Clinical, Medical & Diagnostic Products
New Testing System for Hospital Hygiene
TÜV SÜD has introduced an automated testing system for hospital hygiene, focusing on the machine-washability of medical devices. This system assesses the durability and functionality of products like hospital beds, patient hoists, and walking aids after undergoing washing cycles. It evaluates factors such as surface finishes, electronics, plastic components, and movable parts’ resilience during the washing process.
Previously, manufacturers had to invest in their own washing systems or use hospital facilities for testing. However, TÜV SÜD’s experts can now provide rapid and reliable testing, enhancing the value of products and aiding in promotional efforts.
The testing adheres to industry standards, with specific criteria for the number of washing cycles devices must withstand. For example, medical beds are evaluated based on DIN EN 60601-2-52, which previously required 50 cycles but has been proposed to increase to 250 cycles in the latest standard draft. Similar standards exist for patient hoists and walking aids. TÜV SÜD has developed corresponding test procedures, considering factors like temperature, pH, and cleaning agents.
In Germany, where 20 million people are treated as hospital inpatients annually, machine reprocessing is becoming increasingly popular. Beds are taken to a central department, cleaned, disinfected, and dried with the push of a button, reducing the workload on nursing teams and minimising contact with potentially infectious surfaces.
The healthcare industry’s demand for efficient and reliable cleaning processes is growing, especially in the face of competition, rising costs, and the COVID-19 pandemic. Reliable hygiene measures are crucial in preventing infections, and TÜV SÜD’s testing system contributes to this goal.
From a sustainability perspective, the testing facility recycles about 75% of the water used in the washing process, saving energy and water. Further optimisation measures, such as heat recovery from wastewater and carbon-neutral energy generation through photovoltaics, are also being considered.
TÜV SÜD’s automated testing system enhances the hygiene and durability of medical devices, addressing the growing demand for efficient and reliable cleaning processes in healthcare settings, while also contributing to sustainability goals.
More information online:
ilmt.co/PL/zBwy 61198pr@reply-direct.com
FDA Approves First Automated Test for Neuroendocrine Tumour Progression
Thermo Fisher Scientific, a global leader in scientific services, has received FDA clearance for the Thermo Scientific™ B·R·A·H·M·S™ CgA II KRYPTOR™ immunoassay, marking the first FDA-approved chromogranin A (CgA) test. It’s also the only automated immunoassay globally designed for evaluating tumour progression in gastroenteropancreatic neuroendocrine tumour (GEP-NET) patients.
GEP-NETs originate from neuroendocrine cells, potentially developing in the pancreas or other gastrointestinal areas. While these tumours are categorised as rare diseases, data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program reveals a remarkable 500% increase in the disease’s incident rate in the United States over the last thirty years.
This innovative test empowers laboratories and cancer centres to measure CgA concentration in human serum, offering valuable insights into tumour progression and treatment effectiveness evaluation. With FDA clearance, this assay becomes readily accessible for deployment in laboratories across the country, promising enhanced patient care and improved outcomes.
Tina Liedtky, President of Clinical Diagnostics at Thermo Fisher Scientific, commented: “Thermo Fisher is dedicated to developing clinical diagnostic solutions that empower healthcare providers to enhance patient outcomes. This assay allows customers to replace manual laboratory-developed tests, streamline lab workflows, and provides clear result interpretation.”
The new assay is compatible with the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS random-access immunoassay analyser, utilising TRACE™ technology, rooted in Nobel Prize-winning chemistry, to deliver highly precise results in less than 30 minutes.
More information online:
ilmt.co/PL/8Nov 61259pr@reply-direct.com
Transforming Clinical Trials with iPSC-Derived Liver Organoids
AMSBIO has published a blog about the groundbreaking research of Dr Satoshi Okamoto from Yokohama City University Graduate School’s Department of Regenerative Medicine. Dr Okamoto’s research focuses on the production of induced pluripotent stem cells (iPSC)-derived liver organoids, which have demonstrated remarkable potential in clinical research trials for liver diseases.
The primary objective of Dr Okamoto’s research program was to establish large-scale, stable production of clinical-grade liver organoids, poised to revolutionise liver disease treatment. These organoids hold promise as therapeutic treatments for patients suffering from liver diseases.
To support their study, Dr Okamoto’s research group collaborated in the development of StemFit® for Differentiation, a chemically defined and animal component-free supplement designed specifically for the differentiation of induced pluripotent stem (iPS) cells. StemFit® for Differentiation played a critical role in achieving a stable differentiation induction protocol, successfully differentiating three types of liver progenitor cells from human iPS cells and culturing them into small liver organoids.
Dr Okamoto commented: “StemFit® for Differentiation is very easy-to-use and has allowed us to produce a stable differentiation induction protocol. In our study, three types of liver progenitor cells (endoderm, vascular endothelial and mesenchymal) were induced to differentiate from human iPS cells and then cultured to produce small liver organoids. The supplement’s versatility was vital to our project. In addition, we believe the reason we have been able to achieve stable culture, even when scaled up, is because StemFit® for Differentiation is a fully defined chemical supplement.”
AMSBIO offers StemFit® for Differentiation, a proven solution enabling unmatched differentiation of human induced pluripotent stem (hiPS) and embryonic stem (hES) cells. Its chemically defined composition ensures minimal lot-to-lot variation, providing highly consistent cell differentiation. Moreover, being free of animal-derived components, StemFit® for Differentiation eliminates the risk of immunogenic contamination. This innovative product has found applications in lineage-specific differentiation as well as the spontaneous differentiation of hiPSCs to organoids via embryoid body formation, surpassing the performance of serum-free supplements.
Read the blog in full:
ilmt.co/PL/X1Jd More information online:
ilmt.co/PL/8Nby
60670pr@reply-direct.com
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