Agreements on coding Sample Clauses
Agreements on coding. 1. The supplier ensures that the medical devices, as defined in Section 2.2, are furnished with a unique identification (UDI), to make them traceable.
2. The UDI has at least a Unique Product Number, a Lot Number, the Expiry Date and, optionally, a Serial Number. See also Section 4.2.
3. Each UDI must be present on the packaging both as script and as a bar-code.
4. The supplier – if they are not the manufacturer – verifies that the manufacturer has furnished the medical device with a UDI. If there is no bar-code, the supplier will ask the manufacturer to furnish the device with a bar-code, because the rule is ‘coding is done at source’.
5. The supplier shall ensure that the code – as requested by Dutch healthcare providers – is clearly recognisable. See the above examples, in Figures 1 and 2: This is done by:
a. Ensuring that the packaging is furnished with as few bar-codes as possible;
b. Ensuring that, as far as possible, the information can be included in a single bar-code, rather than being spread over a number of different codes.
6. The supplier shall be responsible for ensuring that the bar-code is located at a suitable point on the packaging, to make it user-friendly for the purposes of scanning. To this end, the supplier shall use national and international agreements reached by standardisation organisations and governments.
7. The supplier shall ensure that the bar-code meets international specifications for bar-coding, such that the bar-code is always scannable. For details of the internationally coordinated label requirements, we refer to the International Medical Device Regulators Forum (IMDRF) document entitled ‘Guidance UDI - Unique Device Identification (UDI) of Medical Devices’.
Agreements on coding. If interoperability for automatic identification is to be achieved, then agreements must be reached at additional levels. The Centre of Expertise for Standardisation and eHealth’s (Nictiz) interoperability model is the starting point here. Policymakers Information analysts, terminologist Healthcare professionals Patients Healthcare managers Strategic Tactical Operational Regulatory Policy Healthcare processes Information Applications Infrastructure Sta nda rds, pro file s, cer tific atio n Sec uri ty, Pri vac y, Go ver na nc e Legislators and advisors Administrato rs Lawyers System architects Business and information architects System engineers System administrator s Software developers The interoperability model builds on developments and agreements within Europe, and provides clarity about what agreements have to be made with which professionals, for which aspects. Source: Nictiz The hospital is responsible for the following agreements:
1. ( Governance) The Board of Directors is responsible for organising and implementing the agreements contained in this document.