OPA Solution as a high-level disinfectant, it is recommended that a thermometer and timer be utilized to ensure that the optimum conditions are met.

Monitoring Temperature in Automatic Endoscope Reprocessor that can be set to a minimum of 25°C: As with all high-level disinfectants, temperature monitoring is critical for use of CIDEX OPA Solution at a minimum of 25°C for 5 minutes in an AER. If you cannot monitor temperature appropriately in your machine, contact ASP at (888) 783-7723 for further instructions.

Visually inspect the solution during the reuse life for the presence of precipitates which may result from the use of hard water. Discard solution if precipitation occurs.

POST-PROCESSING HANDLING AND STORAGE OF REUSABLE DEVICES: Disinfected reusable devices are either to be immediately used, or stored in a manner to minimize recontamination. Refer to the reusable device manufacturer’s labelling for additional storage and/or handling instructions.

STORAGE CONDITIONS AND EXPIRATION DATE

1. CIDEX OPA Solution should be stored in its original sealed container at controlled room temperature 15 - 30°C (59 - 86°F) in a well-ventilated, low-traffic area.

2. Once opened, the unused portion of the solution may be stored in the original container for up to 75 days until used.

3. The expiration date of the CIDEX OPA Solution is found on the immediate container.

EMERGENCYAND TECHNICALPRODUCT INFORMATION

For further hazard information please refer to the Material Safety Data Sheet. Emergency, safety, or technical information about CIDEX OPA Solution can be obtained from Advanced Sterilization Products at (888) 783-7723, or by contacting your local Advanced Sterilisation Products sales representative.

The user should be adequately trained in the decontamination and disinfection of medical devices and the handling of liquid chemical germicides. Additional information about CIDEX OPA Solution can be obtained by contacting your local Advanced Sterilisation Products sales representative.

Disinfectant Disposal: Check state and local disposal regulations. Glycine (free base) may be used as a neutralizer for CIDEX OPA Solution prior to disposal, if required. A minimum of 25 grams of glycine (free base) should be used to neutralise one gallon of CIDEX OPA Solution. The minimum recommended neutralisation time is one hour. Discard residual solution into drain. Flush drain thoroughly with water. Container Disposal: Do not reuse empty container. Rinse and dispose per hospital policy.

HOW SUPPLIED

Reorder Description Case Contains

20390 One Gallon (3.785L) Container 4 gals (4 x 3.785L)/case

20392 CIDEX OPASolution Test Strips 60 strips/btl; 2 btls/case

20393 CIDEX OPASolution Test Strips 15 strips/btl; 2 btls/case

MARKETED BY:

33 TECHNOLOGY DRIVE, IRVINE, CA 92618-9824

For technical information and/or information regarding safety and effectiveness, call 1-888-783-7723

©ASP, 2004 LC-20390-008 Rev. C (mailer, 4/04)

 

ANNEX 4C. WASHING AND CARING FOR YOUR HANDS

1. Preferably use warm water.

2. Thoroughly rub your wet hands with soap (from the soap dispenser).

3. Rinse your hands with lots of water.

4. Dry them with disposable paper towels.

• It is important to have thoroughly dry hands, as they contain fewer bacteria.

5. Close tap with the same paper towel.

6. Regularly treat your hands with hand cream.

• Splits may occur by washing regularly. Micro-organisms may nestle in these splits, which are rather difficult to wash out.

7. Make sure that your nails are clean and short. Where required, use a nailbrush in addition to washing your hands.

Note: You can use regular liquid soap, preferably ‘Unicura’. The use of extra disinfectants for your hands is not necessary.

ANNEX 4D. OVERVIEW OF RELEVANT TELEPHONE NUMBERS AND E-MAIL ADDRESSES

Alarm for life-threatening situations 0112

Alarm, other calamities (020-525) 2222

6260

5222

Poisoning:

OLVG hospital (020-) 5999111

Ask for the hospital pharmacy

National Poisoning Centre 030-2748888

First aid (020-525) 6228/6770

REC emergency room (020-525) 6260

Municipal Collection of Chemical Waste (020-) 5876250

UvA H&S and Environmental Service (020-525) 6201

Johnson & Johnson Medical BV (manufacturer of CidexR OPA) 0800-0225566 (free)

033-4500500

REC parking administration (020-525) 6606

Central Helpdesk callcenter-ic@uva.nl (020-525) 2200

Technical Support

Psychology m.spaan@uva.nl (020-525) 6760

e.molenkamp@uva.nl

Audio Visual Service

(supplies) n.notebaart@uva.nl (020-525) 6805

r.vandebelt@uva.nl

FacilitairMeldpunt* facilitairmeldpunt@uva.nl (020-525) 7575

* cleaning

* accommodation, furniture, keys, connections

* complaints, malfunctions, ID cards

-----------------------

[1]There is no separate guideline yet for research conducted outside of the laboratory. Where possible, this guideline should also be observed for research outside of the laboratory.

[2]See Annex 4C.

[3] Currently: K16, ‘electrophysiology assembly room’.

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ã-When in doubt about its correct use, the substance can be looked up in a reference book for chemical substances. These reference books can be found in the library of the Faculty of Chemistry at REC.

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