For many years here at Barwick Dental Services we have been using a DAMAS laboratory management system, which in effect gives you the reassurance that our dental laboratory operates in compliance with the MHRA regulations. It is essential that all laboratories are registered with the MHRA and comply with the Medical Devices Directive. The DAMAS management system gives you, our client, the assurance we produce all of our dental appliances with consistency and in compliance with all of the relevant and essential requirments set out in Annexe 1 of the Medical Devices Directive (93/42/EEC).

 

Although the DAMAS management system has been used extensively throughout our dental laboratory for many years, and we have adhered to all of the DAMAS management system specifications, we have until now not been a DAMAS accredited labratory.

 

After an Intertek audit on Friday 7th September 2012, I am pleased to inform you that we are fully accredited with DAMAS.

 

Nationwide the list of DAMAS accredited laboratories number approximately 130, and as such puts us in the small percentage of laboratories which have sought to attain DAMAS accreditation.

 

We hope this will give you the added assurance that all of your dental appliances are manufactured in such a way as to give you the confidence that you are providing your patients with clinically compliant and professionally produced crown and bridge work, prosthetics and orthodontics.

Your patients rely on you to provide the highest levels of quality and service. At your practice you can be confident that you are doing exactly that - but unfortunately you cannot always exercise the same control over your chosen dental laboratory.

 

Now with the Care Quality Commision inspections it makes sound sense to use a laboratory that has implemented DAMAS, the Dental Appliance Manufacturers Audit Scheme as it provides you with total reassurance that the laboratories processes are independently inspected and validated.

 

It's a sad fact that some laboratories operate illegally and that work outside the EU & US is poorly regulated, which could put patients' health at risk and potentially leave you open to litigation. The good news is that when you choose a DAMAS registered laboratory, you can be secure in the knowledge that they fully comply with the requiements of the Medical Devices Directive (MDD) and the Medical Device Regulations (MDR) which ensure full consideration of your patients' health and safety.

What does DAMAS involve?

DAMAS certification is far from a simple rubber-stamping exercise. Laboratories wishing to become registered have to undergo a stringent auditing process and implement regular checks throughout every stage of their production process. DAMAS is based on proven quality management principles and is tailored to reflect the practical aspects of manufacturing dental appliances and compliance with dental industry regulations.

Using a DAMAS laboratory means:

  • The laboratory undergoes a yearly site audit.
  • The laboratoy's Medicines and Healthcare products Regulatory Agency (MHRA) registration is verified.
  • The laboratory's dental technicians are checked and verified as registered with the General Dental Council.
  • Patient contact materials are verified as CE Marked and fit for their intended purpose.
  • The laboratory's equipment maintenance processes are validated as appropriate.
  • The laboratory'spost market surveillance and vigilance procedures are inspected and verified as complying with the law.
  • Purchasing and verification of purchase products to enable traceability of materials is inspected and verified to ensure recalling of devices is possible - should this be necessary.
  • Contract review and final inspection of appliances is auidted to ensure compliance with the dentist's original perscription.
  • Statement and labelling of appliances including issuing the patient statement is verified as complying with the Medical Devices Directive.
  • Laboratory sub-contractors are verified as fit for the purpose they are intended for.
  • Staff training and competences are checked as verified as undertaken by the laboratory 

What does this mean to you and your patients?

By choosing a DAMAS laboratory you will be working alongside a laboratory that is proactive, interested in quality measures and serious about their business. These laboratories have invested in their business to provide their clients with exceptional levels of service. The laboratory you use will be a reflection of the treatments you provide to your patients.

Print Print | Sitemap
© Barwick Dental Services