June 2025 - Issue 6

Dr Amber Downes MRCSI, recently published an article as part of the Special Edition of The Surgeon focusing on Surgery and the Environment (October 2024). Her research article entitled ‘Expiry dates in surgical equipment: What are the options’ was one of the most read articles of last year - you read it online here.

We recently spoke to Amber and posed some questions to further explore and discuss this hugely important topic.

Q. You referenced the paucity of research in this area but were you surprised at the lack of results returned as part of your literature review?

Absolutely. When I initially started my research, I expected that to find several studies on the topic. Despite using multiple different search engines, I didn’t find any studies across all specialties, which was a surprise to me.

Within my own specialty of Cardiothoracic Surgery, I thought there would be at least one article given that we use disposable, single-use equipment and implantable devices on a day-to-day basis. At an organisational or systemic level, I expected that the costs of surgical equipment and, particularly disposable equipment, would have encouraged health systems such as the NHS to undertake research for cost-saving or stock management purposes – I quickly found that this is not the case.

Furthermore, given that surgical equipment is intrinsically linked to patient-safety, I thought that manufacturers would have had research into expiry dates and published their recommendations so that there is complete transparency around how ‘use-by’ dates are identified. Once again, I could not find any research of this nature.

I was struck by the lack of discourse around the level of waste, both financial and physical that is generated by having to dispose of expired equipment.

Q. Your study noted that none of the articles in your literature review provided an insight or a description into how expiry dates are assigned, nor do they outline the options for the utilisation of the expired equipment. Why do you think this is?

I know how rigorously tested equipment and devices are by the medical device companies, but I do think that there is a lack of transparency when it comes to how expiry dates are identified, assigned and the impact upon patient-safety.

While the issue of sustainability is not a new problem, it has received greater attention in recent years. Perhaps it is only now that people are beginning to ask these questions of manufacturers. Given that manufacturers have rigorous systems in place for other processes, I would hope that the same applies to assigning expiry dates and it would be helpful if these could be shared with healthcare professionals to understand why these expiry dates are being assigned and whether there is something we can do to prolong or extend the expiry dates, without compromising safety.

We know that the devices themselves are safe to be implanted into patients and remain there for many years thus, specifically, I’d be interested to learn more from manufacturers about the degradation of packaging and the impact upon sterility. If healthcare professionals had better knowledge of this, then perhaps we could work alongside the medical device companies to try to preserve sterility for longer or indeed, if appropriate, reprocessing the equipment to ensure sterility.

Q. Sterility is cited as the main reason for disposal of out-of-date equipment – did your research uncover who assesses this? Is it regulatory authorities or manufacturers?

It is difficult to answer this question with confidence, as it was not clear who had the final say. Ultimately, it seems to be that regulatory bodies advise on how use-by dates are assigned to guarantee sterility and to preserve and to guarantee device function. However, it does appear that it is the manufacturers themselves who decide the actual use-by date.

Q. Your article references a study by Mahmoud et al that recommends reducing waste by closely monitoring expiry dates of equipment and devices. Did the study provide practical examples of monitoring processes and, if so, could these be reasonably applied within our hospitals?

Within that study they looked at applying a Japanese business model of lean manufacturing that they would have in many of their major companies such as Toyota, and applying that model to the operating theatre environment in two countries – Australia and France.

I was interested in the choice of countries particularly as I have worked in Australia, and when I was there the system seemed similar to the Irish system in many ways – where there is close budget management, but perhaps less so than in other healthcare systems.  
Mahmoud et al’s research was an interview-based study with a variety of healthcare professionals and stakeholders in the hospital. As part of the study, the main source of waste for surgical products was identified as excess inventory. The study noted that this excess inventory resulted from factors such as surgeon preference, patient preference, preference based upon the particular case, meaning that a huge amount of stock is pre-ordered to meet all the different stock requests that may arise but is not then used by the expiration date.

Within the study, the authors explored a number of different models to reduce excess waste, including the ‘just in time’ ordering system, a dedicated stock management system plus an automatic order system.

The study looked at several hospitals using the ‘just in time’ approach, whereby disposable equipment is only ordered as required. Now, this approach naturally has both pros and cons about that. You must be very careful to ensure that there is always enough stock ordered to compensate for something going wrong. But within the study, the hospitals that applied this system didn't run into this as they allowed for a slight stock surplus through the just in time system. The important element was that the stock surplus was viewed as a small buffer that was carefully managed, rather than having huge generic orders.

The second approach considered whether an operating theatre had a nurse, or another member of staff specifically assigned to doing their stock management. I felt this system might be a bit more challenging to apply in an Irish context, in part because it would involve hiring an extra person as a dedicated stock manager or else giving that role to somebody who already has a full-time job as theatre nurse etc.

Interestingly, the study also referenced one hospital that had a computer system that would automatically order stock once it reached a particular level. Again, it struck me that this could be costly and would require hugely robust tech.

While the study provided practical examples, I think further questions needed to be asked before you could properly assess whether such examples could be adopted or adapted to an Irish context. Another aspect that the study didn’t elaborate on was the potential role of the manufacturer within the process. For example, let's say they place a ‘just in time’ order for three sizes of aortic valve and only one gets used – does the manufacturer then come to the hospital and take away the two that were used? It also struck me that the study didn’t provide clear results in terms of the amount of waste and or money saved through each approach.

Ultimately, I felt that the ‘just in time’ ordering was probably the most transferable or applicable to an Irish context, but further scoping and interrogation would be required to fully understand it and to ask questions that weren’t answered within the study.

Q. In your opinion, could more be done in this area?

Absolutely, but it is a hugely complex issue that will require a multi-factorial approach involving multiple stakeholders.

I think primarily there needs to be an agreement between surgical teams and the manufacturers that they are going to assist each other to tackle this issue.

First and foremost, I think there is a need for surgeons to ask key questions about the processes involved in identifying and assigning expiry dates and for manufacturers to provide transparent answers. Then, in collaboration, stakeholders need to consider researching other ways to package devices or indeed to store devices to optimise their shelf-life and improve their longevity.

Another key element is a commitment to better stock management whether at hospital or indeed health system level – this probably requires further analysis of existing approaches to see what the most efficient and effective solution in an Irish context is. At an individual level, I also feel there is an onus on surgeons to reflect on the equipment they are using and the variety or amount of devices being ordered – is it excessive?

Separately, stock return is something that should be considered. Can we coordinate with manufacturers to return equipment that is due to expire so that they might be able to use it again? Perhaps this question has already been asked but it would be good to know the answer!

Q. Your piece in The Surgeon was one of the most-cited articles in 2024. Why do you think that is?

I think that it probably caught people’s attention as I think the question about expiry dates is one that many have asked themselves in the past. From putting together this paper, I think more needs to be done to fully understand the options!