Act now for UDI compliance, urges printing firm
Inline digital printing group DataLase is urging suppliers to the US drug and device market to act now to ensure their packaging is compliant when new legislation comes into force in six months’ time.
From 2017, a unique device identification (UDI) number is required on all medical devices and their packaging.
In 2013, President Barack Obama signed into law the Drug Quality and Security Act (DQSA), which outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US.
Manufacturers in the life sciences sector must include a UDI on any container of tablets or box of surgical devices.
The code must be human and machine-readable and will enable product identification whilst also containing secondary information such as an expiry date and batch lot number.
US and overseas manufacturers supplying the US pharmaceutical sector are required to comply with the new regulations by 2017 in order to continue to supply the US market.
DataLase says it can help suppliers meet the deadline by bringing together its proprietary colour change technology and lasers to print variable human and machine readable codes on a variety of label and packaging substrates at the point of fill, allowing manufacturers, co-packers and wholesalers to comply with the track/trace, UDI and validation requirements.
The group claims that its technology also delivers improved digital print performance which can endure the rigors of the supply chain and lifespan of a product to preserve data integrity.
It can be applied on a variety of primary and secondary packaging materials and enables high speed printing.
For packers and fillers the inline aspect of Datalase technology includes avoiding the need to invest in large-scale out of line digital capacity and there is a reduction in SKUs through the removal of the requirement for pre-printed materials, according to the group.
UDI is recognised as a key tool in ensuring a stable and secure supply chain to boost efficiency and protect the general public.
The code will help to improve track and trace of drugs for recalls and anti-counterfeiting purposes, said Datalase. It means that recall procedures are more efficient, medical errors are reduced and inventory visibility is increased, the group stated.
Vice president new business development in North America, Chuck Pemble, said: “DataLase can provide manufacturers with the tools to be compliant with the forthcoming US legislation. Other markets are expected to follow shortly, with similar legislation.
"Our unique technology platforms have been designed to meet the needs of brand owners and deliver enhanced flexibility, quality, productivity and efficiency.”