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Standard methods of decontamination, such as Disinfector Washers (e.g. using hot alkaline solutions and surfactants), are known to be inconsistently effective in removing protein from surgical instruments. Advanced Ultrasonics offers an exciting and tantalizing alternative. Preliminary results suggest that intense cleaning using “advanced ultrasonic technology” can potentially result in disinfection without the need for any thermal or chemical methods.
by David Jones
In the UK, concerns about Creutzfeldt-Jacob Disease (CJD) date back to the mid-1980s when an outbreak of Bovine Spongiform Encephalopathy (BSE, a similar transmissible neuro-degenerative brain disease) in cattle raised concerns that the disease might be transmissible to humans. Confirmation came in 1996 [1] that BSE can indeed lead to a form of human CJD (variant (v)CJD) that particularly affected younger adults. This resulted in widespread public health concern, heightened again a few years ago when a study in the British Medical Journal [2] suggested that as many as 1 in 2000 Britons may be infected with the abnormal prion protein that causes vCJD. To date there have been 178 deaths due to vCJD in the UK with a few more elsewhere [3]. In both model experiments and in actual human studies it has been shown that the prion protein is readily transmitted on stainless steel instruments from one animal to another.
vCJD highlighted to clinicians and decontamination / sterile services professionals alike, the critical requirement to remove protein, as well as other infectious agents, from neuro-surgical and other reusable surgical instruments. In addition to the risk of patient-to-patient transferal of vCJD prions, there is a danger that bacteria hidden in or under any residual protein e.g. biofilms could also be passed on. A recent study in the journal Acta Neuropathologica [4] also highlighted the potential dangers associated with cross-contamination of neurosurgical instruments with the peptide amyloid beta (Aβ), a substance implicated in brain hemorrhages and Alzheimer’s disease.
Standard methods such as Disinfector Washers (e.g. hot alkaline solutions and surfactants) are known to be inconsistently effective in removing protein from surgical instruments [5,6] and other difficulties in ensuring consistent cleanliness has led to a move towards single use instruments. However, questions remain as to how manufacturers of single use instruments can achieve consistent cleanliness and sterility when modern, well equipped Sterile Service and Decontamination (SSD) units apparently cannot. Unfortunately, single use instruments are not always clean and sterile as recent unpublished investigations have shown.
In the UK, concerns about contamination mean that GPs and dentists, who have historically performed minor interventions such as lancing of boils, removal of small cysts and abscesses etc., are now being discouraged from doing so. This, in turn, is funnelling more patients to A&E departments, which are already under tremendous strain. Post-operative infections also add to strain on the health service, leading to extended hospital stays and bed-blocking.
There is a clear need for a new approach to improve the cleaning of surgical devices. “Commercial grade” ultrasonic cleaning systems have been available for a number of years and have been used as a first stage in the cleaning process.
Ultrasonics works via the process of cavitation. Transducers bonded to the base or side of a tank are excited by high frequency electricity causing them to expand and contract at very high speed. This mechanical action causes high speed downward flexure of the radiating tank face. The speed of this movement is too fast for the water in the tank to follow, resulting in the production of vacuum chambers. On the upward flexure the vacuums are released in the form of vacuum bubbles which rise up through the fluid until they hit an object, upon which the bubbles implode under high pressure, thus drawing away any contamination that may be on the surface of the object.
However, it has been shown that machines used in sterile services departments in the past have an erratic distribution of sound that does not consistently render instruments clear of residual protein. It was felt by many that a new way of applying ultrasound into a fluid was required. To achieve the safe cleaning of these items, the sound needs to be applied in a way that is both even as well as intense, with no gaps in activity where cleaning would not be effective.
In order to develop a new cleaning technology, a reliable method for measuring residual protein was needed and agreement reached on acceptable levels. The UK HTM 01-01 Guidance on the Management and Decontamination of Surgical Instruments [7], released in 2016, specifies that “there should be <5µg of protein in situ, on a side of any instrument tested”. In situ testing is specified since: “detection of proteins on the surface of an instrument gives a more appropriate indication of cleaning efficacy related to prion risk” than the swabbing techniques used in the past [8,9,10]. Currently the ProReveal system, from Synoptics Health, Cambridge UK, is the only in situ system on the market worldwide. As well as high levels of accuracy, the system also identifies the precise location of any remaining proteins on the instrument. To comply with UK HTM 01-01 guidance, therefore, any new cleaning system, ultrasonic or otherwise, needs to be validated against the levels of detection offered by ProReveal.
A second issue to be addressed by any ultrasonic cleaning technology is how to measure the ultrasonic activity. HTM 01-01 states that machines should be periodically tested for ultrasonic activity.
Historically, the only method available to Sterile Services Managers and AED’s for validating the activity in an ultrasonic tank has been to insert a piece of aluminium foil into the fluid for a set time and then visually analyse the indentations in the foil to determine the ultrasonic activity. This is a somewhat inaccurate way of validating what is a critical phase in the decontamination process. Troughs of sound can be either macroscopic or microscopic and, as such, the reliance on sight alone is unacceptable when such high levels of consistent cleanliness are expected.
With both these issues in mind, Alphasonics (a Liverpool/UK company with over 25 years’ experience in the field of ultrasonic cleaning systems) launched the ‘Medstar’ project with a view to developing ‘advanced ultrasonic technology’ for cleaning surgical equipment. The project started in 2013 but it was not until 2015 when a ProReveal was purchased that substantive advances were made. Progress then accelerated quickly and over a 3-year period, a point was reached whereby instruments could be rendered “completely” free of residual protein, as assessed by ProReveal technology.
To overcome the problems around accurately measuring ultrasonic activity, the world’s first Cavitation Validation Device (CVD) was developed from 2016 to 2018 which, for the first time, allows the validation of ultrasonic cleaning devices by listening exclusively for cavitation noise.
CVDs are included within most Medstar systems and the below graphs show how Medstar devices perform compared to existing ‘commercial grade’ ultrasonic cleaners (Data on File).
It is this unique, intense ultrasound technology that is so effective in removing protein residue from medical devices, as measured by the in situ ProReveal method. To assess the effect on removal of bacteria, a UKAS (UK Accreditation Service) accredited laboratory was engaged to carry out independent trials. Instruments were contaminated by the laboratory, first with Enterococcus faecium and Staphlyococcus aureus (as specified within ISO15883 annex N- “test soils and methods for demonstrating cleaning efficacy”) and then with “dirty” conditions (specified in ISO13727). They were then cleaned in a Medstar device. Since all residual protein was being removed, the question arose: was the (now exposed) bacteria also being removed by the intense ultrasound?
Work is on-going, but preliminary results suggest that intense cleaning using ‘advanced ultrasonic technology’ can potentially result in disinfection without the need for any thermal or chemical methods.
Medstar devices have several other features to allow compliance with UK HTM01-01 guidance, such as the Generator Output Monitoring System- which constantly monitors the generator output and adjusts the input accordingly, thus ensuring that the system is always performing optimally. The CVD device is then used for periodic independent validation.
Advanced Ultrasonics offers an exciting and tantalizing alternative to thermal disinfection devices. The HTM01-01 UK guidelines are only the start of things to come and it is already widely recognized that the 5µg limit set out in the guideline is still too high. The many trials undertaken by the manufacturer have clearly shown that the Medstar range of equipment leaves no more than 0.5µg of residual protein per side on an instrument and as such renders the bacteria fully exposed to the intense, very even, action of the ultrasound and enzymatic chemicals.
High throughput systems are also available that would be of great benefit to single-use instrument manufacturers and SSD units alike. These systems will deliver a consistently lower residual protein count and a better log reduction than thermal disinfection devices.
References
1. John Collinge, Katie CL Sidle, Julie Meads, James Ironside, Andrew F Hill. Molecular analysis of prion strain variation and the aetiology of “new variant” CJD. Nature, 1996; 383(6602), 685. doi:10.1038/383685a0
2. Gill O, Spencer Y, Richard-Loendt A, Kelly C, Dabaghian R, Boyes L, Linehan J, et al. Prevalent abnormal prion protein in human appendixes after bovine spongiform encephalopathy epizootic: large scale survey. British Medical Journal, 2013; 347, 11.
3. See www.cjd.ed.ac.uk/sites/default/files/figs.pdf
4. Jaunmuktane Z, Quaegebeur A, Taipa R, Viana-Baptista M, Barbosa R, Koriath C, Sciot R, et al. Evidence of amyloid-β cerebral amyloid angiopathy transmission through neurosurgery. Acta Neuropathologica, 2018; 135(5), 671–679. doi:10.1007/s00401-018-1822-2
5. Murdoch H, Taylor D, Dickinson J, Walker JT, Perrett D, Raven NDH, Sutton JM.
Surface de-contamination of surgical instruments – an ongoing dilemma. Journal of Hospital Infection 2016; 63: 432-438
6. Baxter RL, Baxter HC, Campbell GA, Grant K, Jones A, Richardson P, Whittaker G. Quantitative analysis of residual protein contamination on reprocessed surgical instruments. J Hosp Infect 2006; 63, 439-444.
7. Department of Health and Social Care. Health Technical Memorandum (HTM) 2006; 01-01: management and decontamination of surgical instruments (medical devices) used in acute care.. Available: https://www.gov.uk/government/publications/management-and-decontamination-of-surgical-instruments-used-in-acute-care. Last accessed July 2018.
8. Nayuni N, Cloutman-Green E, Hollis M, Hartley J, Martin S, Perrett D. A critical evaluation of ninhydrin as a protein detection method for monitoring surgical instrument decontamination in hospitals. J Hospital Infection 2013; 84 97-102
9. Nayuni N, Perrett D. A comparative study of methods for detecting residual protein on surgical instruments. Medical Device Decontamination (incorporating the IDSc Journal) 2013; 18 16-20
10. Perrett D, Nayuni N. Efficacy of current and novel cleaning technologies (ProReveal) for assessing protein contamination on surgical instruments 2014; Chapter 22 in Decontamination in Hospitals and Healthcare Edited by Dr. J.T. Walker, Woodhead Publishers, Cambridge, UK.
The author
David Jones
Alphasonics, Liverpool, UK
www.alphasonics.co.uk
The use of flexible endoscopes for endoscopic retrograde cholangiopancreatography (ERCP) is increasing as it represents a relatively non-invasive method for the diagnosis and treatment of certain conditions of the biliary and pancreatic ductal systems, such as gallstones, undefined biliary strictures, bile duct injury or leaks, and cancer. The design of duodenoscopes, however, is complex; they have long narrow channels and a recessed elevator at the distal end that enables good use of any accessories. All the external surfaces and internal channels are in contact with body fluids, presenting a risk of contamination and transmission of infection from patient to patient as well as from patient to endoscopy personnel. As these flexible devices are heat labile and not suitable for steam sterilization, careful cleaning (reprocessing) is needed to minimize the risk of contamination.
A recent event on Hygiene Solutions in Endoscopy was held at PENTAX Medical R&D Center (October 2019, Augsburg, Germany) to discuss insights on the need for infection control and how to minimize contamination. The event brought together a number of key opinion leaders in the field of ERCP hygiene (endoscopists, microbiologists and chief nurses) and included Paul Caesar, Hygiene and Infection Prevention expert at the Tjongerschans Hospital (Heerenveen, The Netherlands), Dr Hudson Garrett Jr., Global Chief Clinical Officer at PENTAX Medical and Assistant Professor of Medicine (Division of Infectious Diseases) at the University of Louisville School of Medicine, Kentucky, USA, as well as Wolfgang Mayer, Managing Director of Digital Endoscopy at PENTAX Medical.
Endoscopy-associated infection
The healthcare community is increasingly aware of the risk of hospital-acquired infection associated with endoscopy following documentation of several outbreaks of patient infections linked to duodenoscopes in the USA and around the world in the last decade as well as regulatory recalls. However, Paul Caesar made the point that in reality there is very little data regarding infection rates. One of the issues is that patients are discharged from hospital more and more quickly following procedures. Then, if any infection subsequently develops, the patient usually attends their local general practitioner and the link to the endoscopy is not made. The point was made that currently no surveillance is done for post-endoscopy infection and this should be put into place to generate reliable data on infection rates.
Endoscope reprocessing
The role of endoscope reprocessing is crucial for mitigating the risk of infection and is achieved by mechanical cleaning detergent cleaning, high level disinfection, and rinsing and drying (Figs 1–3). However, research shows that in 45% of cases key reprocessing steps are skipped. Additionally, 75% of the reprocessing staff reported time pressures and non-compliance with guidelines related to reprocessing as a result. Paul Caesar emphasized this point saying, “Manual cleaning is still the most important step in reprocessing. However, in daily practice this stage is often downgraded to just a simple flush and brush. I call upon the field, to shift from reprocessing quantity to quality”. Another crucial step is to ensure that the device is thoroughly dried before storage. This reduces the risk of biofilm formation and bacterial growth. However, there are currently no official guidelines for the optimum drying time; even within Europe alone different countries use different drying times.
Suggestions for the improvement of reprocessing included:
1. proper explanation to and understanding by staff of the importance of the reprocessing stages to gain their commitment to following the procedure fully;
2. use of shorter visual pictogram explanations of the reprocessing stages rather than manuals that are approximately 150 pages long and are too complicated to thoroughly read and understand; and
3. traceability and tagging of the people performing the various tasks so that all the steps can be scanned and shown to be done in an optimal fashion.
Improving duodenoscope design
According to Calderwood et al., patient-to-patient transmission of infection has been linked to the elevator channel endoscopes (such as duodenoscopes) and attributed to persistent contamination of the elevator mechanism, the elevator cable and the cable channel. One solution to infection control is to use disposable duodenoscopes. However, this is not practical for every endoscopy because of the cost and the environmental impact. The one-time use of a disposable device is therefore recommended only for high-risk patients.
Hudson Garrett confirmed the company’s commitment to minimizing infection outbreaks with careful consideration of advice and requirements from the CDC (Centers for Disease Control and Prevention) and FDA (U.S. Food and Drug Administration) in the USA, and “using integrated feedback from all clinical stakeholders, optimizing reprocessing processes, and innovating products to directly tackle patient safety and infection prevention needs”. This has led to the development of a duodenoscope with a disposable distal cap with integrated elevator, hence eliminating the part of the device that is most associated with contamination. Additionally, use of the company’s dedicated dryer helps to ensure the device is fully dry, reducing the risk of microbial growth and subsequent potential contamination that can result from moisture. PENTAX Medical also has a strong commitment to the training of reprocessing staff, which (according to current data) requires a minimum of 8 hours to be done properly.
Hospitals have evolved considerably over the years from the early Greek temples of healing, asclepeia, to the large dark, cramped multiple-patient wards of the early Western hospitals, essentially for those who could not afford private care at home, and the brighter, more open smaller ward or single room hospitals of today. These changes have come about as medicine has advanced, technology has progressed and societal and patient conditions and demands have changed. It is difficult to predict how the hospital of tomorrow will look with any precision, but we can make some fairly accurate suggestions based on current trends and developments.
by Prof Jean-Louis Vincent
One key change is that intensive care unit (ICU) patients will represent an increasingly large proportion of hospital patients in the future. There are several reasons for this. First, improved disease prevention and primary care, shorter post-surgery hospital stays and facilitated home care will mean that patients who are hospitalized will be more seriously ill than at present and more likely to need intensive care. Another reason for the increased need for ICU beds is prolonged life expectancy. Improved healthcare means that the average age of the population is increasing worldwide, and older patients are more likely to have multiple comorbidities and to develop complex acute illness. In one report from the US, the number of hospital beds decreased by 2.2% while ICU beds increased by 17.8% over a 10-year period.
As such, the hospital of the future will be composed of a large number of ICU beds with relatively few hospital beds (other than daycare) for other patients (see figure). The ICU may be a physical unit at a strategic place within the hospital, or it may be a more “virtual” ICU with beds dispersed around the hospital. It is possible that in the future all hospital beds will have the potential to be an ICU bed, limiting the need for patient transfers between wards and reducing the time for key ICU interventions to be put into place when a patient is identified as deteriorating. This could also reduce any problems associated with ICU bed shortages. The potential limitations of such an approach include the need for all nursing staff to be trained in intensive care.
So, assuming that the physical ICU structure remains, at least for the near future, what will it look like? With current patient demands for privacy and problems associated with multiresistant pathogens, the ICU will almost certainly consist of multiple single rooms. These rooms will be large and spacious with easy access to the bed from all sides and room for relatives to visit and stay and for the patient to mobilize when possible. The rooms will have large interactive screens with access to patient results and monitored parameters, the ability to call and speak to healthcare staff via telemedicine, and of course standard entertainment channels. Because almost all monitoring, of hemodynamic parameters as well as laboratory values, will be non-invasive and results transmitted to the doctor’s smartphone and to central remote monitoring hubs by wireless technology, there will be much less visible equipment, cables and tubes. What equipment is still necessary will be much smaller, less cumbersome and more user-friendly than at present. Continuous monitoring, multiple feedback systems and computerized interrogation across multiple systems and disciplines will make ICUs much safer with fewer iatrogenic errors.
Visiting hours will be unrestricted throughout the hospital, including in the ICU, and family members, including children, will be welcome. This open access and greater involvement will impact positively on patients and on their families, reducing anxiety and helping to reduce post-ICU stress.
The hospital as a whole will be much more technology oriented than at present and interactive screens will be responsible for much of the routine administration with robots involved in basic services, such as delivery of food and medication, as well as patient mobilization and social stimulation. Care will be more patient-centered and personalized and the flow from home to general ward to ICU will be much more of a continuum. Indeed, some patients may be discharged directly home from the ICU, an option facilitated by continued surveillance using telemedicine. Patients and healthcare staff will have continuous and real-time access to patient medical results and data. Such data will be fed automatically into large international databases to help continuously improve patient management. This process will have become routine and current issues related to data privacy will no longer be a problem.
There will be fewer medical and nursing staff physically present on the wards as telemedicine will be more widely used, enabling remote control of drug infusions and other interventions and e-consultations at the request of the physician or patient. Although healthcare staff may therefore be seen less frequently, they will actually be able to spend more quality time talking to patients and their families.
Technological advances are changing how the world around us operates and the hospital is no exception. Future hospital and ICU design needs to provide flexibility and adaptability to continued technological developments. Healthcare workers and patients will need time to adapt to these changes and to learn how best to use them to improve care and outcomes. We must all be involved in developing the ICU of the future. As Abraham Lincoln said, “The best way to predict the future is to create it”.
Suggested reading:
1. Vincent JL. Critical care–where have we been and where are we going? Crit Care 2013;17 Suppl 1:S2.
2. Halpern NA, Goldman DA, Tan KS et al. Trends in critical care beds and use among population groups and Medicare and Medicaid beneficiaries in the United States: 2000-2010. Crit Care Med 2016;44:1490-1499.
3. Ewbank L, Thompson J, McKenna H: NHS hospital bed numbers: past, present, future. https://www kingsfund org uk/publications/nhs-hospital-bed-numbers#hospital-beds-in-england-and-abroad.
4. Vincent JL, Creteur J. The hospital of tomorrow in 10 points. Crit Care 2017;21:93.
5. Vincent JL, Michard F, Saugel B. Intensive care medicine in 2050: towards critical care without central lines. Intensive Care Med 2018;44:922-924.
6.Denis K, Bidet F, Egault J et al. Utilization of Robo-K for improving walking and balance in patients affected by neurological injuries: A preliminary study. Ann Phys Rehabil Med 2016;59S:e88.
7. Bailly S, Meyfroidt G, Timsit JF. What’s new in ICU in 2050: big data and machine learning. Intensive Care Med 2018; 44:1524-1527.
8.Michard F, Pinsky MR, Vincent JL. Intensive care medicine in 2050: NEWS for hemodynamic monitoring. Intensive Care Med 2017;43:440-442.
The author
Jean-Louis Vincent, MD, PhD
Dept of Intensive Care, Erasme Hospital, Université libre de Bruxelles, Brussels, Belgium
April 2024
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+31 85064 55 82
info@interhospi.com
PanGlobal Media IS not responsible for any error or omission that might occur in the electronic display of product or company data.
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