Linvatec 電動骨鑽cable 及Handpiece 一級回收

(http://bme.freebbs.tw 醫學工程論壇 同步發表)
ConMed Linvatec - Power Pro Handpieces
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm181784.htm

ConMed Linvatec - Universal Cables
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm181786.htm

Recall Class:Class I

Date RecallInitiated:July 31, 2009

Product:Universal Cables, MC5057-->我們醫院用的是MC5056，但因為財產沒有登記細項，必需去清查一下或是問一下台灣代理商
The lot numbers affected by this recall are included in this attachment. The cables have date codes etched on one end of the cable and range from JAN-01 to NOV-06 representing the month and the year.Attachment: Universal Cable Serial Numbers, Excel (158kb)These cables were manufactured from January 3, 2001 through November 30, 2006 and distributed from January 24, 2001 through February 27, 2009.See related Linvatec Class I recall

Use:The cable connects Linvatec MicroChoice Small Bone, MicroChoice, Advantage and APEX Shaver System and Power Pro Electric I and II Large Bone System electric handpieces to the power source.

Recalling Firm:Linvatec Corporation doing business as (dba) ConMed Linvatec11311 Concept BoulevardLargo, Florida 33773-4908

Reason for Recall:The cable may cause the electric handpiece to self-activate.

Public Contact:ConMed Linvatec Customer Service1-800-237-0169Monday-Friday, 7 AM to 7 PM Eastern TimeFor more information, see Useful Links below.

FDA District:Florida

FDA Comments:The company sent a letter to their customers with the following instructions:
Inspect the cords for signs of excessive wear or damage.
Stop using the cable if damaged or worn and replace it immediately.
Stop using the cable immediately if the handpiece self-activates or an intermittent operation occurs. Return the cable and handpiece to the company for evaluation.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.Useful Links:
Firm Press Release http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm
MedWatch: The FDA Safety Information and Adverse Event Reporting Program

LifePack電擊器(AED)一級回收(特定序號)

http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm182458.htm

Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (AEDs)

Recall Class: Class I

Date RecallInitiated: July 31, 2009

Product: Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillator (AED)
Only the Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.

Serial Numbers
37026963, 37026983, 37026984, 37026997, 3702700237027008, 37027039, 37027040, 37027049, 3702705337027063, 37027065, 37027066, 37027070, 3702707137027073, 37027075, 37027090, 37027099, 3702710537027122, 37027197, 37027529, 37027569, 3703139337037850, 37037893, 37037986, 37038002, 3703821137038365, 37135986, 37154526, 37154638
The serial number is located on the underside of the device.
The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008.

Use: This device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient’s heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.

Recalling Firm: Physio-Control, Inc.11811 Willows Road NERedmond, Washington 98052-2003

Reason for Recall: An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

Public Contact: Physio-Control Customer Care1-800-442-1142, 6 AM through 4 PM Pacific Time

FDA District: Seattle

FDA Comments: Physio-Control called their customers from August 18-19, 2009 with a follow-up email message on August 20, 2009. The company sent replacements on August 19, 2009.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.

水銀洩漏地面收集

(http://bme.freebbs.tw 醫學工程論壇同步發表)

這不算是故障，而是插曲，算是工作上的插曲，也是我第一次碰到的。
通常水銀會洩漏都是因為水銀血壓計有問題，而漏在桌面上或是盒子裡，這樣對使用者或維修的人來說一張紙片就足以應付了，但今天的狀況是滿地開花！麻煩的是連地上瓷磚的小縫隙都有，真的很傷腦筋，這也凸顯出在醫院裡使用無縫地毯的需要性。

本來使用單位打電話下來只說水銀漏了，很自然的回答請她們用紙片鏟起來，用小瓶子裝好送下來集中。結果不一會兒，有人打電話下來很義正詞嚴的說，你們怎會讓護理人員蹲在地上用紙收集水銀呢?水銀很毒呢，那麼多人在那踩來踩去的，會讓人中毒的，你們應該有什麼設備可以來清除水銀吧！

清除水銀？我們又不是每天碰到這種事，怎會有這種設備呢，就婉言回答，水銀會毒是因為變成水銀蒸氣吸入人體才會造成問題，目前是元素型態時，是不會有太多問題的，我們會上去看看，不過我們也是只能用紙去鏟！

到了現場，真的是傻眼，怎會有人把水銀灑滿地呢，當下請人都出去護理站，因為開空調，本來是應該停空調開窗通風的，但天氣太熱，估計一會就可以清除，所以就沒開窗通風，蹲在地上，真的是沒法用紙鏟，有的躲在縫中，根本耐它無法，想想只能用吸的，可是一般吸塵器會把水銀打碎並且會經過排氣變成水銀蒸氣，那更慘哦，突然靈機一動，跟理站要了小型的motor suction，平常用來抽痰的吸引器。

一般suction有緩衝瓶，不會直接吸入馬達，應該可以，借到了suction，用矽膠管壓著開始吸水銀了，真的很好用哦，而且吸進去的水銀因為緩衝瓶的作用，都收集在瓶中，再加上suction的空氣不會太熱，所以應該不會變成水銀蒸氣。連小縫裡都乾乾淨淨的，差不多連地板都吸乾淨囉，任務圓滿達成。

所以提供大家參考，可以用suction來吸水銀，記得吸力不要開太大，緩衝瓶高度要夠，以免水銀又飛濺出去那就不好了，千萬不要拿吸塵器直接吸，那真的會讓水銀無影無踪的。如果前面再加個緩衝瓶，那才可以哦。

醫療儀器相關法規

最近整理了一下相關的醫療儀器法規，供大家參考，如果有不足，請大家互相增補一下資料

母法	法規名稱	負責單位	內容
醫療法	醫療機構設置標準	衛生署醫事處 第二科	各項醫療機構設置所需標準
藥事法	醫療器材管理辦法	衛生署藥政處 第二科	醫療器材認證審查
	特定醫療技術檢查檢驗 醫療儀器施行或使用管理辦法	當地衛生局	CT、MR、ECMO...等24項
	危險性醫療儀器審查評估辦法	衛生署醫事處 第六科(分機6668)	醫用粒子治療設備

這是依特定醫療技術檢查檢驗醫療儀器所整理出依科別所需的設備，可以提醒相關科別在購置這些設備時應注意適法性的問題

科別	特定醫療技術檢查檢驗醫療儀器
心臟外科 胸腔外科 心臟血管外科	一、準分子雷射血管成形術系統用於經皮下心臟冠狀動脈血管成形術 二、準分子雷射血管成形術系統用於經皮下周邊動脈血管成形術 三、準分子雷射血管成形術系統用於直視下開心手術或周邊動脈手術 四、冠狀動脈旋轉研磨鑽用於經皮下冠狀動脈血管成形術 五、冠狀動脈旋轉研磨鑽用於直視下冠狀動脈繞道手術 六、心房中膈缺損關閉器 七、腹主動脈支架 八、電動式或氣動式左心室輔助器
心臟內科 心臟外科	九、經皮下植入心律去顫器 十、直視下開心手術植入心律去顫器
骨科	十一、震波骨科治療機
放射線科	十二、電腦斷層掃描儀 十三、磁振造影機
放射線科 放射線腫瘤科	十四、電腦斷層掃描模擬定位儀 十五、高能遠距放射治療設備 十六、近接式放射治療設備
核子醫學科	十七、核子醫學設備 十八、正子斷層掃描設備 十九、醫用迴旋加速器
泌尿科	二十、體外震波碎石機
專任醫師(不分科)	二十一、高壓氧設備
神經外科、神經科	二十二、顱內血管支架
耳鼻喉科、復健科、精神科	二十三、人工耳蝸植入術
專任操作醫師	二十四、臍帶血移植

一級回收 Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]

(http://bme.freebbs.tw 醫學工程論壇同步發表)

 

 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173239.htm

己停產的設備，如果仍有在使用的，Drager己發通知請勿使用，也不要再轉賣或是捐贈

Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]

Audience: Pediatric and Obstetric Healthcare professionals, hospital risk managers

[UPDATED 08/25/2009] FDA notified healthcare professionals of a Class 1 recall of these models of the Stabilet infant warmer because these out-of-date devices may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire. On July 20, 2009, Draeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

[Posted 07/22/2009] Draeger Medical and FDA notified healthcare professionals that it recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service as soon as possible due to concern that continued use of these devices may result in serious injury to the patient and/or caregiver.  A January 2008 fire in a Minnesota neonatal unit injured an infant and an independent investigation concluded that the Hill-Rom Stabilet 1250 was likely the ignition source of the fire.  Draeger agrees with the recommendation to remove the referenced Stabilet models from service immediately.  Immediate actions required include:

• Locate and identify the devices listed in this notice.

• Remove the referenced devices from service as soon as possible.
• Once removed from service, the warmers should be rendered unusable by removing the heating element and the power cord. These warmers should not be used or sold for any other purpose.
• If an infant is currently receiving therapy from one of the referenced devices, consider the risk of moving the patient before changing to an alternative mode of therapy.

A recall notification is being sent out to all known current users and is available in the Draeger website at www.draeger.com/Stabilet.   Health care professionals and consumers should report serious adverse events (side effects) or product quality problems with the use of this product to Draeger Medical Systems Inc. or to the FDA's MedWatch Adverse Event reporting Program (www.fda.gov/medwatch/report.htm)

[08/25/2009 - Recall Notice - FDA]
[07/20/2009 - Press Release - Draeger]

 

 

危險性醫療儀器審查評估辦法

行政院衛生署有關「危險性醫療儀器審查評估辦法」〈原名稱為「具有危險性醫療儀器審查評估辦法」〉業經該署於中華民國98年8月12日以衛署醫字第0980261439號令修正發布施行

http://dohlaw.doh.gov.tw/Chi/NewsContent.asp?msgid=2484

1.修正簡稱為「危險性醫療儀器」。
2.修正危險性醫療儀器之定義。
3.附表中原三項刪除二項列管：一、正子斷層掃描造影設備、二、醫用迴旋加速器

醫用質子治療設備更名為--> 醫用粒子治療設備 列管

------------------------------------------------------------------------

經與衛生署醫事處六科(分機6668)，一般直線器為並非本辦法所稱"醫用粒子治療設備"，不需補辦登記，日後有相關設備需購置時依辦法申請後始能設置。

直線加速器適用於"特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法" ，依規定向當地衛生局報備。

醫儀每日使用前查核

(http://bme.freebbs.tw 醫學工程論壇 同步發表)

勞安作業有對危險性設備及機械，所謂的自我點檢表,年定檢，醫儀的使用，有些使用用者只會用，很少也有的不大會去檢查設備使用前的狀態，甚至誇張點的連配件丟了都不知道，等出問題了，送修好像就沒事了，有時碰到遺失或碰撞損壞時，一查原因，大部份都是一攤二手，真的是很令人困擾。

因此，對於一些較昂貴或具臨床高風險的醫儀，日常的清潔保養的記錄，我思考加以擴大，以自我點檢的方式作基本的查核，以免有問題時，找不到原因及事主，同時，主管或醫工到單位稽核時，也可以依實際及記錄作事否落實。

目前思考中的設備有
昂貴性設備：超音波、內視鏡
高風險性設備：電擊器、高壓氧艙、化療配葯操作櫃

點檢表如附件，如果各位有類似的經驗，歡迎一起修訂討論哦
http://rapidshare.com/files/266380014/_______M_______O____.pdf.html 內視鏡清洗測試記錄表.pd
fhttp://rapidshare.com/files/266380015/_________O_O____.pdf.html 化療室壓力記錄表.pdf
http://rapidshare.com/files/266380016/_________C___O_i____.pdf.html 高壓氧艙每日保養程序.pdf
http://rapidshare.com/files/266380017/_W___i_____O____.pdf.html 超音波檢測記錄表.pdf
http://rapidshare.com/files/266380018/_q_________O____.pdf.html 電擊器檢測記錄表.pdf