I wrote this editorial article for Michael Joseph, CEO of outsourced NHS dental lab service Maxident. It was published in one of the leading professional titles for the dental profession, under Michael’s name. I’ve used an informal but appropriately professional tone of voice. Editorial article contribution for dental lab CEO Michael Joseph, of Maxident.

completed: 2013
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Labwork. Touching the regulations bases.

The concept of a black box is an attractive one. Sealed and isolated, the black box performs its magic away from prying eyes, and anyone making use of it need pay no heed to what goes on inside, so long as it appears to be doing its job.

It’s an appealing model. Yet while its charms overcome all of us at one time or another (for my part, I have absolutely no need to understand what’s going on beneath the bonnet of my car, so long as the net result is that it works), it’s a view no dentist can afford to apply to the labs supplying their practice.

With the pernicious implications for dentists whose practices are found guilty of knowingly or unknowingly using dentures, crown and bridge and other lab work constructed using unauthorized materials, it’s both reckless and, potentially, professionally suicidal to assume that anything offered to you by a lab must meet required standards.

Under guidelines issued by the Care Quality Commission, it’s beholden on dentists to ensure that all labwork in use in their practice complies with both NHS requirement guidelines and those published by the Medicines and Healthcare products Regulatory Agency (MHRA), the government body whose remit it is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. NHS requirement guidelines are codified in Schedule 3 of the Department of Health Information’s Statutory Instruments 2005 No. 3477.

While it may be tempting to tell yourself that any dental lab must know the rules regarding materials, and so that whatever they send you is certain to conform with all standards, it’s a mistake that can prove extremely costly. A dentist found to be using labwork not conforming to required guidelines runs the risk of losing their license to practice.

So what should you expect of a lab that you are entrusting with supplying you with work? The Care Quality Commission requires that all labwork should comply with both NHS guidelines and the requirements set out by the MHRA.

So, to begin with, all labs you use must be registered with the MHRA as ‘manufacturers’. This ensures ongoing inspection of their manufacturing facilities by the MHRA approximately every 2 years.


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