This page contains questions about Equipment for Dental Decontamination.
What is meant by installation, commissioning, validation, periodic testing and maintenance?
For decontamination equipment as used in dental practices, the following explanations apply. SHTM 2010 part 3 (http://www.hfs.scot.nhs.uk/online-services/publications/engineering/) provides more detailed explanation.
Installation: the process of putting a piece of equipment or machinery in place and making it ready for use. This includes carrying out a series of installation checks and tests and is usually carried out by the equipment supplier. Installation forms part of the commissioning process.
Commissioning: the process of establishing and documenting that a piece of equipment has been provided and installed in accordance with the equipment specifications and that it functions within predetermined limits when the operating instructions are followed. It includes a number of tests, carried out by both the equipment supplier and a qualified Test Person.
Validation: a documented procedure for gathering, recording and interpreting data to show that the process is consistently complying with a predetermined specification. Validation is required for new equipment at installation and annually thereafter. It includes all of the tests carried during commissioning plus additional tests carried out by a Test Person, the results of which are verified by an Authorising Engineer (Decontamination) [AE(D)]. In due course, it is expected that there will be sufficient AE(D)s available for this.
Periodic Testing: decontamination equipment needs to be tested regularly to ensure that it continues to perform satisfactorily. Some tests are carried out each day, others weekly with additional more extensive and elaborate tests performed quarterly and/or annually according to manufacturer instructions. Collectively this is called periodic testing. Quarterly and annual testing is carried out by a qualified Test Person.
Maintenance: work carried out regularly to keep the equipment in good working order. This is carried out by a qualified Maintenance Person and should follow a planned programme as specified by the equipment manufacturer. .
Why do we need to test decontamination equipment so often?
Since it is not practical to test the decontamination status of instruments at the end of the decontamination process, testing is required to ensure that decontamination equipment is working consistently and effectively to the parameters that were set when it was installed and during validation.
If equipment has a failsafe device in that it stops when a cycle fails and goes back to the beginning, why do we need to document every cycle?
The reliability of the failsafe devices is not yet proven but is currently under review.
What about direct data download?
Using a data logger is alternative to using a printer to record data about each sterilization cycle. This avoids the need to store printed records, although a backup copy of the data should be kept. There is little information in current technical guidance about the practicalities of using data loggers.
How often do these pieces of equipment need to be tested?
This depends on the type of equipment (ultrasonic cleaner, washer disinfector or sterilizer) but there are tests carried out each day, some additional tests carried out weekly and further test (most of which a qualified Test Person must carry out) performed according to manufacturer’s instructions. Details can be found in SHTM 2010 and/or SHTM 2030.
How often do they need to be maintained and who does it?
The maintenance programme should be as specified by the manufacturer. If this is not available, a Maintenance Person can devise a suitable programme in consultation with an Authorising Engineer (Decontamination). All maintenance should be carried out by a suitably qualified Maintenance Person. The Maintenance Person can be an employee of the equipment manufacturer or supplier or an independent contractor. Further explanation can be found in SHTM 2010 and/or SHTM 2030.
What is an automatic control test and why do we need to do one if we have a printer?
An Automatic Control Test (ACT) is used to determine whether the machine is continuing to reproduce the cycle parameters (e.g time and temperature,) specified at validation. It is recommended that an ACT is performed daily. This can be done by checking that the parameters recorded on the printout or data logger are compatible with the values obtained when the equipment was last tested by a test person. However, in order to provide reassurance that the recorder is functioning correctly, a manual ACT is recommended to be carried out on a weekly basis. This involves directly observing, timing and recording the parameters during a normal cycle.