Cross-Site Scanning: Ensure Full Compliance with ISO 13485

Cross-Site Scanning is emerging as a critical element in patient safety and compliance across healthcare. It refers to the process of tracking and verifying the sterilisation of surgical instruments across different hospital sites.
Recently, Cross-Site Scanning has become a legal necessity for trusts, as a critical preventative measure for patient safety risks and litigation.
What’s at stake?
Not only do hospitals face the harrowing potential for patient safety risks posed by inadequate tracking across sites, but also severe litigation costs.
Costs that have amounted to a sheer £ 2.8 billion, in 2023/24 according to one legal firm.
Under ISO 13485 standards, all surgical trays and reusable invasive medical devices (RIMD) must be reprocessed according to stringent guidelines, and their use must be traceable to each individual patient.
Legal frameworks, including the Consumer Protection Act, also require hospitals to provide documentation proving this compliance.
And across sites? That’s a near-on impossible task for most trusts.
Without proper tracking, hospitals face potential litigation if patients claim harm from improperly sterilised equipment.
For adults, claims can be filed up to 11 years after a procedure, and for children, this window extends to 25 years. That’s huge potential for loss that could be mitigated simply by the proper tracking of equipment.
Moving towards cross-site scanning
Recognising these risks, Athera Healthcare has developed features that integrate with the FingerPrint platform, allowing trusts to align with MDR/MDOR regulations and the latest ISO guidelines. Such features include:
- Enhanced labelling to contain comprehensive UDI-PI (Unique Device Identifier – Production Identifier) data
- Expansion of the Devices Global Registry services and automatic updates to ensure consistent data access across sites
- Peelable sections of labels provide critical details for manual patient record attachment, ensuring traceability even without electronic systems.
Looking ahead, by synchronising RIMD data across the Devices Global Registry, Athera Healthcare can ensure comprehensive traceability across all customer sites.
But why now? The case for immediate adoption
Cross-Site scanning is now a legal and ethical imperative for several reasons:
- Audit readiness
- Label modernisation – improving durability, readability, and adhesiveness, necessary for long-term tracking needs
- Training theatre and CDU staff to use updated systems effectively.
The bottom line
Cross-site scanning is no longer a mere nice-to-have— it’s a critical safeguard for patient safety and legal obligations (obligations that will save millions in litigation fees).
Athera Healthcare is uniquely positioned to lead this transformation, having the forward-thinking culture needed to bring safety to the forefront of an increasingly complex industry.
Ready to comply? Once we’re aligned on your requirements, we’ll proceed with implementing Cross Site Scanning, enabling your team to take full advantage of its capabilities. Email your Customer Success Manager, Shane. 👉
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