FDA警示:Medline指出使用非配套配件可能导致病患被困风险

美股速递
Feb 14

美国食品药品监督管理局(FDA)发布最新安全提示,医疗设备制造商Medline Inc在报告中明确指出,当医疗机构在Medline病床上使用非原厂配件时,可能引发患者肢体或躯干被卡住的安全隐患。

该警示源于Medline主动提交的产品安全评估报告。报告显示,第三方生产的床栏、护栏等附件若与Medline病床混用,可能因尺寸匹配度或结构兼容性问题,导致患者意外被困的潜在风险。监管部门强调,此类安全隐患在长期照护机构和居家护理环境中尤为值得关注。

目前FDA建议医疗机构严格遵循设备配套使用规范,并对现有设备进行安全排查。Medline方面也表示将加强原厂配件的标识管理,同时提醒用户通过官方渠道采购认证配件。

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