IDI - Irish Decontamination Institute

Recommendations by the Quality Task Group
[6] Deciding How to Process a New Medical Device

The instructions of the manufacturer of the respective medical device are needed to ensure proper reprocessing. Here it must be borne in mind that IN DIFFERENT COUNTRIES different requirements, directives and laws exist, hence corresponding procedural steps are common and must be taken into account in the recommendations for processing. Described below are some of the different procedures in use.

In Germany transportation in closed containers is the established practice for transportation to the CSSD. Processing should be performed in a standardised manner in washer-disinfectors with a thermal disinfection step. In the interest of personnel protection, a process that is effective against hepatitis B (e.g 10 min exposure time at 93°C) should be selected when processing all medical devices which can cause injury to personnel. Mildly alkaline and neutral cleaning agents with or without enzymes are available for cleaning. Appropriately optimised programme sequences must be set in microprocessor-controlled programmes. The instruments are packed after this and preferably sterilised in a steam steriliser.

In France medical devices are to begin with generally placed in a disinfectant solution after use, then they are often manually cleaned and, if necessary, mainly sterilised for 18 min at 134°C. Manual processes are used predominantly.

In the United Kingdom and in the Netherlands the instruments are to begin with often cleaned in ultrasonic baths and then cleaned again in washer-disinfectors and thermally disinfected. The temperatures required are 70°C in the United Kingdom and generally between 80 and 90°C in the Netherlands.

In the USA washer-disinfectors are being used increasingly. In addition, cleaning in ultrasonic baths is widespread. "Washer sterilizers" are also used for safe disinfection of infectious instruments, but these are difficult to clean due to burnt proteins. In the USA chemical sterilisation without packaging is also used for sterile storage. Here a distinction is made between "low level" and "high level" disinfection with gluaraldehyde or peracetic acid in closed containers.

THE CSSD often finds itself in the awkward position of having to elucidate how, on the one hand, the hygiene requirements can be complied with while taking account of the respective national characteristics and, on the other hand, how to rule out damage to the materials or premature wear. Not uncommonly must the question be posed as to whether an instrument can at all be processed and if so by which means. Furthermore, it must be established whether the necessary equipment is available.

Therefore before buying new or innovative instruments and other reprocessable devices, it must absolutely be carefully checked whether and how reprocessing can be properly conducted without having to effect fundamental and expensive changes to the processing procedure. Here it is absolutely necessary to consult the CSSD management before making a decision.

The following catalogue is intended as a basis for compiling AN INTERNAL CHECKLIST with which the most important questions can be clarified¹. The following questions must absolutely be clarified before purchasing new processable medical devices (incl. loaned instruments and their accessories).

• Is a similar medical device already available or is the device in question being newly introduced? (If similar devices are already available, the following questions should already have been clarified).
• Does the instrument have a CE mark?
• Can it be easily recognised whether the instrument has been designed for single or multiple use?
• Is the number of incidences of processing limited?
• Is the instrument unambiguously labelled in order to assure its assignment later to the corresponding operating manual?
• Is an operating manual that is easy to understand available and in the national language?
• Does the operating manual contain, in addition to the medical indication, also detailed information on processing?
• Is each separate processing step explained clearly:
• cleaning (manual, automated, ultrasonic)
• disinfection and
• sterilisation (chemical, thermal)?
• Is information given on checking, or the test results for, the individual steps, and if required the validation results for the particular device
• If so, are the various parameters affecting processing (chemical parameters, machines, water, etc) specified?
• Are alternative cleaning (alkaline, acidic, neutral), disinfection and sterilisation procedures mentioned?
• Are certain processing methods and modalities excluded?
• Does the operating manual give information on potential logistic problems (transportation times, wet transportation, use at weekends, etc)?
• Are the methods referred to available in the hospital?
• Can the new instrument be processed with a routine process in use in the establishment or is separate processing needed? (As regards the last two questions, the facilities available in the establishment should be communicated to the administration²)