Global Dates Format and Use of ISO Standard

By Ameila Boldrick, Elizabeth Pugh and Evangeline Loh

Many medical device manufacturers struggle when it comes to choosing from among the wide variation of date formats used around the world. The format of dates (date/month/year, year/month/date or month date year) still poses a morass to medical device manufacturers.

As a global consultancy, we understand the importance of respecting regional conventions. We also recognize different preferences. However, we still see cases where using different date and time conventions can become an issue.

Background on ISO 8601

The ISO 8601-1 standard, ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules, was established in 1988 and most recently revised in 2019. While not always the customary format in every region, ISO 8601-1 offers a consistent, internationally accepted approach.

The standard recommends formatting dates as YYYY-MM or YYYY-MM-DD and using the 24-hour clock for time. Both the U.S. Food and Drug Administration (FDA) (21 CFR 801.18 Format of dates provided on a medical device label (a)) and EU (EN ISO 15223-1 and ISO 20417) advance use of the ISO 8601-1 date format. Interestingly, the Therapeutic Goods Administration (TGA) in Australia purports the use of month and year. However, with the Australian unique device identification (UDI) framework now in effect, labeling conventions may shift to a YYYY-MM-DD format, aligning Australia with the U.S. and EU.

UDI in Australia

The TGA accepts UDI Carriers that meet requirements in the U.S. or EU, provided that a TGA-recognized issuing agency issued the UDI-Device Identifier (DI). TGA currently recognizes the same three issuing agencies that are accredited by the U.S. FDA: GS1, the Health Industry Business Communications Council (HIBCC) and the International Council for Commonality in Blood Banking Automation (ICCBBA). In addition to GS1, HIBCC and ICCBBA, the EU has also designated Informationsstelle für Arzneispezialitäten (IFA) to provide UDIs to assign to medical devices.

Software - Present day and generally speaking

Software manufacturers have had issues with advancing a month, date and year format. While month, date and year may be presented in writing in the U.S., it is not aligned with ISO 8601-1. The misalignment can be problematic, particularly when software transmits time-sensitive patient data, and can even lead to vigilance events.

Another consideration is time zones. Monitoring software that collects data from patients through sensors and then transmits this to clinicians needs to track the time zones from which the data is collected and the clinician’s time zone.  

Concluding remarks

Medical device manufacturers must assess date, time and time zones carefully. To date, there are still vigilance events related to these errors. These types of errors are preventable, and manufacturers should identify and consider these types of risk in their device design and development. Hence, the use of a global team in device design and development and risk management. In addition to adherence to international standards assistance, we strongly advance the use of ISO 8601-1.