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出海时代的技术沟通:为什么人工心脏需要统一语言?
思宇MedTech· 2025-12-03 05:18
Core Viewpoint - The article emphasizes the necessity for a unified language in the medical technology field, particularly regarding the terminology used for blood pump bearing technologies, to ensure ethical communication and patient safety [2][3]. Group 1: Importance of Terminology - Accurate terminology in medical devices is crucial as it directly impacts clinical decisions and patient safety [2]. - The inconsistency in terminology, particularly regarding "fully magnetically levitated" blood pumps, can lead to misunderstandings among manufacturers, clinicians, and regulators [3][4]. - The call for a standardized language is essential as more Chinese medical devices enter international markets, facing diverse regulatory and cultural challenges [3][4]. Group 2: Case Study of Blood Pump Technologies - The article discusses a specific case involving the CorHeart 6 blood pump, which was described differently by industry representatives and independent experts, highlighting the need for open scientific discussions to resolve such discrepancies [3][4]. - The classification of blood pump bearings is critical, with three fundamental types identified: contact-type plain bearings, hydrodynamic bearings, and magnetic bearings [6][22]. - The differences between magnetic and hydrodynamic bearings are significant, particularly regarding their impact on hemocompatibility and blood damage characteristics [10][27]. Group 3: Recommendations for Manufacturers - Manufacturers are urged to ensure that their descriptions align with international consensus and that the terminology used in marketing and technical documents is clear and consistent [4][5]. - It is recommended that manufacturers disclose the rotor suspension methods of their products, including any combination of magnetic and hydrodynamic support, to promote transparency [5][18]. - The article advocates for the establishment of an independent working group to standardize definitions and classifications of blood pump technologies to enhance scientific clarity and patient safety [12][32].