DDL PROVIDING HOSPITAL STANDARDS OF VALIDATION - the enforced laws
Dental Decontamination Limited has always been known to provide an exceptional standard of validations which has set us apart from competitors, however, this coming April there may be a much more serious difference between ourselves and other dental decontamination companies as the En17665 will become more prominent in the industry and En13060 will be re-enforced. With D.D.L you won’t have to worry about these issues as our hospital standard validations have always been compliant with En17665 and 13060 but many other companies will find that harsh realities lie ahead.
In this blog I will be referencing 4 very important documents that all dentists, podiatrists and tattoo artists alike should become familiar with. Firstly the Medical Devices Agency’s Device Bulletin on Benchtop Steam Sterilizers- which provides guidance on Purchase, Operation and Maintenance [Oct 2002]. Secondly HTM01-05 with the latest information on the ever changing decontamination guidance, En17665 which administers the new laws on validation and most importantly your user manual. In this case we will use a sample Mocom B Futura manual which provides an easy-to-use instructions on how to correctly use your machine.
HTM01-05 is a guideline, not law, with MDA document that is law
“If the sterilizer fails any safety check you should not attempt to test it until the faults have been corrected and the sterilizer passes all safety checks” [5. Maintenance, periodic testing, routine monitoring and documentation. Benchtop Steam Sterilisers – Guidance on purchase, operation and maintenance] Safety checks should be done at daily, weekly, quarterly and yearly intervals. Manufacturers recommended routine maintenance tasks intervals are specified in the user instructions or manual, for example a Mocom B Futura manual asks for…
Another point that the MDA brings to light is the importance of using specialist equipment when running tests.
“Some of the weekly tests for vacuum bench top steam sterilisers normally require the services of a TP (Test person) and use of specialist equipment, and therefore cannot be performed by the user.”
Some machines already possess automated test facility that the machine can perform itself. All Mocom machines have programmes already installed e.g. Vacuum test/leak test and the helix test cycle can be run on a Mocom with the results seen using the specialist equipment, the helix test and device strip.
MDA argues “If you do not use the test device and indicator combination specified by the sterilise manufacturer, the results might be dangerously misleading.” So it is vital that one uses the correct testing devices.
“The quarterly and annual tests require specialised equipment and skills, and should be carried out only by a properly qualified Test Person. Each cycle available to the user should be tested”
This is mirrored in Mocom’s B Futura user manual
The Law (En17665) now clearly states that it is “the manufacturer's responsibility to develop the process and provide guidelines/ instructions for operation and validation of the process.” The standard also requires “detailed documentation of all conditions that affect the process performance now and in the future.” ISO 17665-1 only provides very general guidelines on steam sterilization requirements and operations. ISO 17665-2 tries to describe these guidelines more specifically through the use of examples and further explanation.
It is essential to compare a printed record of every cycle with records given when the machine was known to be functioning properly (after periodic testing) “You should check with the manufacturer whether you have to pre-heat the sterilizer chamber before performing these tests, as this can extend the test time” Automatic control test is not required if the steriliser is equipped with a programme that maintains permanent records of the temperature, pressure and elapsed time during all sterilising cycles. Keeping a log of all these records is extremely important and is also beneficial when comparing data and reviewing the productivity of your machine.
Many dentist, tattoo artists and podiatrists will soon find that there will be added costs due to these changes but Dental Decontamination customers can rest well assured that they are already covered and compliant. Once again putting your practice and equipment one step ahead.
Validation and testing of Autoclaves on all types unless noted
Before checks, examine door for wear and tear and possible signs of deterioration or leaks and check the security and performance of door safety devices.
Who: It is important that a TP* (test person, this can be a user or operator based in the practice.) is trained to carry out the daily and weekly tests, and their training is documented on personal training records. To receive the correct training, a practice should contact manufacturer of the autoclave
Daily: Automatic control test, steam penetration (Helix or Bowie Dick) not necessary on non-vacuum autoclave.
Weekly: Including daily tests plus residual air test (not necessary on non-vacuum) and air leakage test (not necessary on vacuum) performed by user/TP
Quarterly: Including weekly tests plus automatic control test and thermometric tests. These tests should be carried out by a CP(D)/service engineer to manufacturers’ recommendations.
Annually: Including quarterly tests plus steam generator overheat cut-out test, thermometric tests (small load, large load) dryness tests (small load and large load). Dryness tests are not necessary on non-vacuum autoclaves.
Medical Devices Agency [MDA DB2002(06)]
Mocom B Futura User’s Manual