GreatLab is a lab management cloud-based solution to dental labs, and the most common concern we discuss with our users is the rules around the digitisation of dental records.
We have been able to source this excellent article “Reducing Paper in the Dental Laboratory – Medical Devices Regulations (MDR) and DAMAS Compliance” in the DentalLab journal that is written by Sharon Ranshaw.
Please take a look at the shared article below:
Reducing Paper in the Dental Laboratory – Medical Devices Regulations (MDR) and DAMAS Compliance
Maintaining MDR and DAMAS compliance whilst trying to reduce your carbon footprint may seem a challenging process, but with a little planning and understanding of what can be recorded
electronically the process can be surprisingly straight forward.
For MDR/DAMAS compliance we will look at the control of records procedure and discuss each section individually:
As detailed in the 2017 MDR which comes into force in May 2020, records should be maintained for 10 years. Completed prescription can be stored as hard copies or electronically. If storing electronically laboratories should ensure that all information on the prescription is clear and visible.
Laboratories may choose to store electronic documents as a single upload that is attached to a laboratory software system or prescriptions may be scanned and saved in bundles of days, weeks etc. With saving prescription as electronic bundles then the laboratory should ensure that they have additional information available to locate an electronically saved prescription to that specific time bundle such as booking information within a laboratory software package, spreadsheet or appropriate hard copy book or diary.
Approved materials and suppliers list
Whilst many laboratories keep hard copies of their approved materials and supplies list it relatively easy to keep an electronic copy. Laboratories wishing to do this should simply type the information on to the approved materials template or use a spreadsheet to retain the information. Laboratories using the electronic method should ensure that any changes are saved, and no material is deleted as records of previously used patient contact materials should be retained.
Materials and/or process evaluation forms
These forms are easily transferable to an electronic format. Rather than printing out hard copies of the form, each section can be completed using the Microsoft Word document and stored with your DAMAS files.
Purchase order forms
To move from a purchase order system that is paper based to keeping records on a computer-based system, laboratories need to ensure that all the relevant information is still recorded. The DAMAS system offers two types of templates that can be used. The information within the templates can be completed on your computer and saved accordingly or some laboratories may wish to copy the template information on to an Excel type spreadsheet which becomes more useful in terms of searching and analysing information. In addition, various finance software systems may also be used as long as the relevant information is still recorded.
Materials and equipment instructions
Maintaining instructions for use electronically can sometimes be challenging as many catalogues are provided in paper format. Although with many companies now thinking about the impact of climate change, many instructions for use are now available as a download from the supplier’s website. To ensure you comply you will simply need to maintain a specific folder on your computer which holds
these downloaded copies or links to relevant websites.
Maintenance and cleaning logs
Retaining records of cleaning and maintenance of equipment is again a simple process. The forms should be kept as an electronic copy and completed accordingly when verifying cleaning has been undertaken or maintenance or servicing of equipment has been carried out.
Staff training records
Staff training records for MDR/DAMAS purposes should contain staff competencies within the dental laboratory and any training that has been undertaken. Electronic copies are easy to maintain, and laboratories can simply use the templates provided with the DAMAS system or ensure their own records contain this information.
Complaints, remake and feedback logs
These records often benefit from being held electronically as statistical reports can be more easily produced. Laboratories may wish to use their dedicated laboratory software as some of these systems contain a feature for logging remakes. Alternatively, the information can be entered into a spreadsheet or the DAMAS template may be used.
Annual Post Market Clinical Follow-up Forms, Periodic Safety Update Reports, Risk Management, Forms and internal audits and reviews
As these reports must be completed annually many laboratories are now completing them electronically by simply filling in the templates that are available from DAMAS on to their computer system. Records should be completed diligently and saved appropriately by date.
As climate change is an ever increase concern, maybe now is the time to look at your business systems and processes to reduce the dental laboratories carbon footprint. If you would like to discuss ways of becoming a paper free in relation to your MDR or DAMAS obligations, then please contain the DLA or DAMAS office.