August 15th, 2013
Are you still thinking of implementing DAMAS but are still not quite sure? This article aims to look at one aspect of the DAMAS system and the benefits it brings to the already existing DAMAS laboratories by ensuring they are operating within the law and that the materials they select are fit for their intended purpose.
Selecting suitable patient contact materials is an intrinsic part of the DAMAS Specification as well as being a requirement of the Medical Devices Directive (MDD).
This essentially means that whilst all DAMAS labs are audited yearly to prove that they are controlling the selecting and purchasing of materials, all dental laboratories should be adhering to the MDD by having suitable records in place.
The DAMAS system insists laboratories prove that they select and record suppliers and their materials and also adopt a purchasing policy and procedure to ensure that the materials that enter the laboratory for use in the oral cavity are suitable for their intended purpose and are all verified prior to being processed.
Many DAMAS laboratories choose their suppliers and the materials they sell based on a number of different requirements. These requirements can be the history and reliability of the product within the marketplace, the fact that the product is CE Marked or through evaluation of the product by the laboratory itself.
It is imperative that such procedures on purchasing exist not only to prove the correct materials will be processed but for traceability of the material and patient safety.
Implementing a purchasing procedure is relatively easy. For DAMAS labs it is essential that materials are only purchased from suppliers that the laboratory has approved and is therefore on the laboratories list of approved suppliers and sub contractors.
So how easy is it?
Once the materials and suppliers list has been adopted the DAMAS laboratory then orders materials via a purchase order system. Orders are simply recorded by detailing who ordered the item, the date, details of the supplier and any other pertinent information to ensure that the order can be processed by the supplier. The method of communicating the order is usually recoded i.e. fax or telephone and the order is then signed by the person responsible for purchasing and filed away until the material arrives.
Upon receipt of the order all materials are verified against the associated purchase order, whereupon it is signed off and dated if the order is accepted within the laboratory.
If the material is incorrect and not what was ordered or only part of the order has arrived, it should be referenced on the purchase order form detailing the outcome i.e. was the material sent back, did you accept the alternative material or for part orders, details of when the remainder of the order arrived.
As stated previously this is a simple procedure and can be processed on a basic form, but the benefits are great, allowing you to control your purchasing and more importantly allowing traceability of a product should a recall of any type be necessary.
It should be stated that the recalling of products would be extremely rare and would only happen in the event of compromising patient safety but having comprehensive procedures in place would essentially cover you in such an event.
In a nutshell DAMAS labs can prove that they are operating within the law but the system is also there to protect their businesses and the patients they supply.
Maybe its time to take at look at your own laboratories procedures!
For more information on DAMAS including help in implementing the system call the DLA office on 0115 9254888.