IVDR调节是诊断微生物实验室的主要挑战。鉴于病原体(包括稀有但高毒性的微生物)的高度多样性和提交分析的大量样品,IVDR使广泛的方面复杂化并带来风险。新的病原体(包括E-11型Echovirus,腺病毒41型,猴痘病毒,阿龙山病毒,和肠道病毒D68,作为SARS-CoV-2后时代在欧洲的最新例子)是使IVDR调节具有风险的另一个因素,因为它对内部测试的生产的不利影响将对开发新的诊断测试的知识和专业知识产生负面影响。此外,这些法规对诊断测试的可用性产生了负面影响,特别是对于被忽视的病原体,并对测试的总体成本产生不利影响。因此,IVDR的监管负担增加可能对公共卫生构成重要风险。一起来看,这将对诊断微生物实验室(尤其是小型实验室)的财务平衡产生负面影响。所有ISO认证和Swissmedic授权实验室的质量管理标准已经很高,这使得IVDR法几乎没有价值,至少在瑞士,同时极大地增加了监管负担和相关成本。最终,患者需要在保险框架之外支付诊断化验费用,以便获得适当的诊断评估,这可能会导致社会不平等。因此,基于上述风险评估,临床微生物学协调委员会建议通过(i)引入ISO15189认证的义务和(ii)不实施IvDO2028里程碑来调整IvDO条例。
IVDR regulation represents a major challenge for diagnostic microbiology laboratories.
IVDR complicates a broad range of aspects and poses a risk given the high diversity of pathogens (including rare but highly virulent microbes) and the large variety of samples submitted for analysis. The regular emergence of new pathogens (including Echovirus E-11, Adenovirus 41, Monkeypox virus, Alongshan virus, and Enterovirus D68, as recent examples in Europe in the post SARS-CoV-2 era) is another factor that makes
IVDR regulation risky, because its detrimental effect on production of in-house tests will negatively impact knowledge and expertise in the development of new diagnostic tests. Moreover, such regulations negatively impact the availability of diagnostic tests, especially for neglected pathogens, and has a detrimental effect on the overall costs of the tests. The increased regulatory burden of
IVDR may thereby pose an important risk for public health. Taken together, it will have a negative impact on the financial balance of diagnostic microbiology laboratories (especially small ones). The already-high standards of quality management of all ISO-accredited and Swissmedic-authorized laboratories render
IVDR law of little value, at least in Switzerland, while tremendously increasing the regulatory burden and associated costs. Eventually, patients will need to pay for diagnostic assays outside of the framework of their insurance in order to obtain a proper diagnostic assessment, which may result in social inequity. Thus, based on the risk assessment outlined above, the coordinated commission for clinical microbiology proposes adjusting the IvDO ordinance by (i) introducing an obligation to be ISO 15189 accredited and (ii) not implementing the IvDO 2028 milestone.