Disinfection & = Sterilization of Patient-Care Equipment, 1985

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Disinfection and = Sterilization of=20 Patient-Care Equipment, 1985=20

Excerpted from the Guideline for Handwashing = and=20 Environmental Control, 1985

Section 2: Cleaning, Disinfecting, and Sterilizing Patient-Care=20 Equipment

Introduction

Cleaning, the physical removal of organic material or soil from = objects, is=20 usually done by using water with or without detergents. Generally, = cleaning is=20 designed to remove rather than to kill microorganisms. Sterilization, on = the=20 other hand, is the destruction of all forms of microbial life; it is = carried out=20 in the hospital with steam under pressure, liquid or gaseous chemicals, = or dry=20 heat. Disinfection, defined as the intermediate measures between = physical=20 cleaning and sterilization, is carried out with pasteurization or = chemical=20 germicides.

Chemical germicides can be classified by several systems. We have = used the=20 system originally proposed by Spaulding (1) in which three levels of=20 disinfection are defined: high, intermediate, and low (Table 1). In = contrast,=20 EPA uses a system that classifies chemical germicides as sporicides, = general=20 disinfectants, hospital disinfectants, sanitizers, and others. = Formulations=20 registered by the EPA as sporicides are considered sterilants if the = contact=20 time is long enough to destroy all forms of microbial life, or = high-level=20 disinfectants if contact times are shorter. Chemical germicides = registered by=20 the EPA as sanitizers probably fall into the category of low-level=20 disinfectants. Numerous formulations of chemical germicides can be = classified as=20 either low- or intermediate-level disinfectants, depending on the = specific label=20 claims. For example, some chemical germicide formulations are claimed to = be=20 efficacious against Mycobacterium tuberculosis; by Spaulding's system, = these=20 formulations would be classified at least as intermediate-level = disinfectants.=20 However, chemical germicide formulations with specific label claims for=20 effectiveness against Salmonella cholereasuis, Staphylococcus aureus, = and=20 Pseudomonas aeruginosa (the challenge microorganisms required for EPA=20 classification as a "hospital disinfectant") could fall into = intermediate- or=20 low-level disinfectant categories.

The rationale for cleaning, disinfecting, or sterilizing patient-care = equipment can be understood more readily if medical devices, equipment, = and=20 surgical materials are divided into three general categories (critical = items,=20 semicritical items, and noncritical items) based on the potential risk = of=20 infection involved in their use. This categorization of medical devices = also is=20 based on the original suggestions by Spaulding (1).

Critical items are instruments or objects that are introduced = directly into=20 the bloodstream or into other normally sterile areas of the body. = Examples of=20 critical items are surgical instruments, cardiac catheters, implants, = pertinent=20 components of the heart-lung oxygenator, and the blood compartment of a=20 hemodialyzer. Sterility at the time of use is required for these items;=20 consequently, one of several accepted sterilization procedures is = generally=20 recommended.

Items in the second category are classified as semicritical in terms = of the=20 degree of risk of infection. Examples are noninvasive flexible and rigid = fiberoptic endoscopes, endotracheal tubes, anesthesia breathing = circuits, and=20 cystoscopes. Although these items come in contact with intact mucous = membranes,=20 they do not ordinarily penetrate body surfaces. If steam sterilization = can be=20 used, it is often cheaper to sterilize many of these items, but = sterilization is=20 not absolutely essential; at a minimum, a high-level disinfection = procedure that=20 can be expected to destroy vegetative microorganisms, most fungal = spores,=20 tubercle bacilli, and small nonlipid viruses is recommended. In most = cases,=20 meticulous physical cleaning followed by an appropriate high-level = disinfection=20 treatment gives the user a reasonable degree of assurance that the items = are=20 free of pathogens.

Noncritical items are those that either do not ordinarily touch the = patient=20 or touch only intact skin. Such items include crutches, bedboards, blood = pressure cuffs, and a variety of other medical accessories. These items = rarely,=20 if ever, transmit disease. Consequently, depending on the particular = piece of=20 equipment or item, washing with a detergent may be sufficient.

The level of disinfection achieved depends on several factors, = principally=20 contact time, temperature, type and concentration of the active = ingredients of=20 the chemical germicide, and the nature of the microbial contamination. = Some=20 disinfection procedures are capable of producing sterility if the = contact times=20 used are sufficiently long; when these procedures are continued long = enough to=20 kill all but resistant bacterial spores, the result is high-level = disinfection.=20 Other disinfection procedures that can kill many types of viruses and = most=20 vegetative microorganisms (but cannot be relied upon to kill resistant=20 microorganisms such as tubercle bacilli, bacterial spores, or certain = viruses)=20 are considered to be intermediate- or low-level disinfection (Table1). =

The tubercle bacillus, lipid and nonlipid viruses, and other groups = of=20 microorganisms in Table I are used in the context of indicator = microorganisms=20 that have varying degrees of resistance to chemical germicides and not=20 necessarily because of their importance in causing nosocomial = infections. For=20 example, cells of M. tuberculosis or M. bovis, which are used in routine = efficacy tests, are among the most resistant vegetative microorganisms = known=20 and, after bacterial endospores, constitute the most severe challenge to = a=20 chemical germicide. Thus, a tuberculocidal chemical germicide may be = used as a=20 high or intermediate-level disinfectant targeted to many types of = nosocomial=20 pathogens but not specifically to control respiratory tuberculosis.

Control Measures

Since it is neither necessary nor possible to sterilize all = patient-care=20 items, hospital policies can identify whether cleaning, disinfecting, or = sterilizing of an item is indicated to decrease the risk of infection. = The=20 process indicated for an item will depend on its intended use. Any=20 microorganism, including bacterial spores, that come in contact with = normally=20 sterile tissue can cause infection. Thus, it is important that all items = that=20 will touch normally sterile tissues be sterilized. It is less important = that=20 objects touching mucous membranes be sterile. Intact mucous membranes = are=20 generally resistant to infection by common bacterial spores but are not=20 resistant to many other microorganisms, such as viruses and tubercle = bacilli;=20 therefore, items that touch mucous membranes require a disinfection = process that=20 kills all but resistant bacterial spores. In general, intact skin acts = as an=20 effective barrier to most microorganisms; thus, items that touch only = intact=20 skin need only be clean.

Items must be thoroughly cleaned before processing, because organic = material=20 (e.g., blood and proteins) may contain high concentrations of = microorganisms.=20 Also, such organic material may inactivate chemical germicides and = protect=20 microorganisms from the disinfection or sterilization process. For many=20 noncritical items, such as blood pressure cuffs or crutches, cleaning = can=20 consist only of 1) washing with a detergent or a disinfectant-detergent, = 2)=20 rinsing, and 3) thorough drying.

Steam sterilization is the most inexpensive and effective method for=20 sterilization. Steam sterilization is unsuitable, however, for = processing=20 plastics with low melting points, powders, or anhydrous oils. Items that = are to=20 be sterilized but not used immediately need to be wrapped for storage. = Sterility=20 can be maintained in storage for various lengths of time, depending on = the type=20 of wrapping material, the conditions of storage, and the integrity of = the=20 package.

Several methods have been developed to monitor steam sterilization = processes.=20 One method is to check the highest temperature that is reached during=20 sterilization and the length of time that this temperature is = maintained. In=20 addition, heat- and steam-sensitive chemical indicators can be used on = the=20 outside of each pack. These indicators do not reliably document = sterility, but=20 they do show that an item has not accidentally bypassed a sterilization = process.=20 As an additional precaution, a large pack might have a chemical = indicator both=20 on the outside and the inside to verify that steam has penetrated the = pack.

Microbiological monitoring of steam sterilizers is recommended at = least once=20 a week with commercial preparations of spores of Bacillus = stearothermophilus (a=20 microorganism having spores that are particularly resistant to moist = heat, thus=20 assuring a wide margin of safety). If a sterilizer is working properly = and used=20 appropriately, the spores are usually killed. One positive spore test = (spores=20 not killed) does not necessarily indicate that items processed in the = sterilizer=20 are not sterile, but it does suggest that the sterilizer should be = rechecked for=20 proper temperature, length of cycle, loading, and use and that the test = be=20 repeated. Spore testing of steam sterilization is just one of several = methods=20 for assuring adequate processing of patient-care items (Table 2).

Implantable items, such as orthopedic devices, require special = handling=20 before and during sterilization; thus, packs containing implantable = objects need=20 to be clearly labeled so they will be appropriately processed. To = guarantee a=20 wide margin of safety, it is recommended that each load of such items be = tested=20 with a spore test and that the sterilized item not be released for use = until the=20 spore test is negative at 48 hours. If it is not possible to process an=20 implantable object with a confirmed 48-hour spore test before use, it is = recommended that the unwrapped object receive the equivalent of = full-cycle steam=20 sterilization and not flash sterilization. Flash sterilization [270=B0F = (132=B0C)=20 for 3 minutes in a gravity displacement steam sterilizer] is not = recommended for=20 implantable items because spore tests cannot be used reliably and the = margin of=20 safety is lower.

Because ethylene oxide gas sterilization is a more complex and = expensive=20 process than steam sterilization, it is usually restricted to objects = that might=20 be damaged by heat or excessive moisture. Before sterilization, objects = also=20 need to be cleaned thoroughly and wrapped in a material that allows the = gas to=20 penetrate. Chemical indicators need to be used with each package to show = that it=20 has been exposed to the gas sterilization process. Moreover, it is = recommended=20 that gas sterilizers be checked at least once a week with commercial=20 preparations of spores, usually Bacillus subtilis var. niger. Because = ethylene=20 oxide gas is toxic, precautions (e.g., local exhaust ventilation ) = should be=20 taken to protect personnel (2). All objects processed by gas = sterilization also=20 need special aeration according to manufacturer's recommendations before = use to=20 remove toxic residues of ethylene oxide.

Powders and anhydrous oils can be sterilized by dry heat. = Microbiological=20 monitoring of dry heat sterilizers and following manufacturers' = recommendations=20 for their use and maintenance usually provides a wide margin of safety = for dry=20 heat sterilization.

Liquid chemicals can be used for sterilization and disinfection when = steam,=20 gas, or dry heat sterilization is not indicated or available. With some=20 formulations, high-level disinfection can be accomplished in 10-30 = minutes, and=20 sterilization can be achieved if exposure is for significantly longer = times.=20 Nevertheless, not all formulations are equally applicable to all items = that need=20 to be sterilized or disinfected. No formulation can be considered as an = "all=20 purpose" chemical germicide. In each case, more detailed information can = be=20 obtained from the EPA, descriptive brochures from the manufacturers, = peer-review=20 journal articles, and books. The most appropriate chemical germicide for = a=20 particular situation can be selected by responsible personnel in each = hospital=20 based on the object to be disinfected, the level of disinfection needed, = and the=20 scope of services, physical facilities, and personnel available in the = hospital.=20 It is also important that the manufacturer's instructions for use be = consulted.=20

Gloves may be indicated to prevent skin reactions when some chemical=20 disinfectants are used. Items subjected to high-level disinfection with = liquid=20 chemicals need to be rinsed in sterile water to remove toxic or = irritating=20 residues and then thoroughly dried. Subsequently, the objects need to be = handled=20 aseptically with sterile gloves and towels and stored in protective = wrappers to=20 prevent recontamination.

Hot-water disinfection (pasteurization) is a high-level, nontoxic=20 disinfection process that can be used for certain items, e.g., = respiratory=20 therapy breathing circuits.

In recent years, some hospitals have considered reusing medical = devices=20 labeled disposable or single use only. In general, the primary, if not = the sole,=20 motivation for such reuse is to save money. For example, the disposable=20 hollow-fiber hemodialyzer has been reprocessed and reused on the same = patient in=20 hemodialysis centers since the early 1970s. By 1984, 51% of the 1,200 = U.S.=20 dialysis centers were using dialyzer reprocessing programs. It has been=20 estimated that this practice saves more than 100 million dollars per = year (3).=20 When standard protocols for cleaning and disinfecting hemodialyzers are = used,=20 there does not appear to be any significant infection risk to dialysis = patients=20 (4). Moreover, the safety and efficacy of dialyzer reuse programs are = supported=20 by several major studies (5-7). Few, if any, other medical devices that = might be=20 considered candidates for reprocessing have been evaluated in this = manner.

Arguments for and against reprocessing and reusing single-use items = in the=20 1980's have been summarized (4). Since there is lack of evidence = indicating=20 increased risk of nosocomial infections associated with reusing all = single-use=20 items, a categorical recommendation against all types of reuse is not = considered=20 justifiable. Rather than recommending for or against reprocessing and = reuse of=20 all single-use items, it appears more prudent to recommend that = hospitals=20 consider the safety and efficacy of the reprocessing procedure of each = item or=20 device separately and the likelihood that the device will function as = intended=20 after reprocessing. In many instances it may be difficult if not = impossible to=20 document that the device can be reprocessed without residual toxicity = and still=20 function safely and effectively. Few, if any, manufacturers of = disposable or=20 single-use medical devices provide reprocessing information on the = product=20 label.

Hydrotherapy pools and immersion tanks present unique disinfection = problems=20 in hospitals. It is generally not economically feasible to drain large=20 hydrotherapy pools that contain thousands of gallons of water after each = patient=20 use. Typically, these pools are used by a large number of patients and = are=20 drained and cleaned every one to two weeks. The water temperature is = typically=20 maintained near 37=B0C. Between cleanings, water can be contaminated by = organic=20 material from patients, and high levels of microbial contamination are = possible.=20 One method to maintain safe pool water is to install a water filter of=20 sufficient size to filter all the water at least three times per day and = to=20 chlorinate the water so that a free chlorine residual of approximately = 0.5 mg/l=20 is maintained at a pH of 7.2 to 7.6. Local public health authorities can = provide=20 consultation regarding chlorination, alternate halogen disinfectants, = and=20 hydrotherapy pool sanitation.

Hubbard and immersion tanks present entirely different problems than = large=20 pools, since they are drained after each patient use. All inside = surfaces need=20 to be cleaned with a disinfectant-detergent, then rinsed with tap water. = After=20 the last patient each day, an additional disinfection step is performed. = One=20 general procedure is to circulate a chlorine solution (200-300 mg/l) = through the=20 agitator of the tank for 15 minutes and then rinse it out. It is also=20 recommended that the tank be thoroughly cleaned with a = disinfectant-detergent,=20 rinsed, wiped dry with clean cloths, and not filled until ready for use. =

An alternative approach to control of contamination in hydrotherapy = tanks is=20 to use plastic liners and create the "whirlpool effect" without = agitators. Such=20 liners make it possible to minimize contact of contaminated water with = the=20 interior surface of the tank and also obviate the need for agitators = that may be=20 very difficult to clean and decontaminate.

Recommendations

Cleaning=20

All objects to be disinfected or sterilized should first be = thoroughly=20 cleaned to remove all organic matter (blood and tissue) and other = residue.=20 Category I
Indications for Sterilization and High-Level Disinfection=20
1. Critical medical devices or patient-care equipment that enter = normally=20 sterile tissue or the vascular system or through which blood flows = should be=20 subjected to a sterilization procedure before each use. = Category=20 I
2. Laparoscopes, arthroscopes, and other scopes that enter normally = sterile=20 tissue should be subjected to a sterilization procedure before each = use; if=20 this is not feasible, they should receive at least high-level = disinfection.=20 Category I
3. Equipment that touches mucous membranes, e.g., endoscopes, = endotracheal=20 tubes, anesthesia breathing circuits, and respiratory therapy = equipment,=20 should receive high-level disinfection. Category = I=20
Methods of Sterilization=20
1. Whenever sterilization is indicated, a steam sterilizer should = be used=20 unless the object to be sterilized will be damaged by heat, = pressure, or=20 moisture or is otherwise inappropriate for steam sterilization. In = this=20 case, another acceptable method of sterilization should be used.=20 Category II
2. Flash sterilization [270=B0F (132=B0C) for 3 minutes in a = gravity=20 displacement steam sterilizer] is not recommended for implantable = items.=20 Category II
Biological Monitoring of Sterilizers=20
1. All sterilizers should be monitored at least once a week with = commercial=20 preparations of spores intended specifically for that type of = sterilizer=20 (i.e., Bacillus stearothermophilus for steam sterilizers and = Bacillus=20 subtilis for ethylene oxide and dry heat sterilizers). = Category=20 II
2. Every load that contains implantable objects should be = monitored. These=20 implantable objects should not be used until the spore test is found = to be=20 negative at 48 hours. Category II=20
3. If spores are not killed in routine spore tests, the sterilizer = should=20 immediately be checked for proper use and function and the spore = test=20 repeated. Objects, other than implantable objects, do not need to be = recalled because of a single positive spore test unless the = sterilizer or=20 the sterilization procedure is defective. Category II=20
4. If spore tests remain positive, use of the sterilizer should be=20 discontinued until it is serviced. Category = I=20
Use and Preventive Maintenance

Manufacturers' instructions should be followed for use and = maintenance of=20 sterilizers.
Category = II
Chemical Indicators=20

Chemical indicators that will show a package has been through a=20 sterilization cycle should be visible on the outside of each package = sterilized. Category II
Use of Sterile Items=20

An item should not be used if its sterility is questionable, = e.g., its=20 package is punctured, torn, or wet. Category=20 I
Reprocessing Single-Use or Disposable Items=20
1. Items or devices that cannot be cleaned and sterilized or = disinfected=20 without altering their physical integrity and function should not be = reprocessed. Category I
2. Reprocessing procedures that result in residual toxicity or = compromise=20 the overall safety or effectiveness of the items or devices should = be=20 avoided. Category I

References

Favero MS. Chemical disinfection of medical and surgical = materials. In:=20 Block SS, ed. Disinfection, sterilization and preservation. 3rd ed.=20 Philadelphia: Lea and Febiger, 1983;469-92.=20
Fed Reg June 22, 1984, 29 CFR 1910, Occupational Exposure to = Ethylene=20 Oxide.=20
Romeo AA. The economics of reuse. In: Reuse of disposable medical = devices=20 in the 1980's. Proceedings of International Conference on the Reuse of = Disposable Medical Devices in the 1980's, The Institute for Health = Policy=20 Analysis. Georgetown University Medical Center, 1984 Mar 29-30. = Washington,=20 D.C.: Institute for Health Policy Analysis. 1984:43-9.=20
Institute for Health Policy Analysis, Georgetown University = Medical=20 Center. Proceedings of International Conference on the Reuse of = Disposable=20 Medical Devices in the 1980's. March 29-30, 1984. Washington, D.C.=20
Jacobs C, Brunner FP, Chantler C, et al. Combined report on = regular=20 dialysis and transplantation in Europe VII. 1976. Proc Eur Dial = Transplant=20 Assoc 1977;14:3-69.=20
Levin N. Dialyzer re-use in a hospital. Dial and Transplant=20 1980;9(1):40-6.=20
Wing AJ, Brunner FP, Brunner FP, et al. Mortality and morbidity of = reusing=20 dialyzers. Br Med J 1978;2:853-5.

Table 1. Levels of Disinfection According to Type of = Microorganism=20


Levels	Vegetative	Bacteria=20 Tubercle Bacillus	Spores	Fungi¹	Viruses
Lipid & Medium Size	Nonlipid & Small =

High	+²	+	+³	+	+	+
Intermediate	+	+	=B1⁴	+	+	=B1⁵
Low	+	-	-	=B1	+	-

¹Includes asexual spores but not necessarily = chlamydospores or=20 sexual spores.
²Plus sign indicates that a killing effect = can be=20 expected when the normal use-concentrations of chemical disinfectants or = pasteurization are properly employed; a negative sign indicates little = or no=20 killing effect.
³0nly with extended exposure times are = high-level=20 disinfectant chemicals capable of actual sterilization. =
⁴Some=20 intermediate-level disinfectants can be expected to exhibit some = sporicidal=20 action.
⁵Some intermediate-level disinfectants may have = limited=20 virucidal activity.

Table 2. = Methods of Assuring=20 Adequate Processing and Safe Use of Medical Devices=20

Object and
Classification = Example Method Comment

PATIENT-CARE OBJECTS

Critical

Sterilized in the hospital
Surgical instruments and devices; trays and sets = 1. Thoroughly clean objects and wrap or package = for=20 sterilization.
2. Follow manufacturer's instructions for use of = each=20 sterilizer or use recommended protocol.
3. Monitor = time-temperature=20 charts.
4. Use commercial spore preparations to monitor = sterilizers.=20
5. Inspect package for integrity and for exposure of sterility = indicator before use.
6. Use before maximum safe storage time = has=20 expired if applicable.
Sterilization processes are designed to have a = wide margin=20 of safety. If spores are not killed, the sterilizer should be = checked for=20 proper use and function, if spore tests remain positive, = discontinue use=20 of the sterilizer until properly serviced. Maximum safe storage = time of=20 items processed in the hospital varies according to type of = package or=20 wrapping material(s) used; follow manufacturer's instructions for = use and=20 storage times.

Purchased as
Sterile
Intravenous fluids;
irrigation = fluids;
normal=20 saline; trays and sets 1. Store in safe, clean area.
2. Inspect = package for=20 integrity before use.
3. Use before expiration date if one is=20 given.
4. Culture only if clinical circumstances suggest = infection=20 related to use of the item. Notify the Food and Drug Administration, local and = state=20 health departments, and CDC if intrinsic contamination is = suspected.=20

Semicritical

Should be free of vegetative bacteria. May be = subjected to=20 high-level disinfection rather than sterilization process =
Respiratory therapy
equipment and = instruments
that=20 will touch mucous membranes 1. Sterilize or follow a protocol for high-level=20 disinfection.
2. Bag and store in safe, clean area.
3. = Conduct=20 quality control monitoring after any important changes in the = disinfection=20 process. Bacterial spores may survive after high-level=20 disinfection, but these usually are not pathogenic. Microbiologic = sampling=20 can verify that a high-level disinfection process has resulted in=20 destruction of vegetative bacteria, however, this sampling is not=20 routinely recommended.

Non critical =

Usually
contaminated with
some=20 bacteria
Bedpans; crutches;
rails; EKG leads 1. Follow a protocol for cleaning or, if necessary = a=20 low-level disinfection process.

Water produced or treated
Water used for
hemodialysis fluids 1. Assay water and dialysis fluids monthly.
2. = Water=20 should not have more than 200 bacteria/ml and dialysis fluids not = more=20 than 2000 bacteria/ml. Gram-negative water bacteria can grow rapidly in = water and=20 dialysis fluids and can place dialysis patients at risk of = pyrogenic=20 reactions or septicemia. These water sources and pathways should = be=20 disinfected routinely.

Date last modified: June 22,=20 2005
Content source:
= Division=20 of Healthcare Quality Promotion (DHQP)
National Center for = Preparedness,=20 Detection, and Control of Infectious Diseases

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Object and Classification =	Example	Method	Comment

PATIENT-CARE OBJECTS
Critical
Sterilized in the hospital	Surgical instruments and devices; trays and sets =	1. Thoroughly clean objects and wrap or package = for=20 sterilization. 2. Follow manufacturer's instructions for use of = each=20 sterilizer or use recommended protocol. 3. Monitor = time-temperature=20 charts. 4. Use commercial spore preparations to monitor = sterilizers.=20 5. Inspect package for integrity and for exposure of sterility = indicator before use. 6. Use before maximum safe storage time = has=20 expired if applicable.	Sterilization processes are designed to have a = wide margin=20 of safety. If spores are not killed, the sterilizer should be = checked for=20 proper use and function, if spore tests remain positive, = discontinue use=20 of the sterilizer until properly serviced. Maximum safe storage = time of=20 items processed in the hospital varies according to type of = package or=20 wrapping material(s) used; follow manufacturer's instructions for = use and=20 storage times.
Purchased as Sterile	Intravenous fluids; irrigation = fluids; normal=20 saline; trays and sets	1. Store in safe, clean area. 2. Inspect = package for=20 integrity before use. 3. Use before expiration date if one is=20 given. 4. Culture only if clinical circumstances suggest = infection=20 related to use of the item.	Notify the Food and Drug Administration, local and = state=20 health departments, and CDC if intrinsic contamination is = suspected.=20
Semicritical
Should be free of vegetative bacteria. May be = subjected to=20 high-level disinfection rather than sterilization process =	Respiratory therapy equipment and = instruments that=20 will touch mucous membranes	1. Sterilize or follow a protocol for high-level=20 disinfection. 2. Bag and store in safe, clean area. 3. = Conduct=20 quality control monitoring after any important changes in the = disinfection=20 process.	Bacterial spores may survive after high-level=20 disinfection, but these usually are not pathogenic. Microbiologic = sampling=20 can verify that a high-level disinfection process has resulted in=20 destruction of vegetative bacteria, however, this sampling is not=20 routinely recommended.
Non critical =
Usually contaminated with some=20 bacteria	Bedpans; crutches; rails; EKG leads	1. Follow a protocol for cleaning or, if necessary = a=20 low-level disinfection process.
Water produced or treated	Water used for hemodialysis fluids	1. Assay water and dialysis fluids monthly. 2. = Water=20 should not have more than 200 bacteria/ml and dialysis fluids not = more=20 than 2000 bacteria/ml.	Gram-negative water bacteria can grow rapidly in = water and=20 dialysis fluids and can place dialysis patients at risk of = pyrogenic=20 reactions or septicemia. These water sources and pathways should = be=20 disinfected routinely.