John Prendergast discusses the challenges facing the decontamination sector, including the need to invest in training. He invites the profession to question the status quo and raises the question: is it time for revolution or evolution?
Decontamination is the combination of processes, including cleaning, disinfection and/or sterilisation, used to render a reuseable medical device safe for further use. Decontamination, standards, as we know them today, evolved as an industry in the late 1990s, early 2000s.
Concerns increased regarding the prevention of healthcare associated infections (HCAIs) and minimising the reduction of the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs), especially the hypothetical risk of variant Creutzfeldt Jakob Disease (vCJD). Risks were highlighted concerning human to human transmission from several sources; in this instance, the possibility of transfer from inadequately decontaminated reusable medical devices.
Ineffective medical device processing continues to pose a significant risk for HCAIs and other patient complications, to this day. As surgical techniques advance, the realm of medical devices is transforming into increasingly sophisticated technologies, many of which involve robotic and AI systems. Often, visual inspection and monitoring of cleanliness can be challenging. Is the science of decontamination keeping pace? Can the equipment we manufacture and have historically used for decontamination accommodate changes in such evolution? For instance, can we steam sterilise these new systems or must we explore alternative methods of terminal processing? Do we actually need terminal sterilisation processes (reference Spaulding, discussed later in this article)?
Can the existing infrastructure used to decontaminate medical devices accommodate such changes in evolution of decontamination technologies? Have we the flexibility to expand? Do we need investment and new infrastructure, or should we outsource responsibilities? Each option brings challenges to healthcare organisations with regards to responsibility and accountability. These responsibilities may not be part of initial considerations when surgical improvements are agreed by healthcare planning teams
Are national standards and guidance flexible enough to direct users and healthcare organisations in the correct manner? Should our Health Technical Memorandums be more pro-active and be easier to review and change? Many of the guidance documents were developed over 10 years ago. Systems and awareness have changed in many instances. Decontamination of flexible endoscopes is one such area where there has been significant progression and technical innovation within that period.
Changes to the regulatory framework in the UK presents us with greater challenges as providers and ‘manufacturers’ of decontaminated devices. The revisions to the Medical Device Regulations, although delayed, will considerably affect our culture within the clinical environment and behind the scenes, within the decontamination centres. Increased accountability and documentation are the part of that emphasis, but is this any different to other sectors such as the ‘food’ industry?
Government directives and objectives related sustainability and the transition to Net Zero, provides difficulties for decontamination providers. We are being urged to evaluate our systems and consider whether our decontamination practices can be more environmentally friendly. The response is possibly ‘yes’; however, we must never contradict patient safety, which must be the priority of any healthcare provider.
Where any such systems are to be assessed, it must be through a multi-disciplinary and independent stakeholder group that includes Clinical Teams, Infection Prevention and Control Officers/Estates and Facilities Management/ the Authorised Engineer (Decontamination)/ Decontamination Leads responsible within the organisations, along with other key stakeholders who are responsible for the individual services. All this expertise must be involved in any independent decision-making process. External commercial information may not be as accurate as it seems and may not be correct for the individual application
Shrinking financial resources often result in lack of investment; hence equipment used for medical device decontamination is used beyond the recommended replacement period. Additionally, such limited resources often result in lesser standards for servicing of such equipment, infrastructure and/or ancillary service provision. This can result in a false economy, when managing equipment and premises, and can potentially result in risks to patients and/or staff.
As a sector, we are losing a significant amount of expertise as careers come to an end. Many individuals became skilled, as awareness of decontamination grew. So, how do we replace that expertise? Do we have the appropriate career advancements established for the upcoming generation and are training systems and budgets available for education/ training? If so, have we got the necessary resilience to release key personnel for such training? Such a demise in expertise is evident across many of the decontamination disciplines highlighted within HTM 01/01 (including regional equivalents). Training must be the primary focus within all disciplines allied to decontamination.
Eastwood Park Training’s General Manager, Lyndsay Corbett, concurs that the training individuals receive in this discipline is paramount for continuing standards and longevity of skills, and notes that Eastwood Park deliver this required training standard, providing learners with hands-on experience across a wide range of equipment within their specialist decontamination facility. This function is pivotal for this next generation to continue delivering decontamination expertise.
The backlog recovery is a well-documented area for political debate, but have things ever been any different? Organisations try hard to look at ways to reduce the waiting lists and are under continuous scrutiny to lower the figures,. However, decontamination services are often not considered when initiative lists are organised - resulting in increased pressure on existing staff and assets needed to carry out decontamination duties.
We must address the problem, utilising key stakeholders who know the organisations processes directly, supported by consultancy chains. A holistic approach is needed to overcome clinical pressures.
When we look at medical device decontamination within our organisations, we also still find areas where unknown device usage exists. Often these areas are high volume, and decontamination may not be a high priority and/or risks are not always perceived correctly. Device decontamination must be considered, and often innovative technologies are needed to provide repeatable and validated processes. Such devices include ultrasound probe usage within departments who use scanning technologies. Often such applications are within unscheduled care areas. Often these areas are busy with high clinical priorities, and decontamination may not be the highest importance
Historically, medical device decontamination has been based upon the criteria listed within the Spaulding classification for microbial reduction. This guidance evolved around the Second World War and is this still relevant and does it continue to provide the required the required mechanisms to connect manufacturers and healthcare providers? As an example, should we be migrating to sterilisation for flexible endoscopes? After all, what would you want if you were a patient? Can we achieve sterilisation with relevant flexible endoscopes, as dimensions and design can present an obstacle to sterilant penetration?
As Henry Ford stated, ‘If we always do what we always done, we always get, what we always got’. Therefore, the question arises: is it time for revolution or evolution?
About the author
John Prendergast is the Principal Decontamination Engineer working within the specialist team at NHS Wales Shared Services Partnership/Specialist Estates Services. His role is dedicated to all aspects of decontamination/reprocessing techniques of medical devices. John leads the team that provides validation services, advice and guidance to Health Boards/Trusts within Wales and works closely with Welsh governmental departments to deliver policy and strategy in this unique and often complex field. John has worked within the NHS in Wales for the past 37 years. John is the Chairperson of the Central Sterilising Club and also Chairperson of the IHEEM AE(D) Registration Board. He participates independently of his NHS role, delivering training on behalf of Eastwood Park Training
