Date posted: March 27, 2015
DLA Update – Sharon Ranshaw
I frequently find that many lab tickets do not conform to the Medical Devices Directive (MDD) statement of conformity and labelling requirements. Typical errors are: the words ‘custom-made’ missing; conformity statement missing or incorrectly worded; the words ‘intended for exclusive use by’ missing.
The following information is going over old ground for some of you, but there is no harm in reminding labs what should be on lab tickets and making some suggestions on how to meet the requirements.
Information supplied by the manufacturer – labelling and statement requirements
Labelling – The minimum requirements for a dental lab are: the name or trade name and address of the lab; the details strictly necessary for the user to identify the device; the words ‘custom-made device’; any special storage and/or handling conditions and any warnings and/or precautions to take.
I know this is stating the obvious, but the lab ticket must have the lab’s name and address on it. There should be a field to record the dentist’s name and where applicable, the clinic name and address; a field to record the patient’s name; a field to record the design requirements of the appliance and the words ‘custom-made device’. It is up to the lab to decide if there should be any special storage and/or handling conditions and any warnings and/or precautions to take.
Statement – The laboratory statement must contain the following information for custom-made devices:
Therefore an example of a suitable statement including all of the above requirements could be “This is a custom-made medical device that has been manufactured to satisfy the design characteristics and properties specified by the prescriber for the above named patient. This medical device is intended for exclusive use by this patient and conforms to the relevant essential requirements specified in Annex I of the Medical Devices Directive and the United Kingdom Medical Devices Regulations”.
Note how Annex I is spelt; it should not be referred to as Annexe 1.
It is usually a good idea to add an additional statement to cover repairs and additions etc. for example: “This statement does not apply to medical devices that have been repaired and/or refurbished for an individual patient’s use.”
If you use computer software to generate your label and conformity statement, e.g. as part of your invoicing system, then the above MDD requirements still apply and you should ensure that the label and conformity statement satisfy these requirements.
It is a requirement that the manufacturer must supply a statement with the finished appliances so it can be made available to the patient by the healthcare professional who writes the prescription.
There are no strict guidelines on how the patient statement should be presented, however, it is compulsory for the following details to be present:
The laboratory should decide the most appropriate method for the patient statement which can include for example – a separate patient statement or a triplicate of the lab ticket.
A reminder about your Competent Authority registration number, i.e. the number allocated to you when you registered with the then, Medical Devices Agency or the now, Medicines and Healthcare Products Regulatory Agency. There is no specific requirement for this number to be on your lab ticket but it is good practice to do so. Many dentists are now asking labs for their CA registration number – as part of the dentist’s quality system – and it helps if the number is clearly on display. The display of this reference should state for example – UK CA Registration Number or MHRA Registration Number or a suitable abbreviation e.g. CA Reg. No., MHRA Reg. No.
So does your lab ticket adequately address the MDD labelling and conformity statement requirements? If not, get them corrected as soon as possible as they are legal requirements. I am always willing to review lab ticket artwork for labs and to make suggestions for correcting any errors or omissions in the artwork.
Date posted: March 23, 2015
The prospect of having your systems inspected can be quite daunting so to try and allay your fears below is a brief overview of what you can expect to happen on your DAMAS inspection day.
Most laboratories are choosing to purchase an off the shelf system from the DLA which guides you through the implementation stages. It is very important that your laboratory procedures comply with each clause of the DAMAS Specification and it is important to remember that simply buying the ‘DAMAS Implementation System’ from the DLA is not enough to prove compliance.
Once you have implemented all of the procedures to comply with DAMAS you need to check that it actually satisfies the requirements. This check is called internal auditing. What you may find by undertaking this internal audit is that not everything is being done correctly – this is called a nonconformity. Don’t worry about getting nonconformities just fix them and make sure they don’t happen again. Once you have one internal audit under your belt, you should carry out a management review which should determine if your system has been compromised by the number of nonconformities found.
When you are satisfied that your system meets the requirements of DAMAS, and you have a minimum of three months records, you may then apply to have your audit.
On the day of the assessment, the assessor will explain what will happen during the day. They will then assess your system for conformity with the DAMAS requirements. This will be done by examining samples of your records and assessing if these are sufficient to demonstrate conformity. The assessor will need a tour of your laboratory to look how your processes are undertaken which will include amongst other things, booking in, booking out and final inspection.
The assessor will take lots of notes and ask different questions about all different aspects of your manufacturing processes. Don’t worry about this. The assessor has to make records of their assessment so that random checks may be made to ensure that assessors are doing the job correctly!
When the assessor has finished, they will confirm any nonconformities they have found. It is up to you to fix nonconformities. In some instances, the assessor will guide you in the right direction but there are limitations on what guidance they can give. In all circumstances the assessor will let you know how to complete any paperwork which puts right any nonconformities that are identified.
In most cases, the assessor will find nonconformities of a minor nature that can be quickly fixed and that are not a cause for concern. The assessor will advise you that, in their opinion, your system meets the DAMAS requirements and that they will be recommending your registration as a DAMAS laboratory.
The DLA will confirm your DAMAS registration in writing and provide a copy of the DAMAS logo which may be used to promote your DAMAS status and on your lab stationery and lab tickets. It is also worthwhile writing to your clients to tell them about your success and that you now have independent proof that you are complying with the law, namely the Medical Devices Regulations and Medical Devices Directive. This is principally what DAMAS is about!