Leading clinical publication, Operating Theatre Journal (OTJ), recently looked at the expanding role of nurses and registered operating department practitioners (RODPs), in particular, their accountability regarding commercial visitors in theatres. With kind permission from OTJ, we have a pdf of the article available here.

OTJ’s article brings up a number of considerations for nursing staff and the medical industry alike. In particular, asking if nurses can be confident of the levels of theatre awareness and training of commercial visitors and looking at issues surrounding consent and confidentiality.

In our experience, there are also other considerations that are important to hospitals when it comes to working with commercial visitors in theatres namely, safety checks, a documented audit trail and management of commercial risk. Here we take a look at each of these and then at examples of how hospitals and the healthcare industry have worked together to address these challenges.

Safety checks

Aside from general theatre competence, as discussed in the article, ensuring that all those present in theatre have the appropriate immunisations and background checks is key to patient and staff safety and the prevention of HAIs. So, in terms of commercial visitors – what can clinicians expect?

The NHS Code of Practice 2003 states that ‘Anyone who is invited into hospitals or any areas of clinical care in an advisory capacity is bound by the same legal and ethical obligations of those as those employed within the hospital’. And, as one of our customers recently said, “As our theatre staff are trained, immunised and DBS background checked – it’s reasonable to expect the same of commercial visitors who attend theatres.”

OTJ asks if nurses can rely on healthcare companies to carry out pre-employment checks before deploying employees to work sensitive clinical areas. Many companies indeed do extensive checks but some experiences suggest this can’t be assured. For example, a large teaching trust found ‘40% didn’t have basic immunisations’ when they implemented our service four years ago.

Audit trail

From a number of legal and due diligence aspects, another important consideration for many hospitals is having a documented audit trail.

In terms of a record of who was present in theatre cases, the theatre register plays an important role. However, it is unlikely to provide evidence that a hospital has ensured the visitor has up-to-date theatre training, immunisations, background check or has accepted hospital policies. So, on its own, the register can be of limited use in the event of say, a legal claim. Indeed, last year’s GIRFT report on general surgery highlighted the lack of accurate documentation around procedures, making analysis of claims difficult and also meaning some claims could not be defended (read our full article).

Is it feasible for clinical staff to perform and document checks themselves? Considering the range of different proof documentation and formats, hospitals would need to consider training sufficient staff to be able to check each visitor, for what can often be hundreds of visits each month. Consideration would also be needed around confidentiality and data protection.

Similarly, medical industry representatives are experts in their field, but unlikely to be experts in immunisation evidence, so could inadvertently arrive with incomplete documentation. Also, individual hospitals and clinical areas have differing requirements, so each visitor would need to check requirements (and any recent changes) before each visit, impacting both visitor and hospital time.

Commercial risk

With hospitals under ever-increasing budget pressures, clinical and procurement teams work closely together with their medical industry partners to ensure the best products for patients, at the best price. However, with surgeons and other clinical staff often working at more than one facility (often with different policies and supplies contracts), there is significant risk that non-contract suppliers can inadvertently be invited into theatres, or loan kit moved between facilities. Unsanctioned products and devices can present patient safety issues, unauthorised invoices and also present issues for contracted suppliers.


OTJ poses the question as to whether ‘credentialing’ companies can help mitigate these risks. As you can imagine, that’s a subject close to our hearts!

As the article also says, a team ethos and collaborative approach is fundamental in the perioperative field. Commercial visitors are an essential part of the clinical team, bringing expertise and innovation to ensure the best patient outcomes. However, as we’ve outlined, having non-staff present in theatres can bring safety, skills and policy challenges to nursing and other clinical staff, often in time-critical situations.

That’s where we would see a commercial visitor management company, like ourselves, playing a role in that team. Helping the hospital to communicate what’s expected – be that safety requirements or procurement policies – and helping the industry representatives to ensure they’re compliant with each hospital’s individual needs, plus taking such checks out of the theatre environment and addressing them before each visit.

In terms of audit trail, clinical staff then have access to evidence that commercial visitors were compliant with safety, training and background checks. Additionally, it gives the opportunity to see the overall visitor activity and re-direct some visits to non-clinical areas, thereby reducing risk overall. For example, Chelsea and Westminster Hospital was able to manage its supplier visits to theatre areas more effectively, reducing overall visits by 60%, with no reduction in essential clinical training and support visits.

Clinical supplies staff can see which companies have been visiting and how often, and manage that activity. Additionally, should unsanctioned products occur, there is an audit trail of commercial visitors having read and signed up to policies, which for example, helped one of our customers reject a £23k unsanctioned invoice.

Finally, looking to the future, GS1 barcoding offers the potential (and reality to current Scan4Safety demonstrator sites) of a complete audit trail of which products were used where, on which patients and by which staff. Until recently, commercial visitors were the missing part of that data picture, however as we can now provide GS1 barcoding for commercial visitors, this completes the Scan4Safety audit trail.

By Leigh Dunkley, Business Development Manager, IntelliCentrics

Article reproduced with kind permission from Operating Theatre Journal (OTJ). A subscription to OTJ online is free of charge. For more details, please visit https://otjonline.com/


Abercrombie, J. (2017, August) General Surgery: GIRFT Programme National Specialty Report. Retrieved from www.gettingitrightfirsttime.co.uk