Hospitals routinely rely on loaned surgical instruments and consignment trays – particularly in orthopaedics, spine, cardiac, and other complex specialties. These trays often arrive from external suppliers just in time for a procedure, carrying the promise of precision and speciality.

But what happens when these tools aren’t yours?

What if they haven’t been sterilised on-site?
What if they’re missing critical IFUs?
And more importantly – what if you can’t prove any of it?

Loan Sets: A Hidden Gap in Theatre Safety

While hospitals have invested heavily in improving surgical traceability and instrument sterilisation protocols, loaned sets often fall outside of that rigor.

They arrive late. They’re sometimes incomplete. And more alarmingly, they’re occasionally used without being reprocessed at all – a clear breach of MHRA and HTM standards.

A study on complex loaned orthopaedic instruments, including screws and reamers, found significant contamination both on arrival and after hospital reprocessing, with tools still carrying debris or bacteria despite standard cleaning protocols. Another study revealed bone fragments and biological residue inside supposedly sterilised instruments.

Even non-loaned instruments aren’t exempt: research into cannulated instruments showed that residual debris often remains sterile, but its presence demonstrates how cleaning alone doesn’t guarantee safety.

The Cost of Inaction

• Patient harm from contaminated instruments

• Surgery delays due to incomplete or unsterile trays

• Litigation exposure from infection-related claims

• Regulatory breaches under UK Health Technical Memoranda (HTM 01-01) and EU MDR

• Staff burnout, scrambling to chase and reprocess unfamiliar tools

Ensuring Traceability, Even for Temporary Tools

Just because a set is “temporary” doesn’t mean it should be treated differently.

Modern traceability systems, like Athera FingerPrint, offer a robust way to track loan sets from arrival to return, ensuring they’re held to the same standards as permanent inventory. In fact, our MS1 solution provides you with a suite of loanset tools, including IFUs, instrument details and more:

• Arrival Scanning: Barcode loan sets into your inventory system immediately.

• Sterilisation Confirmation: Flag items that haven’t been decontaminated on site.

• Usage Assignment: Link each instrument to a specific patient/procedure.

• Digital Audit Trail: Maintain full documentation for inspection, compliance, and QA.

By building loan sets into your traceability system, you gain assurance that every instrument, even one you don’t own, is safe for use.

Compliance is No Longer Optional

Regulators are paying closer attention to these issues. Recent guidance emphasises the need for full traceability of all reusable medical devices, including those from third-party suppliers. NHS Trusts and private hospitals alike are expected to:

• Maintain sterilisation records

• Log equipment use per patient

• Track loan sets just like owned assets

Without a traceability solution in place, that becomes nearly impossible.

The good news? Tackling this gap brings new operational benefits too:

• No more missing sets or late returns

• Automated documentation for loaner compliance

• Time saved by avoiding last-minute reprocessing

• Fewer cancelled or delayed procedures

At Athera Healthcare, we’ve helped hospitals go from chaotic loan set management to a fully auditable, transparent workflow – with measurable improvements in safety, staff efficiency, and governance reporting.

Royal United Hospital’s experience

Unfamiliar instruments from loanset providers have always been a challenge, not just for RUH, but for Trusts across the UK. The complexity of gauging new equipment protocols and the time it takes to learn these protocols often cause delays in the cleaning process. “When we get new instrument sets we review the manufacturer’s instructions for cleaning and assembling and they can be really challenging to learn” says Beverley Parmenter, Decontamination Quality & Resourcing Manager. With FingerPrint, however, the process has become much more manageable: “we’re able to set up tracker alerts for each phase of assembling and cleaning, providing detailed guidelines for staff to follow.”

Athera FingerPrint helps not only extend the lifespan of our instruments but also enhance patient safety.

Chat to us about your challenges with loansets…