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Regulation in hemostasis and thrombosis: part I-in vitro diagnostics
Emmanuel J Favaloro1, Mario Plebani, Giuseppe Lippi
1Department of Haematology, Institute of Clinical Pathology and Medical Research ICPMR, Pathology West, Westmead Hospital, Westmead, New South Wales 2145, Australia. emmanuel.favaloro@swahs.health.nsw.gov.au
Regulatory processes for hemostasis and thrombosis diagnostics, including in vitro diagnostic devices (IVDs), may inadvertently block new technologies. This can negatively impact patient care for bleeding and clotting disorders.
Area of Science:
- Medical Diagnostics
- Regulatory Science
- Hematology
Background:
- Hemostasis and thrombosis diagnostics are influenced by professional, expert, and government organizations.
- These organizations aim to standardize and regulate diagnostic tests and therapeutic products, including in vitro diagnostic devices (IVDs).
- While standardization and regulation intend to improve diagnostics and patient health, limitations exist.
Purpose of the Study:
- To analyze the impact of regulatory processes on diagnostic technologies for hemostasis and thrombosis.
- To identify how regulation of in vitro diagnostic devices (IVDs) affects the adoption of new and existing technologies.
Main Methods:
- Case studies examining the regulation of in vitro diagnostic devices (IVDs).
- Analysis of how regulatory frameworks influence the introduction and use of diagnostic technologies.
Main Results:
- Regulation, intended to mitigate risks, can paradoxically hinder the adoption of clinically useful, novel diagnostic technologies.
- Existing, potentially outdated technologies may be favored over newer, improved ones due to regulatory hurdles.
- This can lead to the "lock-in" of old technologies and the exclusion of innovative solutions.
Conclusions:
- Current regulatory approaches for hemostasis and thrombosis diagnostics may have unintended negative consequences.
- The exclusion of advanced diagnostic technologies can adversely affect the clinical diagnosis and management of hemostasis and thrombosis disorders.
- Re-evaluation of regulatory strategies is needed to ensure patient benefit and technological advancement.
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