Module 16 2024

17/10/2024

Unique Device Identification (UDI) – Why UDI?

• GS1 was implemented through certain departments within six hospitals.

• GS1 barcodes were applied to:

Patient wrist bands

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Equipment

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Locations

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Staff badges

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Results

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• 140,000 hours released for clinical staff

• £5,000,000 inventory savings

• £9,000,000 non-recurrent inventory reductions

• Pharmacy error rates reduced by 76% (one hospital)

• Product recall time reduced from 8.33 days to 35 minutes (saving £84,500 per annum) (one hospital)

The Organisation for Professionals in Regulatory Affairs

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Unique Device Identification (UDI) – What is it?

• UDI is a two-part system used to mark and identify a Medical Device at any given point in time within the Healthcare supply chain. • The first part of the system is the actual physical UDI which is made up of two parts: • A UDI-DI (Device Identifier) – this is a unique alphanumeric code allocated to a medical device at each packaging level. • A UDI-PI (Production Identifier) this will be the control method used in manufacturing: • Expiry Date or Date of Manufacture / Lot/batch number / Serial Number • DI + PI = UDI • The UDI is printed on the packaging of the product in both human and machine (barcode) formats.

The Organisation for Professionals in Regulatory Affairs

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