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Testing, testing …

Jenny Nixon, Sales Director at Dentisan, outlines the simple steps practices can take to make sure decontamination equipment is fully compliant.

In the current climate, it goes without saying that the safety of the dental team when handling and decontaminating dental instruments and treating patients is of equal importance. Latest figures from the Office of National Statistics[i] have shown that over 53 per cent of people with COVID-19 do not report any major symptoms, underlining the risk of people spreading the virus without knowing they’re infected.

Decontamination and sterilisation equipment are at the forefront of the battle against cross-contamination and the protein residues that can leave people open to the dangers of pathogens. Ensuring such equipment is performing according to specified parameters is a vital first step in identifying possible shortfalls in performance. Routine testing and maintenance schedules providing details of daily, weekly, quarterly and annual testing, following manufacturers’ guidelines, must be clearly laid down in a practice’s infection control policy and be properly recorded by those responsible to ensure compliance with HTM 01-05, CQC, SDEP and other relevant local guidelines.

What is testing and validation?

Validation provides confirmation that decontamination equipment is working to manufacturers’ specifications, in the way that the manufacturer intended, demonstrating that the equipment complies with the CE-marking process under the terms of the Medical Devices regulations and that all instruments cleaned by the equipment are done so reliably and consistently. Validation is required for all new equipment at installation and annually thereafter and should be carried out by an accredited engineer.

Section 3.11 of HTM 01-05 states: Validation is the means by which an entire process is verified, tested and documented, with the ability to be consistently reproducible.”

Section 11.1 states: All decontamination equipment should be subjected to validation, testing, maintenance and servicing as recommended by the manufacturer/supplier. All records of these procedures should be retained for audit/inspection.”

Testing, on the other hand, refers to the routine, regular tests that should be carried out in the practice on a daily, weekly or quarterly basis. These test ensure that the equipment is working effectively and meets validated parameters and that the results delivered provide accurate evidence of compliance required by the relevant regulatory bodies.

To help meet the demands of monitoring and recording there are a number of easy-to-use products that help to provide everything a practice needs to fully audit the performance of washer disinfectors, ultrasonic baths and autoclaves on a daily, weekly and quarterly basis. These include:

  • Protein Residue Test - this weekly test determines if any residual protein (a certain type of protein found in blood), remains on dental and surgical instruments cleaned in washer disinfectors or ultrasonic baths, and which cannot be picked up by visual inspection. At the end of the cleaning cycle, a random instrument is selected, rinsed, ideally with RO or distilled water, then swabbed with a reagent. If protein residue is present the reagent will quickly turn purple, allowing immediate corrective action to be taken.
  • Wash checks - if an instrument isn’t clean, it can’t be sterilised effectively. The wash check indicator clearly identifies problems with cleaning processes in washer disinfectors and ultrasonic baths, enabling remedial action to be taken. This process satisfies the appropriate cleaning schedule as determined by the manufacturer.
  • Helix Device - the Helix Test measures the strength of steam penetration into the chamber of vacuum autoclaves and should be carried out on a daily basis to monitor autoclave performance and the effectiveness of instrument sterilisation. The Helix Device is used with a disposable chemical indicator that changes from pink to black to confirm correct steam sterilisation conditions.
  • TST Strips - TST stands for Time/Steam/Temperature, the critical parameters for the sterilisation cycle. TST strips are chemical indicators that show, at a glance, whether or not correct sterilisation conditions have reached the instruments. This monitoring can detect sterilisation failures in packaging, loading or steriliser function. Steam penetration tests should be carried out daily.

Once instruments have been through the sterilisation process, flexible pouches, subject to manufacturers’ advice, can be used to post-wrap instruments in order to protect against recontamination before they are once again required in surgery. Self-seal, tight closure sterilisation pouches are also vital components for the preparation and organisation of dental instruments, files, burs and handpieces prior to sterilisation in a vacuum autoclave. This conforms to BS EN ISO 11607-1 as specified in HTM 01-05.

Staying compliant

The requirements for cleaning, decontamination and sterilisation procedures are strict for good reason and that is to protect staff and patients. Maintaining the correct level of testing and monitoring for all equipment provides clear evidence that a dental practice is compliant and carrying out its duty of care using clinically proven products that conform to all necessary regulations relating to infection control.


[i] https://www.independent.co.uk/news/health/covid-symptoms-report-coronavirus-ons-b1828361.html