New GS1 database system meets essential US FDA and UK Department of Health requirements
DM Orthotics has recently updated and improved its ordering and manufacturing systems using GS1 standards meaning it is now fully compliant with the UK Department of Health’s and US Food and Drug Administration’s (US FDA) regulations on Unique Device Identification. The changes have wider implications across our business, improving efficiency and better monitoring.
DM Orthotics creates a high volume of custom products for patients and customers in the USA each year and must comply with the US FDA’s own set of regulations. The US FDA requires all medical devices sold in the USA to carry a Unique Device Identifier (UDI), a type of identification number which holds traceable information about that product. Each item’s UDI is held on a central global database by the US FDA .
Similar practices have recently been adopted by the UK’s Department of Health and there is likely to be further legislation with similar regulations across Europe.
GS1 standards use a barcoding system which creates a UDI once an order for a product has been placed. This barcode and number is then used throughout the production process and records each step taken during manufacture and quality control to the point of despatch. Touchscreen and scanning technology has been installed throughout the factory giving us unrivalled monitoring of processes and traceability.
Company Managing Director Martin Matthews commented on the company’s new approach,
“As market leaders it makes sense for us to adopt the latest practices used by our industry. By employing GS1 standards in our manufacturing process we are not only more efficient and accountable, but we are also making ourselves more serviceable for our business customers. Putting systems in place which make us fully compliant with the US FDA and UK Department of Health shows we are proficient and reliable suppliers – which can only be a good thing.”