Events in 2023
CONGRESS 2023 - Validation and Verification Workshop
28/09/2023
Validation and Verification Workshop
CONGRESS 2023 - Benign glandular histology as potential for BLEC
28/09/2023
Benign glandular histology as potential for BLEC
CONGRESS 2023 - Role of MDT – Clinical Perspective; Colposcopy for patients with learning difficulties
28/09/2023
Role of MDT – Clinical Perspective; Colposcopy for patients with learning difficulties
CONGRESS 2023 - The IBMS's view of ISO 15189:2022 (Thursday)
28/09/2023
The IBMS's view of ISO 15189:2022
CONGRESS 2023 - HPV Entrapment Syndrome: a difficult problem in the Triage Pathway
28/09/2023
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.
CONGRESS 2023 - A modular approach to the Specialist Portfolios
28/09/2023
A modular approach to the Specialist Portfolios
CONGRESS 2023 - In-house tests to CE marked - Impact on the laboratory (Debate – impact on laboratory vs commercial company)
28/09/2023
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.
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.
CONGRESS 2023 - Biomarkers, disease severity and triaging the role of mid-regional proadrenomodulin
28/09/2023
There is a lack of validated tools to assess potential disease progression and hospitalisation decisions in patients presenting to the emergency department (ED) with a suspected infection. The aim to identify suitable blood biomarkers (MR-proADM, PCT, lactate and CRP) and/ or clinical scores (SIRS, SOFA, qSOFA, NEWS and CRB-65) to fulfil this unmet clinical need and recognising the “ill looking well” and the “well looking ill”. We found in patients presenting to the ED with a suspected infection, the blood biomarker MR-proADM could most accurately identify the likelihood of further disease progression.
Incorporation into an early sepsis management protocol may therefore aid rapid decision-making in order to either initiate, escalate or intensify early treatment strategies, or identify patients suitable for safe out-patient treatment. There is currently a randomised controlled trial to assess the accuracy of the above findings.
Incorporation into an early sepsis management protocol may therefore aid rapid decision-making in order to either initiate, escalate or intensify early treatment strategies, or identify patients suitable for safe out-patient treatment. There is currently a randomised controlled trial to assess the accuracy of the above findings.