Challenges and Solutions for Addressing Critical Shortage of Supply Chain for Personal and Protective Equipment (PPE) Arising from Coronavirus Disease (COVID19) Pandemic - Case Study from the Republic of Ireland - Beyond the Abstract
Ireland, akin to other countries, is also progressing with the production of ventilators and exploiting industry and academia for plugging the gap so as to avoid reprocessing. Medtronic has been authorised to produce more ventilators.1 This article also reports that EU has agreed to temporarily suspend new regulations covering medical devices while the pandemic rages. The introduction of the new regulations may have led manufacturers to decommission older models of ventilators, taking them out of service before the rules come into effect in May. The REAPPE team comprises clinicians, researchers, and industry who have come together to address a workable contingency plan for this PPE shortage need.
Reprocessing of single-use PPE in Ireland is considered as a last resort in a pandemic crisis. Our REAPPE team reviewed the best candidate options for the decontamination of PPE and are still progressing with hydrogen peroxide in vapor state (VH2O2) and UV light technologies. We recognise, as akin to use in Galway hospitals, reprocessing capacity for PPE in hospitals would be limited by size of chamber, fixed or pre-set full cycle operation to reduce operator error, lack of knowledge of required levels for COVI-19 reduction, lack of knowledge on material stability and so forth. At the time of writing the article, our REAPPE team recognised an important move by FDA to authorise Batelle to reprocess N95 facemasks in the USA for use of VH2O2. This provided supporting evidence to inform the decision to pursue the decontamination option of PPE in Galway University Hospitals, which will be with industry providers. This development was also followed announcements that the FDA had also granted authorization to other leading industries to deploy VH2O2 technologies for complex PPE processing in the USA.2 Critical is also valuable information generously furnished by original equipment manufacturers on the potential options for reprocessing of PPE products. In addition, there are limited studies conducted in the past that looked at PPE reprocessing, with a gap in the specific important area of validation and safety for use post processing. Our Irish contingency plan is for the hospitals to work closely with established industries that have a long history of providing decontamination services in hospitals. A logistic challenge, in a pandemic, is placing early orders for technologies in REAPPE contingency planning as there will be substantial lead-time for the arrival and deployment of technologies. Additionally, it is recognised that reprocessed PPE will have lost its CE mark and deployment of any contingency plan for PPE reprocessing must be closely aligned with validation by a competent body. In Ireland, this is met by the Health and Safety Authority (HSA), where our National Standards Authority of Ireland (NSAI) has also provided helpful information on EU regulations for this potential need.3
This highlights, in a short time frame from writing our case study article in STOTEN, that there has been a huge wealth of new knowledge and information sharing by academia, companies (including OEMs), regulators to help with this COVID-19 crisis for this complex challenge. Grant awarding bodies in Ireland, keen on rapid funding to support COVID-19 crisis, are also seeking details and confirmation that regulatory and ethics needs that must be met before award. At this time of writing, Ireland is still in a national lockdown with restricted movement of non-essential services (stay-at home, social-distancing, cocooning, etc adopted) to flatten the curve so as to protect and enable our frontline HCWs to support COVID-19 patients. Ireland is now experiencing a reduction in mortality where strategic measures to address the rate of reported cases appear to be proving beneficial. However, in the absence of a vaccine, there will be a concerted effort to reduce and sustain this trend with a view to eventually returning to the movement of citizens and for businesses to return to what they do. We recognise that other countries, particularly emerging ones, are not as fortunate in terms of enhanced pressure to use re-use PPE supply lines.
On reflection, this coronavirus is successful at transmission due to its genetic and structural make-up - but it is due to this complexity that provides a vulnerability to mild biocides, such as alcohol, hydrogen peroxide, and sodium hypochlorite, as reported recently by Kampf and colleagues.4 Thus, hand hygiene remains a very effective prevention strategy for COVID-19. Ultimately, it’s a demand and supply issue- if Ireland keeps on top of supply lines for PPE and continues to make positive steps to reduce reported cases – then reprocessing technologies for PPE will remain as a contingency plan.
Written by: Neil J. Rowan and John G. Laffey
Department of Nursing and Healthcare, Athlone Institute of Technology, Ireland; Centre for Disinfection, Sterilization and Biosecurity, Athlone Institute of Technology, Ireland. Electronic address: ., Lung Biology Group, Regenerative Medicine Institute at CURAM Centre for Medical Devices, National University of Ireland Galway, Galway, Ireland; Anaesthesia and Intensive Care Medicine, University Hospital Galway, Galway, Ireland.
References:
1. "Coronavirus: Medtronic Aiming To Make 500 Ventilators A Week". 2020. The Irish Times.
2. "Emergency Use Authorization". 2020. U.S. Food And Drug Administration.
3. "Quick Guide to manufacturing and importing of Personal Protective Equipment and Medical Devices for the COVID-19 pandemic to ensure compliance." 2020. Nsai.Ie.
4. G. Kampf, D. Todt, S. Pfaender, E. Steinmann. "Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents." 2020. DOI:https://doi.org/10.1016/j.jhin.2020.01.022.
Read the Abstract