The information below shows the paragraphs from HTM 01-05 2013 Edition Section 2.0 that have changed from those within HTM 01-05 2009 Edition.
This section highlights the changes in the 'Advice to Dentists and Practice Staff' from the 2009 and 2013 editions of HTM 01-05.
This diagram has altered to reflect the changes in the decontamination process regarding the storage times for instruments.
For more information on storage times for instruments please see the relevant sections of the Isopharm website.
Wrapped instruments may be stored up to 1 year.
(see paragraphs 4.25 to 4.29)
The major change that comes with the 2013 Edition of HTM 01-05 is related to the storage of instruments.
Regardless of the type of sterilizer you use within your practice, a wrapped or pouched instrument can now be stored for up to 1 year without the need for reprocessing.
The 21/60 days guidance previously advised is no longer applicable.
Pouched instruments, either pouched prior to sterilisation in a Type B/Type S vacuum cycle or packaged after sterilisation in a Type N non-vacuum cycle, can now be stored for up to one year.
Unwrapped instruments in the clinical area: Maximum storage 1 day.
Instruments should be: protected from contamination, for example in mini-racks placed in cupboards or in covered drawer inserts. Instruments should not be stored on open work surfaces, particularly in clinical areas. It is important that practices have well developed protocols and procedures in place to prevent contamination of these instruments by ensuring that those required for a particular patient are removed from their protected environment before treatment commences. This eliminates the need to open cupboard doors or drawers during patient treatment. If an instrument does need to be retrieved from a cupboard or drawer during treatment, the practice should have protocols in place to prevent contamination and to ensure that staff hands are clean and that new gloves are donned before handling unwrapped sterilized instruments. Regard all instruments set out for each patient as contaminated after the treatment whether or not they have been used.
Instruments that are kept unwrapped should be reprocessed at the end of the working day, regardless of whether they have been used. Alternatively, instruments can be reprocessed at the beginning of the next working day.
The advice relating to unwrapped instruments stored in the clinical area has been worded differently and further guidance on protocols and procedures for this type of storage is given.
The 2009 Edition stated that unwrapped instruments in the surgery had to be used within that treatment session. This was interpreted in different ways, with some practices regarding 'session' to be one full day, and others as morning or afternoon.
2013 edition now states that the maximum storage time for unwrapped instruments in the clinical area is one day.
Paragraph K (ii) suggests that instruments stored open in surgeries (either in mini-racks or covered drawer inserts) are out ready for the patient in order to prevent the need to open drawers during treatment. The paragraph also goes on to provide guidance on the retrieval of instruments from a drawer if required.
This is not something new for HTM 01-05, the requirement has always been there for practices to follow the procedures as set out in the 2013 Edition. It is likely that all dental practices were following
These procedures before HTM 01-05 was released back in 2009, however advice on protocols and procedures has been documented regardless.
Unwrapped instruments in a non-clinical area: Maximum storage 1 week.
Non-clinical area in this context is designated as a clinical area not in current use, or in a clean area of a separate decontamination room.
Instruments should still be stored as follows: Dry, and protected from contamination, for example in mini-racks placed in cupboards, or in covered drawer inserts. Instruments should not be placed on open work surfaces.
This is new guidance in the 2013 Edition, providing a protocol for storing unwrapped instruments in a non-clinical area.
Obviously this does not mean that instruments can now be stored in a cupboard on reception, but it does mean that instruments (for example on lidded trays or mini-racks in cupboards) can be kept in a non-clinical area.
A non-clinical area could be identified as an unused surgery or the clean area of a separate decontamination room.
These instruments can be stored for a maximum period of one week.
Instruments required for particular patients or sessions should be taken into the surgery, but must remain in the lidded trays or other transport storage until used.
If a full days' worth of instruments is taken into a surgery, these should then not be returned to the non-clinical area to store for the rest of the week.
A rigid protocol should be in place and instruments monitored to ensure that they do not remain stored for longer than the one week period specified.
Develop a quality system approach so that the storage of wrapped instruments does not exceed one year.
The 2013 Edition now requires that your ‘monitoring’ system be amended so that wrapped or pouched instruments do not exceed one year of storage without reprocessing.
An easy solution may be to add a note in the appointment diary. This backup would cater for the long length of time whilst also compensating for staff changes in this position.
Washing and rinsing of instruments can be achieved by:
Two dedicated sinks with a separate or shared water supply.
One sink with a removable bowl, which can be contained within the sink that can accommodate the instruments for rinsing. This is the least preferred option as it requires lifting and moving bowls of contaminated water with associated spillage risks. The practice should have clear processes and protocols in place to ensure that the removable bowl is not used for the washing of instruments.
These sinks should not be used for hand-washing.
The 2009 Edition of HTM 01-05 created much confusion around whether a ‘bowl’ was suitable for use as second sink in the wash/rinse process. The guidance was meant to be interpreted as two sinks and two sinks only.
The 2013 Edition of HTM 01-05 states that one sink and a removable bowl is acceptable, however it does then go on to state that it is still the least preferred method.
The bowl should be used for rinsing instruments only, not for washing instruments, and never as a hand wash sink.
A separate sterilised instrument tray should be used for each patient. These trays should be of a suitable size to enable them to be placed in the sterilizer. Alternatively, single-use instrument trays may be used, provided these have been stored in a clean and dry environment
This alteration may appear to be text only, however it could have an impact on the procedures followed within the practice.
The 2013 Edition now recommends that ‘a separate sterilised instrument tray should be used for each patient’ and then informs about single use trays.
The 2009 Edition only recommended that a clean sterilised tray was to be used for the transportation of sterilised instruments to the treatment room.
This may be a textual change for clarity as some dental practices still use the same metal treatment tray throughout the sessions rather than changing per patient.
Instruments for decontamination should be transferred as soon as possible after use to the decontamination area in order to avoid the risk of drying. Prompt decontamination is appropriate. Potable water immersion or the use of commercial gels/sprays may be considered if a delay in reprocessing is unavoidable.
The 2013 Edition states that instruments may be kept moist using potable water (potable meaning safe for human consumption). The 2009 Edition stated that either immersion in potable or reverse osmosis (RO) water may be considered.
RO water is still recommended for other processes throughout the document.
2.18: Where endodontic reamers and files are designated reusable, they should be treated as single patient use or single use – regardless of the manufacturer’s designation – to reduce the risk of prion transmission. Practices must have effective procedures in place to exclude errors in identifying the instrument(s) and associating them with the correct patient.
2.19: Care needs to be exercised in the cleaning of re-usable endodontic reamers and files. Where automated washer–disinfectors are used, the risk of cross-contamination to other instruments would be very low, in view of the dilution factors. These instruments do not need to be processed on a separate cycle. However, owing to the variability in dilution during manual washing, the files/reamers should be washed separately from other instruments.
The original paragraph in the 2009 Edition was subject to change in March 2010 as evidence had been provided to the Department of Health stating that endo files and reamers could be reused but only on the same patient.
"The Department of Health accepts a proposed relaxation in this area, but only in so far as endodontic files and reamers may be re-used on the same patient. This is conditional upon the instruments being marketed as re-usable and the dental practice’s registered manager being satisfied that the tracing and audit procedures used are such as to exclude error in identifying the instrument(s) and associating them with the correct patient. As a key part of this assurance, particular care will be needed in respect of storage, and the advice given in paragraphs 4.27 to 4.31 of the guidance should be rigorously applied.
Care needs to be exercised in the cleaning of these instruments. Where automated washer–disinfectors are used, the risk of cross-contamination to other instruments would be very low, in view of the dilution factors. Therefore, these instruments do not need to be dealt with on a separate run. However, owing to the variability in dilution during manual washing, the HTM guidance needs to be carefully applied so that when manual washing is used the files/reamers should be washed separately from other instruments.
Regardless of the washing system employed, the instruments can be sterilised as usual and do not require a separate run." - Chief Dental Officer’s update March 2010
The key point is that you must have effective measures in place to ensure that re-used endo files or reamers are associated with the correct patient.
If it cannot be 100% guaranteed that a file or reamer is being re-used on the correct patient, then it must be disposed of as patient care could be compromised.
At a minimum, practices should audit their decontamination processes every six months, with an appropriate review dependant on audit outcomes.
Previously this was required every three months, the 2013 Edition now only requires an audit every six months.
This may be due to practices not managing to make the required improvements within the three month period. A six month period is more realistic time frame.
The Infection Prevention Society provides the most widely used and recognised audit document. This was previously only available as a paper copy, however it has more recently been provided as an online document.
Containers for transporting instruments for decontamination should be kept visibly clean. When transporting sterilized instruments, to avoid recontamination it is preferable that they are wrapped or separated from direct contact with their container on a tray that itself has been sterilized. If this is not feasible, sterilized instruments may be transported in a container that has been disinfected with a single-use disinfectant wipe and allowed to dry, but chemical disinfection is a lower quality assurance process than sterilization
This is more specific than the 2009 Edition paragraph. Ideally instruments would be transported in a transport box whilst either pouched or a sterilised instrument tray. Where this is not practicable then the transport box should be disinfected using a single use disinfectant wipe and allowed to dry.
This is to prevent contamination of unwrapped instruments with anything that may remain in the transport container.
Isopharm are of the opinion that Best Practice would be to pouch instruments, store them centrally, and transport them in the clean box as required for every patient.