CLINICAL ENGINEERING CONFERENCE
details and commonality can then be established. The non-active cardiovascular device team (the team that monitors events related to devices such as stent-grafts, IVC filters and peripheral stents) has set trigger levels purposely low. There are currently three reports concerning the same type of problem with the same make and model device over a three month period. Although single reports have, on occasion (by themselves) enabled the MHRA to bring about changes to the design or instructions for use of a device, multiple reports enable us with much more leverage when working with manufacturers to initiate change.”
Decontamination focus
Professor David Perrett, Professor Emeritus of bioanalytical science at Barts and London School of Medicine, asked the question: “In terms of decontamination, where are we now?” David cited an incident from 1974 in which brain electrodes were used on a patient with Creutzfeldt–Jakob disease (CJD). Despite being cleaned and rinsed, another patient subsequently caught CJD from the electrodes.
“CJD is caused by prions,” he said. “Infectious prions are misfolded proteins that can cause normally folded proteins to become misfolded. Most cases occur spontaneously, while about 7.5% of cases are inherited from a person’s parents in an autosomal dominant manner. Exposure to brain or spinal tissue from an infected person may also result in spread. “There is no specific treatment. Opioids may be used to help with pain, while clonazepam or sodium valproate may help with involuntary movements. “Transmissible spongiform
encephalopathies (TSEs) are a group of progressive, invariably fatal, conditions that are associated with prions and affect the brain (encephalopathies) and nervous system of many animals, including humans, cattle, and sheep. Then, in 1984, Bovine spongiform encephalopathy (BSE) emerged– a new disease – in which five million cows died.
This was said to be resolved in 1990, and to alleviate public fears, then-Agriculture Minister John Selwyn Gummer arranged a press event where he fed his four year old daughter a beefburger.”
While CJD is not related to BSE, they are both considered TSEs - only people get CJD and only cattle get mad cow disease. “CJD has been on the rise since 1990,” warned David. “In total there have been 2582 cases – mainly from older people – and one person in every 2000 carry variant Creutzfeldt-Jakob disease (vCJD). CJD could be transmitted by surgical instruments. “In 1999 the Department of Health assembled a research working group on vCJD transmission, in a bid to evaluate protein detection techniques and improve instrument design to enable better cleaning. “A number of decontamination challenges were identified. In 2003, the Department of Health randomly collected instruments for testing from 25 hospitals and devices such as lumen instruments were found to be highly contaminated. The protein released from visually clean instruments was analysed, and there were some terrible failures. Visually clean does not mean clinically clean.
“In 2008 the working group concluded that present protein detection methods on reusable surgical instruments were not fit for purpose. Swabbing was deemed inefficient and inaccurate. Prion proteins are highly infective and, in particular, stick to stainless steel – they also resist all cleaning agents and processes. Sterilisation does not kill prion proteins.”
Based on the working group’s findings, David explained that new detection methods were developed, such as fluorescence, which is 1000 times more sensitive than colour analysis. “In May 2015, ACDP Guidance suggested a maximum residual of 5µg. HTM-0101 suggests minimising the time between theatre and SSD, and to keep instruments moist – proteins are easier to remove when not allowed to dry on surfaces. Detergents work better on dry instruments.”
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However, David warned that adoption of HTM-0101 has been slow, with some objections to the approaches.
Urodynamics and connections
Roger Lewis from Lewis Medical discussed urodynamic investigations, equipment and the working environment. Urodynamic studies (UDS) test how well the bladder, sphincters, and urethra hold and release urine. These tests can show how well the bladder works and why there could be leaks or blockages. He said: “There are many types of urodynamic tests. A healthcare provider may recommend one or more based on the symptoms, but they are typically performed together as one test. “The following tests are all UDSs:
Cystometry, electromyography, urethral pressure profile; uroflowmetry; voiding pressure study (pressure flow study). “Urodynamics help find the cause of problems related to: Urine leaks, a bladder not emptying all the way, the need to go too often – or to go suddenly; weak urine flow; intermittent urine flow.” Roger provided evidence of how urodynamics equipment is helping, such as video urodynamics. “This equipment demonstrates the bladder and shows it emptying when a patient passes urine. This reveals any anomalies. “Recent developments include
ambulatory urodynamics, using a small mobile recorder and Bluetooth wireless technology.”
The Clinical Services Journal’s technical editor, Kate Woodhead RGN DMS, asked delegates how well connected healthcare really is. Kate focused on the lack of response to digital transformation, warning: “The NHS is a culture of innovation, but the NHS is a slow adopter – sometimes due to budgetary constraints, and sometimes due to culture. There is a great need to balance people, culture, processes, and new technology.”
CSJ NOVEMBER 2019
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