Manufacturer Guidelines


How do manufacturers guidelines help reduce your validation costs and ensure you are testing correctly?

Obtaining and following manufacturer guidance ensures your equipment is tested correctly.

The tests and procedures explained within manufacturers guidance have been taken from the existing HTM guidance and have been proven to validate the majority of equipment currently used in healthcare decontamination.

HTM 01-05 can only ever be a universal guidance document, due to the vast amount of different equipment make and models that now require validation.

Because of this, HTM 01-05 often refers to manufacturer guidelines and specific schedules that indicate how the user should validate to comply with the latest HTM requirements based on the knowledge of those who know the capabilities of the equipment.

HTM 01-05


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.


In terms of testing schedules for washer-disinfectors and ultrasonic cleaners, manufacturers guidance should be sought. Note that the schedules outlined in Chapters 13 and 14 of HTM 01-05 should be followed in the absence of manufacturers  instructions.

Decontamination Health Technical Memorandum 01-05: Decontamination in primary care dental practices click here >

Investing In New Equipment

Manufacturers guidelines should always be sought out prior to purchasing any consumable product. Relying on HTM 01-05 alone is likely to prove an expensive endeavour as the terminology is universal and not machine specific.

A good example of this is the daily steam penetration test for which there is a vast range of products available.

The problem lies in knowing which one to purchase. You need to know which products your equipment can process, and the manufacturer’s guidelines should help with this.

Steam penetration testing is usually performed with either a Bowie Dick pack or Helix device, but again there are specifics with each product type.

For example, some vacuum sterilizers can only process a Bowie Dick pack, and even then this must be a specific one; otherwise, the machine will fail the test. It is generally Type S sterilizers that need the Bowie Dick test however to add further grey to the area some Type B sterilizers are not able to process a Type B Helix device so must be validated using the Bowie Dick method.

This all sounds very expensive and quite often is; however, the tests have to be completed correctly, and the product you can use is very much dictated by your equipment.

Many practices are looking at the cost of ownership due to the ongoing expense of validation consumables. Purchasing new equipment is expensive in the short term, but if you compare this initial outlay with the cost of validating your existing equipment for the foreseeable future, it often makes sense, ensure you know the ongoing cost of validating your prospective new equipment and obtain the manufacturer guidelines before you buy.

 click here for more details >

How do manufacturers guidelines help to reduce validation cost if you are not able to purchase new equipment?

HTM 01-05 was created using the NHS guidelines; however, these also take into account much larger equipment. For example, the reason why you need to use nine strips of foil in the Ultrasonic Activity test is that typically ultrasonic cleaners in a hospital sterile services department have nine transducers underneath the bath.

A typical dental practice ultrasonic cleaner has only one or two transducers and is a much smaller unit. Because of this, some manufacturers are stating that the foil test is not required on their specific equipment; however, an increase in frequency of other less time-consuming tests should be done instead.

The most significant cost saving using manufacturer guidelines is without a doubt the reaction to HTM 01-05’s requirement for engineer validations every quarter. An engineer’s validation proves that the machine is performing as dictated in HTM 01-05 and creates a ‘snapshot’ of machine performance. This is a common occurrence within a hospital but an expensive requirement for a dental practice.

Most manufacturers agree that for a dental practice a visit by a validation engineer once a year is enough; however, an increase in user testing should be done to make up for this, for example monthly or even weekly soil testing on a washer disinfector or ultrasonic cleaner.

CQC States

All equipment must be used, stored and maintained in line with manufacturers’ instructions.

CQC Regulations 15 Premises and Equipment click here >

ByRick Craven