08/12/2022 | 16:10:48
Không có thiết bị y tế nào là không có rủi ro. Và, trong sản xuất thiết bị y tế, việc quản lý rủi ro cần đặc biệt được coi trọng. Những thất bại có thể gây nên những tác động sâu rộng đến sức khỏe và sự an toàn của người tiêu dùng, cũng như gây ra mối đe dọa hiện hữu đối với các công ty sản xuất.
ISO 14971 là gi? Tại sao doanh nghiệp sản xuất và cung ứng thiết bị y tế cần áp dụng?
Bạn không cần phải tìm kiếm xa để tìm ví dụ về các công ty thiết bị y tế bị FDA thu hồi loại I hoặc thu hồi tự nguyện. Vào năm 2019, Medtronic đã buộc phải thu hồi hơn 1.000 máy bơm insulin MiniMed của mình do rủi ro an ninh mạng trong đó tin tặc có thể chiếm quyền kiểm soát điều khiển từ xa của máy bơm này. Máy bơm insulin được sử dụng bởi những người mắc bệnh tiểu đường nhằm hỗ trợ người bệnh có thể tự sử dụng insulin trong lúc cần thiết. Theo FDA, người ta đã phát hiện ra rằng những người không được phép có thể truy cập và hướng dẫn máy bơm phân phối quá mức insulin, dẫn đến lượng đường trong máu thấp (hạ đường huyết), hoặc ngừng cung cấp insulin, dẫn đến lượng đường trong máu cao, nhiễm toan ceton do tiểu đường và thậm chí tử vong. Vào tháng 4 năm 2021, Cordis thu hồi Hệ thống động mạch cảnh Hoa Kỳ Precise PRO Rx, một thiết bị dùng để điều trị cho những bệnh nhân bị hẹp động mạch cảnh. Việc thu hồi được thúc đẩy bởi nguy cơ tách biệt trong hệ thống phân phối, có thể gây đột quỵ. Đã có bảy khiếu nại về vấn đề này, trong đó có năm trường hợp bị thương được báo cáo, may mắn là không trường hợp tử vong nào được ghi nhận.
![Ảnh minh họa: hơn 1000 máy bơm insulin của Medtronic bị thu 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spHnrVW3cYq9E2QKQAsIx0pfKParC1JszQBRkiGOaqSx8GtWVKpyqPSgDJmGFz+FQYAq5drgHFU8cA+tAEsZq5AcjmqEZwatxNgigDThbFW42rPibOKvRGgCbcaZI1B6VSv5fLtZmz0U0AVNU1m0sITJcSjZ3wc4qKPV7eeFJUJKOMj3FeVXFwb67aGVmKbzuGeoroLaVyEVVIRRhV9qB2OzOoRt/Fj61FJqUaqSzjArCS3nc85VT0pl3o7zRMrTld3pQKxtwaxbzkiKVSR1+arK3OehU/jXHaX4YFqXaOdmZj3NaB0ect/x8sPYUBY6Yu4GeMfWo2uGHYVn29pKiBTMTj1NW0tl28vk07AK16F5JxTP7Tj7GkksVZetVmsUXoRVJICyNTjzjJzSnU0z0b8qrJaBGzgGiVAOi03FAWf7RQkdR+FKdQjXgtxVIReauMY96xbzSpGlJE7j6GiyA6Z9UgXhpAPrUP8AbdsGx5orl59DaZMNPJn1BqrH4XYy5N0+PrUtAdous2zA/vBke9KdYtv+egrnLbw5hSPPbPqamHhkH787fnSsFjcGs25bHmL+dSf2pDjO8Vzg8MIk27zyR6Zq0uiKBzIfzpDsbEmqwouS64qJdctC2PNUfWsS88PCddvnuB7GqUfhFFO43DnHvQFjqRrVtnHmCnHV7bPEoz9a5dvCo83ety/+7mn/APCMAZP2hs/WgLHRDWrbdgyqPqasLqMT8rIv51yyeFkLhmnY4960I9EVF4mOB2zQI2W1CNerj8DUceqQOSBIoPvWNc6KXA2zsOPWq0HhwRtua4Yk+9AHQHV7cMR5gJpf7Ytx1lXP1rmX8LhpS/2pwPTNI3hVdvN0+T3zQB0p1q2VwplXJ96nTUIn5Vx+dcgfCaF0P2l8Drz1rTt9GWEACViPrQBuvfxopLOKiGqwkZ3jH1rNn0oSoUMrDIrOHhwxkhblyp9TQB0LaxbLz5opv9t2oYBpRk965qbwwsmP9IkH41E3hMF1P2h+PegDrW1i2U5aUYpo1u1IJEoxXMy+Gcji5b86jHhgIMfaH596AOr/ALYtzjEgOac+qwou5pAF+tcsnh0rybhjipzpojVVLk/WgDpRqURAbzFIPv1qaO8Rx8rA1yJtGjtHBkyVJP4ZqCV5rILJE7YoA7uO4DCrMUwIrlNP1JZ4VcHqOfrWrb3I45p2A3UkqwjcVkRTZ71eikzikBeBzS1FGaloAWiiigAooooAKKKKACiiigAooooAKKKKACiiigAoooNAAajkPFPNV5G4NADJXCgk9qy5JPMc5Pyjv6U++kLOEU1SuH2Jtz7mgBlzNnhenYU+3gESGaXqORntTLWLzP3j8D0PasnW9T8wmCFsIOpHegBmr6obg7IjiEe/3qxmOeKGbLYp6Lk00Asce7FXYYDxS28YOOK0YYhxTAS3teK0ILYDBIqS3iGBV6JBgUmwI4YPYVbSCpI1XFSrgYxSAasQFSbMdqcD71Jn6UAMVMnpT9gzTgRS5oAYUHpTSntUtJQBAyZ7VC8VXSKYyigDKkhyaozwdcCt10HpVaaEelAHMXNr7Uthdm2IhlOY88E9q17mDmsq6t+DxmmA/WtOW+hLx481eQR3rG0bUDZz/ZrjPlE4Of4TW3p9yynyZD/umqHiHTt2bmBef4gKQFnV7UOgniO51GTjuPWs+1n5HNTaDfechtZiCyj5c9x6VWv4fst3xnY/IPpRcDctZs8dq1beQYrlrWbnrW1aS5A5p2A3I2yBVlDxWdDJwOauRtmkBI/IqrOOKtnmoJl4oAy7pcqazR0x6VrTgbTWWg+Zh70AMHXNWYz0qsc7jU0PagDRhPSr8bYxWdAR3q7Cw70AWGJ21h+IZSlhIB34rZc8Vga+dyxqO+aAPMbODdqjIOCCWJ+tdtBYlbRXA5HSue0+Nf7bl4BOc5rvLVVa2UDtU3K6GRDFdyJlyQM0/wCyy7fmJNdNbpE9uuAMjg0pgQj5gMVQmcwqTJ93IqVEmP8AEa6BbePOAAaVLZC2OKLCOcZbkdCajzcA966praL2qJ7WMt0GKaCxzZluAR15pCZSclq3pLVPQVFJax+lUgsYpeQfxGqtxPNnAY1uPaIaiazTHIGadgMQ3M23AzmnRzysuHB+tbC2kY6gVJHZoewoAyoywI5NO2Ss4IyK3EtIwB8oqZLeMduaGBjRxygc1Nsk21srAh6in+THipYHNuk2eppuyc9zXTNBGV6Uz7PF7VIHOhJvWgLN710P2eMinC2ix05pjOaUXGTu49PenbJcdSM10YtovQGl+zQ+gpC1Ob2z+pxRtnyOtdF5MQ4pRbxnoKAOe2zH1pu2X3FdH9njo+zxelAHN7ZfejbNxXSfZ4vSj7NH7U7Dsc4VlHrQRNya6I28XtR9miPpT0EcwTPnqaD53Uk10DW0Q44pv2eLnNFkBh/vMcE00ebnBzW95EQFH2eLOeKLIDCxJ70oEnvW35EeegpGgTtRZAYh8z3pjRuRzW55EdI0MWKLAczIGa2m5BOOlR6iv/Euyw5C5rTuI44vPjUAEDOPrVC+IbS3GeiVIHPeH7nHmrnjORXS21znHNcNosg3z4OT/wDXrorOfpzVAdjaSAgVq278CuYsZsjrW5aPkDmkwNqM8VOnNUoWziridaQElFFFABRRRQAUUUUAFFFFABRRRQAUUUUAFFFFABQaKRjigBjmqV1J5akntVmVuKyNRkJYIOe9AFct8rSGqiAyy47DqakuH4VF/GmzzJY2jSHG8/dB9aAKmu34t4jBEfnI+YjsK5aST5utSzvLczFgGdyewzU1vol7cMDsCKe7UwKaZ6mr1uucVrW/hsgYmlyR2FaEOhwIP480XAyrdcVpQjpVxNMiTpmpVs1HQn8qGwGRnFWo3HFRfZfc/lSiF16GkBZElSrJVELKD0zQZGU8qRQBpCUdqXzc1nLN6mn+b3zQBpLJxT1cetZyS8VKstAF4MO1PBqmko71IsmaALGaCKjV6eDmgBpGTTJEzU1NIzQBRlj46VQnhyOlbMicVVmjoA5u4g2tkdQeKt28izxbW5OPmFT3MOe1Z3MM24Zx0ND1AxdUtGsLwTRcITuUj+VaVwF1DThIn3sZ+hq9dQJeWxjP3SMg+hrM0UtDLNaydQcigDMt5MHnr6Vs2U3A5rJ1GE218wA+VuRVi0fpmmgOntpM4wa04GrAs5Ola9u3SkBpjBFRyjg0IaH70AUJ14NY8Yy7fWti44BrKT+I+9AETDk1LF2pj4FOiPFDAvQCrkdUYetX4ulAD3PFYmrcsnrmtp/u1iakAWDe/wDSgR50l0kPiW4VmxXe6bexta4DcgZrx3XZWTxncBWwAK6Pw5czNuG4nHFSX0PRbS7YAkHIzU73pA71lWkmEAPWnSycZzVoTZafUWXNLa6qjTbJZVjwM5Y9axpHwTXOeLZJY7OSW3OJlQ7T6GmxHpkdwjj5bmI596c0i5/16Z+tfO1j4k8QRRgHUH49ulWv+Ew19Tj+0GP4Vk523KPemY/89k56c1ExYnHnR/nXhJ8ba8B/x/kfWox4017tqS/n/wDXpe0QaHuzbs486PP1prKx+7JH+deGt4y1/vqQ+uaE8Y+ICcLqO76VXtUF0e57WGMSx/nSqkgz+9jx9a8OHi7xH/z/AJBobxj4h/i1Aj0J4zR7RCue6jzMfLKhP1px80dJY68Jbxf4jGP+Ji2DTf8AhMPEp6alIKTqoLnvSmbPEyEetNZpuP30WfrXgh8XeJTwNVbd6d6hbxZ4mz/yFyrHopPP5UvaRC576zXPI8+HH1/+tTALt+lxEPx/+tXgR8UeKweNYk/Kox4r8UMcDWyW9Ac/1pqaC59BhbzP+vh/P/61N3XecefF+dfP7+K/FQIB1wqfQnk/rR/wlHizPOsNn1Io9oguj34Nehv9fFj60okujn99F+f/ANavn4+KfFuedZ5H+fWnf8JT4v8A+gr+n/16FNDue+F7rfjzotueuaUyXnOJ4vbJrwMeKfF3/QU/8dP+NH/CU+LlGP7SGD/sn/GnzoVz3wvfAcTQE/X/AOtTTPegjM0P5/8A1q8EPizxcv3tUQD6f/Xph8W+LM/8haLH+fel7RBdHvrXF6OksJH1/wDrU4T3ecGWLH1/+tXgC+LvFqn5dVhP4f8A16evjHxeRj+04mJ7Y/8Ar0vaILnvaT3hLfvoPbn/AOtTvOucZaa3A7fN3/KvAv8AhL/GHa9iz/un/GpdP8R6zf3UKanMhkEmxigIyD+NWpJgeznVmZirEbgcHac0LqT89a8G1v4nX+k37Wen28CpGcMzgksfXrUMPxg1fd+8tbZh7D/69aKLEz6AGpPk5JzTv7RavDIfjJL8pn02N/XBxWxZ/GLSmIF1YTx57qc/0oswPXTqBxnmlXUD3Jrz+y+I3hu9wFvGhb0kU10NlqNpfLvsrqGdf9hwT+VFmBv/AG49iTTXvTjnIrNV8Z5wfSlkfAGTzQK5Qv76UXE2OrjrUV7e+XZGMjJkj4qK6dWuZA3XFZetzbPIAJPy1DGZOjttvpI92C/GfxroY8xTGMnoa5G1Km+O+Qxr1LA4xzXVNNHLKjwyCVGUYbOc00wOh0+TGOa6Kyf7pNcnpz9K6SwfOKGgOht3BxWhHzisq2bgVpRHgUgLI60Ui9KWgAooooAKKKKACiiigAooooAKKKKACiig0AIaZI3FObpUMrYFAEMzDkNxWPI+6V37Dmrt9LhD2z0rMXdsIHfrSuAyAbnLN0NNuLJLqYPKSyr0XNOuJo7WAu3PpXMahq1zLkI5jXpheKdgOlaXT9PGWaNT3A5NZ03iiIZFtCze5rlHBZsklj6nrT4oyexppAdD/wAJDeS/cCIKempXch5lIz6CsqCI46VowwnjinYC2l1MxGZGP41YE8oH+sb86rpFx0qURnFAEwupAPvtUi3ko/jqAR8UoTHagC2moSLjIBqZNQVvvpis/YaNp70aAayy28vcZ9O9K0GcmNvwNZODUkdzLGQEbj0NSwLreZGPmBA9aVZQMc02K+RhtlBHuORUzQxyLuX5f9pTkUAPWUVMkwArOkSWLlh8vYilSU8UAayScVMristJTViOQmgDQV6eDVNJOMVPG/FAErLmonQHpT85NBoAoTxZFZd3Dwa3ZE71SuIwc0AYtvJ5ZMTnr0pssOLuOdPvjhvcVNeQ7eR2pqS70Bbr3pMDO8RR/uo3A6HGazLZuRW5qiCWykPXHNYEHUZqogb1m/Tmtq2bgVztm3Nbdo3ApAbETGnvyKgiY4FSM3FAFS7YCJqy0BC49eauX7cBR35qscKPekBA/Jp0QwRTW4NSQ9aYF2Ac1di6VTh6Vci7UAOb7tc/rTtGRx8vUfWugl+7WDrq5hDf3TQB4nrYJ8TXc5HBOBWx4emdJkXnlhU99p6vfXDuP4iafpFt/p0IAyN1FrjO2jYjPTNEz8c01sK747VXlfir6CGStWH4jJNlM24YVORWs5yawPFLkWMijuhyaTGjhosfZyR0OT+tZc8uxXcqW2gnaOprRt8/Zhnpj+tZtwwLsOgNcd9RvY5y51CSd1G7aW6Z6L/9eoftJ2FgMhOMZ5Y+9a8mmQ3fMbKpzlh1B/D1qT+w2DbleIEDC8c/jVcyM7MxJLp1jPILNyCCcAegq7YXZiiuHw5d4xgr0B3Dk1eXQB5WzdEVzk8fyqaCxjtTKkk8aRypswDjuD/SlzImzRrWjZgR5MHCBjVC2to7tFubndIZCcLuICj04q3HJbrGFE6EYxkt2qnH5tmWS2nt3hJ3KGYfLU3ZoSWY+zXslqpZ4mXzE3HJX2/WtDgc4/Cs+zQCR5rq4iknfj5TwB6CrZnjBIaWMNnGN1TewFe8H+m2MqALJv2tz1HNVp4Ektr6dsGdZG2vuPyjsKtTmOeS3ZJ4wYm3EZ69aqy27N50cd3CttKxd1b73PXnNCYGgpUoqAjzGjyR+HWs608mBY4pYHS66GU/dJ9K0VxlDG6Mirt6ZP51Xlt7mdwJrhDArhwoGCMdOaYDL827s8fkvLcBdu5Oin3qG9sru5hto45ApiUE5OMt7/rVj7Lcx3Er21zGqSsGZWXn+ftVwYBJ3A7utF7BYw20q7kulkZwo3hyAx5roFjCr6mmK6liNykjqAelAmTdtEiE+gbmhyvsBla9Jf2xSW1ceSx27cDg1p6aJ/sy/bGDTHk8dKZe7ZYdjyKg3BuT6U8XET5CyI2B2NK4GX4lbH2fHQbj1xmubN03kI3GCxH3jXU6hEl+I/Llj/d9RnINZ66PaufLWSE7TuwCM1cWQ0zHNxsndQMgKDncamtLuWMW1xgb2kKH5jgjitf+xIzkkRlyMZ9qkh0iGJ4wQhhQlgnue9NzQ0jXtn3ADAI61Hb4OtRrkAl6fAMH5eBVe0VW8Qwq33WYc06e9yjgvF426/cDIIz2rKiXcTg81reLFx4guhxw3FZa8NkfmK7Y7AOCHkd66Dw34N1rxAGfTLN5Il6yHhai8F6Dc+Jdft7C1BO5gZGx91e5/LNfWFjpqaPpkGnaegjhiUAj1Pc0N2A+TvEPhjVfD0wi1S1eFj0YjIP41n6fqV3YTCS0uJYXU5+Vj/KvrDxVoKeJtCn067CmbBaB/wC63avlHVrKTTdSuLW4UrNE5RhihO4Hr/w++IY1GaPT9aKpcNxHN0Dexr0l5MjrXyZEzLIGQ4YHII7V758PvEJ1rRE85t1xB8kh9felLRiNm+lxeSADsOazdaJEsGf7lWb9h9qc/SqmtyfvrfPPyVDQIwopPLuJG2eZ/setdPbSeZHA/wBn+zjZxGQBj8q5ASfv5Sp2nsfxrrIJFeG3/e+aQuGbrzSW4ze09uldLp56YrlbE8jFdLp56ZqwOltScVpQk8Vk2jcVqwc4qALi9KWkXpSigAooooAKKKKACiiigAooooAKKKKACkoPemM3FAA5A71TuXwCSeKllfjPasu6m8xiB90UAVrqTzD8xwoPFVZpip2r+NMu5iW2D7oqCVsB3PQDNSBQ1q53sEU8LWI2WJqzcuWYk1Ei57VogGRxZNX4bcntS20Oa1ra3xjIoegEMFscDIq/FBircEPy9KtRw+1K4FNIPapEh68VfEPtTlhxQ2BQ8o+lHlH0rQ8qjyaQFDyvamtDWiIvakaH2oAzTDUbR4rRMNMaEYp3AzGQ/SlikeE5RiKuvCMdKgeLHWi4Fu3vlchZAEY9+xp81osgLRna3b0NZbR9qlt7uS2IH3k/umhAOO+FsSAg1NFLz1q0hivI/l5HcHqKoXNu8B3L80fr6UgL8c2T1q0kuehrEhlyetXIpTQBrI+e9SqQRWfFJ61ZV+KAJyMiq0yDBqcHIpHAIoAyLqPIxisqQeUx9D2roLhM5rMuo+vFG4FVgJInA6FcVgBNrke9dAF2x5Hfisd0w5PvSiBLan5q2bRiBWPDw9atq3AqwNeBjtFSu3FVYWIFLMxCkdzU9AK053y+oFQStUvIVvXpVeVvSiIEJ5NWIuMVAvWrMQ5FNgXYeSKvRDpVSAdKuxDmkAko+WsbVk3W7/nW3KOKxNYfy7WRj6UAeU63etFdzKvUtR4cn36jGN3OeaxfEt0BfzeobFL4YuidUgIbgnt3qhnpUjfO+D3qu7FutSyYMz4oCA0xFKQ4NYPilj9imIH/ACzP8q6SWMCub8WsotZVHUxH+VJu4I4e15tVHUkf1rHvz8/pzWpZP/oy7fl4Oaz73nDEAc1xPcplPSclM5U8npnFaqZxis/S13R4Oc56kYzWonygEdDSZI3B61z3ilgptvXnn866XGAPfvXOeKhvNv8AJuxmiO4HPfMDkE56dae0hyitu49DTmRcruG008Kc8fhmtRWGxsTdLjevI43daZdtJ50gO9ju7mpUQGVCy5O7BOcCi4Qea4DDk8AHNILFbeVOdzKemAaBJMG+8ce5qQoQuGXnPXFBjUSDGef1phY6bw07Np5LE7g9a2TjrWT4dUrp53Hkv0rV9h1rGW4wLHbyKZyRgEjHcU5s+vNNKfKx3beOvp71IGFYF0fUgHY7AcN3qtbP+8sGUsGkLBmz161c0/7OL2UG53+blWyMBj7Gp2sYbOSBp5GdAxEUeMFSc/nWiaQFK6inktdqzC5YT/wnG0Zp9q0c32q2dPIdMbpIyeRx61o3dhBDZzbA0W0l2KtzmqKJamFFEzFrzo+ME47Y/Cno9QKsCMDPcWrukCRlQD/Ew71DZTbbqx2cSNxJjPP1rdTTHSIx+cxj27cbajg0hYmt2EhzF3x9760rgah4J780hHsaeowcnrQTwRnnFQ0BJbHAwaqwZHie2K8Zbv2q1b44GeaqQsf+EihwM45rWm9bAcR4r51+7P8At9fWqFrD50ix9Mnk+lW/E5H9v3RwQN9aPgfSm1nX7SxQEmZwDj+7XcnZAe9fBzQodE8OtqZjAuLkYUkc7f8AJrr3lkZicnJp06R2scNnAAsEC7VAqeSJEiUqNzqMup9KjfUCuTLbyK5BDA5ryL4+eHUU22vWUQ2zDZcYHQ+v8q9mG14x8xaM8EH+H3rK1/TE1Xw/qOmTgMXjJT6jkfypp2A+QioxjtXoPwhuTHqV3CzfKyA4rg7uF7S4mtpVIkico31BrrPhjJjXZB/ej/xq3sB6tM3mTyH8qp6wcm23ddtWYCC7MSOneq+tEAwL32VlcLWOakbb55AJIGQPxrp9Fulu9LtZBA0J24ZWHf1rlkY+bMBjOO/1rr7F7h7K2F0ioQMLt7j1pLcDcsDgiul089K5ewPIzXTadn5aoDo7StaA9KyLOtaHtUgXUPFOpkdPoAKKKKACiiigAooooAKKKKACg0UhoAQ8CoJGqRzVS5k8tGY9hQBTv58ZRTz3qjK+1DnOacpLkuT71Su5OSM0AMdQWzVbUj5dhK3c8CrpGQMf3aztaO3Th7sKlIDALEmrVuuTVReWFaNoucVaA0LOHpxW1bw5AqlZx8Ctq3TgcUMCWGDA6VaSHA5FPiXirATgUgIRFntThFmpgooxQBD5VHlVPijFAEHlU0x5qzijAoApmKmNDx0q8VFMKZ6UAZzwnHSoHh9q1GT06VC0WaAMl4faq0kRGcitl4eKrSw+1AGUrPC4aMkGtS1ukuAUkwsnoehqtLCBVR0KnIzxT0YF67siv7yEdOq1UjlweetXLO+ORHMeezf40t9ZByZIuHxkgdDQwGwzDHWrkcuaxY2weeCOuauQy80gNiN6m3ZArOilyBVpHoAdIoxVC4TOa0GPFU56EBmqoA5HAyayrtcSH0bkVrngMT0AJrPuELQbv7ppdQZWjGDxV+BuAazEfmrcLgcVYI14pOlSu3yFsewqlE28qo6k4q5NhcgdFGBUNjRVkbHBqu5yae78ds1CeaewiSMZNXYl4BFVYlq/brwKALMIJxxVyMYqCFeQatovGaAI5RWRqcAnt3jJxnvWzIDVG4HJoA81vfCdrHcXNzcgSkjKD0rznw8dniQKuQqyYAHavb9aGLSYjsprxrw/GP8AhJQTkEyGqGj0vdl3PfNSociocYkkAx15qZOlAiGYDBrlPF+fs8mP+eR4/Cuqn71ynixgLaTIOTE38qBo4WzOLZBgHgj9ao6gsuY9jKq89RnJ7Vo2CL9mTJ4IJ4+tUNYuY7cKzsFHOM1xtO42U9LWfbgsOD35q+fOCHMsY69eOawdH1ZB5yyKFAyVxzmp4S+tXQxvjtU6t0pOJJZkma1n+0G43W9xnHGdnpVLXJEkeEO/mqFz8nGDW6lnClotttDRDrnqayNTsIbeBik2wv8Awt3+lKO4GXvg3LuhfjHemK1vzlHBI659/wDColcspw2TSpwCDitQLEZi8xcoxXd0J7dqWX7OZXHluOe1QwkeahDHr25Na8GbYSvcQPIZflQEYP40gMj90B0Zjgjk988fpS7rfJ3I4HbnpTHx5jfwEcFfSowSFJU5B7mmB0GjAtYqbQ7VDEPvHU+oq8izgjcyE8ZwPzqv4fYvp6/7xzgVHctdXlw6ae6osXDMe5rJrXUC+FuDj506enepgSVIbjjn+tUtN1CO5gCuQkynaynufatB0ypBH3hg0rAc/HFFf3sRiCR2sD5DbgCzf5xVLXHnGp2zyhhtk+UZwGHtU2qy2WkyLHbxl3U7mUscA1tvBBfQWk1ymNg8wZP3aeoD71y1hcsykbomJX04rlLZpzJo28DZlvL/APHq19S16EM0VtF5+7IYdOKbpE+nXkdqgBjmhJKKTwp54qk7AUpL643zXYlPmx3OwR+oye34U67u5o7zVgsmAqAoOn5Vd1d9Ns7vzJIy10fmCjpntkVnnU7S7uQ2o2phbjay/wAX1p2C5LNPdTvZ2kL7XuIQST2PFbeni4S0CXZBlU4B9R605ba2mmgu0ALRphCvTFTODg8VLfYCe2+9Va3cL4lhbt0Iqa2/1gGetQQ/8jHCuD1FVT+IcThfEx3a7eEDjf0r1b9njSRJfXmryJ8lsuxD7n/9VeTeI8DXLznP7z+lfRnwgs10/wCHkDJw9y5diPqf8a7rqwjs/LHE0zcE5UDqaBMwn8zB2njGO1Rw3MZiCSqWKn5aDePk/dCemKgCwqiOSRcgIyHFMkfyp4m7FcH86hmuvNQAqFK96pySEnqc0AfP/wAZ9IGmeOLpowVhuVEy8cHPJ/nWT8P5/J13djPyEfzr074/2Al0vStR/jUmJj+X+FeT+Ej5erAhsEg0qkmqbaHFXZ69aSiRHYDmjXR81qw6+WKoabcL5R3EZPFXNelUSWi4x+7rKk24JsqSs7HOD/WXHpj+tdlYrILC1MkgkBXK+w9K49Cvl3RHUL/Wur0jy/7LtWiZjuXLAn7prVEs3rDqK6bTv4a5mx6ium0/+GqEdFZVrQ1kWRrXg5xUAXI+lPpkdPoAKKKKACiiigAooooAKKKKAA0nelNMagCKVsdelZGpyHKxqfc1pztgc9KwZX826Y9hSbAH+WMd6ybt8tz61pXL4H0rHuTkk1aA0hkKPTbWZr3NgvHRsVpA5jX/AHaoayu7Tz7NmoTswOfi6itazHSs6JenFatmORVgbdkOBWzbjpWPZVs23apAvRjgVOBxUMfQVMKACiiigAooooAKKKKACiiigBCKYy1JSYoAgKZqGSPrV0jNMZBigDMliNU5YTWxInWq0sdAGLLEenQVPZXLIRFMcp2PpViWHNU5o9vagCxe2vmDzI8bv51nq5U4PBHWrdrcmM7JOVPQ+lPu7ZZPnThv50ARwy81fjlyBzWKrFTyMVchloA1Q4I61DOwwaiWTIqOV8kDPWgCGUlYnJ7iqoAkhZR3FT6g+2FR/eNVbBt28Z6UW0AyC2HqxFKARVW9/d3MiDsaLcmSRUTO5jgU09AOi0vqZcZA4H1ou5sts7DrViTbZWPH8AwPdqxFlLZLHJJzUxXM7gWWbPSnp0qCM5NWYRnFWwLMC1fhU4qvCoyK0IV6VIEsQIHNWU6VGi1MOBQBHJ0qncLyavP0qpcd8UAcL401y20lFt5lJmnUhRXnGgxltfjbpl810PxdQHXNGz2J/HpWXoyEa7HtwBmrWwHYkDzpOc/NU6Djio0X97JwB81TfwnFSwKs/euY8WrjTp3I48sjP4V1MqHFcZ4ouLiW1vVMYS2QFQc8s1Fxo5DTFH2dT7VmeILW2nMf2kA4zjnFa2kjdbjPYf1rO1mJTIpKhuvWuRvUbMiygtZ4VSQqQrcEfKa6CBYVX5SijHrWLpccZz+75LZy/X9K14oogCrIOfc1LbJJiUI/1i56cn0rH1dwLm3QRi43Agop5781sGOL/nmOpOPr1rC8SkW720kBEb4IyOtEVqBg+UUndVR12kgjGcUbHVifLb15WtGDWlijXzIcyHG9sD5h/jUzyJqpDW8nlOuAyt6ZzWl7AVNPtXuZwyrt8s7mJ4qXUr66mu9y5URkEL15qS7e5ssW6lGikYHzD1PscVmz3DtPJ+879VHHFJasDbQWuoW7T3duUaIckHlvU4+tZN7ZBblDa+YYpQCq7elQrPLt/wBbu7Y/Wrdvqs8A2kK3fLD+VFragaWmTpYRLbXrbJScge1SaIoWe8Uvgl+CeM9abpkcWo20ktwu+QnGfT6VoW1nHBCEwZCCDuPXI6VEpagMa0tGnjnZU3p0KsAD71dYjG5SOeQRVdreIptCDGMYyelSRqqqEUbVHGKVwOY8aWkQtoZ412yuzBj68CtiPA0AE8jyKo+OBt063P8ADvbj8q0bf5vDylh/yw6VfREp2ZzvgmNG8+SRQXAG0n05qvcwJD4vRYuE8wHGO+Kt+CmVvtKcA4GB+dQ3skZ8WJsw3zjkd+KdtW0NPQXxRA9vrkd26b7YkZXpnFJ4mu7S/jt4bSPdJ0DdMe1HiZ2l15rYv8mQBnouaTX9Mh0yCGWCUFz/AA9z7imuhDdmdPplsbawghlADovOO1WQ6PHvUghuhHesmy1GOPSbeW7dt0gIzjrS6BewTWUVsh/eouSuOlRylo1oAN49e1VbV/8AiqoAwPY8VaiwXX61Uibb4qjC9BjmrpL3ikcH4kbOuXuMbfM4I+ldx4E+KN74c01dOubdLyzU5UHgr9DXC+ID/wATu9JHAfiqC9Mn7tdiEfRFp8X/AA5NzcWNzCxHODuH8q0R8TPCLKC1xcLntsPFfNG89ulP38dvxpuKYH0hJ8TvCKAlZriRh/DsP+FZd18YNAgybbTrid+xY7R/KvAWYg8AUm7PrS5LBodt8QPHl74taOKSNbeziyUiQ9/U1zvh9mW9Xu2D0rKGc1oaLzd8HBwaVSK5GVDdHpelBnt1Zzt71s+IT++sz6wjFYOlqVs4+d2RzjtW14kUlrMg8CIVjT+FIuppI521nBkvUPULn9RXa6PH5emWjbs+YucY6V53YI/2m8Ygnjj8xXo2jed/Y9iZ1QMVwAvpxWiM2rG9YdRXTad/DXNWPUV0unfw1QjoLTtWvb9RWTadq17fqKgC5H3p9MTvT6ACiiigAooooAKKKKACiiigAqJzwalqCU4zQBUu2xGx9BWLb9WYitTUGxC1ZsfENFrgVbk8GsyccVo3HNUJhwcU0Bc5FuHHZahulE+nvt5+XIqxCN1mvptNRaYQ8LRtxtOD9KkDn4sjGa07Q8iqdxF5F06HoDkVYtzyMVaA3rTpWzbHIFYNo9bVq/AqbAacfQVOOlVozkVYU8UALRRRQAUUUUAFFFFABRRRQAUUUUAFIRS0UARsPaopEzVg0hGetAFF0A7VSmiBPArWkSq0seKAMWaLBPFOtZ9jBJOU7H0q7NFnJqlLCBzQAt3BuG5ev86oo7K2DxV2CXBKSfd7H0pt1a713J98frQBGJcCpbdjIxPpWYXYcE4I4rVswIrbe3XG407XAo6vLibZn7oxVbSpM3Dr6iq13OZXZz1Y5pNJf/Tl9xijoBHrqlL04/iGa0fC9phWu5f92PP86i1q2a4urdIwctxVzULhdOsEROu3ag/rSu7Ayvrd8JrgQxt8kfX3aqkJz1NZ0JJPXJPJJ71ft6pKwF+Bc1fgTgVUtVzitS3T5akCeBMmr8S8CoIl44q5GuBQBIg4p1A4oNACP92qc/Wrbn5aqXHegDgfH3h59Wkt7qOQJJbZIB6H/OK4zRSf7eQMcYbH6V6xqhDQSL1yK8k0jI8QDI6SGqQHYocyTezGrKcrxVdVxJN7tUisQtJoBX5Bya4bxVlbK7JAxvOK7dj61w3iiZXs7zJBCuaQ0ctpDYtWyaqX43HcBnBqO0uPLtzgglh0/Gqc8su7nkelczV2DF06B0JBQg5z65rRCtn7prKt55hIeDVwXUg7Gp5RFshweFNYfiW3lnW32RO7DPQdK0TdSdSDR9rl4o2A5J9PuwOYJRj1WkFrdBsi3mUeqiuw+2SDtmm/bJOy1SkwOVS3ufMXdHOADnlc4pJbS5MjsYJXVm4ITFdV9rkPRT+lKLhyen50uZgcpHZ3HRbeUH2WlNndD71tKR7rXVi5fGeM08XLccijmkBT8ORvHZYaNkO/OCK1cOOoqAXL+1Kbhz6VMlqBKVyOhNG0jnFQfaG55FNaZ8jJGPepswMbV9KvL24kzODDuyqHtVrR7O6tUljum8yIrhRnpV1p25PBFIJmOeQKvUDFm0GSOcS6bK0T8556D2p+laELeaOe4YvOCSR2z61rCU/3hmnGYgjLD8KNRFPVtIivyZMbZsYDDuazk0CaZwb6ctEowAp5HtW4Lgk8YJFNefPynFGo2rifZYDaC1KgwgcD+tJp9nDYQeXF8zk5Zz1NL5pHYU3zm6kCjUC2uN2RwRVO2BbxRFtzggdaDOQ3JHNGkyM3iWExqHIUdK0hpqNHHajam88US2xbaJJsZHPatNPCQe9WFblo4Cr4aZNrBgeBjPfmsvUrprTxPPdKoLpKSAfXFTW3ifULYSmJ8yyS+azsMk9ePpzXWtgZNF4bzpBu5JXjcBicp8gwM4J9arLoDtplrdmVczSbWi7ovPzf59asXnii4uEkSSGPyJAQ8QzgkjrRH4svFXynjia22BRHjgYx/hT1EDeHopriaOyu/NWFmSQMuCCPx6Gmf2DHlYPPka6DKJAqZSPJxyc++aSXxIRNI9raRwLIWaQAnLk9+tSQeJ2QFmtITcsu1pucsM5GeetADrvwxPb32pQPMgSyj8zzOz+gH1rN0Qhb8cdj1q/c+Krm6gaJ4kAKupPdgTxn6VS0T/j8yvJweKio3ysuHxI9J04AWanoCO1a+vfM1qccCOsbSyWsY2zlvf61ta8GK22zG7yxWNLZF1dzmLNR/prdPl5/Ouy0Ewto9oIZzMAvJJzg+lcfCjNHerkA7cfrXR+DbdbfRIgr7yzEnjpWq3M2djY9RXS6cfu1zNh2rpdOHSmSdFadq1rftWTadq1rftUgXU70+mJ3p9ABRRRQAUUUUAFFFFABRRRQAHpVeU9asHpVWXpQBl6i2YzVQ/6kVbvxmJqpN/qhTQFOY5OKqt0NWpetQFeKdwLFp/x7AehxVCFvs+psh+6xrQseUdT25rP1iMrOsq9WqeoEmt2+6ITKMleGxWZA+CMHNdBZyrc2uTzxtYVhXtsbO6K/wnlTTT1A07OStu0fIHNczaPjGa27OTpzTYHQQtxVlGrOt5OKuowPepAs0UwHNPoAKKKKACiiigAooooAKKKKACiiigAoxRRQAhAzUMq+1T01hQBRkXrxVWaIEVpuuaruhoAxZ48A+tLbT4/dyHHoauXEdZtymOnHvQA68s/NZSuA+cn3qLWrkQWYiU4d/wCVW7UtJADIOemaztZsnnG9M71HA9RQtAOfkk6ipNKl/wCJlBk9TVGYkMVIIfoR3FdN4e0oxJ9onT94w+VT/Om9gNUhFEkjnAUH5vQVx2p3pvbwsT8i/Ko9q2fFFyyWqRK2Nxw2O9cxHywpRAuW/WtO2XkVRt1yRWtax9KsC/aryOK1oE+XNU7VOlacK8VHUCaIcdKsoMCo4x0qUcUALTSaGOPSonfigAdqo3kyxIzucKOtQa1fGys2lUAsD3rh/EOvXMloxZgqjngUAdHNdxzxt5bAgV5npg26+Sc58w02DWJ4p3kibKyDBHrTdLy1+Gbgs1UgOxTJklOf4qc7nHFEYGSM8UoUZoBkLMSODiuEk8P3w1vUZXPmW8/3VLHA69q72QAis3U5WggldCdwjYgjscUAjza50l7STYLWPIPI8w5qP7IWyGtEI9pDXmGpanfT308kl1MzF253e9VftlyxwbiUN67qXIgPWhbEKMWif9/DQYXU4Fmpz/t15hYjUbuZYbVrmWUnhI8sf0rv9I+Ffi/UI1keUWqNz+9kGfyzRyoC40D45tFx/wBdDTDEy9bLt2c1buPg14oWPMWqQSMP4d2P61xfiTwp4o8Pbmv4rnyunmRnev6dKaii9DqFidhzabR/v0NEccWuR6h68sa7ulHNzLn2NNN/dDpcy/nRyLsTc9RVCD/x7HJ6fPTFjfqbY5Pbea8xa/uiARcS5/3qBf3ZAH2mX86ORBc9MEb7WP2YH0w9II5P+fTnr96vNPtt5kAXMvHvW3oWna/rk4i0xbudj/Eudv4npRyCO0toTcRb/ss27ONqmlnt5IiMW0m09ycVLZfCXxjPGGluo4M9FaQE/wA6j1D4V+MrWMssy3IHZJBn+dHIgKZEjH/j0Ydz85pp3leLSTH++a43V4tY0u5aG/F3BKOCHBGfpxzWcb26A/4+Jce5pqKA9D2HbuFs30MhqWPzCB/oJOe26vODfXJGDcS/nT01C8HS5l/OjlTA9I2Snj7CR/wKonSboLEgjvurl9CsvEmtyqmli8mP99QQo/HGK7SD4Z+NJk3T3sMLHnEky5/nTVMV0UlhnOc2h4P940xbeVwS1k6j/fOak1PwB41soi6v9qjXqYZQT+lcReXmsWc7RXctzDKpwVcFT+tHJYenQ7BbaZuPsUh+shp7WbgqBZykn/poa4Uaxfg5F3KD9aQazqBOftcv50uUDtpbOTaCbSRTnvIa09DuIdDEtxPFHGjfeZ2yfwJrzM6rfNuzdSn8ailupp1xNK7j0Jo5UBLqd0LzUrmcYAkcsBUC5LdeDTY0OK9a8BfClte0qLUtSvPssEv3EUckeuap6AeTkHPSl25HIr6a034SeFrZczJNcZ7uwx/KtaP4e+C4UCjTUb3PNLmA+TdhFN2kEg19W3Hw88GynjTVAHpxWDqPwi8N3IP2O4ntnPbcCB+lPmQNHzljANa3h9A12wJx8pPBrpPiH4AufCDwym4W4s5jhJQOh965zQlxdu2cYQmlPWJUdGek6JGp06MjOMHk/Wt7VkB+zDAI8odK5Xw9dk6amc8E8/jXeG3F5YeYMbo4QQR+NYxVkhyldnE2sRb7YiDLEcfnXVaNbTW2l2yThQTlsLXKxBil9jOSvGPqK6nRfNbSbMTqVcJ0PXHFWkI6Gx7V0unD7tc1Y9RXTad/DTJOgshnFa8AxismyHNa0HapAuJ0NPpkfSn0AFFFFABRRRQAUUUUAFFFFACN0qvL0qw3Sq8vSgDMvOUYVnt/qxWlccgis/A2OvpQBRk60ypJKiPWmgJLNglxg/xcUurxFrUnuh/SomOGBHatBgJ4QB/GuPxpPcDndPufstzkn923DD0rcvLdLy2wME9Uaudu49jsD2OKt6PqRgcRTf6o9+4oAgXdDKY3BDCta0l6VNqNktyoli+9jgj+Ksy3Zkba+QRQB01vJV+N+BzWBby+9akEucUAasbcVKGqjHJyKsq+cUATg0tMDDNONAC0UCgUAFFFFABRRRQAUUUUAFFFFABQaKKAG45qGQVPUT4HWgCjOOKzpY974PTvWlcMMGqJxGpkk5A7UAVNTn+zWxRMB2/QVS03VBIRBcff6Kaiu/MvZvlGWPAPpV/TtJjt8STYeTrk9qAFeytmvEneIEj070t9qix3kdnCMyOOW9B7VTv9fs4L0QqNw6M46CryRw3KpcKqv/dYdRSYHOeJm2eSvc5NZMByRWp4uilE8TqhaEDG4VkQcEVSA17QZIrbtFBxWLaHpzW3ZEU0Br2wHFaUajFZtsRwa0YnqQJ14pXbimeZ9KillA5P40ALI/pVaWcc4PNRSzM2ey9qrSkkfN+lAHP+NdRSLTjCxPmNyK4nX5D/AGRO2ekQb+VX/iHPi+gRFDDaQxPaqF+jTWEyEZHkf0q0gOT0m+FxYQzAfKy1u6ddRLMr+hrhvA4mRLiylJMKOSnPT2rsrawKSYPGaGNncWMizJuU8HmrZwfrXHwy3MOUjY4HpVa71fVoW/dKXXikI7faMHmszWE/0SfviNv5Vx8viPWQvEe057jp71Qu/FOoNBJESGZlIPHFAHiV2T9qmP8A00b+ZrY8I+HrrxLrEFhYqd7nlscKPU1jzkm6lOern+dfSHwO0KPSfCraq6D7XeHCseu3/JqgOn8IeFNK8J2qQ2UCSXZH7ydxkk/j0redtxPmSlvpVYk8hQfemZPp1qdwLPyYyrMD9aWRw8TRXCJPCwwUYA02ztnnYhCAB1q3/Z8m3AdaAPC/i38NYILaTW/D0eIRzNbL/D7ivEioUkYr7YEPkyNb3S7opRtI7EGvlD4l6H/wjni29s0XEJbzI/8AdP8A9eqTA5E9acgyR/SgnvVzRrN9Q1S1tIvvzSrGPbJApiR3nwq+Hr+KLk3t+Gj0qE/M3TzD6Cvo7S7K00u0S20q3itrdRjIXk/j1qtpthBomkWemWihEijG4Du2Of1qwWeU7EycdqgZO5H8TsT65poyhykjA+5p2I4VBmIZv7gpxJuIGZIwCDwBQBj+INH0vxHaNaavboxYYWUDDKfXPWvmj4heDLnwpq5t5svbP80M3Zl9PrX1HNBcYyEbjvXPfEDRY/Engy7gZA13bDzIj3BHb9aa0A+Twvz4GB716b8M/Aceqwvq+ukwaVDzzx5n/wBauP8ADWkvrPiO009RgyyhWx2XPP6V7d42ukt5LPw7pykW1qoDIv8AG2K6aFF1Z8vTqY16qpRuSXHiF0thb6BDFpumoNokCjcw9a5q4uS7kyXl1K394yEf1qpqrXcMwiu43hYDhHXHFQ2dpeX0pS0glmfuEBNe5To06cdLHjzqTqO8jStdRu7Q+ZY6hOrg/dZiQfzrTludJ8Zwf2f4ht44L/pFeIMEntnFc1fWV5p8gS8t5YS3QOpGaedH1RlWRLG5I6j92eamtQo1VrZDpVasHoef+LvDt14b1eWzvVHByjjo69iKxNvAxXufjHTLnxB8P2uL63kj1PTOVLrgtH6fyrw5jzwK8KpDkk49j2oT543GkAdKQCnZAFIpHOOhrMdyUZOB0FfTvwf1BdT8A26k5a0cofzOP5V8vls4Ar2j9njWhHqF9pEjfLcJ5iA+o4/rQ9ho9nd3k4T7qjtThAm+IjJVutQxu8U5APOcY9anmn8htseM9SagYxogI2fvnCj1qlIrq4yMNWhHN5kZbaPMQZqnDma5BfJ7k+goEeVftBagqxaVpqnnaZWHp0x/OvIdNlMJmYc/Liui+LOtDV/Gt9IhzFA3kp+HH9K57TofMtLx8hSqjBP1quhS3Ox8M3XmabGpHPzdB716xpihtKcsMf6P278GvJ/DcawaXb5YDIbnPfNet6cQmiM2QWMHX8DUMHuef26SSNdRwj94T8vtyK6y2yVjDHlVA4rndBkB1C4CnBOefxrpbQcimJmxYryK6bTh0rnrBMkGumsFGBimBuWi1qQKOKzrUfKK04BjFQBaQYFOpF6UooAKKKKACiiigAooooAKKKKACq8w4NWKgloAzpl61QZQsvsa1JhWbcjByKTAzp12sfrUNXLxfusOhFVMVYCYzVyybdG0Z6r8wqoenFOicxyBh2PP0pAVtYt8OJF+63X61juhzxwa6+5gWaIqOQRkVzc8e1iMcjrSTAs6TqRtcRTZaInr6Vs3NpHdIJYsZPQiuWCH8q0NOvZbRsLyh6rTaAtqrROVYEHNaEEuO9Sxtb36Db97+73FQSWskRO3lRSAvxTdOauRyj1rDSRhjIx9atJNQBsJJ3qZXzWXFPxjNWFm5GDQBfDUoNVVk96kWXigCfNGai8ylD5oAloqPzKPMoAkoJqMyUnmUAS0VEZKYZPSgCctimlqgMnPNRvNg0AWHfFV5ZBjrULzHr2qBpC3HagBXbceelU5w07bR8sY61ac8YAz6nsKzr2/jiVlT526ewoAsEwWcJY7QP7xrm9a1qSdTFbExx9C3dqivriWc5kbIHQdqzZFzTsBnyjk85z611Hg0yJbyksShbABrAaHOcV1ekRC101CeoBY0SAuxX1ldzSWzlVkU4Kt0as++8OruMlm23vsPT8K5mfMk7ydCzE8VsaZrN1ahVdvNjHZuv50raACW81u+JUZfetO0fgc1oW+o2d+oVvkf0fpUj6dERuTKjtt6UALBJ0q9HIMVni1lj5X5hTwzr1GKANDzh61Xlk35GeKqPOACc/nThcxJCpdwu71oAnJ468VDO2FJFRC9t3BCTIce9ULjWLPzjAJQzjqBTSA4HxSftN8W7eYVrbs7AzFoyOGUL+G2s7VIoP7Rwrg7pNyrjpzXZ6eEjQlsZ3Dn/gNaXA8p0LR/J16/iGPLUnPHSte5SWykKSLlR0NWtGnibxfqisQQQePXrXV6rpUN3BHhlBK5qQOHtrvymZSobIzzVu2nheBSwGfpV1PDUxmJXBJBwaSz0GcQuD0ViM4pAU5kt5ImJUciuP1HRI5DJMsxChWwg9a9EGivtOW7VnPobC34HU8n0pgfMrIBeOh6+YQc/Wvrrw1GsHhTRYoxhRAh/QV8seJbFtM1+7glB3JJkfzr6Z8B341LwJpdwrZaJBGw9MACiWqA7g2qPGGXCvjrVIwrudMLgDJ9DUDaiW+XkJjoD1qBrklcY5zwD0pIDRsgtudw5V+AO4p62jGUN53Gemag0l/MkkLnLYwPalNlOZM+ZxnPWkwItcdvOiHIA714H+0jAq6/ps3G6S35x9TX0BqeJHhhUguDXzX8fdUj1DxobaJty2kYiJHr1/rRDcDy48ACu8+CtrHdeP9PWUAhNzjPqBmuHKg45rqPhlqQ0rxnpty5wnmCNj/AL3H9asD6tZfPvZSSQATn6VNbOHk8tE2rtyfU/Wq12xhuhJGTtf5gfapba5QtmQBXPGT0P1qQJfKjaYBlA4z1zS+TtfIDIoXcQD1qCaR45A3loF7EDg1LDM7jzMqiLxg9KAI3mVnj8ssDnBB6UyEBry4jYfIwORUkjRsQTIihTngdaoXd5HaWWo6jIcRRRs2aYHinwhs4v8Aha13gcQ+YUHboa6/w5am98d6rf3A3RWZZ2zzz2rzj4Ta3HbfEeK5mbat0zL+J4H869Z1jVLfwadTWALLqF5L5gRx8u3HWu3DN3ajq2cuJitG9kZvjt01vw3a65FFtdHKOMYOOKk1O6fwv4M0saYBHc3nzPMBlh1/wqvbeNbbVNF1HT9Xigt0aP8AdeUoA3YNR2Gr6Rrvh6DS9cnNrPbE+TN2Ir0IxlFKM1omcUnFtuL1aMy78Y3F9oUlhqESTz5BjuGAytdN8P8AXtQvbTVRdT+YLe3LR/KODg+1c7rU3h3TdEkstNdb6+lOTOVHyVD4H1m00uHVVu5dpngKR8dTg8Vc4RnSfLHqTGTjUXMzR8Jave60+sw6jcGaM2zgAgADkV4BIMOyjoOle2eFWGmeF/EWszHagiMSZ7kn/wCtXiTZyfXvXm41JVWo7I78K26d2MopQOM9qQEGuM6AHXit3wfrEmh+JbG/QkeU4Le696wsjPFSLkEUho+zHnjuIoLyAhopkDqR0p12gdFmB68Ee9ed/BLxEur+HW0a4f8A0uz5jBPLJ/kGvTLKW3SFo7jnB5FS9wsVlAhtt7fekGFA7CsPxTqqaB4V1HUHIEmwpED3Y8f1rfu2SeaOO3GQeBivCvjv4nS91CHRbFwbez/12D1f/JFNDPKGlaaWSWXJd2LMfUmrMUuy0mQfxkfoarKvzVKwYgIASOpIpsaOi024aPTLaME53k8/Wvb4ht8PSBT0ts/oa8P0yN3tbcBc7WwT6c17jAd2i3A9LTr+BqQe55V4Kvml1+aEtu5P869OtAMivHvAJz4vlx03NXsdn2oHI3dOAOK6WxQYGK57Thgiulse1BJs2wxjmtGIYAqhbjkYrSi6CpAmXpS0g4paACiiigAooooAKKKKACiiigAqNxUlNYcUAUpxzWZcqa15V4rPuF4oAzmG6MrVE8cVoMNpNU7qMq27saAI1PNBGf60gHFKKoC5ZSb0MZ+8vKmqmqW+T5qjjuKVGKNuXqK0sLcQ7v4SMEe9S0BzG32oxg+lXLq2aCXaenY1BiqAfAzIQyEqfUVtWupjaFuF/wCBCsZeB0qYDIFFgOgaGG5XchUn1X/Cq0lnKhymGWsyN3jYFGKn2NX4dTlH+sAceo4NTYBQzIfmyKnSbOOafHe20ow/B9GFP8iFxlcD3BoAFm461KsvvUBth/DJ+dHkSfwkGgC2JfelWX3qn5Mw/hNKI5s8qaALvm+9J5vvVYRyY6UeTJ6UAWfN96RpveoRBIe9Atznl6AJDJ70wz7R1pwth1JNB8iIZYqPqaAI/NZugJoCSHBYgCmNf2yNtjYu3oop3nl+Au3Pr1puwCFU5BJJqCe7jtm24DH0qrqGoJbgpEQ0nr6VhtMWYsxOTSA0Lu+lm+8do9BWdK2RTg+aNpPaqsBWKkimGDPatCODNSiD2oewGbDa75FX1NbN+3lWRRRyw2iltoAH3Y+6KZfKXYL2Wp3AwfJxxilSI9AKvNFTkh71QEMce3HH41oWtzPDjY5x6GmpD61OkPHFFkBowapx+9jGfVatre20g+9g/wC0KyBEQOlRupz0paAampNAbKVlK5A6g81RhFo8MTb5eQDyODWddKzRSICQWGM1v6XbraaVBEcTMqjnGe1IaIYobRmHAYdTiqTWVguoNIwYKwraypJbygnsFFc1NI02qSx3CypEPuHaBVIRzviOawa7gSxib7UGySQcY+tOu9ZuLSznnCHy413EE98YqLxPLb2U6vAdypx7596zr+Q3FjPCzoPMjOBnnpQB554a8RyXHiWW4LHdLkmvVDqzvGucnHfPtXhfg21KeJTFyShIOe1exRWzmEbQTzQVKyOj0zxAYViDLuw3OfSr8GvQD7UoU8tnFcvHbHau4FSDnFWI7dVu5cHggUEm82qArwvFQR36mFlbkEniq4jAQZ5FIsQ2dO9K4Hk/xi0KS42avZx5KfLNgdvX+VR/BHxkmmXj6PqT7LG6Pyux4R/8mvVLm3jlgkjkQPG42sp6EV4r458D3GkyvfaUrS6exydvWL2NNO+gH0NdQmFsg5jPIYcg1BknvXjfgP4r3GlQR6drsZu7JeFk/jQf1r1XTPFHhjVkD2eqxRk/wynBFO1gNJJGjb5SRT/tMzHCuxJ7VUm1HQ4VaSbWbUIPRq5PxH8U9B0eJk0ZTqF0Oj9EWi1wOj8X+I7fwjoc1/dOGvHUiCLPzFuxx6V8uSi61nVZHVXmuJ3LNgZ61tanea14513zH33F1IcCNfuIPb0FeheHPC0Ph222MwlvpB+9cdF9hRpDcDzmTwfepEfNeBH7KWH+NYl3ZXGnTqJlKODuQjofcGvWtasxgjaPUnFV7zQLfVdNSynPltjdFKex9PpRzoZ3/wAMPFMPizw7FbTSAanaKEKseXUcAj9K6VlZXIbg9we1fMPkax4M1pJAZLeeM7kkX7rj+or2Hwt8WtL1SNYPEafZbnoZ0Hysf6UNdhWPQo7hoiB95fQ9KkmuEMOyNCvOTVCDUdFuUVrXWLVlYZGWxUN9regabGZLzWLYAdVVsk0BYtokkzhVB5ry/wCOPi6G2sV8O6ZIryOQ1y6HOP8AZ/X9Kg8a/F1DbS2PhaMoHG03UnXHsOa8otdMvdUaS4Y/ISS88xOCfrTS7gZkM8ltcRTQuVljYMhHYg5FfQltPb/EbwhDcWrKNZs1CujHlsV4o+gjZ+5vrd2/u5/TpRoeqan4U1ZLq0doZV6qT8rj0PrWtObpyUobomcFUTizqriCa3neKdGjlU4KsORUJz3rtrLxl4U8YQKniKP+ztRxgzJ90n696sHwXpM/z2XiG0MR6bjzXtU8wpu3Nozy6mEqJ3Sujgcnp2rR0LR7rWr5Le1Ukn7z9lHck108nh7wxpIMmteIoWUc+XF1Nc14o+I0EVi2l+D7b7LaEFXuSB5jj69f1rOvmEErQ1Y6eEk37yshvxX121gs7bwzozhrW25uJF6SP3H6mvLTySexrZs9GvL2I3MhEUROTJMSM/40+TQ+P3F5BM4/hzj+lePOTcm2epGKirIwtpA9qNvpwKvXOm3duMywOo9cZBqoVIGP51IMjK9Kd6CgqSe+KOpxjmiwkzd8I67P4e1u2vrdiDGw3j1XuPyr6ksbiLWrCDUNNcSxzKGIB+6e4NfIAPUDrW1oniXWNFjK6dezQoeqBiR+VKxR9FePfECeEvD80xlU6jKCkEYPI9zXzDdTvc3Mk0rFpJGLMx65NW9U1S91a4M9/cy3Ex/idicfQVHYWct7OIrePe/cjoPc07JAMtoizcDgdzW/pV3aQQncis2eSaz70R26fZLdhKx4llHr6CoEhCoADz3pMaOw0bULcBwExubgYr023lZdL1DbwRafpg147ptu4gtnTOWJ5/GvZ0gI0a/Yg/NagfoakGeNfDkh/FkhHq3869nsh0rx74dQ7PFU5A6buPxr2KyPSgcjodO7V0tiMgVzundBXSWPRaZJs23GK0Y+1Z9uOBWhH2qAJsUUCigAooooAKKKKACiiigAooooAKRulLQelAEEgzVOdKvsOKqzLQBkzptPSoXj8xCD0P3far86c1Sb5GOfumgDMZWRyp6igHmtK5gEyAgjzAOMdxWYQQxDDBHFNAPqW1nMMo/uHqKgFKaYGpdW8dzF8v8AwE1hzwNC5Vhg/wA6vWd20DbW5jP6Vo3EMd5EM9f4WqQMBBxU6jOKSeB7disg5oQ8iqQEuKXYaWPrzUlAEO0jtQu5emRVgrkUnl1LYDVuZl6SH8akW+lHXYfwqIp1ppWnYC2uouOqj8Klj1Ud42/OswrTWBA4osBrf2qh/wCWbfnQ2qqOkRP41jtnFMJIosBrNqxA+WNQfeom1af+FlX6Cspm6VH87vtQEk9hTuBen1KZgS0rH2zVaLzrp9sYJJ7npVuz0eSUhrhsLn7tak0trpsGWIXHQDqaW4EdpZrbIWOC/dielZeq6yFzDaHkdW/wrO1PVprxyq5jiz0HU1m85FFgLAlLMcnJPWpUycVBGpJ5q9BETimA+JCT0q5DEepFOhh5FaMUPFFwII4MnpUhhx2q4qbVqOTrSbArhQq8jGKpyruJNXZjxjrVRutCAgEfFSRR5xxTlXJzVuKPNMBiQ57VYSA46VYhi4FWkh4qb3Az/KPpUMkR9K1/KqF4qNgMKeIgE4pYZiI8EkFa0LiHg1mzx7GzT3AHumU8Ek1DealKLdxgbscGopTjjNQS4ZG9+KFoBwOpSG4STzGLEnc2a1biJBFuCD/VcH04rOv7dotTmi/gZSRW5cRf6Izc8Q/0qrg3Y8f8ILu8YXPpk5/OvXYchAFOBXlHgdd/jG7zxjd0+tev28QZM0hy3BQWPPNK3Fyp9RVuO1Y4IqKWGQzqdpwKNhEy/cpy/dpypQqdakBki1TnRkLNEAQRgqejD3rR8ot0pDb7uMUgPPdd8EaDrBLRBtMuyckoPkJ+n/165O7+FesxsTZ3llcp/Dhwp/LNezTaesinKiqh0ds/uyy/Q1XMx3PFh8NPEhcK0Vso9TMP8a2NL+GAhZW13U49mc+VbjJ+mQTXp40mbo0jH6sakTSgnP8AFS5mDZjabp9lpdsbfRrZbeJuGc8u/wBTVk2+1MGtZbIjFMNmxJHNS9dQsc7e2Kyggjn1pPsIkt1QjkDityaycZ4zSRWxoA5W+jxAbbVLYXlmf4SPmX6GuS1HwFpl4TJo+pLbZPENz2P14r1iWy3ptcZB9qyrvwwl8BEp2sxyDTUmhnk8vw310H9wbWUD+JJRg/rUVx8PtWt4/OvZ7S3jXq7Sg4/DNew2egyWMbQO7kqcZBNYvjay8vR3RQWYnHzc1zrFT9py2NuSLje55jBZ6Pp7fOX1K4XoNu2MH8c5/Om3U0l44NywEY+5Ggwqj0xVgWMq5G3H4Un2F+ODiuvfcysinJDCRjYB7inRSBAIrqFbm1/unqPcGrTWLhgoGaVbGTIBHXtTvYNCqdA0++OdO1BbZj/yyuR0/Hio/wDhDdTA+S4spF9VuVA/nV6TTWZsbOfWnrp0gX7jHPoxFO7E4pmePB06/PeajY26d8SCRvyBqxFbaRp+DbxvqF0OBJKMRj3wf8anOnvnJj6+vNONg6pjacmldhyoq3Msl3IHvHMhH3R2UegqPyoWXmOrxsZMD5WGenFNNnIONpyKLjsVUaaBh9nncD0J4pzzxS/8f+nwT/7SjDfnU/2KQEgqQP50/wCxMB86nnt3ouJq5Ray8PzDhL20c++4D8hUX/CN2T82+sxDPaWMr/M1pmwcpnbxmo3059wVkz+FO7DlRnP4QuSP3N9Yyg/9NFX+tEPhC9YNuubKMDqTOv8AjWmdLl52pnoacumSZye3bmk5BymfFomm2IZ7+8a6Yf8ALO3G38N3IqG51JniNtYQrZ2h/gT7z/U9617jSpTESVwCOwqra6O7yIpUgUuYdkYi25G0EfnV1bdhGSOtdQnh58gspcZ6kVbj0H9yWCsvXINK4rlLSbZ2srIle57e9eu3CeXoFxkYPkflwa5bRtI/0W0DL8qqTn6muy1z91os3+1Hii4rni3gKDb4ivXHQZ6/WvUbPtXF+D7IxXV7MwxngfmK7az61QN3Oh07oK6Sy6LXO6d2rpbIfdpN2EbEHQVfj7VQg6Cr8fapAmooooAKKKKACiiigAooooAKKKKACiiigBG+7UDrkVYNMYcUAUJEqlNHweK1JFGaqyx9aAM1D5Z2sMg9/Si4tROu5MeZ6j+KpJ4/aoYpfLbDZMft2oAzpEKMVYEGm1tzQJcxjnk9GFZFxA8DEMPl7EU0wIH6VYtLp7cgHJj7iq5PFNzT0A6JWivIsH50/VaoXGnPFlovnT2rNjlkifdGxU1sWmrI2FnGxv7w6GkBngleDwfeplYACth4YLlAxCnPdapy6aw5jcEdgaNQK64Pen01oJo+qH8KbuYcEGiwDiOaRgMUuaOcUwIiKa2O1TiN26ITUgsZm9B9aWoGe/SotrE4UEmtqPS14MjZqwwtrVeSqn16mjUDIt9LlkG6Q7BWpFbW9jGXYqg7se9U7rV8Ai2XJ/vGsW5mluCTM5Y0tQNTUNdwhSzGf9siucnkkmkLSsWJ65qbZ6k0ohBqkgKmw+lSJCSc4q5Fb57VbhtaAKkEBPY1o29vwOKsQW2KvxQACpuBDbw4NXEQDNPRNopXYAZFAEcpCrxVV271JIxNU5n4NAEcr8moc5NDHJzSpyaaAkiX5sVegTgVFCnIq/CmMUrgTQpwKsxpTIlPFWk6UAR+WKjeMelW6aQDQBmyxZzWbc2/B4rdlTriqU0eaLgczcRYJOOKovtJI3AfWuguoMg1j3lrmmgOW1S2L6oGUZXyzlhWlcRk2kigf8s8fpRND5ccvvU8EqyxOpP8OP0phY8a8CwMni7VGZeIyQfzNeyWECm3Vh3Ga4HwvYrBqmuysvPmEBvxNd3pF2Ft0V+oFK7G9WadvDkcnpU7QZGAazWvwkh5wDS/2nx1FGojQFqApqs6KGCDFVX1MbCARz71lTaoYHLsN7dhmlYDp47GaVQysEj7e9PbSpyRibH41yo8Rz44jOPrTl8R3H9w/nQB0/8AZMx/5bdKibSLtm/4+iornv8AhIrnH3D+dKdfuj0U/nRYDeOiXTD/AI/DSf2Hc5/4/jWB/b93/dpp1689KTjcDoDoN0T/AMhA/wCfxo/sG5/6CJ/z+Nc9/bl0expDrN2fWnyjub0mj3dud7Xazx/xIRyPcGoLVF89oyenINYr6xdkDk0n251dZs/7wo5RXOsW1UgYPNVrvZYukg7VljXCEGM5rI1nVJbgIEJ45pAdjAsdyhlY9axvEOlre7IFIIzk8Vn2usGK3VSOali1geaWYnJ7VHIr3KcrKxQPhCFvvCg+EIiPlQYFa51pcADGaRtaXdwa0VyTJHhCJQPkUEd8Ug8JQ4ICgHPXFao1pTiga0ADj1p6gZq+FYQpVlBHcjvSnwvCFXK4A9q0DrakZ5z6Yo/tpO+fyo1AzpPCkDHcUGe2BSN4Wi6lVPvitP8AtlMcdKadYU+tGoFA+GUBB2DGOARUb+FoRkhEB9SK0xrKnrkij+10PWjUDLPheIlSVXPbApW8LwswLKCBwa0v7YTnj6Uf2unpRqBnL4ZhQYUDA9aQ+HIi+7byePrWidWQdB1pp1Zd3FGoFI+HI9rAoMelIvhuIHhRx7Vf/tZeeDTf7VXORketGoFKXQY2xhRg9QRTbfw3ElxuYKe4BFWrjXI4Vyyscf3RmmWeuJOxO1x/vCkBof2ZHx8owOwFRTaZEqEBTg+gpy6ogHvUUurAA4BNFgLltZokWVAwMDio/EZD2Riz1FR2l6vkKGbGck596ivruKQg53H0pgYNpaC1iWMDDE7jWxZp0xVaNC77j1Na1lB0pga2npwK6GzX7tZGnx4xW/aoBikwNG3XiryDOKp24wKuxikA+iiigAooooAKKKKACiiigAooooAKKKKACkpaKAIiASc1XkXnpVsimOvFAGbNHVKaLBPrWvIlVZY+c0AZSyPAxKHj07VdimiuE8sgZP8ACf6VHNFx0qk6bTkAgjvQBJe6cVy0A3L3HcVlkEMQRgiti3vmQgTZI/vDqKsy28F4u4gFj0Zf600BzY700n0rQutOmiyyYdPUdaz3BB5BpgPhmkhOYnZfoa0YNYmGPNVXA9ODWTSc0AdPFrFu/wB/en61KLyzkPMifiBXKg4qRWxQgOn860/vx/lR9otAeGT8BXNh6erH3oA33v4F+7uP4YqB9TbPyIPxNZQbikzn1oYFqe+nkyC5A9uKqMNxySTTsEilVCaAK7LzzyKDHmrQizUghoAorBk1PHbe1Xkg9qnSGlcCpFbjjircUA9KsRx4qdFA6daGBFHHjqKmVQO1B4781G8hBwoyfakA92AzUDtgc9KRjtG5jk/yqlNMTkdBQAssnJxVVm5od6YeaYCgZqeFM02JKvQpg0mA+CM56VeiXpxUUS9KuRrQBJGvQVLjmmgdKeKACkIpaDQBG68VXcA9qt4z1qN1zQBmzRZU1mXMHtW+ycVUnizxihaAcpeWoORisqa1KAhcjNdjPbE54rMuLX2p7gcYLFLd5DEhBkOW561G3mqMLwBXTTWeSeKpvZU0Bz0nnN95mpgjcnlm/Ot42XPSgWXPSgDDWF/7zfnThbHOTya3VsuelSCyx2pgYa2x4+WpFtSe1byWXTip47L2pAc6LM+lSfYz6V0S2XXinizB7UAcybI+lL9jPpXTGz9qPsXtQBzP2M+lAsz6V032L2o+xe1AHM/Yzn7tMNocHiup+xD0ppshzxTA5V7UjtUL2pJyFrq5LLI6VXayIPSpsBzP2Y9xSG24ro2seelIbL2p2A5sWpPb8aUWuO1dF9h9qPsPtQBz32U9hR9mPpXQ/YvanCy9qAOb+yn3pfsx966T7EPSj7EPSgDmvsx96X7Kfeuk+wj0pPsQHagDm/spo+zH0rpPsQ9KPsQ9KAObFsfej7Ma6T7EP7tH2If3aAOc+zf7NH2b2rpPsQ9KPsQ9KAOa+zGlFtXSfYh6Un2If3aAOc+zH0o+ze1dH9iH92l+xD0oA5wW3tS/ZD2HNdF9h9qPsWO1AHOi1P41LHaHPC/pW/8AYR2FSpZH0oAyILXaRxWraW+O1W4rPBBIq/Bb+1ABZwcCte2TGKit4cAVfiXGOKlgSxirS8Co0WpQOKAFooooAKKKKACiiigAooooAKKKKACiiigAooooADTSM06igCJ1zVeROtWyKY65oAzpIwc1Uli64FazpUEkeaAMSSE1EpkgbMbFT+la0kNVZouelABBqQPE64b+8vSrEltbXiZ2g5/iWs2SLv6VAvmQtujYqfam9AJp9GkGWgZXUdu9Z0sMkbYeNh+Fa8OqOpAmQOPUdaupd29wNrsOf4XouBy45pw4FdDPpdrKN0eUPqORVCbSZ1/1ZEi+x5oTAoDtUi9KVoZIziSNl+ooFMB4p6gU2MVMo5oARQDxUirilQDNPUZPtSuA5UFSBOlIBUi8DpRcB6LjFTAACoVcU9dx6A0gJNwH1pc+nNIImLfMwHsKHkji64H86AAqf4+BUcsqQqRkZ7DvUE14W4TI96ovJkkk5p2AmmmLHJ6VVds9KQnIpqqSeKAFGTxUsaU6KPNW4Ys02AQxcCrsUfNEUeKtxpUgEcdWVHSmqMEVKKACloooAKKKKACkxS0UARsOKhZOasnrSEZoAz5Is1Ukt/atZ0qFo80LQDDltcnpVZ7Melb7Q+tRmCncDANng9KUWY9K2/I9qUQe1FwMZbQelSi0HpWsIOelPENK4GStoPSni1x2rVWGniHincDLW2B7U4W3tWosHtS+T7UXAzPswo+zCtTyfajyaLgZf2YUfZhWp5Jo8mi4GUbfHamm2BHStbyvakMPtRcDGa29qja16/LW20HtTGgouBh/Zc9qDZjHStryPal8j2ouBiCzHpR9kHpW15OO1Hk+1FwMX7IPSj7IPStryfajyfai4GL9jHpR9kHYVteV7UeT7UXAxfsvtR9k9a2vJ9qPJ9qLgYv2MelH2MelbXk+1Hle1FwMX7GPSj7GPStryvajyvai4GL9kHYUfZD6VteT7UeT7UXAxfsmeoo+xj0ra8n2o8n2ouBi/ZB6UfYx6VteRR5FFwMYWuO1L9lB7VseR7UogouBjC1A6Cnpa+1bAg46UeR7UXAzUt/arMcIUjiriw4p4jpAQxx4xVhF5FPVOlP24oAB1p4pAKWgAooooAKKKKACiiigAooooAKKKKACiiigAooooAKKKKADFIaKKAGOvFRsgxRRQBC8YqtJGKKKAK0kYqq8YoooArPGOtQyJxmiiqAWOaWLmNyPrV2HVJFI81Q3uOKKKTAvQXMdyM7SPYgU9rWFxloloopAQfYrfPAYfSnjT426MwoopAOGmjrvNL9gC/xmiimAqWiDqxNP8mJTgAk+9FFADgioMhFqCW8C8Bcn3oooAqS3UjHA+XPpVd3OcnOaKKaAiZ+KZ1NFFMB6rnNSxpRRUsC3DHVyFBRRSAtxrxU6iiimA8Cn4oooAKKKKACiiigAooooAKQ0UUAIRTSooooAaVBPSm+WKKKAE2CjYKKKAHKg9KXYPSiigBQgpQADRRQA7AowKKKAF20baKKADbRtoooATAowKKKAEIpu2iigA2UbKKKADyxR5YoooANgo8sUUUAJsFGwUUUAGwUbBRRQAbBRsFFFABsFGwUUUAGwUbBRRQAbBRsFFFAC+WKXyx60UUAJsFKEFFFAC7aNlFFAAFpcUUUAAHIp1FFABRRRQAUUUUAFFFFABRRRQAUUUUAf/9k=)
Những ví dụ này minh họa lý do tại sao FDA và Tổ chức Tiêu chuẩn Quốc tế (ISO) tồn tại — để cung cấp một cái nhìn thận trọng đối với các nhà sản xuất và hỗ trợ họ trong việc xác định và giảm thiểu rủi ro. Cụ thể trong trường hợp thiết bị y tế, ISO 14971 là tiêu chuẩn vàng quốc tế để quản lý rủi ro. Nó cung cấp một khuôn khổ được thiết kế để hỗ trợ các nhà sản xuất xác định các nguy cơ tiềm ẩn liên quan đến các thiết bị y tế riêng lẻ, để ước tính và đánh giá các rủi ro liên quan, cũng như để kiểm soát những rủi ro này.
Tiêu chuẩn ISO 14971 là tiêu chuẩn quản lý các rủi ro thương tích liên quan đến sức khỏe của bệnh nhân, người vận hành và những bên khác, cũng như thiệt hại tiềm ẩn đối với tài sản, thiết bị và môi trường. Tiêu chuẩn được xem xét và cập nhật định kỳ để phù hợp với những thay đổi trong các quy định về thiết bị y tế trên toàn thế giới.
ISO 14971 quy định các thủ tục để xem xét và giám sát trong quá trình thiết kế, chế tạo và hậu sản xuất. Quản lý rủi ro không kết thúc khi sản phẩm xuất xưởng, việc tuân thủ ISO 14971 cũng yêu cầu các công ty quản lý rủi ro trong toàn bộ tuổi thọ của sản phẩm.
Tuân thủ tiêu chuẩn quản lý và đánh giá rủi ro ISO 14971
Để đảm bảo tuân thủ ISO 14971, các công ty phải chứng minh rằng họ có một chiến lược quản lý rủi ro hiệu quả. Điều này bao gồm việc xác định, đánh giá và kiểm soát các quá trình để ngăn ngừa sự cố. Họ cũng phải có khả năng thực hiện phân tích hoặc đánh giá rủi ro để xác định các vấn đề tiềm ẩn có thể gặp phải liên quan đến việc sử dụng thiết bị y tế.
Đánh giá rủi ro là một nội dung không mới đối với ISO 14971 nhưng đã được phát triển theo thời gian, bắt đầu từ tiêu chuẩn Châu u EN 1441 về phân tích rủi ro, được ban hành vào năm 1994. Các nhà phát triển tiêu chuẩn quốc tế nhận ra rằng còn nhiều điều hơn là phân tích rủi ro đơn giản và bắt tay ngay vào việc phát triển một tiêu chuẩn để quản lý toàn bộ quy trình rủi ro. Từ đó, ISO 14971 - Ứng dụng Quản lý Rủi ro cho Thiết bị Y tế , được phát hành lần đầu tiên vào năm 2000. Tiêu chuẩn này xác định rủi ro và quản lý toàn bộ vòng đời của các thiết bị y tế.
Trong khi ISO 14971 quy định thuật ngữ, nguyên tắc và quy trình để quản lý rủi ro của thiết bị y tế và cung cấp một khuôn khổ cụ thể, các nhà sản xuất có thể làm nhiều hơn nữa để đảm bảo họ đang giảm thiểu rủi ro bằng cách xây dựng văn hóa chất lượng. Điều này đòi hỏi việc quản lý chất lượng trở thành một sáng kiến của toàn doanh nghiệp, một sáng kiến nằm ở trung tâm của tất cả các quyết định về thiết kế, sản xuất và chuỗi cung ứng.
Thực hiện một phương pháp tiếp cận quản lý chất lượng chủ động để quản lý rủi ro thông qua ISO 14971
Khi tốc độ đổi mới trong các thiết bị y tế tiếp tục tăng tốc và nhu cầu đưa các thiết bị mới ra thị trường ngày càng tăng, thì việc ưu tiên chất lượng càng trở nên quan trọng hơn. Đánh giá tuân thủ cho nhà sản xuất biết liệu một sản phẩm có tuân thủ các quy định hiện hành của FDA và ISO hay không, nhưng nó không cung cấp thông tin chi tiết về cách công ty đó có thể cải thiện các quy trình của mình, dự đoán và giảm thiểu gián đoạn chuỗi cung ứng, tối ưu hóa lưu trữ và phân phối cũng như điều hướng sự phức tạp của việc tuân thủ . Đó là lúc các chiến lược quản lý chất lượng chủ động phát huy tác dụng.
Thực hiện các biện pháp chủ động để giảm thiểu rủi ro bằng cách thiết lập các sáng kiến chất lượng có thể có những tác động sâu rộng — từ việc phân bổ nguồn lực hiệu quả hơn đến giảm xác suất thu hồi.
Xem xét các bước chính sau đây để thực hiện một cách tiếp cận quản lý chất lượng đối với rủi ro:
![Tiếp cận quản lý chất lượng đối với rủi ro nhờ ISO 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Xác định người quản lý chất lượng
Đây là những người trong tổ chức của bạn, chẳng hạn như trưởng nhóm Đảm bảo chất lượng (QA), người có thể đặt ra các mục tiêu chất lượng, truyền bá tầm quan trọng của các sáng kiến chất lượng trong toàn doanh nghiệp và giáo dục các nhóm về giá trị thực của chất lượng cũng như chi phí thấp phẩm chất. Trong khi người quản lý về chất lượng có thể phát triển kế hoạch quản lý chất lượng chiến lược, thì sự hỗ trợ nên đến từ cán bộ nhân viên để đảm bảo kế hoạch trở thành một phần của văn hóa.
Thiết lập các quy trình tự động
Hệ thống quản lý chất lượng (QMS) có thể giúp bạn xác định các khu vực có vấn đề, phát triển các kế hoạch, hành động khắc phục, tự động hóa các quy trình cốt lõi, quản lý kiểm soát tài liệu tốt hơn và làm suôn sẻ quy trình đánh giá. Không giống như các quy trình thủ công, các hệ thống tự động giảm thiểu sai sót của con người và mang lại hiệu quả cao hơn.
Thực hiện tiếp cận một cách chủ động
Một kế hoạch quản lý chất lượng hiệu quả không chỉ cung cấp một chiến lược để khắc phục các vấn đề về chất lượng mà còn ngăn chặn chúng trước khi chúng có thể xảy ra. Tận dụng phân tích dự đoán nâng cao, các công ty có thể tận dụng dữ liệu kinh nghiệm của mình để hiểu rõ hơn về những gì có thể xảy ra trong tương lai.
Làm việc hướng tới cải tiến liên tục
Mặc dù điều quan trọng là phải thiết lập các quy trình được xác định rõ ràng, nhưng điều quan trọng không kém là sử dụng dữ liệu quản lý chất lượng để thúc đẩy tính linh hoạt và thúc đẩy những thay đổi quan trọng trong quy trình sản xuất của doanh nghiệp để đảm bảo sức khỏe, an toàn và kết quả kinh doanh tối ưu.
Trong một ngành công nghiệp toàn cầu ngày càng được quản lý chặt chẽ, nơi mạng sống của bệnh nhân và danh tiếng của công ty được đặt lên hàng đầu, việc quản lý rủi ro cần phải vượt ra ngoài mục kiểm tra tuân thủ và được xem xét trong bối cảnh rộng hơn của quản lý chất lượng để giữ an toàn cho người tiêu dùng là ưu tiên hàng đầu.