Events in 2023

EUCAST – striving towards a complete system

Shiga toxin-producing Escherichia coli (STEC) O157:H7 has been the most clinically significant STEC serotype in the UK for over four decades. However, over the last 10 years we have observed a decrease in STEC O157:H7 and an increase in non-O157 STEC serotypes, such as O26:H11. Little is known about the microbiology and epidemiology of non-O157 STEC. This presentation describes the virulence, clinical outcomes and epidemiology of non-O157 STEC, focusing on the most commonly detected serotype, STEC O26:H11.

This presentation will give delegates an introduction to important human viruses, their treatment with antivirals and possibilities for preventing antiviral resistance. Implications of recently identified metabolic capping of hepatitis C virus.

The management of low grade smear abnormalities has posed problems for over 30 years and these will be described in some detail leading on to the most recent difficulty caused by the HPV Triage Pathway in the Cervical Screening Programme. The concept of HPV Entrapment Syndrome will be introduced and management strategies to deal with this difficult problem will be discussed. As well as explaining what HPV Entrapment means, there will be a detailed case presentation of a typical patient followed by a review of some of the numerous smear abnormalities that prevented her from leaving the Triage Programme.

A modular approach to the Specialist Portfolios

The IBMS's view of ISO 15189:2022

The IVDR is the new regulatory instrument for placing IVDs on the European market. The aims of the IVDR are to provide a robust, transparent and sustainable IVD framework, harmonize divergence in implementation (as experienced with the IVDD) and most importantly to increase patient safety. The document runs to 156 pages (compared to 43 for the IVDD, containing 114 articles and 15 annexes. The IVDR places more emphasis on the economic operators (actors) involved in the IVD supply chain, from the manufacturer to the customer.

Manufacturers have the obligations to design and manufacture products in compliance with the IVDR; evaluate product performance and manage risk, have a Quality Management System, create and maintain product technical documentation, conduct post market surveillance, and implement field safety corrective actions. One of the biggest changes with IVDR is the introduction of a new rules-based approach for product classification. Under IVDR, Notified Bodies perform conformity assessment on 80% of IVDs (compared to 20% under the IVDD, which becomes stricter as the risk class increases. There are also enhanced concepts for performance evaluation and clinical evidence.

Under the IVDR there is a requirement to state the clinical purpose in the intended use. Thus, in order to comply with the new regulation, manufacturers must revise all intended purpose statements in product labelling. Further, there is the obligation to gather a large amount of data to evaluate both analytical and clinical performance. Manufacturers are required to continually evaluate performance across the whole product lifecycle through post market surveillance and vigilance, with reports for the highest-risk devices uploaded to the new EUDAMED database on an annual basis.

Heroin markers

High Sensitivity Troponin in the Community

There are many job roles and opportunities available to biomedical scientists outside of the laboratory, but what does a biomedical scientist do working within the Blood Stocks Management Team?

Learn about a different role, the transferable skills that are required and how this role is different from working in a laboratory environment. Why is this role important to Blood Transfusion laboratories and is it beneficial having a biomedical scientist as part of the team?