{"id":4848,"date":"2016-08-01T21:17:30","date_gmt":"2016-08-01T21:17:30","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4848"},"modified":"2022-06-12T18:24:55","modified_gmt":"2022-06-12T18:24:55","slug":"home-use-medical-wellness-devices-article-by-leo-eisner","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2016\/08\/01\/home-use-medical-wellness-devices-article-by-leo-eisner\/","title":{"rendered":"Home Use Medical & Wellness Devices Article by Leo Eisner"},"content":{"rendered":"
\"InCompliance<\/a>
photo courtesy of In Compliance Magazine, August 2016<\/figcaption><\/figure>\n

Near the end of writing this article<\/a> I had an\u00a0unfortunate incident\u00a0that I personally had to use a\u00a0home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an IV bag) after a knee joint infection that I had to have emergent surgery & stay in the hospital for 2 days in Early June 2016. \u00a0I was out of work for about a month and so I got a close birds eye view of why the medical device and wellness device markets are exploding. \u00a0This explosion of interest comes from several factors including the “Super aging” of societies around the globe, Internet of Things (IoT), the portability of devices, the growth of wearable technologies and\u00a0other factors discussed in the article<\/a>.<\/p>\n

There is a huge need to support those at home that are\u00a0sick, injured, has an acute issue or chronic illness that want a comfortable life\u00a0and\u00a0would rather stay at home then be in a sterile hospital or other clinical setting any longer than they have too. \u00a0I know I was\u00a0ready\u00a0to get home after 2 days in the hospital, even though I had to rest at home, I was much more comfortable at home than in the hospital setting. \u00a0So, now I can appreciate how important it is to have these medical and wellness devices evaluated for the proper environment and proper standard(s) and to meet national regulations. \u00a0 One of the issues that is important to this conversation is the blurry line between home use medical devices and wellness devices. \u00a0FDA has written guidances for\u00a0both Home Use Medical Devices and Wellness Devices to clarify from their perspective. \u00a0There, also is a newer IEC System Committee called Active Assistive Living (SyC AAL) that is looking at the gaps in standards and\u00a0other IEC technical documents\u00a0for\u00a0home use medical devices and non-medical devices (Some being wellness devices). \u00a0The article<\/a> goes into detail on this SyC AAL\u00a0and\u00a0also looks at the medical electrical device standards focused around Home Use Medical Electrical Devices.<\/p>\n

Enjoy the article<\/a> and if you have\u00a0interest in or need help\u00a0with the IEC 60601-1 series, home use medical electrical devices or the SyC AAL please\u00a0email Leo Eisner at\u00a0Leo at EisnerSafety dot com<\/a>, or call Leo at +1 (503)-244-6151. Leo\u00a0is the Principal Consultant of Eisner Safety Consultants<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Near the end of writing this article I had an\u00a0unfortunate incident\u00a0that I personally had to use a\u00a0home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an<\/p>\n","protected":false},"author":4,"featured_media":4854,"comment_status":"closed","ping_status":"closed","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":[61,41,1250,1304,262,163,74,27,9,10,1243,1305,1244,93,88,1306,91,13,1307,1308,1309,95,330,174,175,149,1310,1311],"class_list":["post-4848","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-60601-series","tag-aami-es60601-1","tag-active-assisted-living","tag-active-assisted-living-system-committee","tag-active-implantable-medical-devices-directive","tag-ansiaami-es60601-1","tag-cdrh","tag-escnews","tag-fda","tag-fda-guidance","tag-general-wellness","tag-general-wellness-devices","tag-general-wellness-guidance","tag-home-healthcare-environments","tag-home-use","tag-home-use-guidance","tag-home-use-med-dvcs","tag-iec","tag-iec-aal-syc","tag-iec-syc-aal","tag-iec-system-committee","tag-iec60601-1-11","tag-medical-device","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-syc-aal","tag-wellness-devices"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4848","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=4848"}],"version-history":[{"count":1,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4848\/revisions"}],"predecessor-version":[{"id":7270,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4848\/revisions\/7270"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=4848"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=4848"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=4848"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}