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FDA新规影响可重复使用的33类医疗器械

6月9日，FDA发布一则通告，对特定可重复使用的医疗器械的再处理使用及验证提出要求。该通告将于2017年8月8日生效。

可重复性使用的医疗器械是指，预期反复用于同一个患者或不同患者，在每次使用之间需进行清洁或其他再处理步骤的器械。FDA之前已发布过一些关于可重复使用器械的再处理规定，包括2015年发布的“Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”。本次，FDA规定表1和表2中的器械，在510(k)申请中必须提交清洁消毒灭菌的验证数据，否则将被视为非实质等同，导致注册失败。具体要求见表1下方文字。

表1 510(k)申请中必须包含再处理的验证数据与经过验证的使用说明的器械

1?对于在上述产品分类范围内的软性内窥镜，在510(k)申请中必须提交再处理验证数据。

2?对于在上述产品分类范围内的器械，若器械拥有表2中的设计特征，在510(k)申请中必须提交再处理验证数据。

表2 Arthroscopes, Laparoscopic Instruments, and Electrosurgical Instruments, and Their Respective Accessories产品中会导致风险的设计特征

Lumens (especially lumens of flexible design, multiple internal lumens, lumens that are not freely accessible, bifurcated lumens, lumens with internal surfaces that are not smooth, have internal ridges or sharp angles, or are too small to permit a brush to pass through).

Hinges, depressions, joints with gaps, overlapping or butted joints that result in acute angles, or ribbed or otherwise “roughened” surfaces (e.g., jaws).

Interior device channels.

Sleeves surrounding rods, blades, activators, inserters, etc.

Shafts within lumens.

Adjacent device surfaces between which debris can be forced or caught during use.

O-rings.

Stopcocks/Valves.

Crevices.

Fittings with very close tolerances.

Clamps that cannot be fully opened for cleaning.

Small internal parts (e.g., springs, magnets, etc.) that may become soiled.

Ridges, articulations or grooves.

Rough, irregular, discontinuous surfaces that can entrap or retain soil.

Capillary gaps.

Luer locks.

Porous materials (smooth surfaces are desirable, where possible).

Junctions between insulating sheaths and activating mechanisms (as in certain laparoscopic instruments).

Dead-ended chambers.

Internal movable device components such as multiple cables.

Device features that may entrap debris that can later become aerosolized (e.g.,through application of power, etc.).

Devices with these or other design features that cannot be disassembled for reprocessing.

FDA认为上述两个表中的产品，可能会因不充分的再处理导致极高的感染风险，及影响产品性能。生产上述产品的器械厂商，在申请FDA 510(k)时，请遵循上述要求。