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
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)
1 See Working Group on Quality Assurance in the Hospital: Quality Assurance in Sterile Supply (Part 1-4), Central Service 1994; 2 (3): 181-192; 1995; 3 (1): 27-37; (2); 95-118; (3) 179-185
2 See Working Group on Quality Assurance in the Hospital: Quality Assurance in Sterile Supply (Part 3), Central Service 1995; 3 (2) 95-118. here 111-118
with kind permission of|
How does one find out whether, and how, a newly purchased medical device can be processed?
IN DIFFERENT COUNTRIES there are different requirements, directives and laws, hence the manufacturer's instructions must list the different procedures suited to processing.
THE CSSD must decide whether and by which means an instrument can be processed.
AN INTERNAL CHECKLIST should contain the questions that must be clarified before purchasing new processable medical devices.