DECONTAMINATION


This would ultimately benefit both medical device manufacturers through stronger customer relationships and increased product efficacy, and healthcare providers. Reducing HCAIs is critically important for hospitals but, if materials are not appropriately selected for the healthcare environment, the frequent application of cleaning chemicals can cause device enclosures to crack prematurely, leading to device failure, and eventually increased maintenance costs for healthcare providers and negatively impacting health and safety of staff and patients. Once a medical device is in use, it becomes a vector of transmission, so will require cleaning to prevent harming a patient or healthcare worker because of contamination.


Therefore, it is important to establish a platform and a framework that can connect both medical devices manufacturers and hospitals on a collaborative level to conduct independent material and compatibility testing against certain disinfection products and cleaning protocols, to further educate healthcare staff and cleaning personnel regarding medical devices failures, and to develop standardised testing methods that ensure damage of medical devices is minimised. We still see equipment manuals and guidelines suggesting “soap and water” as a single cleaning recommendation for surfaces. This pandemic highlighted sharp contrast between guidance given by manufacturer manuals and infection prevention and control practices. Healthcare should not be penalised for doing whatever it can to reduce the risk of infection – but they are penalised with broken equipment and increased cost of maintenance. The quality of healthcare provided must not be impacted by these substandard instructions as users only follow the instructions that they are provided, and consequently damage devices.


While we look ahead to establishing the “new normal”, the impacts of cleaning processes on medical devices must be analysed now to set the standard for the months and years to come. Product manufacturers must work in harmony with health organisations to understand the daily pain points that pose risks, to pre-empt and resolve them earlier on in the product development process. While the data shows that medical device failure is not new, COVID-19 has exacerbated the issues and now is the time to reflect on the lessons we can draw from the handling of the pandemic to make improvements for the future.


References 1 Stewart, C. (2019). Quarterly number of medical device recalls in U.S. 2015-2019. Available at: https://www.statista.com/statistics/618239/


SEPTEMBER 2021


quarterly-number-of-class-ii-medical-device- recalls/


2 FDA (2018). Medical Device Enforcement and Quality Report. Available at: https://www.fda.gov/ media/118501/download


3 Heneghan et al. (2010). Medical-device recalls in the UK and the device regulation process: retrospective review of safety notices and alerts. BMJ. Available at: https://bmjopen.bmj.com/ content/1/1/e000155.info


4 Solvay (2018). Medical plastic failure: why it happens and what OEMS can do about it. Available at: https://www.solvay.com/en/chemical-categories/ specialty-polymers/healthcare/why-medical- plastics-fail


5 Runt J (2017). Crack under pressure – mitigating environmental stress damage. Available at: https://www.medicaldevice-developments.com/ features/featurecrack-under-pressure-mitigating- environmental-stress-damage-5846816/


6 UK Government (2014). Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces – risk of degrading plastic surfaces. Available at: Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces – risk of degrading plastic surfaces - GOV.UK (www. gov.uk)


7 Moskala E.J., & Jones, M. (1998). Evaluating Environmental Stress Cracking of Medical Plastics. Medical plastics and biomaterials magazine. Available at: https://www.mddionline.com/news/ evaluating-environmental-stress-cracking-medical- plastics


8 Jansen J (2015). ESC, “the plastic killer,” is a frequent cause of field failures. Plastic engineering. Available at: https://www.madisongroup.com/ publications/JansenESC Article.pdf


9 UK Government (2014). Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces – risk of degrading plastic surfaces. Available at: https://www.gov.uk/drug-device-alerts/ medical-device-alert-detergent-and-disinfectant- wipes-used-on-reusable-medical-devices-with- plastic-surfaces-risk-of-degrading-plastic-surfaces


10 FDA Medical Devices Databases (2006). Class 2 Device Recall System 1000, TINA, AURORA and Altratouch. Available at: https://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res. cfm?id=44321


11 FDA Medical Devices Databases (2009). Class 2 Device Recall ILED Surgical Light. Available at: https://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfres/res.cfm?id=79361


12 Lewis, P.R. (2009). Environmental stress cracking of polycarbonate catheter connectors. Engineering Failure Analysis, 16, 1816-1824. Available at: https://www.semanticscholar.org/paper/ Environmental-stress-cracking-of-polycarbonate-Le wis/7483755d07d391f81b7aebbac268304b4a3ca 5f1 - paper-header


CSJ


13 WHO (2020). Infection prevention and control during healthcare when novel coronavirus (nCoV) infection is suspected. Available at: Infection prevention and control during health care when novel coronavirus (nCoV) infection is suspected (who.int)


14 HSE(2021). UK authorised biocidal products. WWW.CLINICALSERVICESJOURNAL.COM l 43 About the author


Tautvydas Karitonas has bachelor and master’s degrees in mechanical engineering and is a leading expert in harnessing decontamination technology to eliminate viruses, bacteria and other contaminants from hospitals, care homes and public spaces. He has over six years of experience developing UV-C and HPV decontamination technologies. His work over the years in conducting trials and studies to showcase efficacy and safety of hydrogen peroxide vapour and ultraviolet radiation have further helped in the provision of reliable and fast results. Currently he is the principal at Test Labs where he’s fuelled by his passion for working to determine and refine best practice methods of decontamination through validation of efficacy. Test Labs is a high specification laboratory that specialises in testing products and equipment for healthcare facilities and NHS Trusts.


Available at: UK authorised biocidal products - Biocides - HSE


15 Ebnesajjad, S. (2016). Effects of chemicals on plastics. Chemical resistance of commodity thermoplastics. Available at: https://www. sciencedirect.com/topics/chemistry/environmental- stress-cracking


16 National Center for Biotechnology Information (2021). PubChem Patent Summary for US- 4829839-A. Available at: https://pubchem.ncbi.nlm. nih.gov/patent/US-4829839-A.


17 Rodriguez-Martinez, C. E., Sossa-Briceño, M. P., & Cortés, J. A. (2020). Decontamination and reuse of N95 filtering facemask respirators: A systematic review of the literature. American Journal of Infection Control, 48(12), 1520–1532. https://doi. org/10.1016/j.ajic.2020.07.004


18 Thaper, R., Fagen, B., & Oh, J. (2021). Decontamination of respirators amid shortages due to SARS-CoV-2. Photochemical & photobiological sciences: Official journal of the European Photochemistry Association and the European Society for Photobiology, 20(7), 955–965. https:// doi.org/10.1007/s43630-021-00064-4


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88