Essential Quality Requirements (EQR)

Essential quality requirements (EQR) were set out in HTM 01-05 as the minimum level of compliance to be achieved for decontamination within a dental practice.

Essential Quality Requirements (EQR)

EQR are presented throughout HTM 01-05 as the following points required in maintaining and developing dental decontamination practices:

EQR: HTM 01-05 Section 2.3

Instruments should be reprocessed using a validated decontamination process, including a validated steam steriliser, and at the end of the reprocessing cycle they should be sterile.

What Does This Mean? 

As a practice you should ensure that the machines used for the decontamination process have been validated and that they function as intended.

Unless instruments have been pouched prior to sterilisation and processed on a vacuum cycle, instruments will not be sterile at the point of use, but they need to have been through the sterilisation process therefore being sterile.

EQR: HTM 01-05 Section 2.4: A & B

A local infection control policy subject to update as required by the Code of Practice, or at two-yearly intervals, whichever is the shorter. The policy should have detailed requirements and procedures for the decontamination of instruments.

What Does This Mean?

All aspects of infection control are documented in this policy. It is the policy that practices put in place to ensure that patients are not at risk from cross infection issues.

All staff should review this policy regularly and adhere to the policy. The policy should be specific to the practice, generic policies should be amended to suit YOUR practice. Having a policy that is not possible to follow is no use to anyone.

This means that either the policy should be changed, or the way that the practice operates.

EQR: HTM 01-05 Section 2.4: C

The practice should have a nominated lead member of staff responsible for infection control and decontamination.

What Does This Mean?

One person within the practice is charged with the responsibility for ensuring that all aspects of decontamination and infection control are carried out within the practice. Usually this is a dental nurse or practice manager.

It is good to have someone who is involved with the decontamination processes on a day to day basis. All staff members should report issues regarding decontamination and infection control to the decontamination lead. For more information on roles and responsibilities please see the relevant sections of the Isopharm website.

EQR: HTM 01-05 Section 2.4: D

The storage, preparation and use of materials should take full account of the requirements of the Control of Substances Hazardous to Health (COSHH) Regulations 2002. Particular care should be taken in the storage and preparation for use of decontamination chemical products. Manufacturers’ instruction sheets should be consulted for further information. Guidance on COSHH is available from the Health & Safety Executive website

What Does This Mean?

Practices should have the COSHH data sheets for all chemical products that are used within the surgery. It is important to keep this file up to date, and when new products are purchased all staff members are made aware of any handling issues.

EQR: HTM 01-05 Section 2.4: E

Practices should have a clear procedure for ensuring appropriate management of single-use and reusable instruments, which safeguards their status. (HTM 01-05 Section 3 contains detailed guidance on instrument purchase and disposal).

What Does This Mean?

Practices should have a single use policy which staff must be aware of. This may make up part of the infection control policy.

Single use items are NOT designed to be decontaminated and/or sterilised.

Doing so may compromise the integrity of the device.

If you see the single use symbol then the item MUST be disposed of after use.

A typical example of the single use symbol is shown on the left.

If a device is classed as re-usable then the manufacturer's instructions regarding decontamination should be followed.

Further details can be found on the Medicines and Healthcare Products Regulatory Agency (MHRA) website

EQR: HTM 01-05 Section 2.4: F

Reprocessing of dental instruments should be undertaken using dedicated equipment (see HTM 01-05 Section 3).

What Does This Mean?

The equipment used for decontamination should be designed for that exact purpose. For example, some ultrasonic baths which are not designed for dental or medical use have built in heaters which take the temperature of the bath too high before instruments have been properly processed.

EQR: HTM 01-05 Section 2.4: G

Dedicated hand-washing facilities should be provided.

What does this mean?

In each surgery there is a requirement to have a sink that is dedicated to hand washing only. No other activity should take place at this sink.

Alternative arrangements should be made for:

  • The rinsing of impressions
  • Pre soaking of instruments
  • Easing of dentures

All of the above activities are likely to occur in the surgery and be performed by different clinical staff (nurses and dentists), therefore the decision as to which sink is the dedicated hand wash sink must be thought through to ensure the smooth running of the surgery for other activities.

EQR: HTM 01-05 Section 2.4: H

Cleaning and inspection are key parts of satisfactory dental instrument reprocessing.

Instruments may be cleaned using an ultrasonic bath, but this should be covered during use to restrict the release of aerosols. Manual cleaning may also be used. Practices should plan for the introduction of washer disinfectors.

Inspection processes should ensure that the standards of cleaning achieved are visually satisfactory, that instruments are free from particulate contamination, salt deposits or marked discoloration. The use of a simple magnifying device with task lighting is required.

What does this mean?

Historically, proving that an instrument had been processed through a steriliser meant that it was thought fit for use. In recent years this has changed and a quick clean followed by a sterilisation cycle is now not enough.

This has become more prevalent since the discovery of vCJD. 

EQR H states the different methods that are acceptable for the cleaning process:

  • Manual Cleaning
  • Ultrasonic Bath
  • Washer Disinfector

Inspection of instruments also plays a key part in the decontamination process as soiling or staining which remains on instruments will hamper the sterilisation process.

For more information on cleaning and inspection please see the relevant sections of the Isopharm website.

EQR: HTM 01-05 Section 2.4: I

There is no paragraph 'I' in the EQR list from HTM 01-05.

This may be due to ease of reference and any letter that could be misinterpreted as a number has not been used.

EQR: HTM 01-05 Section 2.4: J

The separation of instrument reprocessing procedures from other activities, including clinical work, should be maintained by physical or temporal means.

Decontamination equipment including sterilisers should accordingly be located in a designated area. The layout within this area should reflect the progression from the receipt of dirty, used instruments towards clean instruments sterilised in a specific controlled clean area.

In the first instance, where practices are meeting the essential quality requirements defined by this guidance, the designated area for decontamination may be in, or adjacent to, a clinical room.

At a later stage of development, more complete separation involving the use of a designated room or rooms will become appropriate (see Figures 1–3 in HTM 01-05 Chapter 5).

What does this mean?

It is important that decontamination processes are as far away from the area where clinical practice takes place.

Regardless of the space that a practice may have, available decontamination processes need to follow a contaminated to clean flow so that instruments that are clean do not come into contact with instruments that are contaminated and vice versa.

Ideally a separate decontamination room would be installed to meet best practice requirements. However to comply with EQR, the reprocessing of instruments can be performed within a surgery providing that there is a clear flow process in place.

EQR: HTM 01-05 Section 2.4: K

Instrument storage and wrapping recommendations:

(i) Wrapped instruments may be stored up to 1 year:

  • Pre-sterilization wrapped if type B or S.
  • Post-sterilization wrapped if type N. 

See HTM 01-05 paragraphs 4.25 to 4.29 for further details.

(ii) Unwrapped instruments in the clinical area:

  • Maximum Storage 1 Day.

Instruments should be dry and 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.

(iii) 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 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. 

What does this mean?

There are 2 ways in which instruments can be stored:

  • Pouched
  • Un-pouched

There are however three different storage times that can apply and this depends on where and how instruments are stored:

  • Pouched: 1 year
  • Un-pouched in the surgery: 1 Day
  • Un-pouched in a non-clinical area*: 1 Week

* A non-clinical area would be defined as a spare surgery, the clean side of the decontamination room or a purpose built cupboard/unit.

EQR: HTM 01-05 Section 2.4: L

There is no paragraph 'L' in the EQR list from HTM 01-05.

This may be due to ease of reference and any letter that could be misinterpreted as a number has not been used.

EQR: HTM 01-05 Section 2.4: M

Develop a quality system approach so that the storage of wrapped instruments does not exceed one year. 

What does this mean?

Ensuring that protocols are put in place to ensure that are procedure to check that instruments that have been pouched have not exceeded the 1 year storage time.

A tip for this would be to have box for instruments that are used infrequently. This should be checked routinely.

Instruments which have exceeded the expiry date should be re processed before use.

EQR: HTM 01-05 Section 2.4: N

Equipment used to decontaminate dental instruments should be fit for purpose and validated.

This means that the device should be commissioned, maintained and periodically tested by a Competent Person (Decontamination) or service engineer, that records of maintenance should be kept and that correct functioning should be monitored and recorded (see HTM 01-05 section 3).

What does this mean?

As previously mentioned, this is a critical requirement. Incorrect decontamination and sterilisation of instruments could put patients at risk.

It is of great importance that dental practices ensure that the equipment they are using is functioning properly, is being used correctly and has been commissioned and then periodically validated by either the manufacturer, supplier or fully qualified engineer.

Commissioned and periodically validated meaning that the afore mentioned people have set the machine up as intended by the manufacturer and have ensured that all the required parameters are met.

EQR: HTM 01-05 Section 2.4: O

There is no paragraph 'O' in the EQR list from HTM 01-05.

This may be due to ease of reference and any letter that could be misinterpreted as a number has not been used.

EQR: HTM 01-05 Section 2.4: P

The appropriate and controlled disposal of waste is a key aspect of risk control in local dental practices (see HTM 01-05 section 3).

What does this mean?

The guidelines as set out in HTM 07-01 regarding the safe disposal of waste should be followed and all staff members should have training in waste disposal. For more information on waste management please see the relevant section of the Isopharm website.

EQR: HTM 01-05 Section 2.4: Q

A documented training protocol should be in operation with individual training records for all staff engaged in decontamination (see HTM 01-05 section 3).

What does this mean?

The GDC requires all registered dental care professionals to gain CPD with decontamination being one of the suggested core topics.

HTM 01-05 requires that ALL staff members, whether registered or trainee’s, to be provided with the training necessary for them to be able to carry out the decontamination process successfully.

It is useful for staff to have training in the use of the autoclave for example (usually provided by the service engineer or manufacturer) as these topics are generally not covered in group courses or online courses.

Training should be documented and updated regularly.

EQR: HTM 01-05 Section 2.4: R

The practice should carry out an assessment of the changes needed to move from compliance with essential quality requirements to compliance with best practice requirements.

What does this mean?

Essential quality requirements were set out in HTM 01-05 as the basic minimum level that a practice should be at to achieve compliance with decontamination requirements.

Practices should be aiming to move to what is named ‘Best Practice’.

This is considered to be the ‘gold standard’ where all aspects of compliance have been met and improvements made upon those set out in essential quality requirements therefore potentially creating a risk reduction.

EQR: HTM 01-05 Section 2.4: S

Staff involved in decontamination should demonstrate current immunisation for hepatitis B and, subject to local policy, tetanus.

Staff must be informed of both the benefits (for example protection against serious illness, protection against spreading illness) and the drawbacks (for example reactions to the vaccine) of vaccination.

What does this mean?

All clinical staff should have immunisation against Hepatitis B.

Blood reports showing the serology levels should be given to the practice manager or principal dentist. These should be kept in staff personnel files.

Staff who have not completed the full course of hepatitis B immunisation should not work chairside until proof of immunity can be given.

Advice from Dental Protection is available from their website

EQR: HTM 01-05 Section 2.4: T

The effective cleaning of handpieces in accordance with manufacturers’ guidance.

Dedicated cleaning equipment is available and may be of value, however validation in this area is difficult, and the advice of manufacturer or supplier should be sought.

What does this mean?

There are a number of devices on the market that are both handpiece cleaners and handpiece sterilisers. EQR T confirms their use and possible benefit.

However as these machines are doing the job of both a washer disinfector and a steriliser this may make validation of the entire process difficult. It may not be possible to validate both the washer disinfector cycle and the sterilisation cycle. 

In a separate note, HTM 01-05 states that in most cases the machine should be treated as a type ‘S’ vacuum autoclave and tested accordingly.

In any case, manufacturers specific advice on validation must be sought.

EQR: HTM 01-05 Section 2.4: U

Separate hand wash basins for use by staff conducting decontamination should be provided.

What does this mean?

As with the dedicated hand wash sink where clinical practice takes place, a dedicated sink should be available wherever decontamination takes place.

If this is in a dedicated decontamination room then the likelihood is that the room will have three sinks (see EQR V below).

It is not believed to be acceptable to have a decontamination room without a dedicated handwash sink.

EQR: HTM 01-05 Section 2.4: V

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 that can be contained within the sink, and can accommodate the instruments for rinsing.

One sink with a removable bowl 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 handwashing.

What does this mean?

It has been recognised that in the interim some dental practices may not have the space available to have a both a cleaning and a rinsing sink along with the dedicated handwash sink, particularly if decontamination is still being carried out in the surgery.

Therefore a removable bowl can be used. This is to be used as the rinsing sink and has to be able to fit within the ‘washing’ sink. This is the least preferred option as there are risks involved, where possible EQR should be met by having two dedicated sinks for cleaning and rinsing.

To achieve best practice, two sinks have to be present.