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世界胃肠病学会实践指南-内窥镜消毒

BSG Guidelines for Decontamination of Array Equipment for Gastrointestinal Endoscopy

The Report of a Working Party of the British Society of

Gastroenterology Endoscopy Committee

February 2008

Summary

1.Decontamination of endoscopes should be undertaken by trained staff in dedicated

rooms. Staff training programmes should be implemented and documented.

Training should include an awareness of the channel configuration of all

endoscopes and of the automated endoscope reprocessors (AER) and available

irrigation adaptors.

2.Traditionally it has been recommended that, before the start of each list, each

endoscope to be used should undergo a full reprocessing cycle unless last used and decontaminated within the preceding 3 hours. Many units are now using purpose

built drying and storage chambers, some of which have been shown to prevent

colonisation of endoscope channels for up to 72hr (some manufacturers claim 7

days). Where appropriate quality assurance data is available, the use of such

chambers may obviate the need for repeat endoscope reprocessing at the start of

each list.

3.Thorough manual cleaning with a compatible enzymatic detergent, including the

brushing and flushing of all accessible endoscope channels, must be undertaken

before automatic endoscope disinfection. This routine must be undertaken during

lists, between patients and after each patient examination.

4.Units should move away from using aldehyde- and alcohol-based disinfectants

because of their fixative properties, which in theory could anchor prion and other

protein within endoscope channels.

5.Single use disinfectants are now widely used within AER. Units in hospitals serving

large populations of patients at risk of variant CJD (such as haemophilia centres)

should employ either single use disinfectants or purpose-designed automated

reprocessors that generate single use biocides.

6.All disinfectants should be used at the correct temperature and concentration in

accordance with the manufacturers’ instructions. Some manufacturers recommend the use of test kits or strips in order to ensure the optimal activity of their product.

Machine testing should include the accuracy of the dosing system.

7.It is important to ensure that the endoscope manufacturer has approved the

chosen disinfectant as being compatible for use in decontaminating their product,

and that the disinfectant is also compatible with the AER in which it is being used.

8.It is essential that all reprocessing stages are included after every use of the

endoscope, and that none are omitted. It is also essential that all channels of all

endoscopes are reprocessed after every use of the endoscope, even if the channels were not used during the preceding patient procedure.

9.Automated endoscope reprocessing machines (AER) should be used for all

endoscope decontamination following manual cleaning. Manual disinfection is

unacceptable. Users must ensure that the correct adaptors are available for all

endoscopes to ensure irrigation of all channels.

10.Filtered air should be used as part of the drying process at the end of the working

day prior to endoscope storage. An alternative is to dry and store endoscopes in

cabinets that are designed to deliver high efficiency particulate filtered air to the

internal channels at the appropriate temperature and flow rate. Because of its

fixative properties the use of isopropyl alcohol is no longer recommended.

11.Water used in AER should be free of particulate contamination and of micro-

organisms. This can be achieved either by using bacteria-retaining filters or by

other methods, for example reverse osmosis. In-line water softeners may be

needed if the local supply delivers hard water. The final rinse water should be

sampled from the AER and regularly tested for its microbiological quality in

accordance with the current relevant Health Technical Memorandum (HTM).

12. A record should be kept of the serial number of each endoscope used in each

patient. This log should include any loan endoscopes. This is important for any

future contact tracing when possible endoscopic transmission of disease is being

investigated. Details of the AER and cycle parameters used in decontaminating

that endoscope should also be kept.

13.The agent of variant Creutzfeldt-Jakob disease (vCJD) is resistant to all forms of

conventional sterilisation. The risk of transmission of this agent is probably

extremely low provided that scrupulous attention to detail is routinely employed in the decontamination process after every patient. In particular all accessible

endoscope channels should be brushed through with a single use purpose-made

device or brush tipped wire assembly that has an appropriate length and diameter for each channel.

14. A group of people “at risk” of harbouring vCJD has been defined. Any endoscopic

procedure that breaches gut mucosa and is followed by the withdrawal of an

unsheathed accessory through the working channel of an endoscope is deemed

“invasive”. Procedures that cause tissue vaporisation (e.g. diathermy) are also

deemed “invasive”. The performance of an “invasive” procedure in an “at risk”

patient will necessitate the subsequent quarantining of the endoscope used.

15.The performance of an “invasive” procedure (defined in 14 above) in a patient with

suspected or confirmed vCJD will again necessitate quarantining the endoscope. A separate paper (referenced herein) gives practical advice to the endoscopist on

ways of undertaking some forms of therapeutic endoscopy (e.g. PEG) without

contaminating the working channel of the endoscope.

16.‘Single use' accessories should always be used in preference to reusable

accessories. The choice of single use biopsy forceps, guidewires and cytology

brushes helps to minimise any possible risk of transmitting prion disease.

Reusable accessories should only be used in situations where no single use

equivalent accessory exists, and procedures should be available for tracking each

patient use in these circumstances.

17.Rubber biopsy port caps must be discarded after all procedures involving the

passage of biopsy forceps, guidewires and/or other accessories through the

endoscope. Other detachable valves (primarily air/water and suction

valves/pistons) should be manually cleaned according to manufacturers’

instructions, then decontaminated with their corresponding endoscopes in an AER, keeping the valves and endoscopes together as a traceable unique set.

18.Health surveillance for staff should be considered, in consultation with

occupational health departments for exposures to disinfectants that are

not aldehydes or chlorine-releasing agents or other strong irritants. If

agents similar to glutaraldehyde are used, then health surveillance should be

carried out. Occupational health records should be retained for 40 years.

19.Those involved in endoscopic practice should be immunised in accordance with

local occupational health and infection control policies. All staff should wear single use gloves that are changed after each procedure. Staff involved in endoscope

decontamination should also wear appropriate protective clothing.

20.Out of hours endoscopy should not be done unless there is an endoscopy assistant

available who has been trained in decontamination practice.

21. A summary of recommendations is given at the end of the document. Most are

based on advice from expert opinion, which includes advice from the Medicine and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices

Agency) and from other Working Parties. Some of the recommendations are

derived from microbiological studies. Controlled trials in the field of endoscope

decontamination are lacking because of a reluctance to expose “placebo control”

patients to an infection risk.

22. A summary guideline on avoiding pitfalls in endoscope decontamination practice

has been produced by the MHRA in response to an incident that occurred in 2004.

This is set out in Box 3 at the end of this document.

1. Introduction

Flexible endoscopes are complex reusable instruments that require unique

consideration with respect to decontamination. In addition to the external surface of endoscopes, their internal channels for air, water, aspiration and accessories are exposed to body fluids and other contaminants. In contrast to rigid endoscopes

and most reusable accessories, flexible endoscopes are heat labile and cannot be

autoclaved.

The BSG first published recommendations on endoscope decontamination practice in 1988, and the recommendations from the fourth working party appeared in Gut in 1998 (1). In 2002 a fifth working party reconsidered the recommendations for

decontamination of endoscopes and their devices, prompted by the following

developments:

a. A Health and Safety Executive report that safer alternatives to

glutaraldehyde should be used within health care settings.

b.Emergence of variant Creutzfeld Jakob Disease (vCJD) as an important

pathogen in man.

c.Publication of an updated Medical Devices Agency (MDA) Device Bulletin

DB2002 (05) on decontamination of endoscopes. (2)

In 2004 a review of endoscope decontamination practice was undertaken in

Northern Ireland in response to an incident where stained fluid was seen to

emerge from an auxiliary endoscope channel, the existence of which was not

known to staff. This report recommended that the updated BSG Guidelines should give special emphasis and advice on the decontamination of elevator wire and

auxiliary water channels (3).

The Health Act was published in 2006. This stipulates the roles of decontamination leads and decontamination programmes. It emphasises the need for staff to be

trained in decontamination processes and to hold appropriate competencies for

their role. It decrees the need for monitoring systems to ensure that

decontamination processes are fit for purpose and meet required standards.

Finally it requires that there are systems in place for tracking reusable medical

devices (such as endoscopes and reusable accessories) through decontamination

processes, not only to assist with assuring their quality, but also to enable the

identification of patients on whom the medical devices have been used.

The 6th Working Party met in October 2006 to consider new developments and

recommendations, including (a) the optimal modes for decontaminating water

bottles and endoscope valves (pistons); (b) the latest recommendations for

reducing the risks of endoscopic transmission of vCJD, including the tracking of

equipment; and (c) updated recommendations on drying and storage of

endoscopes, given the evolving range of purpose-built chambers designed for this

purpose.

2.Transmission of Infection at Endoscopy

A guiding principle for decontamination is that of universal precautions: any

patient must be considered a potential infection risk, and each endoscope and

device must be reprocessed with the same rigour following every endoscopic

procedure. Few data exist as to the absolute risk of transmission of infection from patient to patient at endoscopy. In 1993 one report suggested that the reported

frequency was 1 in 1.8 million procedures (4). Estimating the infection risk is

difficult for several reasons: complications such as septicaemia following ERCP may be due to the induction of endogenous infection as opposed to the endoscope

being a vehicle of infection. Additionally the onset of infections complicating

endoscopy may be delayed until after the patient has been discharged home

following their procedure. There is also the potential for transmission of infective

particles with very long incubation periods (vCJD, for example).

Endoscopy-induced infection is usually due to procedural errors in decontamination (5,6). These include failure to decontaminate all channels including auxiliary and duodenoscope elevator wire channels, and the use of incompatible connectors between endoscopes and AER (3). Other potential risk factors for transmission of infection at endoscopy include the use of older endoscopes with associated surface and working channel irregularities, and the use of contaminated water bottles or irrigating solutions. Further potential vehicles of infection are inadequately designed or improperly maintained AER, the use of substandard disinfectant, or inadequate drying and/or storage of endoscopes.

There have been concerns regarding the transmission of hepatitis C virus (HCV) following an instance reported in 1997 (7). Transmission of viral infection occurred because of (a) failure to brush the biopsy channel, (b) failure to clean ultrasonically and steam sterilise reusable biopsy forceps, (c) inadequate exposure to the liquid chemical germicide. Adherence to current reprocessing guidelines effectively eliminates the risk of HCV transmission from endoscopy (8, 9). In fact the hepatitis viruses are among the micro-organisms most sensitive to disinfectants in current use.

Glutaraldehyde-based products have historically been the most commonly used disinfectants in endoscopy units worldwide. Most reports of transmission of bacteria such as pathogenic E. coli Salmonella, Pseudomonas, Enterobacter and Serratia spp. predate not only the introduction of glutaraldehyde for disinfection but also the practice of using fully immersible endoscopes and exposing all working channels to the decontamination process (5).

Three types of micro-organisms have merited particular attention in recent years.

a.Mycobacteria: the emergence of multi-drug resistant strains of

Mycobacterium tuberculosis and the high incidence of infections with M.

avium intracellulare among HIV infected patients has led to a greater

awareness of the risk of transmission of Mycobacteria during

bronchoscopy. Mycobacteria in general, and especially waterborne

mycobacteria (such as M. chelonae) are extremely resistant to

glutaraldehyde.

b.Bacterial spores (Bacillus and Clostridium) – spores from these organisms

can be isolated from endoscopes but there are no reported cases of

transmission of these infections by endoscopy. Studies have shown that

Clostridium Difficile spores can be completely inactivated by a standard

decontamination procedure (10).

c.Pathological Prions including Creutzfeld Jakob Disease and vCJD. These

infectious particles are extremely resistant to standard decontamination

procedures. Recommendations for minimising the risk of transmission of

prion proteins are discussed in detail later in these guidelines.

Although the greatest potential risk is transmission of infection from one patient to another using the same contaminated endoscope, there is also the potential for transmission of infection from patients to healthcare workers. Studies have suggested that endoscopes are potential vectors for the transmission of Helicobacter pylori (11). Another example is the acquisition of Herpes simplex ophthalmitis following oesophageal biopsy (12). Healthcare workers are also at potential risk of infection with blood-borne viruses transmitted via sharps, such as spiked biopsy forceps. (See Section 7: Protecting the Operator)

Traditionally patients harbouring potentially infectious micro-organisms are scheduled for the end of endoscopy lists in order to minimise cross-infection. Given the universal endoscope decontamination regime, which presumes that all patients are potentially infectious, there is not normally a need to examine patients with known infection last on the list. Nonetheless prevailing infection control policies should be adhered to, and these often include scheduling patients with meticillin-resistant Staphylococcus aureus (MRSA) at the end of lists.

3.Decontamination of endoscopes – general considerations.

Sterilisation is defined as the complete destruction of all micro-organisms including bacterial spores. Sterilisation is required for devices that are normally used in

sterile areas of the body (e.g. laparoscopes, microsurgical instruments). Flexible

endoscopes (which make contact with mucous membranes but do not ordinarily

penetrate normally sterile areas of the body) are generally reprocessed by high

level disinfection rather than sterilisation in order to kill bacteria, viruses,

mycobacteria and some spores. Most flexible gastrointestinal endoscopes would

not withstand the conditions normally used in a sterilisation process.

Endoscopes are routinely exposed to mucus and other gastrointestinal secretions,

blood, saliva, faeces, bile, and sometimes pus. The process of decontamination

comprises two basic components:

a.manual cleaning, which includes brushing with a purpose-built single-use

cleaning device, and exposure of all external and accessible internal

components to a low-foaming enzymatic detergent known to be compatible

with the endoscope;

b.automated disinfection, rinsing and drying of all exposed surfaces of the

endoscope.

It is essential that all reprocessing stages are included after every use of the

endoscope, and that none are omitted. It is also essential that all channels of all

endoscopes are reprocessed after every use of the endoscope, even if the channels were not used during the preceding patient procedure. Failure to follow these

recommendations may not only lead to transmission of infection, but also to

misdiagnosis (e.g. if pathological material from one patient is included in

specimens from the next patient) and to instrument malfunction and shortened

lifespan.

Decontamination should begin as soon as the endoscope has been removed from

the patient. Before the endoscope is detached from the light

source/videoprocessor a preliminary cleaning routine should be undertaken.

Water and detergent should be sucked through the working channel in order to

clear gross debris and ensure that the working channel is not blocked. Similarly

the air and water channels should be irrigated with sterile water, not only to check for blockages but also to expel any blood, mucus and other debris. The insertion

shaft is wiped down externally and checked for any bite marks or other surface

irregularities. The endoscope is then detached from the light

source/videoprocessor, removed to the reprocessing room and attached to a

leakage tester to check the integrity of all channels before reprocessing.

When transporting endoscopes to and from areas outside the endoscopy unit, they must be transferred in covered rigid receptacles, not only to avoid damage to the

endoscope, but also to protect staff and the public. The receptacle will itself need

to undergo a separate decontamination process.

The second stage is the dismantling of detachable parts of the endoscope, which

includes the removal of valves and water bottle inlets. Some endoscopes have

detachable tips which should also be disengaged from the insertion tube at this

stage. Biopsy port caps should be discarded whenever breached by biopsy forceps or any other accessory passed down the working channel during the preceding

endoscopy procedure. Detachable parts that are to be re-used (e.g. air/water and suction valves/pistons) should be reprocessed together with the corresponding

endoscope as a unique set in order to allow traceability (2). The practice of

ultrasonic cleaning of valves in batches should be abandoned.

The third stage is manual cleaning and rinsing of all exposed internal and external surfaces. A low-foaming enzymatic detergent that has been specifically designated for medical instrument cleaning should be used at the appropriate dilution

according to the manufacturer’s instructions. Whilst enzymatic detergents have

not been conclusively shown to be superior to other detergents in endoscope

decontamination, they have the ability to digest mucus and other biological

material provided that sufficient contact time is given. These properties are

potentially very important in the manual cleaning of narrow endoscope channel

lumens. All accessible channels should be exposed to detergent by means of

brushing with a purpose-built single-use cleaning device. This is followed by the rinsing of all external surfaces and internal channels in a separate sink filled with clean water.

Detachable components (e.g. air-water and suction valves/pistons), once removed from the endoscope, should be manually cleaned by washing and brushing their external and internal surfaces in detergent, then rinsing them in water prior to reprocessing.

Some endoscopes (particularly older models) have channels that are not accessible to automated decontamination procedures. Special consideration must be given to the cleaning of auxiliary water channels, exposed elevator wire channels and balloon inflation channels in endoscopic ultrasound probes. The channels of these models must be manually cleaned and disinfected according to manufacturers’ instructions.

The fourth stage is high level disinfection using a liquid chemical germicide within an AER. Manual disinfection is unacceptable and must not be done. The endoscope is reprocessed having had its detachable components (e.g. air-water and suction valves/pistons) removed from it; the separated components are appropriately collected or connected within the automatic endoscope reprocessing machine, and reprocessed simultaneously with the endoscope. It is important to note that even the most modern and sophisticated AER do not replace the need for prior thorough manual cleaning including brushing of all working channels. The process of decontamination should be concluded with further rinsing with sterile or filtered water, followed by proper drying of each endoscope.

Throughout each decontamination cycle, tracking of the personnel and patient association of each endoscope is undertaken using manual or electronic methods. For this to happen each endoscope must have a unique identification code or bar code. Each step of the decontamination cycle should be recorded, including the identity of the person undertaking each step, and this information should be linked to each individual patient examined with that endoscope. The detachable components should be kept with their corresponding endoscope, forming a unique set. A record of the decontamination process should be retained. The tracking system operating in each unit should be subject to regular appraisal. There must also be a means of tracking each patient use of reusable endoscopy accessories.

The decontamination of endoscopy equipment is a specialised procedure and should only be carried out by personnel who have been trained for the purpose and who have an understanding of the principles involved. It should be done in a dedicated area with atmospheric extraction facilities that have been maintained according to manufacturers’ instructions. The safe working practices in the decontamination area of each unit should be clearly documented and understood by all staff. Comprehensive records of all decontamination processes and all staff training must be maintained. If an emergency endoscopic procedure is done out of hours, someone with knowledge of the endoscope decontamination process must be available to prepare and clean the equipment.

Water bottles provided with the latest generation of endoscopes are autoclavable, and should be changed and filled with sterile water after each endoscopy session. They should be detached, emptied and cleaned as per manufacturers’ instructions, and then sent for sterilisation. Water bottles do not need to be tracked for purposes of traceability.

Service contracts and guarantees may not be honoured if incompatible disinfectants and detergents have been employed. The MDA Device Bulletin (2) lists the information to be supplied by manufacturers of endoscopes, accessories and disinfectants.

The Health and Safety at Work Act 1974 requires employers to ensure, as far as is reasonably practicable, the health, safety and welfare of all employees. The Act also requires employees to comply with the precautions established to ensure safe working. The Control of Substances Hazardous to Health Regulations 1994 (COSHH) requires employers to assess the risk to the health of staff by exposure to hazardous chemicals such as glutaraldehyde and its derivatives, to minimise and to avoid such exposure where this is reasonably practicable, and otherwise to

ensure adequate control. Engineering methods of control must be used in

preference to personal protective equipment.

4. Special considerations: CJD and other prions

Creutzfeldt-Jakob disease (CJD) is a member of a group of neurological disorders

known as the transmissible spongiform encephalopathies (TSEs) or prion diseases,

which affect both animals (scrapie in sheep, BSE in cows) and man. The precise

nature of the transmissible agents responsible for these disorders is unknown, but

there is widespread acceptance of the prion hypothesis, which states that the

agent is composed of an abnormally folded form of a host-encoded protein, prion

protein. The normal prion protein (PrP c) is expressed in many tissues, but occurs at highest levels in neurones in the central nervous system (CNS). The abnormal

form of the protein (PrP Sc) accumulates in the CNS in prion diseases and, as the

presumed infectious agent, it is remarkably resistant to most forms of degradation.

The sporadic form of CJD affects approximately 1 person per million per annum

worldwide. Variant CJD (vCJD) is an acquired form of CJD affecting mainly young

adults. It was first reported in 1996, and it exhibits a unique neuropathological

phenotype(13). It is now accepted that bovine prions passed into the human

population through the consumption of BSE-infected bovine tissues and that the

transmissible agent responsible for vCJD is identical to the BSE agent (but different from the agent in sporadic CJD). The incubation period for vCJD could be as long

as 30 years. Invasive procedures (such as endoscopy with biopsy) have the

potential to transmit the disease from affected individuals in the incubation phase.

The distribution of the PrP Sc in the body is different in sporadic and vCJD, reflecting their different pathogenesis.In the case of sporadic CJD, prion infectivity is largely

limited to the CNS and retina. Gastrointestinal endoscopy is unlikely to be a vector

for the transmission of sporadic CJD because infected tissue is not breached during the procedure. No special precautions are necessary during or after the procedure

and the endoscope should be cleaned and disinfected in the normal thorough way.

By contrast, in vCJD the lymphoreticular system throughout the body contains

PrP Sc at the time of death, and may contain significant levels of infectivity during

the incubation period(14). Since lymphoid follicles and germinal centres are widely distributed in the gastrointestinal tract (and are often biopsied), endoscopic

examination of patients who are incubating vCJD could expose the instrument (and particularly the biopsy forceps) to PrP Sc.

In general the risks of transmitting vCJD from one person to another are dependent on the infectivity of tissues involved, the amount of tissue contaminating the

instrument, the effectiveness of decontamination processes and the susceptibility of subsequently exposed patients. Experimental studies suggest that levels of

infectivity in prion diseases are highest in the CNS and retina, which are around

100-fold higher than in the tonsils and other lymphoreticular tissue. The abnormal

form of the prion protein can be detected in rectal tissue (15,16). The risk of

transmitting vCJD through an endoscopy is likely to be minimal, but contamination of the endoscope and forceps as a result of biopsying lymphoid tissues may

represent a larger (but currently unquantifiable) risk. The greatest potential risk

ensues from biopsying the terminal ileum because the abundant Peyer’s patches in this region may contain significant levels of prion protein in those incubating vCJD

(15). The biopsy forceps and the colonoscope become potential vectors for disease

transmission under these circumstances.

It should be emphasised that aldehyde disinfectants, such as ortho-phthalaldehyde (OPA) and glutaraldehyde, fix protein, a property which may not only anchor prion

protein within endoscope channels, but also render it more difficult to remove by

other means. Hence the use of these agents should be avoided when

decontaminating endoscopes that have been used in patients with definite or

suspected vCJD, or in patients considered to be at risk of vCJD for public health

purposes.

At present conventional sterilisation methods cannot reliably destroy the infecting

agent in vCJD. All those involved in endoscopy must recognise the potential for

transmission through poor decontamination practice, and ensure that procedures

are in place to minimise contamination and maximise cleaning. Best practice

defined in these terms (17-19) will reduce a very small, potential risk to one too small to be measured.

Disinfection must always be preceded by thorough manual cleaning, with all accessory and other accessible channels brushed and washed with enzymatic detergent and rinsed with water. It follows that brushes or other purpose built catheters used to clean the channels of the endoscope should also be single-use, both to ensure maximum efficiency of cleaning and to reduce the risk of inoculating other endoscopes. Existing detergents are ineffective against prion proteins, but specialised enzymatic detergents are at an advanced stage of development. Meticulous manual cleaning of the endoscope is probably the best way to protect against person-to-person transmission.

Biopsy port caps should be discarded after any endoscopic procedure involving use of any accessory passed through the valve. Every effort should be made to employ single-use equipment, and in some circumstances this may be a cheaper as well as safer option. Adequate funding must be available to endoscopy units for the purchase of single-use biopsy forceps, cytology brushes, guidewires and other accessories. In addition ‘random’ biopsies, particularly of the terminal ileum, should be kept to a minimum as lymphoid tissue is distributed widely throughout the gastrointestinal tract.

It is possible to obtain special endoscopes for patients known to have vCJD who require an endoscopy. Such dedicated endoscopes are available from the National CJD Surveillance Unit in Edinburgh and some other regional centres.

Clearly patients incubating vCJD may undergo endoscopy and be a potential unrecognised infective source for others. Even though the risk of transmitting infection by endoscopy is very small, all units should have a process for tracking equipment used during each procedure in the event that a patient is subsequently suspected of having, or being at high risk for, the disease. Serial numbers of all endoscopes and accessories must be recorded for each patient examined, and endoscopes must be properly tracked through their decontamination processes.

A working group of the British Society of Gastroenterology met in 2005 to produce a consensus document with the Department of Health TSE Working Group entitled “At risk of vCJD for public health purposes”. This has recently been updated, together with Annex F of the UK Department of Health TSE guidance. These web-based documents stratify the potential risk of endoscope contamination according

to the patient vCJD risk, the procedure performed and the methods employed (20). They also give practical advice to the endoscopist on ways of avoiding such potential contamination during procedures such as endoscopic dilatation or percutaneous endoscopic gastrostomy (for the latter, there are also the alternatives of radiological or surgical gastrostomy).

Individuals at risk of vCJD include people (e.g. those with haemophilia) who received plasma based concentrates between 1980 and 2001, and also a group who received blood or plasma products derived from donors who subsequently developed vCJD. The “at risk” group also includes patients with primary immunodeficiency syndromes, Guillain Barré syndrome and other recipients of transfusions derived from multiple donors (e.g. >80 units of blood).

Endoscopic procedures with the potential to introduce vCJD-contaminated tissue particles into the working channels of endoscopes are deemed potentially invasive procedures when mucosa is breached or vaporised and the endoscope accessory and/or tissue vapour make contact with the working channel of the endoscope. Invasive procedures include mucosal biopsy, sphincterotomy, and any procedure employing diathermy or other forms of tissue vaporisation. If such an invasive procedure is done during endoscopy of an “at risk” patient it becomes necessary to quarantine the endoscope. Unless the potential vCJD infection risk to that endoscope can later be rescinded, the quarantined endoscope cannot return to normal use, and will only be available for use with the same patient in future or, alternatively, for a patient with established vCJD. At the time of writing, endoscope manufacturers are expected to be able to offer refurbishment of potentially infected endoscopes, funded centrally from UK Health Departments, allowing some quarantined endoscopes to be returned to use. Prototypes of sheathed biopsy forceps are also under evaluation.

If invasive endoscopy has been performed in a patient with or at risk of vCJD (or

such a patient retrospectively discovered to have undergone invasive endoscopy)

the endoscope used should be quarantined while advice is obtained from the CJD

Incidents Panel (tel: 020 8327 6074 or see CJD webpage of https://www.sodocs.net/doc/9851014.html,). If a contamination risk is confirmed, it should remain quarantined pending possible

refurbishment, or retained for dedicated re-use for the same patient.

It is recommended that single use disinfectants should be used for endoscopes

that have been used in “at risk” patients, and that such endoscopes should be

decontaminated separately from any other endoscope prior to quarantining. The

dilutions and flows of fluids preclude any significant risk of contaminating the AER

itself.

Rigid metal sigmoidoscopes and proctoscopes should be thoroughly cleaned and

then autoclaved (15). The same recommendations apply for all other surgical

instruments with the capacity to withstand this method. This should not be

interpreted as being a procedure that eliminates risk altogether given the resistant nature of prion protein. There is no substitute for thorough manual cleaning.

As research progresses, it is likely that other procedures will be developed to

inactivate prion infectivity and to remove proteins from instrument surfaces. The

development of such techniques (along with more sensitive tests for prion

detection) may well have an impact on future advice concerning endoscopy and

transmissible spongiform encephalopathies.

Regularly updated healthcare guidelines appear in the transmissible spongiform

encephalopathy section of the Department of Health website:

https://www.sodocs.net/doc/9851014.html,/acdp/tseguidance/Index.htm

5. Disinfectants

The ideal disinfectant would be:

?Effective against a wide range of organisms including blood-borne viruses and prion proteins.

?Compatible with endoscopes, accessories and AER.

?Non-irritant and safe for users.

?Environmentally friendly for disposal.

Other factors that will influence the choice of disinfectant include the process of

dilution, stability of the solution and the cost of using the particular disinfectant

(e.g. costs of the appropriate AER, storage space, and conditions required for use,

including staff protection measures). It is essential to use disinfectants in

accordance with their manufacturers’ instructions. Attention must also be paid to

directions from manufacturers of AER and endoscope manufacturers. Some

endoscope manufacturers advise users to undertake specified inspection routines

as a precondition of honouring their service contracts and warranties.

The material safety data sheet (MSDS) must be obtained for all products to ensure appropriate safety precautions, if applicable, are followed.

Although less irritant than glutaraldehyde, all the disinfectants discussed below

may under certain conditions become potential skin and respiratory irritants in

some users. This risk can be circumvented if the agents are used within the

confines of AER in well ventilated rooms. Health care workers should employ

personal protective equipment while handling these disinfectants during endoscope decontamination. (Section 7). A spillage procedure and kit must be available

within the department.

The widely used disinfectants were reviewed in detail elsewhere (19) and are

briefly discussed below. Their properties are shown in Table 1.

a.Aldehyde-based disinfectants

A formerly widely-used glutaraldehyde-based disinfectant (Cidex ?) has

been withdrawn from the United Kingdom market by its manufacturer.

This is not only because there have been advances in the development of

disinfectants with superior bactericidal activity, but also because

glutaraldehyde is chemically related to formaldehyde, and has similar toxic

effects on skin and mucous membranes. Resulting adverse effects include

severe dermatitis, conjunctivitis, sinusitis, asthma, and even chemical

colitis. A further problem with glutaraldehyde-based disinfectants is their potential to cross-link residual protein material. The resulting amalgam is very difficult to remove from working channels of endoscopes that have been repeatedly flushed with aldehydes. This again underscores the

importance of manual pre-cleaning and brushing of all accessible internal channels and valve chambers before disinfection.

Glutaraldehyde and its derivatives kill most bacteria and viruses (including human immunodeficiency virus and hepatitis B) in less than five minutes.

Mycobacteria are more resistant to 2% glutaraldehyde, and earlier

guidelines recommend that endoscopes are immersed for 20 minutes in 2% glutaraldehyde at room temperature (1).

Ortho-phthalaldehyde (OPA, 0.55% solution) is more stable and has a

lower vapour pressure than glutaraldehyde. It is therefore practically

odourless and does not emit noxious fumes. It is non-flammable and is stable at a wide pH range. It has better bactericidal and myobactericidal activity than 2% glutaraldehyde (22-24). In use testing of OPA on

endoscopes has shown cidal activity achieving a reduction of greater than five logs. and stability over a two-week period (25). The manufacturers of Cidex OPA ? recommend the daily use of OPA test strips to monitor the activity of reused batches of disinfectant solution. OPA, like other

aldehydes, can stain and cross-link protein material. It can therefore not be recommended for the decontamination of endoscopes after use in

patients with risk factors for vCJD.

Other aldehyde derivatives and combinations are available. Users should ensure the required spectrum of antimicrobial activity is present and that they follow the manufacturers recommendations for use.

b.Peracetic Acid

Numerous peracetic acid based disinfectants are on the market. They

have been shown to be rapidly effective against a wide range of micro-

organisms (25-30). However, speed of activity can vary and appears to be related to the pH and concentration of the solution. Users should ensure they adhere to the manufacturers’ instructions in terms of contact times and use life. Agents are available as reusable or single use. The reusable products often have test strips for establishing the minimum effective

concentration. Compatibility also appears to vary and users should take advice from the endoscope manufacturers.

c.Electrolysed acid water

This is a mixture of active elements derived from salt by electrolysis

through a proprietary electrochemical cell. It is important that the

parameters for electrolysis e.g. pH, Oxidation-reduction potential etc. are strictly adhered to, as it is only under these conditions that a biocide is

produced. The “Sterilox ?” system automatically changes and regenerates the active biocide, hypochlorous acid, every 23hr within an enclosed

chamber.

Electrolysed acid water is rapidly effective (31-33) but again activity and compatibility with endoscopes can very according the parameters of the solution. Furthermore its efficacy is reduced in the presence of organic

matter, which further underscores the need for assiduous manual cleaning before automatic reprocessing.

d.Chlorine Dioxide

Chlorine dioxide is a broad spectrum agent with rapid activity against

vegetative bacteria including mycobacteria, viruses and spores (34,35).

Solutions are available as reusable or single use. Test kits are available to determine the concentration

e.Alcohols

Due to its fixative properties the use of isopropyl alcohol in the process of drying endoscope channels at the end of the day is no longer

recommended. Heated air or commercially available drying/storage

cabinets should be employed instead.

f.Sterilisation processes

Ethylene oxide, low temperature steam and formaldehyde and hydrogen

peroxide gas plasma may be used for the sterilization of invasive flexible

endoscopes (e.g. some choledochoscopes). Ethylene oxide is classified as

a human carcinogen. These agents are suitable for the sterilization of

some reusable heat-labile accessories.

Long cycle times render these methods impractical during routine

gastrointestinal endoscopy lists. Furthermore sterilization is not

considered necessary for decontaminating standard flexible GI

endoscopes; high level disinfection using the agents discussed earlier in

this section is sufficient.

When you need to change your disinfectant

?Carefully cost the change bearing in mind the use, concentration, stability and additional equipment required for processing.

?Ensure the processed items are thoroughly cleaned, and that the

disinfectant manufacturers’ recommended contact times are achieved,

unless alternative advice from professional organisations is available.

?Ensure compatibility between endoscope brand, AER and the chosen

disinfectant.

?Establish what is required in terms of COSHH regulations (e.g. ventilation, personal protective equipment) and ensure that these are included in the

costing.

6.Automated Endoscope Reprocessors (AER)

These are essential for decontaminating all flexible endoscopes following manual

cleaning. They protect the user from hazardous reprocessing chemicals such as

disinfectants. All AERs should have been validated and tested in accordance with

the guidance provided in the DoH Estates and Facilities HTM publications and

relevant standards where available (36). AER should include flow monitoring for

each individual channel to detect blockages.

It is essential that these machines are properly maintained and should be

disinfected at the start of each working day employing, where possible, the AER’s

self disinfection cycle. It is recommended that thermal disinfection, or an agent

other than that used for endoscope disinfection is used to disinfect the machine.

Care should be taken to ensure that all disinfectants used are compatible with the

AER, and are employed at the correct temperature and concentration. The

microbiological quality of the rinse water and other fluids must be acceptable; it is

recommended that the final rinse water is tested for its microbiological quality on a

weekly basis (see below). An action plan for addressing suboptimal water quality

has been produced by the Hospital Infection Society (37) and the topic has been

reviewed more recently (38). The user should make daily checks of the filters and

pipe work supplying rinse water. Water filters should be changed in accordance

with the manufacturers’ instructions, or more often if the water quality is poor (as

suggested by frequent clogging of filters). Hard water can cause a deposit of

limescale on internal pipe work. Advice may need to be taken from a company

specialising in water treatment, and from a local consultant microbiologist.

The rinse cycle should employ bacteria-free water. This may be achieved either by

using bacteria-retaining filters or by other methods (e.g. reverse osmosis). If

mains water is used a water-softening and/or treatment system may be needed to

prevent contamination with limescale, biofilm and micro-organisms. Some

machine isolates (e.g. Mycobacterium. chelonae) are extremely resistant to

disinfection and an alternative disinfectant should be used for machine disinfection.

Some older machines have facilities for conservation of rinse water. A build-up of

disinfectant will, however, occur if the rinse water is reused. This may transfer

toxic residues to the endoscope and cause irritation of the patient’s mucosa or, if

using fibrescopes, to the endoscopist’s eyes. It is recommended that rinse water

is not reused.

Some special features or performance characteristics are optional but all machines should expose all internal and external endoscope surfaces to disinfectant and rinse water in accordance with the local hospital infection control committee protocols and/or national guidelines. Ideally all channel irrigation should be verified during each cycle. Instructions and training should be given by the machine manufacturers on how to connect the instrument to the

washer/disinfector to ensure all channels are irrigated. It should be ensured that the connectors between endoscopes and AERs are designed to irrigate all endoscope channels, and that all channels are disinfected in accordance with endoscope manufacturer instructions. The machine should be programmable to accommodate the disinfectant contact time recommended by the disinfectant manufacturers, the Department of Health, and the professional societies such as the BSG. They should have also a cycle time compatible with the workload of the unit and run at a temperature that is compatible with the endoscopes. Care must be taken to ensure that AER are used with reprocessing chemicals that are compatible with each machine. The manufacturers of reprocessing chemicals, and the manufacturers of AER, should provide clear instructions on compatibility. Newer machines have automatic leak-testing facilities incorporated within them, but these devices are not foolproof because they do not angle the endoscope tip during leak testing, and may therefore fail to recognise positional leaks. AER manufacturers should specify in their ‘intended use’ statements the makes/models of endoscopes the AER is intended to reprocess, and should supply the necessary channel connection systems to allow effective reprocessing of the identified endoscopes

Older duodenoscopes do not have endoscope tips that can be detached to allow access to the elevator wire channel for cleaning. Some AERs have the capacity to deliver high-level disinfection to this channel. Users of duodenoscopes should ensure the ability of their AERs to decontaminate all internal channels, and should seek advice from their endoscope and AER manufacturers where any uncertainty exists. Additional manual cleaning and disinfection of the elevator wire channel may be necessary.

Following endoscopic examinations in patients with or at risk of vCJD, it is advisable to employ a single use disinfectant. It is also recommended that the endoscope is decontaminated separately from other endoscopes, and that the AER should be subjected to an extra rinsing cycle before the next endoscope is reprocessed. The endoscope will need to be quarantined if an “invasive” procedure has been undertaken (see Section 4). Any solid waste and/or tissue remaining within the AER should be disposed of by incineration. The outlet filter (or strainer) should also be discarded, incinerated, and replaced with a new filter. Liquid waste should be discarded by normal direct discharge from the AER.

When purchasing an AER it should be ensured that it conforms to the minimum specifications set out in the British and European Standards and any additional requirements of the UK health departments. Newly purchased AERs must be installed correctly and safely with regard to proper functioning, safety of personnel and environmental protection. It is important to ensure that the AER will irrigate all channels of each endoscope being processed, and preferably verify that such irrigation has taken place. This facility should include alerting the user to endoscope blockages or disconnections within the AER. Other features to consider when purchasing an AER include (a) a cycle counter and fault indicator, (b) a control system for use when the disinfectant produces an irritating or sensitising vapour, (c) a water treatment system which prevents recontamination of processed instruments during rinsing, (d) a reliable, effective and simple machine disinfection cycle, (e) an air drying facility to expel fluids and dry the channels of the endoscope at the end of the cycle, (f) a leak test facility, and (g) a print-out of cycle parameters which can be retained for quality assurance records.

Users are advised to review independent test reports and consult their local Authorised Persons (AP as defined in DoH Estates and Facilities publications) before purchasing AER.

7.Protecting the Operator (Box 1)

All staff involved in decontamination should wear appropriate personal protective

equipment including aprons, full face visors and single use (preferably nitrile)

gloves. Forearms must be protected during the endoscope dismantling and

manual cleaning stages, and whilst handling detergent and disinfectant solutions.

Staff should be trained in effective hand-washing in a separate sink from that used for endoscope decontamination. Care should be taken to clean and disinfect work

surfaces at the end of each working day.

Staff exposed to disinfectant vapours should receive regular health surveillance.

Pre-employment medical checks are still recommended even when disinfectants

other than glutaraldehyde are used. Occupational health departments should

enquire regarding any history of asthma, conjunctivitis, rhinitis or dermatosis.

Departments should conduct a COSHH risk assessment for substances used in their hospitals’ endoscopy units and, when regular staff health surveillance monitoring is indicated, lung function testing by spirometry should be carried out at the pre-

employment medical visit and annually thereafter. Surveillance of employees for

the appearance of symptoms should be carried out annually either by direct

assessment in the Occupational Health Department or by questionnaire.

Surveillance records should be retained for 40 years. If surveillance demonstrates

the occurrence of occupational dermatosis or asthma, further exposure must be

avoided. Staff should be encouraged to report any health problems to their line

management and occupational health department.

All staff working with endoscopes should be immunised in accordance with local

occupational health policy. Care must be taken in the handling of sharps, including spiked biopsy forceps. Staff should avoid the use of hypodermic needles or other

sharp instruments for removing specimens from the cups of biopsy forceps. A

blunt-ended needle or toothpick can be used to free the specimen.

8.Health and safety

There should always be sufficient numbers of trained staff and items of equipment to allow enough time for thorough cleaning and disinfection to take place (39).

Procedures for dealing with AER malfunctions, accidents and dangerous

occurrences should be documented and adhered to. Each endoscopy unit must

have a policy for dealing with disinfectant or body-fluid spillage. This policy should be prominently displayed within the unit, and all staff must be trained in its

implementation. Training of staff should be documented and reviewed regularly.

Given the policy of “universal precautions”, which assumes that any patient may

be harbouring infectious agents, there is no logic in placing “high risk” patients at

the end of endoscopy lists. An exception would be a patient with Acquired

Immune Deficiency Syndrome who may have resistant and/or atypical

mycobacterial infection. Local infection control policies, however, may dictate that certain patients are listed at the end of the session and before the standard

theatre cleaning routine. Patients with Methicillin-resistant Staphylococcus aureus or Vancomycin-resistant enterococci might fall into this category.

9.Practical Recommendations for Decontamination and Storage of

Endoscopes (Box 2)

Manufacturers of all reusable medical instruments are required under the UK

Medical Devices Regulations to provide validated reprocessing instructions for their equipment. In view of this, the Working Party has decided not to include generic

cleaning and disinfection instructions in this document, but to refer users to the

detailed instructions supplied by the manufacturers.

Before commencing sessions the endoscopes to be used during the list should be

checked for faults. Unless they have been stored in a quality-assured purpose-

built drying/storage chamber, all endoscopes must have been exposed to a cycle

of disinfection in the AER not more than 3 hours prior to use. The exposure times

recommended by the manufacturer for each disinfectant should be adhered to.

Trusts should undertake a risk assessment exercise on the need to repeat manual

cleaning of the endoscope channels prior to automatic reprocessing at the start of

each list.

Care should be taken to ensure that endoscopes prepared for use are stored in a

separate room from endoscopes that await reprocessing. Endoscopes should be

stored in a purpose-built drying/storage chamber, or should be hung vertically in a dry and well-ventilated storage cupboard. Special care should be taken to avoid

coiling of any part of the endoscope so as to reduce stasis of any droplets within

the channels. All valves, seals, soaking caps, angulation locks and detachable tips should have been removed. They should be stored with their corresponding

endoscope, and should not be replaced until the endoscope is next used. Valves

should be dried and lubricated as instructed by the manufacturer.

There are reports of possible damage to the external surfaces of endoscopes

resulting from continued exposure to ultraviolet light emitted by some brands of

storage cabinet. Designs of storage chamber that do not emit ultraviolet light are

therefore preferable.

10.Quality assurance of decontamination, drying and storage of endoscopes

A group was set up under the auspices of the Department of Health Endoscopy

Team to produce a checklist that is designed to assist units in quality assurance

and to facilitate external audits of decontamination practice (40). Potential points

for internal audits are set out therein.

There have been several publications concerning surveillance cultures of

endoscopes following decontamination. (9, 41-44). Other proposed initiatives

include the use of PCR (9) and adenosine triphosphate bioluminescence (45).

Nelson has pointed out the difficulties in standardising surveillance culture

protocols, which are both time consuming and expensive, and may fail to detect

atypical organisms. He also commented that endoscopes are not handled in a

sterile fashion following decontamination, and that the presence of skin and

environmental contaminants cannot be interpreted as a failure of disinfection (6).

Quality assurance of AER requires regular testing in accordance with the current

relevant HTM. There should also be annual testing for atypical mycobacteria, with culture plates incubated at 30o C as well as 37o C. More frequent testing for atypical mycobacteria may be prudent in tertiary respiratory disease centres and/or units

managing a large number of patients with HIV infection. Annual testing for

endotoxin has been suggested (3, 37) but there is no real evidence to support this additional step in non-sterile endoscopy practice.

Purpose-built drying/storage chambers have recently come onto the market.

These are designed to deliver high efficiency particulate filtered air to the internal

channels of the endoscope at the appropriate temperature and flow rate.

According to the manufacturers, their use avoids the need for endoscopes to

undergo early morning repeat decontamination cycles. One endoscope

manufacturer has reported damage to endoscope insertion and light guide tubes

from the ultra-violet light used in some brands of these chambers and has declared UV illumination to be incompatible with its endoscopes. Units considering

purchasing these chambers should therefore discuss compatibility with their

endoscope manufacturer, as well as involving their infection control and

decontamination officers in scrutinising the microbiological and safety data

supplied by the manufacturers.

11.Cleaning and Disinfection of Accessories

This topic was addressed by an earlier BSG Working Party (46). Increasingly the

accessories that are passed via the working channel of endoscopes are single use.

These include cytology brushes, polypectomy snares, injection needles and most

ERCP accessories. Single use balloons are widely used as an alternative to bougies for dilatation, and are now available for forced pneumatic balloon dilatation in

patients with achalasia.

The trend towards single use biopsy forceps has been accelerated by the discovery of vCJD within the gut lymphoid system. Since then there has been a case report

of apparent transmission of Trichosporon asahii oesophagitis by reused forceps

(47). The Working Party now recommends that endoscopy units in the UK should

be employing single use forceps. Indeed it has been suggested that single use

biopsy forceps may be more cost-effective than their reusable counterparts (18).

It is also recommended that, where single use accessories are available, these

should be chosen over reusable accessories. Reusable accessories that are passed into the gastrointestinal tract (e.g. bougies) need to be tracked, and a register

kept on previous patient uses.

The recommendation to move towards single use accessories has been reviewed

by the National Institute for Health and Clinical Excellence. Whilst its experts do

not consider that it is cost-effective to choose single use accessories for

gastrointestinal endoscopy, it is conceded that once-only usage is the only means

of eliminating all risk of transferring infection by way of accessories from one

patient to another (48).

Accessories that are not passed through the working channel of endoscopes, such

as water bottles and bougies, are normally marketed as reusable. Autoclavable

accessories should be chosen whenever possible. Argon plasma coagulation

catheters are now marketed as single use, but other therapeutic devices passed

via the endoscope working channel (such as heater probes) are reusable and can

be autoclaved. Because autoclaving is not reliable in eliminating prion particles,

heater probes and other reusable accessories must be discarded after any invasive therapeutic procedures in patients with established or suspected vCJD, or risk

factors for vCJD (annex F).

The Medical Devices Agency Bulletin DB2006(04) (49) advises on potential

hazards, clinical and legal, associated with reprocessing and reusing medical

devices intended for single use. Users who disregard this information and prepare single use items for reuse without due precautions may be transferring legal

liability for the safe performance of the product from the manufacturer to

themselves or their employers.

12.Staff training and competencies

The 2006 Health Act emphasises the need for staff to be trained in

decontamination processes and to hold appropriate competencies for their role. It decrees the need for monitoring systems to ensure that decontamination processes are fit for purpose and meet required standards. The theme of prevention of

healthcare associated infections has been developed further following the Act (50).

All staff undertaking endoscope decontamination should be trained to the

appropriate standard. The requirements are set out in competency END 21 in

https://www.sodocs.net/doc/9851014.html,. Training should include an awareness of the channel

configuration of all endoscopes and of the AERs and available irrigation adaptors.

Staff training programmes should be implemented and documented.

Out of hours endoscopy should not be done unless there is an endoscopy

assistant available who has been trained in decontamination practice.

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Box 1: Personnel Protection during Endoscope Decontamination (Ref. 50)

1. Wear long-sleeved waterproof gowns. These should be changed between patients.

2. Use nitrile gloves which are long enough to protect the forearms from

splashes.

3. Goggles prevent conjunctival irritation and protect the wearer from

splashes.

4. Disposable charcoal-impregnated face masks may reduce inhalation of vapour from

disinfectants, but experience with them is not yet widespread.

5. An HSE-approved vapour respirator should be available in case of spillage or other

emergencies. It should be stored away from disinfectants as the charcoal adsorbs

fumes and respirators should be regularly replaced.

Box 2: Ten Steps in Endoscope Decontamination

As soon as possible after use:

1. Wipe down insertion tube

2.Flush air/water channels

3.Aspirate water through biopsy/suction channel

4.Dismantle detachable parts (e.g. valves)

5.Perform a leak test

6.Manually clean air/water and suction valves prior to decontamination (or

autoclaving if manufacturer sanctions this)

7.Manually clean with enzymatic detergent followed by rinsing

8.Disinfect and rinse in an automated reprocessor, with detachable parts

alongside

9.Dry

10.Store appropriately

内镜清洗消毒规范操作流程

胃镜清洗消毒操作规程一、个人防护工作人员清洗内镜时应当：穿戴必要的防护用品，包括工作服、防水衣、口罩、帽子、手套、防护镜等。二、预处理 1、内镜使用后立即用酶液纱布擦拭内镜外表污物，并反复送气、送水10秒，擦拭巾一用一更换。 2、取下内镜盖上防水盖，送至清洗消毒室。 3、内镜轻放于水槽内，再次检查防水盖有无盖紧，连接侧漏器进行内镜侧漏，在清洗消毒前确保内镜无渗漏。三、清洗 1、在清洗槽内根据多酶比例正确配置清洗液。将内镜、按钮、阀门完全浸没于清洗液中，用擦拭布反复擦洗镜身，重点擦拭镜身和操作部，擦拭布一用一更换。 2、用清洗毛刷彻底刷洗活检孔道和导光软管的吸引器管道(刷洗时必须两头见刷毛，并清洗刷头上的污物)。清洗刷一用一消毒。 3、连接全管道灌流器，使用动力泵或注射器向管道内注射清洗液，刷洗按钮和阀门。 4、酶洗液浸泡时间一般不少于2分钟。 5、含酶洗液一镜一换。漂洗 1、用压力气枪，用流动水冲洗内镜各管道至少2分钟，充分清洗内镜外表面及及各种附件、按钮和阀门，去除残留的多酶。 2、用干净纱布擦干镜身及附件。四、消毒

1、将内镜及各类按钮擦干后置于消毒液中。 2、管腔内充分注入消毒液，确保管腔内无残留空气。 3、消毒时间：浸泡消毒≥10分钟。五、冲洗、干燥 1、更换手套; 2、流动水充分冲洗内镜及各管道、按钮。 3、将内镜、按钮和阀门置于铺有无菌巾的内镜干燥台上。用75%酒精冲洗所有管道，气枪吹干管道水分，用灭菌纱布擦干镜身，安装好各按钮。六、储存 1、灭菌后的内镜及附件应按无菌物品储存。 2、消毒后的内镜悬挂于镜柜内，弯角固定钮应置于自由位。 3、储柜内表面光滑、无缝隙、便于清洁，每周清洁消毒1次。七、登记内镜清洗消毒登记包括：日期、患者姓名、内镜编号、清洗消毒起止时间、操作者签名。八、其他 1、每天诊治工作结束后，地面和台面应用500mg/L有效氯擦洗。 2、操作人员应做好自我保护，操作时应穿防水围裙，口罩，帽子，手套，手套每人更换。 3、每天工作结束后清洗槽、酶洗槽、冲洗槽经充分刷洗后，用500mg/L含氯消毒剂擦拭。 4、消毒槽在更换消毒剂时必须彻底刷洗。

内镜清洗消毒规范

内镜的清洗消毒技术规范（软式内镜的清洗与消毒）软式内镜使用后应当立即用湿纱布擦去外表面污物，并反复送气与送水至少10秒钟，取下内镜并装好防水盖，置合适的容器中送清洗消毒室。清洗步骤、方法及要点包括：一、水洗 1、将内镜放入清洗槽内： (1)、在流动水下彻底冲洗，用低纤维棉絮反复擦洗镜身，同时将操作部清洗干净； (2)、取下活检入口阀门、吸引器按钮和送气送水按钮，用清洁毛刷彻底刷洗活检孔道和导光软管的吸引器管道，刷洗时必须两头见刷头，并洗净刷头上的污物； (3)、安装管道插塞、防水帽和高压水枪，用高压水枪反复冲洗活检孔道； (4)、用高压水枪冲洗送气送水管道；

(5)、用高压气枪吹干活检孔道及送气送水管道的水分并擦干镜身。 2、将取下的吸引器按钮、送水送气按钮和活检入口阀用清水冲洗干净并擦干。 3、内镜附件如活检钳、细胞刷、切开刀、导丝、碎石器、网篮、造影导管、异物钳等使用后，先放入清水中，用小刷刷洗钳瓣内面和关节处，清洗后并擦干。 4、清洗用低纤维棉絮应当采用一次性使用的方式，清洗刷应当一用一消毒。二、酶洗 1、多酶洗液的配置和浸泡时间按照产品说明书。 2、将擦干后的内镜置于酶洗槽中，用注射器抽吸多酶洗液100 毫升，冲洗送气送水管道，用吸引器将含酶洗液吸入活检孔道，操作部用多酶洗液擦拭。 3、擦干后的附件、各类按钮和阀门用多酶洗液浸泡，附件还需在超声清洗器内清洗5～10分钟。 4、多酶洗液应当每清洗1条内镜后更换。三、清洗

1、多酶洗液浸泡后的内镜，用高压水枪或者注射器彻底冲洗各管道，以去除管道内的多酶洗液及松脱的污物，同时冲洗内镜的外表面1分钟。 2、用高压气枪向各管道冲气10秒，排出管道内的水分，同时用清洁干纱布擦镜表面，并清洗刷，清洗时间不少于1分钟。四、消毒软式内镜采用化学消毒剂进行消毒或者灭菌时，应当按照使用说明进行，并进行化学监测和生物学监测。 1、需要消毒的内镜采用酸性氧化电位水消毒，按使用说明操作;非全浸式内镜的操作部，必须用清水擦拭后再用75%乙醇擦拭消毒。 2、需要灭菌的内镜采用过氧化氢低温等离子灭菌器灭菌。五、内镜附件的消毒与灭菌方法及要点包括：目前大部分附件已经做到了一次性使用，对不能一次性使用的内镜附件应注意严格清洗消毒。 1、内镜器械：拆卸所有可拆卸的部分，用纱布及软毛刷在含酶清洗液中彻底清洗，特别注意关节等难清洗部位。消毒流程为：清洗、干燥、消毒流动水清洗、干燥、装塑封袋、过氧化氢低温等离子灭菌器灭菌。

软式内镜清洗消毒技术要求规范

软式内镜清洗消毒技术规范 1 范围本标准规定了软式内镜清洗消毒相关的管理要求、基本条件、操作规程等内容。本标准适用于开展软式内镜诊疗工作的医疗机构。 2 规范性引用文件下列文件对于本文件的应用是必不可少的。凡是注时期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本（包括所有修改单）适用于本文件。 GB 5749 生活饮用水卫生标准 WS/T 311 医院隔离技术规范 WS/T 313 医务人员手卫生规范 GB 内镜清洗消毒机（2012发布） GB 医用清洗剂标准（2012发布） GB 消毒技术规范（2012发布） 3 术语和定义下列术语和定义适用于本标准。 3.1 软式内镜flexible endoscope 用于疾病诊断、治疗的可弯曲的内镜。 3.2 清洗cleaning 使用含有医用清洗剂的清洗用水，去除附着于软式内镜的污染物的过程。

3.3 漂洗rinsing 用流动水冲洗清洗后软式内镜上残留物的过程。 3.4 终末漂洗final rinsing 对消毒后的软式内镜进行最终漂洗的过程。 3.5 内镜清洗消毒机automatic endoscope reprocessor, AER 用于内镜复用处理，具有清洗与消毒功能的机器。 3.6 医用清洗剂medical cleaning agent 用于医疗器械清洗，增强水的去污能力的化学制剂。 4 管理要求 4.1 医疗机构的管理要求 4.1.1 开展内镜诊疗工作的医疗机构，宜按专业群分别建立集中的内镜诊疗中心（室）。4.1.2 医疗机构应将内镜清洗消毒工作纳入医疗质量管理，制定和完善内镜中心（室）医院感染管理和内镜清洗消毒的各项规章制度并认真落实，加强监测。 4.1.3 医院感染管理部门、医务部门、护理部门等相关部门应遵循本标准，负责对本医疗机构内镜使用和清洗消毒质量的监督管理，包括内镜中心（室）建筑布局与工作流程审核、日常巡查、内镜消毒灭菌效果监测等，发现问题及时处理。 4.2 内镜中心（室）的管理要求 4.2.1 内镜中心（室）应建立健全岗位职责、清洗消毒操作规程、质量管理、监测、设备管理、器械管理及职业安全防护等管理制度和突发事件的应急预案。 4.2.2 应遵循标准预防的原则，将所有用于患者诊疗操作后的软式内镜均视为具有感染性，应立即进行清洗消毒处理，并进行人员防护。

内镜消毒规范

WS 507—2016软式内镜清洗消毒技术规范.软式内镜清洗消毒技术规范 1 范围本标准规定了软式内镜清洗消毒相关的管理要求、基本条件、操作规程等内容。本标准适用于开展软式内镜诊疗工作的医疗机构。 2 规范性引用文件下列文件对于本文件的应用是必不可少的。凡是注时期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本（包括所有修改单）适用于本文件。 GB 5749 生活饮用水卫生标准 WS/T 311 医院隔离技术规范 WS/T 313 医务人员手卫生规范 GB 内镜清洗消毒机（2012发布） GB 医用清洗剂标准（2012发布）GB 消毒技术规范（2012发布） 3 术语和定义下列术语和定义适用于本标准。软式内镜 flexible endoscope 用于疾病诊断、治疗的可弯曲的内镜。清洗cleaning 使用含有医用清洗剂的清洗用水，去除附着于软式内镜的污染物的过程。漂洗rinsing 用流动水冲洗清洗后软式内镜上残留物的过程。终末漂洗final rinsing 对消毒后的软式内镜进行最终漂洗的过程。内镜清洗消毒机automatic endoscope reprocessor, AER 用于内镜复用处理，具有清洗与消毒功能的机器。医用清洗剂medical cleaning agent 用于医疗器械清洗，增强水的去污能力的化学制剂。 4 管理要求医疗机构的管理要求开展内镜诊疗工作的医疗机构，宜按专业群分别建立集中的内镜诊疗中心（室）。医疗机构应将内镜清洗消毒工作纳入医疗质量管理，制定和完善内镜中心（室）医院感染管理和内镜清洗消毒的各项规章制度并认真落实，加强监测。医院感染管理部门、医务部门、护理部门等相关部门应遵循本标准，负责对本医疗机构内镜使用和清洗消毒质量的监督管理，包括内镜中心（室）建筑布局与工作流程审核、日常巡查、内镜消毒灭菌效果监测等，发现问题及时处理。内镜中心（室）的管理要求内镜中心（室）应建立健全岗位职责、清洗消毒操作规程、质量管理、监测、设备管理、器械管理及职业安全防护等管理制度和突发事件的应急预案。

内镜清洗消毒流程

内镜清洗消毒流程一、基本清洗消毒设备及物品：包括专用流动水清洗消毒槽、操作台、治疗车、负压吸引器、高压水枪、计时器、通风设施，50 毫升注射器、各种刷子、纱布、棉棒、无菌巾、治疗盘等。二、软式内镜的清洗与消毒步骤、方法及要点包括： 1、将内镜放入清洗槽内,在流动水下彻底冲洗，用纱布反复擦洗镜身，同时将操作部清洗乾净. 2、取下活检入口阀门、吸引器按钮和送气送水按钮，用清洁毛刷彻底刷洗活检孔道和导光软管的吸引器管道，刷洗时必须两头见刷头，并洗净刷头上的污物. 3、安装全管道灌流器、管道插塞、防水帽和吸引器，用吸引器反复抽吸活检孔道. 4、全管道灌流器接50毫升注射器，吸清水注入送气送水管道； 5、用吸引器吸干活检孔道的水分并擦干镜身。 6、将取下的吸引器按钮、送水送气按钮和活检入口阀用清水冲洗干净并擦干。 7、内镜附件如活检钳、细胞刷、切开刀、导丝、网篮、异物钳等使用后，先放入清水中，用小刷刷洗钳瓣内面和关节处，清洗后并擦干。用水枪或者注射器彻底冲洗各管道。 8、清洗纱布应当采用一次性使用的方式，清洗刷应当一用一消毒。 9、清洗后用2%碱性戊二醛浸泡灭菌时间为10小时，如采用2%碱性戊二醛浸泡消毒时间不少于20分钟，冲洗、乾燥后，方可用于病人诊疗。 10、应将清洗擦干后的内镜置于消毒槽并全部浸没消毒液中，各孔道用注射器灌满消毒液。三、硬式内镜的清洗、消毒步骤、方法及要点包括： 1、使用后立即用流动水彻底清洗，除去血液、粘液等残留物质，并擦乾。 2 、器械的轴节部、弯曲部、管腔内用软毛刷彻底刷洗，刷洗时注意避免划伤镜面。 3、用2%碱性戊二醛浸泡灭菌时间为10小时，如采用2%碱性戊二醛浸泡消毒时间不少于20分钟，冲洗、干燥后，方可用于病人诊疗， 4、应当将清洗擦乾后的内镜置于消毒槽并全部浸没消毒液中，各孔道用注射器灌满消毒液。 5、采用化学消毒剂浸泡灭菌的硬式内镜，灭菌后应当用无菌水彻底冲洗，再用无菌纱布擦干。采用化学消毒剂浸泡消毒的硬式内镜，消毒后应当用流动水冲洗干净，再用无菌纱布擦干。四、注意事项 1、每日诊疗工作结束，消毒后的内镜储存于专用洁净柜内。镜体应悬挂，弯角固定钮应置于自由位。储柜内表面每周清洁消毒一次。 2、吸引瓶、吸引管经清洗后，用有效氯含量为500mg/L的含氯消毒剂浸泡消毒30分钟，刷洗干净，晾干备用。 3、清洗槽经充分刷洗后，用有效氯含量为500mg/L的含氯消毒剂擦拭。消毒槽在更换消毒剂时必须彻底刷洗。 4、内镜置入清洗槽时严禁弯曲过度，损坏镜体。 5、内镜及附件的清洗、消毒或者灭菌时间应当使用计时器控制。

内镜清洗消毒技术操作规范

镜清洗消毒技术操作规第一章总则第一条、为规医疗机构镜清洗消毒工作，保障医疗质量和医疗安全，制定本规。第二条、本规适用于开展镜诊疗工作的医疗机构。第三条、开展镜诊疗工作的医疗机构，应当将镜的清洗消毒工作纳入医疗质量管理，加强监测和监督。第四条、各级地方卫生行政部门负责辖区医疗机构镜清洗消毒工作的监督管理。第二章基本要求第五条、开展镜诊疗工作的医疗机构应当制定和完善镜室管理的各项规章制度，并认真落实。第六条、从事镜诊疗和镜清洗消毒工作的医务人员，应当具备镜清洗消毒方面的知识，接受相关的医院感染管理知识培训，严格遵守有关规章制度。第七条、镜的清洗消毒应当与镜的诊疗工作分开进行，分设单独的清洗消毒室和镜诊疗室，清洗消毒室应当保证通风良好。镜诊疗室应当设有诊疗床、吸引器、治疗车等基本设施。第八条、不同部位镜的诊疗工作应当分室进行；上消化道、下消化道镜的诊疗工作不能分室进行的，应当分时间段进行；不同部位镜的清洗消毒工作的设备应当分开。第九条、灭菌镜的诊疗应当在达到手术标准的区域进行，并按照手术区域的要求进行管理。

第十条、工作人员清洗消毒镜时，应当穿戴必要的防护用品，包括工作服、防渗透围裙、口罩、帽子、手套等。第十一条、根据工作需要，按照以下要求配备相应镜及清洗消毒设备： 1、镜及附件：其数量应当与医院规模和接诊病人数相适应,以保证所用器械在使用前能达到相应的消毒、灭菌合格的要求，保障病人安全。 2、基本清洗消毒设备：包括专用流动水清洗消毒槽（四槽或五槽）、负压吸引器、超声清洗器、高压水枪、干燥设备、计时器、通风设施，与所采用的消毒、灭菌方法相适应的必备的消毒、灭菌器械，50 毫升注射器、各种刷子、纱布、棉棒等消耗品。 3、清洗消毒剂：多酶洗液、适用于镜的消毒剂、75%乙醇。第十二条、镜及附件的清洗、消毒或者灭菌必须遵照以下原则： 1、凡进入人体无菌组织、器官或者经外科切口进入人体无菌腔室的镜及附件，如腹腔镜、关节镜、脑室镜、膀胱镜、宫腔镜等，必须灭菌。 2、凡穿破粘膜的镜附件，如活检钳、高频电刀等，必须灭菌。 3、凡进入人体消化道、呼吸道等与粘膜接触的镜，如喉镜、气管镜、支气管镜、胃镜、肠镜、乙状结肠镜、直肠镜等，应当按照《消毒技术规》的要求进行高水平消毒。 4、镜及附件用后应当立即清洗、消毒或者灭菌。 5、医疗机构使用的消毒剂、消毒器械或者其它消毒设备，必须符合《消毒管理办法》的规定。 6、镜及附件的清洗、消毒或者灭菌时间应当使用计时器控制。 7、禁止使用非流动水对镜进行清洗。

内镜清洗消毒要求规范

镜的清洗消毒技术规（软式镜的清洗与消毒）软式镜使用后应当立即用湿纱布擦去外表面污物，并反复送气与送水至少10秒钟，取下镜并装好防水盖，置合适的容器中送清洗消毒室。清洗步骤、方法及要点包括：一、水洗 1、将镜放入清洗槽： (1)、在流动水下彻底冲洗，用低纤维棉絮反复擦洗镜身，同时将操作部清洗干净； (2)、取下活检入口阀门、吸引器按钮和送气送水按钮，用清洁毛刷彻底刷洗活检孔道和导光软管的吸引器管道，刷洗时必须两头见刷头，并洗净刷头上的污物； (3)、安装管道插塞、防水帽和高压水枪，用高压水枪反复冲洗活检孔道； (4)、用高压水枪冲洗送气送水管道； (5)、用高压气枪吹干活检孔道及送气送水管道的水分并擦干镜身。 2、将取下的吸引器按钮、送水送气按钮和活检入口阀用清水冲洗干净并擦干。 3、镜附件如活检钳、细胞刷、切开刀、导丝、碎石器、网篮、造影导管、异物钳等使用后，先放入清水中，用小刷刷洗钳瓣面和关节处，清洗后并擦干。 4、清洗用低纤维棉絮应当采用一次性使用的方式，清洗刷应当一用一消毒。二、酶洗 1、多酶洗液的配置和浸泡时间按照产品说明书。

2、将擦干后的镜置于酶洗槽中，用注射器抽吸多酶洗液100毫升，冲洗送气送水管道，用吸引器将含酶洗液吸入活检孔道，操作部用多酶洗液擦拭。 3、擦干后的附件、各类按钮和阀门用多酶洗液浸泡，附件还需在超声清洗器清洗5～10分钟。 4、多酶洗液应当每清洗1条镜后更换。三、清洗 1、多酶洗液浸泡后的镜，用高压水枪或者注射器彻底冲洗各管道，以去除管道的多酶洗液及松脱的污物，同时冲洗镜的外表面1分钟。 2、用高压气枪向各管道冲气10秒，排出管道的水分，同时用清洁干纱布擦镜表面，并清洗刷，清洗时间不少于1分钟。四、消毒软式镜采用化学消毒剂进行消毒或者灭菌时，应当按照使用说明进行，并进行化学监测和生物学监测。 1、需要消毒的镜采用酸性氧化电位水消毒，按使用说明操作;非全浸式镜的操作部，必须用清水擦拭后再用75%乙醇擦拭消毒。 2、需要灭菌的镜采用过氧化氢低温等离子灭菌器灭菌。五、镜附件的消毒与灭菌方法及要点包括：目前大部分附件已经做到了一次性使用，对不能一次性使用的镜附件应注意严格清洗消毒。 1、镜器械：拆卸所有可拆卸的部分，用纱布及软毛刷在含酶清洗液中彻底清洗，特别注意关节等难清洗部位。消毒流程为：清洗、干燥、消毒流动水清洗、干燥、装塑封袋、过氧化氢低温等离子灭菌器灭菌。

内镜清洗消毒规范操作流程

内镜清洗消毒规范操作流程一、个人防护工作人员清洗内镜时应当：穿戴必要的防护用品，包括工作服、防水衣、口罩、帽子、手套、防护镜等。二、预处理 1、内镜使用后立即用酶液纱布擦拭内镜外表污物，并反复送气、送水10秒，擦拭巾一用一更换。 2、取下内镜盖上防水盖，送至清洗消毒室。 3、内镜轻放于水槽内，再次检查防水盖有无盖紧，连接侧漏器进行内镜侧漏，在清洗消毒前确保内镜无渗漏。三、清洗 1、在清洗槽内根据多酶比例正确配置清洗液。将内镜、按钮、阀门完全浸没于清洗液中，用擦拭布反复擦洗镜身，重点擦拭镜身和操作部，擦拭布一用一更换。 2、用清洗毛刷彻底刷洗活检孔道和导光软管的吸引器管道(刷洗时必须两头见刷毛，并清洗刷头上的污物)。清洗刷一用一消毒。 3、连接全管道灌流器，使用动力泵或注射器向管道内注射清洗液，刷洗按钮和阀门。 4、酶洗液浸泡时间一般不少于2分钟。 5、含酶洗液一镜一换。

漂洗 1、用压力气枪，用流动水冲洗内镜各管道至少2分钟，充分清洗内镜外表面及及各种附件、按钮和阀门，去除残留的多酶。 2、用干净纱布擦干镜身及附件。四、消毒 1、将内镜及各类按钮擦干后置于消毒液中。 2、管腔内充分注入消毒液，确保管腔内无残留空气。 3、消毒时间：浸泡消毒≥10分钟。五、冲洗、干燥 1、更换手套; 2、流动水充分冲洗内镜及各管道、按钮。 3、将内镜、按钮和阀门置于铺有无菌巾的内镜干燥台上。用75%酒精冲洗所有管道，气枪吹干管道水分，用灭菌纱布擦干镜身，安装好各按钮。六、储存 1、灭菌后的内镜及附件应按无菌物品储存。 2、消毒后的内镜悬挂于镜柜内，弯角固定钮应置于自由位。 3、储柜内表面光滑、无缝隙、便于清洁，每周清洁消毒1次。七、登记内镜清洗消毒登记包括：日期、患者姓名、内镜编号、清洗消毒起止时间、操作者签名。八、其他 1、每天诊治工作结束后，地面和台面应用500mg/L有效氯擦洗。

内镜消毒规范

WS 507 —2016 软式内镜清洗消毒技术规范.软式内镜清洗消毒技术规范 1 范围本标准规定了软式内镜清洗消毒相关的管理要求、基本条件、操作规程等内容。本标准适用于开展软式内镜诊疗工作的医疗机构。 2 规范性引用文件下列文件对于本文件的应用是必不可少的。凡是注时期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本（包括所有修改单）适用于本文件。GB 5749 生活饮用水卫生标准WS/T 311 医院隔离技术规范WS/T 313 医务人员手卫生规范GB 内镜清洗消毒机（2012 发布）GB 医用清洗剂标准（2012 发布）GB 消毒技术规范（2012 发布） 3 术语和定义下列术语和定义适用于本标准。软式内镜flexible endoscope 用于疾病诊断、治疗的可弯曲的内镜。清洗cleaning 使用含有医用清洗剂的清洗用水，去除附着于软式内镜的污染物的过程。漂洗rinsing 用流动水冲洗清洗后软式内镜上残留物的过程。终末漂洗final rinsing 对消毒后的软式内镜进行最终漂洗的过程。内镜清洗消毒机automatic endoscope reprocessor, AER 用于内镜复用处理，具有清洗与消毒功能的机器。医用清洗剂medical cleaning agent 用于医疗器械清洗，增强水的去污能力的化学制剂。 4 管理要求医疗机构的管理要求开展内镜诊疗工作的医疗机构，宜按专业群分别建立集中的内镜诊疗中心（室）。医疗机构应将内镜清洗消毒工作纳入医疗质量管理，制定和完善内镜中心（室）医院感染管理和内镜清洗消毒的各项规章制度并认真落实，加强监测。医院感染管理部门、医务部门、护理部门等相关部门应遵循本标准，负责对本医疗机构内镜使用和清洗消毒质量的监督管理，包括内镜中心（室）建筑布局与工作流程审核、日常巡查、内镜消毒灭菌效果监测等，发现问题及时处理。内镜中心（室）的管理要求内镜中心（室）应建立健全岗位职责、清洗消毒操作规程、质量管理、监测、设备管理、器械管理及职业安全防护等管理制度和突发事件的应急预案。应遵循标准预防的原则，将所有用于患者诊疗操作后的软式内镜均视为具有感染性，应立即进行清洗消毒处理，并进行人员防护。

软式内镜清洗消毒流程

软式内镜清洗消毒流程 1、使用后立即用湿纱布擦去外表面污物，并反复送水送气10秒钟 2、取下内镜装好防水盖 1、用流动水擦洗镜身及操作部 2、取下各种按钮，用清洗毛刷刷洗活检孔道和吸引管道（刷洗时必须两头见刷毛，并清洗刷头上的污物） 3、安装全管道灌流器，用50ml 注射器冲洗送水送气管道 4、用吸引器吸干管道内水分并擦干镜身 5、将取下的各种按钮冲洗干净并擦干，将使用过的附件（活检、细胞刷等）用清水冲洗、刷洗钳瓣内面和关节处并擦干 1、将内镜及附件、按钮完全浸泡在多酶清洗液中2-5分钟，并用注射器吸多酶洗液灌满各管道 2、附件应使用超声清洗机清洗5-10分钟 3、每清洗一条内镜必须更换多酶清洗液 1、流动水清洗内镜外表面及各种附件、按钮，同时用注射器反复冲洗各管道 2、擦干镜身及附件，用注射器排干各管道内水分，将附件完全浸入润滑剂中30秒，将附件取出烘干或用干净棉布吸去多余润滑剂 3、润滑剂应每天更换，并做记录 1、将内镜及按钮放入2%的戊二醛消毒液中浸泡，并用注射器将消毒液注入各管道内 2、胃镜、肠镜消毒时间为10分钟；气管镜为20分钟。结核或其它分枝杆菌感染患者使用后的内镜消毒时间为45分钟；当天不再使用的内镜，最后一次消毒时间为30分钟 3、附件（活检钳、细胞刷等）必须按灭菌处理（戊二醛浸泡10小时或高压蒸汽灭菌），一用一消毒 4、戊二醛浓度必须每天监测并记录 1、流动水冲洗内镜及各管道、按钮 2、用灭菌纱布擦干镜身并吹干管道水分，安装好各按钮 3、支气管镜在使用前，用吸引器吸生理盐水冲洗活检孔道；用75%酒精擦拭镜体并干燥内镜的储存 1、内镜应干燥后悬挂于专用洁净柜中 2、镜柜应每周清洁消毒一次 3、灭菌后的附件应按无菌物品储存要求储存相关物品的处理每天诊疗工作结束后，必须对吸引瓶、吸引管、各清洗槽进行清洗，并用有效含氯量500mg/L 的消毒剂浸泡30分钟消毒。

硬式内镜清洗消毒与灭菌技术规范意见稿

硬式内镜清洗消毒与灭菌技术规范 Regulation of cleaning, disinfection and sterilization technique for rigid Endoscopes 前言本标准按照GB/T1.1-2009给出的规则起草。根据《中国人民共和国传染病防治法》、《医院感染管理办法》制定本标准。本标准第4.4、6.2.2、7.1.2、8.3.1、8.3.2、8.4.3.2、10.1.3、11.1.2条为推荐性条款，其余为强制性条款。本标准由国家卫生标委会感染控制标准专业委员会提出并归口。本标准起草单位：北京大学第一医院、国家卫生计生委医院管理研究所、中国疾病预防控制中心、北京协和医院、浙江省疾病预防控制中心、四川大学华西医院、广州市第一人民医院、中国人民解放军总医院、山东省立医院、华中科技大学同济医学院附属协和医院、广东省人民医院、上海交通大学附属瑞金医院、北京大学第三医院、浙江大学医学院附属邵逸夫医院、安徽医科大学第一附属医院、首都医科大学附属安贞医院、北京世纪坛医院、四川省人民医院。本标准主要起草人：李六亿、巩玉秀、张流波、张青、胡国庆、黄浩、冯秀兰、刘运喜、李卫光、邓敏、侯铁英、钱黎明、郭莉、王亚娟、马红秋、孟黎辉、张宇、薛文英、温秀贤、姚希、陈美恋。硬式内镜清洗消毒与灭菌技术规范 1 范围

本标准规定了硬式内镜清洗消毒与灭菌中基本要求，人员要求，建筑布局，设施与耗材，清洗、包装操作流程，高水平消毒，灭菌，储存，消毒与灭菌效果监测等内容。本标准适用于开展硬式内镜诊疗工作的各级各类医疗机构中硬式内镜的清洗、消毒与灭菌。 2 规范性引用文件下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅所注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本（包括所有的修改单）适用于本文件。 WS310.1 医院消毒供应中心第1部分：管理规范 WS310.2 医院消毒供应中心第2部分：清洗消毒及灭菌技术操作规范 WS310.3 医院消毒供应中心第3部分：清洗消毒及灭菌效果监测标准 WS/T311 医院隔离技术规范 WS/T313 医务人员手卫生规范 WS/T367 医疗机构消毒技术规范 3 术语和定义 3.1 硬式内镜 rigid endoscope 指用于疾病诊断或治疗的不可弯曲的内镜及相匹配的导光束、器械、附件、超声刀系统、电凝系统等。

软式内镜清洗消毒规范操作流程分享

最新软式内镜清洗消毒规范操作流程分享2017年6月1日执行的《软式内镜清洗消毒技术规范》与老版规范在操作流程中有哪些不同呢最新软式内镜清洗消毒规范操作流程图解一、个人防护工作人员清洗内镜时应当：穿戴必要的防护用品，包括工作服、防水衣、口罩、帽子、手套、防护镜等。二、预处理 1、内镜使用后立即用酶液纱布擦拭内镜外表污物，并反复送气、送水10秒。 2、取下内镜盖上防水帽，送至清洗消毒室。 3、内镜轻放于水槽内，再次检查防水帽有无盖紧，连接侧漏器进行内镜侧漏，在清洗消毒前确保内镜无渗漏。

三、清洗 1、在清洗槽内根据多酶比例正确配置清洗液。取下按钮、阀门并刷洗。完全浸没于清洗液中反复擦洗镜身，重点擦拭镜身和操作部，擦拭布一用一更换。

2、用清洗毛刷彻底刷洗活检孔道和导光软管的吸引器管道(刷洗时必须两头见刷毛，并清洗刷头上的污物)。清洗刷一用一消毒。 3、连接全管道灌流器，使用动力泵或注射器向管道内注射清洗液。 4、酶洗液浸泡时间一般不少于2分钟。 5、每清洗一条内镜更换多酶洗液。漂洗 1、流动水清洗内镜外表面及各种附件、按钮。 2、充分清洗内镜外表面及内腔，去除残留的多酶。 3、用干纱布擦干镜身及附件。

四、消毒 1、将内镜及各类按钮擦干后置于消毒液中。 2、管腔内充分注入消毒液，确保管腔内无残留空气。 3、消毒时间：浸泡消毒≥5分钟。

五、冲洗、干燥

1、更换手套; 2、流动水充分冲洗内镜及各管道、按钮。 3、用75%酒精中冲洗管道，气枪吹干管道水分用灭菌纱布擦干镜身，安装好各按钮备用。 4、将内镜置于内镜干燥台备用。六、登记内镜清洗消毒登记包括：日期、患者姓名、内镜编号、清洗消毒起止时间、操作者签名。注意事项：

《内镜清洗消毒技术操作规范(2004年版)》

卫生部关于印发《内镜清洗消毒技术操作规范（2004年版）》的通知各省、自治区、直辖市卫生厅局，新疆生产建设兵团卫生局：为进一步加强医疗机构内镜清洗消毒工作，保障医疗质量和医疗安全，我部组织有关专家，在调查研究的基础上制定了《内镜清洗消毒技术操作规范（2004年版）》（以下简称《规范》），现印发给你们，请遵照执行。为保证《规范》顺利实施，提出以下要求：一、各级各类医疗机构必须高度重视内镜消毒工作，将内镜消毒质量纳入医疗质量和医疗安全管理。本《规范》实施前，开展内镜诊疗业务的医疗机构必须按照《规范》的要求进行自查和整改工作，建立健全并落实有关内镜消毒的各项规章制度，切实保证消毒质量，严格预防和控制因内镜消毒问题导致的医院感染。二、加强《规范》的学习和培训工作。开展内镜诊疗工作的医疗机构，必须认真组织学习和全面贯彻本《规范》，有关的医院感染管理人员、从事内镜诊疗和内镜清洗消毒工作的医务人员应当接受相应培训，正确掌握内镜的清洗和消毒灭菌技术。三、各级卫生行政部门要加强对医疗机构内镜消毒工作的监督管理，未达到本《规范》要求的医疗机构，不得开展相应的内镜诊疗业务。附件：内镜清洗消毒技术操作规范（2004年版）二○○四年四月一日

附件：内镜清洗消毒技术操作规范（2004年版）第一章总则第一条为规范医疗机构内镜清洗消毒工作，保障医疗质量和医疗安全，制定本规范。第二条本规范适用于开展内镜诊疗工作的医疗机构。第三条开展内镜诊疗工作的医疗机构，应当将内镜的清洗消毒工作纳入医疗质量管理，加强监测和监督。第四条各级地方卫生行政部门负责辖区内医疗机构内镜清洗消毒工作的监督管理。第二章基本要求第五条开展内镜诊疗工作的医疗机构应当制定和完善内镜室管理的各项规章制度，并认真落实。第六条从事内镜诊疗和内镜清洗消毒工作的医务人员，应当具备内镜清洗消毒方面的知识，接受相关的医院感染管理知识培训，严格遵守有关规章制度。第七条内镜的清洗消毒应当与内镜的诊疗工作分开进行，分设单独的清洗消毒室和内镜诊疗室，清洗消毒室应当保证通风良好。内镜诊疗室应当设有诊疗床、吸引器、治疗车等基本设施。

软式内镜清洗消毒技术规范WS 507—2016

2017-06-01 实施中华人民共和国卫生行业标准 WS 507—2016 软式内镜清洗消毒技术规范 Regulation for cleaning and disinfection technique of flexible endoscope 2016-12-27 发布中华人民共和国国家卫生和计划生育委员会发布

刖本标准的 4.1.1、4.1.2、5.2.7、5.2.8、5.3.3、5.3.7、5.3.8、5.3.9b)、5.3.11c)2)、5.3.11e)2)、5.3.11f)2)、 6.1.2c)、6.1.4a)1)、6.2.2g)、6.3.2、6.4.5a)1)、7.1.2、7.6.4 为推荐性条款，其余为强制性条款。本标准按照GB/T 1.1—2009给出的规则起草。本标准主要起草单位：中国人民解放军总医院、国家卫生计生委医院管理研究所、总后勤部卫生部医疗管理局、第二军医大学长海医院、首都医科大学宣武医院、中国疾病预防控制中心、北京大学第一医院、浙江大学医学院附属第一医院、华中科技大学同济医学院附属协和医院、黑龙江省医院、首都医科大学附属北京友谊医院、南方医科大学附属南方医院、第四军医大学西京医院。本标准主要起草人:刘运喜、邢玉斌、巩玉秀、田晓丽、李兆申、王力红、张流波、李六亿、方英、刘枫、索继江、孔金艳、邓敏、张宇、张京利、杨云生、陈翠敏、任旭、张澍田、姜泊、郭学刚。

软式内镜清洗消毒技术规范 i范围本标准规定了软式内镜清洗消毒相关的管理要求、布局及设施、设备要求、清洗消毒操作规程、监测与记录等内容。本标准适用于开展软式内镜诊疗工作的医疗机构。注：本标准中的“内镜”系指软式内镜。 2规范性引用文件下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。适用于本文件。下列术语和定义适用于本文件。 3.1 软式内镜flex ible endoscope 用于疾病诊断、治疗的可弯曲的内镜。 3.2 清洗cleaning 使用清洗液去除附着于内镜的污染物的过程。 3 .3 漂洗rinsing 用流动水冲洗清洗后内镜上残留物的过程。 3.4 终末漂洗final rinsing 用纯化水或无菌水对消毒后的内镜进行最终漂洗的过程。 3 .5 清洗液cleaning sOlution 按照产品说明书，将医用清洗剂加人适量的水配制成使用浓度的液体。 1

内镜清洗消毒规范

内镜清洗消毒规范 The Standardization Office was revised on the afternoon of December 13, 2020

2017内镜清洗消毒规范软式内镜的清洗消毒 1、基本原则所有软式内镜每次使用后均应进行彻底清洗和高水平消毒或灭菌。软式内镜及重复使用的附件、医疗用品应遵循以下原则进行分类处理； a进入人体无菌组织、器官，或接触破损皮肤、破损黏膜的软式内镜及附件应进行灭菌； B与完整黏膜相接处，而不进入人体无菌组织、器官，也不接触破损皮肤、破损黏膜的软式内镜及附属物品、器具，应进行高水平消毒； C与完整皮肤接触而不与黏膜接触的用品宜低水平消毒或清洁。内镜清洗消毒应遵循以下流程注意事项如下： a内镜使用后应按照一下要求测漏： 1、宜每次清洗前测漏； 2、条件不允许时，应至少每天测漏1次。 b内镜消毒或灭菌前应进行彻底清洗。 C清洗剂和消毒剂的作用时间应遵循产品说明书。确诊或疑似分枝杆菌感染患者使用过的内镜及附件，其消毒时间应遵循产品的使用说明。 d消毒后的内镜应采用纯化水或无菌水进行终末漂洗，采用浸泡灭菌的内镜应采用无菌水进行终末漂洗。 e内镜应储存于清洁、干燥的环境中。 f每日诊疗工作开始前，应对当日拟使用的消毒类内镜进行再次消毒、终末漂洗、干燥后，方可用于患者诊疗。二、手工操作流程预处理流程如下： a内镜从患者体内取出后，在与光源和视频处理器拆离之前，应立即使用含有清洗液的湿巾或湿纱布擦去外表面污物，擦拭用品应一次性使用； b反复送气与送水至少10s C将内镜的先端置入装有清洗液的容器中，启动吸引功能，抽吸清洗液直至其流入吸引管； d盖好内镜防水盖；e放入运送容器，送至清洗消毒室。测漏流程如下： a取下各类按钮和阀门； b连接好侧漏装置，并注入压力； C将内镜全浸没于水中，使用注射器向各个管道注水，以排出管道内气体； d首先向各个方向弯曲内镜先端，观察有无气泡冒出；在观察插入部、操作部、连接部等部分是否有气泡冒出。 e如发现渗漏，并及时保修送检； f测漏情况应有记录； g也可采用其他有效的测漏方法；清洗流程如下： a在清洗槽内配制清洗液，将内镜、按钮和阀门完全浸没于清洗液中。 b用擦拭布反复擦洗镜身，重点擦洗插入部和操作部。擦拭布应一用一更换。

内镜清洗消毒技术操作规范习题

内镜清洗消毒技术操作规范习题姓名得分一、单项选择题 1、医疗机构应配备专门的清洗消毒工作人员，应定期组织对清洗消毒工作人员进行培训及考核，内容包括（）Ａ．内镜及附件的清洗消毒程序Ｂ．内镜构造及保养知识Ｃ．高水平消毒剂和灭菌剂的使用Ｄ．标准预防措施及个人防护知识Ｅ．以上都不是２、下列哪组物品需要高水平消毒（）Ａ．活检钳、注射针、细胞刷、切开刀、造影导管Ｂ．圈套器、碎石器、取石球囊、扩张球囊、扩张探条Ｃ．注水瓶及连接管、非一次性使用的口圈、运送容器Ｄ．听诊器、血压计、床架、内镜运送车３、铺设于内镜干燥台的无菌巾至少几个小时内更换（）Ａ．２小时Ｂ．４小时Ｃ．６小时Ｄ．８小时 4.清洗用的多酶洗液应多长时间更换（）

A 2h B 1h C 每清洗1条内镜后 D 一周 5.胃镜、肠镜、十二指肠镜采用2%碱性戊二醛浸泡消毒时间不少于多少（） A 30 钟 B 10分钟 C 1小时 D 15分钟 6.灭菌后内镜合格标准为：（） A 细菌总数<20cfu/件 B 细菌总数<10cfu/件 C 细菌总数 <100cfu/件D 无菌检测合格。 7.灭菌后活检钳应多长时间进行生物学监测并做好监测记录（） A 每季度 B 每月 C 每天 D 每周 8.结核杆菌、其他分枝杆菌等特殊感染患者使用后内镜采用2% 碱性戊二醛浸泡消毒时间不少于多少分钟（） A 30分钟 B 15分钟 C 45分钟 D 20分钟二、多项选择题１、医院感染管理部门、医务部门、护理部门等相关部门对本医疗机构内镜使用和清洗消毒质量进行监督管理，内容包括（）Ａ．审核建筑布局Ｂ．日常巡查Ｃ．内镜清洗。消毒灭菌效果监测Ｄ．审核工作流程２、工作人员进行内镜诊疗或者清洗消毒时，应做好个人防护，穿戴必要的哪些防护用具（）

内镜清洗消毒流程

内镜清洗消毒流程 Company Document number：WUUT-WUUY-WBBGB-BWYTT-1982GT

内镜清洗消毒流程一、基本清洗消毒设备及物品：包括专用流动水清洗消毒槽、操作台、治疗车、负压吸引器、高压水枪、计时器、通风设施，50 毫升注射器、各种刷子、纱布、棉棒、无菌巾、治疗盘等。二、二、软式内镜的清洗与消毒步骤、方法及要点包括：三、1、将内镜放入清洗槽内,在流动水下彻底冲洗，用纱布反复擦洗镜身，同时将操作部清洗乾净. 四、2、取下活检入口阀门、吸引器按钮和送气送水按钮，用清洁毛刷彻底刷洗活检孔道和导光软管的吸引器管道，刷洗时必须两头见刷头，并洗净刷头上的污物. 五、3、安装全管道灌流器、管道插塞、防水帽和吸引器，用吸引器反复抽吸活检孔道. 六、4、全管道灌流器接50毫升注射器，吸清水注入送气送水管道；七、5、用吸引器吸干活检孔道的水分并擦干镜身。八、6、将取下的吸引器按钮、送水送气按钮和活检入口阀用清水冲洗干净并擦干。九、7、内镜附件如活检钳、细胞刷、切开刀、导丝、网篮、异物钳等使用后，先放入清水中，用小刷刷洗钳瓣内面和关节处，清洗后并擦干。用水枪或者注射器彻底冲洗各管道。十、8、清洗纱布应当采用一次性使用的方式，清洗刷应当一用一消毒。 9、清洗后用2%碱性戊二醛浸泡灭菌时间为10小时，如采用2%碱性戊二醛浸泡消毒时间不少于20分钟，冲洗、乾燥后，方可用于病人诊疗。 10、应将清洗擦干后的内镜置于消毒槽并全部浸没消毒液中，各孔道用注射器灌满消毒液。三、硬式内镜的清洗、消毒步骤、方法及要点包括： 1、使用后立即用流动水彻底清洗，除去血液、粘液等残留物质，并擦乾。 2 、器械的轴节部、弯曲部、管腔内用软毛刷彻底刷洗，刷洗时注意避免划伤镜面。 3、用2%碱性戊二醛浸泡灭菌时间为10小时，如采用2%碱性戊二醛浸泡消毒时间不少于20分钟，冲洗、干燥后，方可用于病人诊疗， 4、应当将清洗擦乾后的内镜置于消毒槽并全部浸没消毒液中，各孔道用注射器灌满消毒液。 5、采用化学消毒剂浸泡灭菌的硬式内镜，灭菌后应当用无菌水彻底冲洗，再用无菌纱布擦干。采用化学消毒剂浸泡消毒的硬式内镜，消毒后应当用流动水冲洗干净，再用无菌纱布擦干。四、注意事项

内镜清洗消毒技术操作规范

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第十条、工作人员清洗消毒内镜时，应当穿戴必要的防护用品，包括工作服、防渗透围裙、口罩、帽子、手套等。第十一条、根据工作需要，按照以下要求配备相应内镜及清洗消毒设备： 1、内镜及附件：其数量应当与医院规模和接诊病人数相适应,以保证所用器械在使用前能达到相应的消毒、灭菌合格的要求，保障病人安全。 2、基本清洗消毒设备：包括专用流动水清洗消毒槽（四槽或五槽）、负压吸引器、超声清洗器、高压水枪、干燥设备、计时器、通风设施，与所采用的消毒、灭菌方法相适应的必备的消毒、灭菌器械，50 毫升注射器、各种刷子、纱布、棉棒等消耗品。 3、清洗消毒剂：多酶洗液、适用于内镜的消毒剂、75%乙醇。第十二条、内镜及附件的清洗、消毒或者灭菌必须遵照以下原则： 1、凡进入人体无菌组织、器官或者经外科切口进入人体无菌腔室的内镜及附件，如腹腔镜、关节镜、脑室镜、膀胱镜、宫腔镜等，必须灭菌。 2、凡穿破粘膜的内镜附件，如活检钳、高频电刀等，必须灭菌。 3、凡进入人体消化道、呼吸道等与粘膜接触的内镜，如喉镜、气管镜、支气管镜、胃镜、肠镜、乙状结肠镜、直肠镜等，应当按照《消毒技术规范》的要求进行高水平消毒。 4、内镜及附件用后应当立即清洗、消毒或者灭菌。 5、医疗机构使用的消毒剂、消毒器械或者其它消毒设备，必须符合《消毒管理办法》的规定。 6、内镜及附件的清洗、消毒或者灭菌时间应当使用计时器控制。 7、禁止使用非流动水对内镜进行清洗。

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