This document adresses a number of important aspects of safety in gastrointestinal endoscopy with special emphasis on avoiding infection that may result from inadequate reprocessing of endoscopes or endoscopic accessories. It is the direct responsibility of users to follow these guidelines. These guidelines were prepared by consensus of microbiologists, endoscopists, nurses and representatives of the biomedical industry.

At all times, it is important to follow the manufacturer's instructions and to comply with national law.

Patients undergoing digestive endoscopy should be examined and treated without risk of transmitted of infection or side effects that may result from inadequately reprocessed endoscopic equipment (e.g. harm from residual chemicals on inadequately rinsed accessories).

The aim of these European Society of Gastrointestinal Endoscopy (ESGE) Guidelines is to set standards for the reprocessing of endoscopes and endoscopic devices prior to each individual procedure, whether performed in hospitals, private clinics or doctors' offices.

All reprocessing should be carried out by specially trained staff in purpose-designed environment. It is the responsibility of the healthcare provider to ensure that adequate facilities for reprocessing are available. Regular quality control and the institution adherence to validated reprocessing procedures is the responsibility of both endoscopists and healthcare providers and should be monitored by the hospital based hygiene/cross-infection control department or an external organisation.

Microorganisms may be spread by inadequatly reprocessed equipment from one patient to another or from patients to staff members. Bacterial infections have been acquired during endoscopy, such as Salmonella and Pseudomonas. Viral diseases such as hepatitis B and hepatitis C have also been transmitted during endoscopy.

Patients with immune deficiency syndromes or severe neutropenia and those undergoing immunosuppressive chemotherapy or who have artificial cardiac valves, have an increased risk of infection. Diagnostic endoscopic retrograde cholangiopancreatography and all therapeutic procedures carry a higher risk of infection. Patients harbouring clinically latent infections (hepatitis, HIV, TB, Salmonella, Helicobacter pylori) may not be aware of their carrier status, and therefore, all patients should be considered a potential risk.

Creutzfeldt-Jacob disease and endoscopy: Creutzfeldt-Jakob disease is a so-called prion disease. Little is known about the infectivity of prions. Transmission has been documented in patients treated parenterally with extracts from nervous tissue such as meninges and pituitary glands from infected patients. Transmission by the oral route probably occurs only after the ingestion of nervous tissue from infected animals.

Prions are difficult to detect and to eradicate. Attempts to do so using chemical or thermal methods would destroy the endoscope. Accordingly, if an endoscopy is requested in a patient with Creutzfeldt-Jakob disease, the indication for the procedure should be reconsidered.

Diseases may be transmitted from the patient to endoscopic personnel, so protection from direct contact with the endoscopes and accessories is essential. Gloves and aprons should be worn and protective masks and eye protection should be available to avoid exposure to blood or body fluids.

Protection against chemicals used in cleaning and disinfection procedures is of utmost importance in order to avoid toxic and allergic reactions. Separate purpose designed rooms for cleaning and disinfection must be well ventilated and disinfectants should be used within a closed system.

Staff known to be carriers should avoid duties that could transmit infection to patients. It is recommended that all staff be offered vaccination against type B hepatitis.

Endoscopic accessories: All devices used in conjunction with an endoscope to perform diagnosis and therapy, excluding peripheral equipment.

Cleaning: Removal of blood, secretions and debris from endoscopes and accessories.

Disinfection: Reduction of the number of viable microorganisms, on a device, to a level appropriate for safe use on a patient where sterilisation of the device is not necessary. Disinfection may also be undertaken as a preliminary step to sterilisation, if necessary. Disinfection should be carried out immediately after cleaning and immediately prior to use.

Sterilization: Validated process used to render a device free from all form of viable microorganisms (ISO 11137)

Single-use accessories: Also called "disposable", these are provided in a sterile state ready for use. The opening of a sterile package implies immediate use, as is routine in surgery. After a single-use device has been used, all materials should be properly disposed of. Under no circumstances should a single-use device be reused.

Reusable accessories: Reusable accessories should be sterilised. The sterilisation is carried out after proper cleaning, as detailed below. Manufacturers provide validated standard reprocessing parameters (temperature and time) for cleaning, disinfection and sterilisation.

The risk of cross-infection may vary, depending on the procedure. The European Society of Gastrointestinal Endoscopy recommends the following procedures:

1. Gastrointestinal procedures :

Wherever possible, the device used should be sterile, whether it is a single-use and provided in a sterile state by the manufacturer, or a reusable one that has been sterilised (e.g. biopsy forceps, polypectomy snares). If it is not technically possible to achieve sterilisation (e.g. in the case of balloons or bougie dilators), the device should be subjected to disinfection.

2.Biliary and pancreatic procedures :

All accessories used should be sterile. Reusable devices should be sterilisable. Balloons cannot be sterilised for technical reasons. The use of reprocessed (i.e. disinfected) balloons carries a risk of serial contamination of the biliary or pancreatic duct system, or both. The ESGE does not recommend the reuse of single use devices.

3. Injection Needles :

Injection needles should be used once only. The European Society of Gastrointestinal Endoscopy recommends the use of disposable needles for several reasons. There is a danger to endoscopic personnel in dismantling needles. Their narrow lumen is difficult to clean. They are likely to be contamination with blood; and the type of patients in whom they are used, are often infectious.

4. Prostheses:

Prostheses should be used as recommended by the manufacturer.

A. Endoscopes

The ESGE recommends the use of fully automatic washer-disinfectors; alternatively a rigorous manual procedure must be employed. Before starting reprocessing of endoscopes and endoscopy accessories, protective clothing must be put on (as appropriate: protective gloves, glasses/visor, face masks, aprons/examination coats) in order to avoid contact with infectious material and disinfectants or detergents.

1 - As soon as the endoscope is removed from the patient, the air/water channel must be flushed for 10-15 seconds to eject refluxed blood or mucus. Detergent solution should be aspirated through the suction/biopsy channel to remove secretions and debris.

2 - The endoscope should be immersed in water and detergent and cleaned externally. The outside of the instrument is washed with disposable sponges or swabs. The distal end is brushed with a soft toothbrush and special attention is paid to the air/water outlet nozzle and the bridge/elevator where fitted. All valves are removed and washed. The biopsy channel opening and the suction port should be cleaned with a cotton bud.

3 - Brushing through the suction/instrument channel and all accessible channels must be performed using a cleaning brush designed for that instrument. The brush must be passed through the channel several times until clean, and the brush itself must be cleaned in detergent with a soft toothbrush each time it emerges. First the instrument channel is cleaned by brushing at least three times, cleaning the brush between each time. There after pass the cleaning brush through the suction port and down the insertion tube until it emerges from the distal end at least three times, cleaning the brush each time as above. Then pass the cleaning brush from the suction port through the umbilical cord of the endoscope until it emerges from the suction connector at least three times, as above.

4 - Rinse all the channels by flushing with water followed by air to expel as much air as possible prior to disinfection.

A THOROUGH CLEANING OF THE ENDOSCOPE IS A PREREQUISITE
FOR PROPER DISINFECTION, MANUAL OR AUTOMATIC

1 - Disinfection must be carried out in a separate room with proper ventilation. Protective gloves, eye protection and aprons must be used and splashing avoided. The instrument should be fully immersed in 2% glutaraldehyde or other chemical disinfectant of equal potency. All channels must be filled with disinfectant and soaked for not less than 10 minutes.

2 - Rinsing of the instrument with water must be undertaken after disinfection, internally and externally, to remove all traces of disinfectant. The water must at least of drinking water quality. If necessary, filtered water may be used for rinsing.

3 - Dry the endoscope externally and flush each channel with air. Wipe the eye piece and light guide connector as well as the plugs before connecting the endoscope to the light source. Fit the disinfected and rinsed valves and activate air/water channels as well the suction channel. The endoscope is now ready for use again.

After a manual cleaning as described above, the endoscope may be disinfected automatically according to specification, attention being paid to temperature, flushing of all channels of the endoscope followed by a cleaning and a drying procedure. The duration of these reprocessing programs is about 30 minutes.

B. Accessories (1)

a/ Cleaning

1. Wash in detergent immediately after use.
2. Dismantle as far as possible.
3. Brush with cleaning brush or toothbrush.
4. Flush detergent through lumens of hollow components.
5. Use an ultrasonic cleaner for all accessories.
6. Rinse thoroughly in water of drinking quality.

Sterilisation can be achieved by steam autoclaving as per the manufacturer's recommendations. Failure to follow the manufacturer's recommendations may compromise sterility or the integrity of the device. Sterilisation can also be achieved with ethylene oxide, although this procedure is time consuming and not readily available.

Sterile devices should be stored in individual packing. All non-sterilisable accessories should be disinfected immediately prior to use.

Great care should be taken to avoid the use of defective or damaged accessories (e.g. biopsy forceps with kinks on the shaft) because such instruments may not operate properly and may also damage the endoscope's instrument channel, causing both hygienic and mechanical problems, with a consequent risk of incomplete reprocessing and even of serious damage to the endoscope itself.

Due to their nature, endoscopic accessory devices are not designed for repair in the event of breakage and their repair is not recommended by the European Society of Gastrointestinal Endoscopy, since the original properties may be altered, with consequent risks to patients and danger of damage to endoscopes.

These guidelines draw attention to the necessity of increasing the number of endoscopic devices in each endoscopic suite, in order to ensure adequate availability, taking into account the reprocessing time required. The implementation of these guidelines does therefore have economic implications, increasing the cost of endoscopic procedures, but it is necessary in order to protect both patients and endoscopy personnel.

These guidelines have been revised by

Axon A, Jung M, Kruse A, Ponchon T, Rey JF (ESGE)
Beilenhoff U, Duforest-Rey D, Neumann C, Petersen C, Popovic S (ESGENA)
Jurkowski P, Kircher-Felgenstreff I (FUJINON)
Klasen P, Stief M (PENTAX)
Dreyer M, Slowey B (WILSON COOK)
Schuster A, Spencer KB (OLYMPUS)
Papoz A, Wilson D (BOSTON SCIENTIFIC)
Pietsch M, Roth K, Struelens M (Microbiologists)