Godfrey S E
Department of Pathology, St Anthony's Medical Center, St Louis, MO 63128, USA.
Am J Clin Pathol. 1999 Jan;111(1):14-7. doi: 10.1093/ajcp/111.1.14.
A new element in the Papanicolaou smear liability crisis is the recent US Food and Drug Administration approval of 2 automated rescreening devices. Their manufacturers have undertaken aggressive advertising in medical journals and in women's magazines, generating controversy about whether this positions such devices as the new standard of care and whether failure to offer such rescreening might lead to liability alleging to tort of negligent nondisclosure, with contributing opinions from pathologists' and manufacturers' counsels. Cases are cited in prenatal diagnostics and blood banking that established liability for failing to disclose diagnostic modalities used by at most only a minority of practitioners and, therefore, have not yet achieved standard-of-care status. It is concluded that informed consent for cervicovaginal smears should include disclosure of the availability of automated rescreening to reduce negligence liability.
帕潘尼古拉乌涂片检查责任危机中的一个新因素是美国食品药品监督管理局最近批准了2种自动复检设备。这些设备的制造商在医学期刊和女性杂志上进行了积极的广告宣传，引发了关于此类设备是否成为新的护理标准，以及不提供这种复检是否可能导致因过失未披露侵权行为而产生责任的争议，病理学家和制造商的法律顾问也发表了相关意见。产前诊断和血库领域的案例表明，对于未能披露大多数从业者最多仅使用过的诊断方式会追究责任，因此这些方式尚未达到护理标准的地位。得出的结论是，宫颈阴道涂片检查的知情同意应包括披露自动复检的可用性，以减少过失责任。
