Decontamination


respiratory manufacturers and suppliers to assess reusable products, their fit, form, and function, as well as the cleaning and disinfection for wearers to move from one ward to another without cross-contaminating, and without disposing of devices between wards. The Mackwell Health UV-C cabinet, with Bollé Safety eye protection, and the Hello Face respirator, would be the solution, eventually. However, the focus was soon diverted, as Northampton General Hospital NHS Trust, along with others, was experiencing inconsistent and fragmented supplies of single-use anaesthetic masks. The Trust enquired if the Mackwell Health UV-C cabinet could disinfect reusable anaesthetic masks, as they are of a similar shape to the respirators, which is true. However, PPE is regulated by the Health & Safety Executive (HSE), and anaesthetic masks are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), with very different standards and requirements.


Open to the challenge Mackwell Health was open to the challenge, and, coincidentally, the new standard for UV-C disinfection cabinets and disinfecting rooms had just been published, in October 2022, (BS8628:2022). This was the new standard that Mackwell Health would need to be certified against to be able to reprocess MDs, following a proven cleaning cycle to remove soilage and debris. The cabinet had to be registered as a medical device, and to comply with the recently published Medical Device Regulations (MDR), which replaced the Medical Device Directive (MDD) in 2021.


PCC Sustainable Solutions had been involved with innovative disinfection and cleaning solutions through Envirosmart and Rollins Consulting. These included PATHISOL Hypochlorous Disinfectant, and innovative cloths from Decitex in France, with excellent performance over 500 washes, even when laundered through harsh industrial laundries, and non-linting. The integration of these with the Mackwell Health UV-C cabinet could solve cleaning


PER CYCLE


Water (Litres) Power (kWh) Gas (kWh) CO2(e) (Kg)


WD


144-255 8.17


3.86 3.74


Installation required Yes Logisitics (SSD) Capacity (masks)


Transport and 72


AUTOCLAVE 360-760


4.27


46.28 12.13 Yes


Time 35


UV-C 0.74


0.038 0


0.037 No


On site 6


Table 1: Current processes for instrument disinfection vs UV-C disinfection. and disinfection at or near the point of use.


Achieving the testing standards The first step in achieving this, was the to achieve the testing standards for BS8628:20225 certification, which was undertaken by Test Labs, who Mackwell Health engaged in late 2023, and following range finder testing to assess the cycle duration required for the toughest organism in the standard, the full test was embarked upon, culminating in certification being achieved in January 2024. It became the first disinfection chamber to meet the BS8628:2022 standard, and Mackwell Health has since repeated this achievement on two other sizes of UVC disinfection chamber. Next was the evidence that the process


worked on MDs, as testing to a standard only requires inoculated flat stainless-steel discs to be neutralised for the standard to be passed. Therefore, PCC Sustainable Solutions worked with Mackwell Health, and the Northampton Trust’s Infection Prevention and Control (IPC) team, to create the test scenario, including where to inoculate the anaesthetic mask to simulate real-world soilage. To then evidence effective cleaning and disinfection, post- inoculation (wearing in the real world), I wrote a detailed Standard Operating Procedure (SOP) on how to clean and disinfect the reusable anaesthetic masks. The SOP was needed to instruct the test


laboratory on a repeatable process, which – once proven – would form the basis of the Instructions for Use (IFUs), which, when followed, produce a safe, reusable MD, reprocessed to consistently achieve HLD, in a more sustainable, affordable, and environmentally-friendly process. For the simulated real-world testing, masks were inoculated with Geobacillus spores suspended in artificial saliva, and then reprocessed according to the SOP, which Test Labs followed, achieving a Log 5.3 reduction of the pathogen inoculated onto the anaesthetic mask.


Trial initiated


On successful completion of both the certification and the simulated real-world testing, the trial that was being planned while testing was ongoing commenced in February 2024. The outcome of the trial was successful, other than some anaesthetists commenting negatively on the required rigidity of the silicone reusable anaesthetic masks under pressure to achieve a seal with the patient. The anaesthetists’ feedback brought about the creation, by Mackwell Health, of a reusable air- cushioned anaesthetic mask, which is reusable 50 times. This reduces waste, CO2e, and spend year on year, eliminating some 900 tonnes of CO2e, and 160 tonnes of waste, annually. The NHS currently uses around two million single-use anaesthetic masks via NHS Supply Chain annually,6


which – if replaced with


reusable anaesthetic masks, processed using this innovative process – would generate a reduction of 120 tonnes of waste and 765 tonnes of CO2e, following widescale adoption. Since the first trial, Mackwell Health and PCC Sustainable Solutions have developed reprocessing, with, at, or near, point of use cleaning and disinfection for multiple MDs and PPE, with more to follow.


Left to right: The Mackwell Health Microbox – for low volume use, or 12 or 24 V vehicle use; the UV-C Minibox; the UV-C Tallbox for disinfecting cabled devices and higher-volume reprocessing.


50 www.clinicalservicesjournal.com I January 2026


Part of the certification process For clarity, the products used in the testing and subsequent trials are part of the certification process; hence high-quality Decitex microfibre,


UV-C BENEFITS


94%-98% reduction >99% reduction 100% reduction >99% reduction 6KG plug and play At point of use


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