{"id":3191,"date":"2013-03-02T06:48:58","date_gmt":"2013-03-02T06:48:58","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3191"},"modified":"2013-03-02T06:48:58","modified_gmt":"2013-03-02T06:48:58","slug":"med-electronic-dvc-solns-trade-pubed-article-by-leo-eisner-on-fda-home-use-draft-guidance-doc","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/03\/02\/med-electronic-dvc-solns-trade-pubed-article-by-leo-eisner-on-fda-home-use-draft-guidance-doc\/","title":{"rendered":"Med Electronic Dvc Soln’s Trade Pub’ed Article by Leo Eisner on FDA Home Use Draft Guidance Doc"},"content":{"rendered":"

The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012. \u00a0The article that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled\u00a0FDA Issues Draft Guidance on Medical Devices Intended for Home Use<\/a><\/strong>.<\/span><\/p>\n

In Addition to this article I have blogged on the topic a\u00a0couple other times<\/a><\/strong>\u00a0so if you want to see more material (original post<\/a><\/strong>) on the topic please continue to read on more of the details and experiences that impact many different people in many different ways (some good and some not so good) on the use of Medical Devices in the Home Use environment and how that impacts the users and their families that use these old and new technologies in the home. \u00a0Sometime these devices really are only designed for the hospital setting like some IV pumps, patients may have trouble with them to the point that patients pass away, which is a real tragedy no matter how you look at it. \u00a0There are 2 MD&DI articles on the\u00a0Home Use Draft Guidance<\/a><\/strong>\u00a0and one of the articles deals with an\u00a0IV pump that probably shouldn’t have been in the home use environment<\/a><\/strong>\u00a0with really sad results.<\/span><\/p>\n

If you company needs support dealing with the IEC 60601-1-11 standard for Home Use Environment or with the FDA Home Use Draft Guidance document, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval\u00a0we can provide you with regulatory, product safety, standards compliance, quality system\u00a0services\u00a0and more<\/a><\/strong>.\u00a0 Please feel free to contact us at\u00a0Leo@EisnerSafetty.com<\/a><\/strong>\u00a0or 503-244-6151. \u00a0\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012. \u00a0The article that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled\u00a0FDA Issues Draft<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[45,61,15,16,54,41,843,163,844,845,846,74,92,847,848,779,430,27,206,9,849,850,334,851,852,853,854,855,93,88,856,89,91,13,617,309,857,858,53,94,95,188,859,22,174,175,149,861,625,863,864,865,866,167,237,5,867,115,25],"class_list":["post-3191","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-510k","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-aami","tag-aami-es60601-1","tag-aami-ha60601-1-11","tag-ansiaami-es60601-1","tag-ansiaami-ha60601-1-11","tag-ansiaami-ha60601-1-112011","tag-ansiaami-ha60601-1-112011-iec-60601-1-112010","tag-cdrh","tag-collateral-standard","tag-consensus-standards","tag-csa","tag-draft-guidance-document","tag-eisner","tag-escnews","tag-european-commission","tag-fda","tag-fda-consensus-standard","tag-fda-consensus-standards","tag-fda-draft-guidance","tag-fda-draft-guidance-on-home-use-devices","tag-healthcare-environment","tag-healthcare-facility","tag-home-environment","tag-home-healthcare","tag-home-healthcare-environments","tag-home-use","tag-home-use-devices","tag-home-use-environment","tag-home-use-med-dvcs","tag-iec","tag-iec-60601","tag-iec-60601-1-11","tag-iec-60601-1-11-1st-ed","tag-iec-60601-1-112010","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-iec60601-1-11","tag-intertek","tag-long-term-care","tag-medical","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-medical-electrical-equipment","tag-national-deviations","tag-nursing-home","tag-nursing-home-environment","tag-professional-healthcare","tag-professional-healthcare-facility","tag-recognized-consensus-standard","tag-recognized-consensus-standard-database","tag-risk-management","tag-tuv","tag-tuv-sud","tag-ul"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3191","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=3191"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3191\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3191"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3191"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3191"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}