專業戶外活動資訊平台
2016/12/25
最近高山的山屋上出現了許多加壓袋,簡稱PAC,是來自民眾愛心捐贈的急救器材,號稱可以在10分鐘內模擬海拔1500m的氣壓環境,減緩高山反應。
然而最近卻不段傳出問題重重,包括有人在翠池山屋使用之後無效,事後卻在被質疑不具有操作PAC的資格,甚至還要賠償?
http://sant88.blogspot.tw/2016/08/blog-post_23.html
https://www.facebook.com/sant.cpt/posts/1431567430190702
還有聽說當初募款費用包括了PAC的建置,卻叫幫忙背上去的人當免費志工,自己另外花錢雇協作帶記者上山去拍照宣傳(只建置記者就是了!)
這些謠言在岳界傳得滿天飛,讓人搞不清頭緒,也不知道這些PAC 該不該用,該怎麼用
昨天收到一份文件,是台灣野外地區緊急醫療救護協會的內部調查報告
連結在此:https://drive.google.com/open?id=0B3-e32G6T8jnYUpnbWFubjBwNkE
詳細閱讀後,發現PAC確實問題很多,最嚴重的問題是~
按照美國的規定,這應該是醫療器材。但目前山上放的這些PAC,跟本連在澳洲都還沒有合法的登記,而且是還未經過台彎灣衛福部認可的醫療器材,當初是當作運動器材進口的。
如果貿然拿來使用,被救者出了什麼意外,那施救者被追究起來麻煩可大了。在這裡先提醒各位山友,千萬不要隨便用山屋裡的PAC啊,不僅成效可能不大,還有可能害死人(延誤下山)並且觸法,高山反應還是趕快下降高度比較有效。
自105年9年1日,由矯正鏡片製成之產品,包含有度數運動防護眼鏡(例如泳鏡、滑雪鏡、壁球護目鏡及潛水鏡),正式納入第一等級醫療器材管理。--這沒什啊,鏡片還是一級的ㄝ....
http://www.fda.gov.tw/TC/site.aspx?sid=39
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看一下我的賴
加入我 我們一起聊聊登山的樂趣
L I N E 96yzz
WeChat:pengtongtong789
Telegram:chen323
RE: Does PAC has any certificate of medical equipment's in Australia
Thank you for your email to the TGA For a portable altitude chamber to be considered as a medical device in Australia it would need to be presented in a way which would meet the below definition. What is a medical device (1) A medical device is: (a) any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; (iii) investigation, replacement or modification of the anatomy or of a physiological process; (iv) control of conception; and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or (aa) any instrument, apparatus, appliance, material or other article specified under subsection (2A); or (ab) any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or (b) an accessory to an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).
For a medical device to be legally supplied for use in Australia it must hold a current entry in the Australian Register of Therapeutic Goods (ARTG) A search of the ARTG has not identified any entries related to the company listed in your email You will need to check the regulatory requirements with the importing country to determine what permits may be required for the products supply. Kind regards Brian Medical Devices Information Unit Medical Devices Branch Therapeutic Goods Administration Phone: 1 800 141 144 Fax: 02 6232 8785 Email: [email protected]
Therapeutic Goods Administration Department of Health PO Box 100 Woden ACT 2606 www.tga.gov.au