水銀血壓計回收貯放

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名稱: 水銀血壓計回收貯放

故障情形：報廢拆解

故障原因：報廢

近幾年，環保署一直在追醫療用水銀的用量及廢棄物處理，醫院中的溫度計及血壓計是焦點之一。

目前可以取代水銀溫度計有很多，像電子溫度計、酒精溫度計...等，所以完全取代，應該是沒什麼爭議。

但是水銀血壓計就有很大的爭議了，因為血壓的量測單位是mmHg，所以水銀血壓計是直接物理量，根本不需要換算或是再處理(在不考慮水銀量足夠與否的情形下)，就可以直接顯示血壓值，所以在醫療上的參考價值是排第一位，心血管的臨床醫師也是較相信水銀血壓計的數值。

電子血壓計就有換算的電路，所以就會產生校正的需求，但是這幾年的發展下，精準度也是慢慢被臨床醫師接受，只有在懷疑數值時，再回頭用水銀血計再量一次。

其實，水銀血壓計只要水銀量足夠，基本上是不需要校正的，因為是直接物理量顯示，我們在護理站還是會保一些水銀血壓計，作為臨床重複確認用，維修校正也是會會水銀血壓計作並接確認數值。

但在環保的大旗下，還是逐漸在減量了，退下來的，當然不能隨便丟，統一拆解，零件歸類，作為維修使用，廢棄的水銀則是用容器裝好，再用膠帶封好，以免滲出。

拆解水銀血壓計時，最麻煩的是那些細細小小的水銀珠(特別是在拆玻璃管跟水銀槽時)，所以記得要用個大一點的容器承接，這樣那些小小的水銀珠才不會四處亂跑。

安全通報 Philips AED HeartStart FRx, HS1 Home, HS1 OnSite

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Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Automated External Defibrillators (AED)

＊＊＊ 衛署醫器輸字第022831號 ＊＊＊   (登記為M5066A但商名為HS1)     the Philips HeartStart OnSite HS1

the Philips HeartStart FRx  未見QSD上有登記

HeartStart Home Defibrillator 未見QSD上有登記

Date Issued: Dec. 03, 2013
Audience:

• First responders who use Philips HeartStart FRx AED
• Consumers who have purchased Philips HeartStart HS1 Home or HeartStart HS1 OnSite AEDs

Medical Specialty: Cardiology, Electrophysiology, Internal Medicine, Family Medicine

Device:An automated external defibrillator (AED) is a device that analyzes the heart rhythm in victims of sudden cardiac arrest, and delivers an electrical shock to restore normal rhythm.
The Philips HeartStart FRx AED may be used by first responders including Emergency Medical Services (EMS) and fire departments.
The Philips HeartStart HS1 Home AED may be used in the home.
The Philips HeartStart HS1 OnSite AED may be used in public locations including airports, community centers, schools and government buildings.

Purpose: The FDA is alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between 2005 and 2012 that these devices may fail to deliver a shock in the event of an emergency.

Summary of Problem and Scope:In September 2012, Philips Healthcare initiated a Voluntary Medical Device Recall of HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs after determining that an internal electrical component in the AED could fail, and the device could incorrectly indicate it is ready for use. This recall affects approximately 700,000 devices.

In a Medical Device Safety Notice dated Nov. 19, 2013, Philips provided customers with updated information about the failure of an electrical component that could cause the AEDs to fail to deliver appropriate shock. The notification also directed consumers to a Maintenance Advisory¹ .

Recommendations:Please be aware that the Philips HeartStart AEDs are designed to automatically test themselves at regular intervals to ensure they are ready for use. The HeartStart AED should emit a triple chirp sound and have a flashing "i-button" if it detects a serious problem that could prevent the HeartStart AED from delivering an electrical shock. 

該設備會定時自我檢測，如果設備有出現三聲喳喳喳(chirp)(我沒碰過，所以沒法形容,^_^),同時I-button也在閃爍時,表示設備己測到嚴重故障，請即與Philps連絡檢修。

If your Philips HeartStart AED has ever emitted or begins to emit a pattern of triple chirps, please contact Philips Healthcare immediately at 1-800-263-3342, and select option 5 for technical support. Live technical support is available Monday – Friday, 7:00 am – 5:00 pm Pacific Time.

• Keep the recalled HeartStart AED in service until Philips Healthcare replaces the device or you can obtain another working AED. Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator. 

If your Philips HeartStart AED is emitting a series of triple chirps during an emergency situation, and you are unable to locate another working AED:如果您的AED己有上述情形，又沒有替代品時

1. Call Emergency Medical Services (EMS) or 911 and start cardiopulmonary resuscitation  (CPR) (先打119,持續作CPR)

2. Press the flashing "i-button" and follow the voice prompts.  (按下I-button鍵，並依語音操作)

3. If there is an error message, remove and reinsert the battery to attempt to clear some errors and equip the device to deliver an electrical shock if needed. (Note: This step should be followed ONLY during an emergency situation.) (若螢幕上有顯示錯誤訊息，請把電池拆下並重裝，再試看看是否可正常使用，如果己經在急救時，可以試電擊，看有沒有電擊能量輸出。)

4. If an advised electrical shock is not delivered, continue CPR while you wait for EMS. （如果仍無法電擊，持續作CPR待急救人員到達接手）

5. After the emergency is resolved, contact Philips Healthcare for a replacement unit. (事後請連絡Philips檢修設備)

FDA Actions The FDA continues to closely monitor all AED manufacturers' quality system design practices and device malfunctions that have persistently contributed to AED recall and Medical Device Reports.

In September 2012, the FDA classified Philips' recall of HeartStart AED devices as a Class II recall after determining that the chance of serious adverse consequences or death due the device failure is remote. In this current situation, the FDA believes that because the patients who need these devices are in a life threatening situation, the chance of serious adverse consequences or death directly related to AED failure is very difficult to conclusively determine.

In March 2013, the FDA issued a Proposed Order² requiring manufacturers of AEDS and accessories to submit premarket approval (PMA) applications. The FDA is currently reviewing and considering the comments provided by the public, and will take them into consideration when issuing a final order.

Reporting Problems to the FDAPrompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that an AED has malfunctioned, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program³.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements⁴ should follow the reporting procedures established by their facilities.

Contact Information:If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at industry.devices@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Additional Resources:

• FDA press release⁵
• Philips Maintenance Advisory: HeartStart FRx and Onsite (HS1) AEDs ^{6 7}

一級召修 具CAS I/II Absorbers 的的Spacelabs麻醉機系統

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"Spacelabs"BleaseFocus Anesthesia System "斯貝司"百利焦點麻醉機系統   衛署醫器輸字第023291號  漢佑股份有限公司

"Spacelabs" BleaseSirius Anesthesia System　"斯貝司"天狼星麻醉系統 衛署醫器輸字第023172號  漢佑股份有限公司

[03/26/2013] 才發佈過一次

Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall - Bag-to-Vent Switch in CAS I/II Absorbers May Fail

AUDIENCE: Risk Manager, Anesthesiology
ISSUE: FDA notified healthcare professionals of a Class I Recall due to a potential defect in the CAS I/II Absorber products employed in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber. (The Bag to-Vent switch因固定鬆脫問題，可能會造成switch失效)

In the worst case, this would result in a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode. Operation in vent mode along with all monitoring and alarm functions will continue to operate normally.
The affected products may cause serious adverse health consequences, including death.

BACKGROUND: These products are used in the hospital environment and in locations not requiring mobility of the products. They provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to deliver anesthetic vapor.

RECOMMENDATION: On Nov. 1, 2013, Spacelabs Healthcare sent an Urgent Medical Device Correction letter to all affected customers. Spacelabs Healthcare also sent a customer letter (translated as necessary) to all international subsidiaries and distributors of record by e-mail on Nov. 6, 2013.

(SaceLab己經發出通知信給各受影響的使用者，說明如何應因應，有使用本款設備的人，若沒收到通知信，請連絡代理商處理)
Customers were instructed to immediately advise their staff of the problem.

Customers with questions were instructed to contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376772.htm

Stryker infinite 用 LCD 電容故障

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名稱: Stryker infinite 用 LCD

故障情形：No function.電源燈一直閃

故障原因：電容故障

這是最近幾次處理螢幕後，收割的結果之一；現在辦公室的同事只要碰到LCD螢幕有故障，都會先拿下來，檢查一下電容或更換掉後．大概有70~80%的機會完修。Philips 超音波的LCD螢幕也是，至少撙節了20萬吧(好像報價是這樣，不是很確定，處理好的滿足感較重要。)

這次例子較特別，是微創手術主機用的LCD(液晶螢幕)，本來以為是infinite主機有問題，重新開機好幾次，有時就OK，到最後終於罷工了，所以再拿了一台LCD先擋著用，結果17吋的也不行，再拿一台19吋的　可以了，那就先擋著用，觸控功能先改用滑鼠囉。可是拿下來接一般電腦又Ok，原本以為是析度問題，得找時間上去調整一下。

過了不久，又一台同樣的狀況，這次也是先借一台上去擋著用，再把故障的拿來接一般電腦，真的不行，所以真的是LCD掛了。

一檢查，電源板電容有二個有微凸(1200uf/10V)，先換下來再說，試看看，嗯OK，後來想到，之前這台該不會也是一樣吧，再拆開，還真的一樣電容問題，一併解決掉，還給使用單位觸控功能了，耳根子可以清靜一下了。

一級召修 Hospira Inc., GemStar Infusion System

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Hospira Inc., GemStar Infusion System - Pressure Sensor Calibration Drift

＊＊＊ 衛署醫器輸字第009822號 ＊＊＊ 赫士睿" 寶星輸液暨疼痛處理幫浦

(國內引進的型號13000,13150。13086, 13087, 13088)

----今年5月才發布過鋰電池的Recall

Recall Class:  Class I
Date Recall Initiated:  March 15, 2013
Product:  Hospira GemStar Infusion System Models 13000, 13100, 13150, 13086, 13087, 13088
All GemStar Infusion Pumps that were either manufactured or had a pressure sensor replaced during servicing of the pump since January 1, 2009 could be affected.(影響設備自2009.01.01以後製造或更換過壓力sensor的pump)

The pump's date of manufacture can be found on the Product Identity label located on the back of the pump.
Use: The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods and blood/blood products.  The device can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries.  When powered by batteries, the GemStar Pump is used for ambulatory patients.
Recalling Firm:
Hospira Inc. 275 North Field Drive Lake Forest, Illinois  60045-2579
Reason for Recall:  The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test(近遠端壓力sensor在作阻塞測試時會出現失敗時，可能就是校正值漂移), as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion:

• Cassette Check – D
• Cassette Check - P
• Proximal Occlusion  
• Distal Occlusion
• Pressure Calibration Error
• Bad Pressure Sensor Event
• Bad Pressure Sensor State
• Distal Pressure is Out of Range
• Proximal Sensor is Out of Range

(若有出現以上的Error Code,就有可能是壓力sensor校正值漂移)

A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.  This issue may also result in the pump shutting down.
Potential Risks:

• If these errors are observed, the infusion is stopped, resulting in delay/interruption in therapy.
• A full or partial occlusion may prevent fluid from reaching the patient, resulting in delay/interruption of therapy.
• An undetected distal occlusion may cause excessive pressure and fluid build-up within the distal line undetected by the pressure sensor. When the distal occlusion is resolved, the build-up fluid will be administered into the patient possibly causing a maximal over-infusion of <1.0 mL.
• The severity in the delay/interruption in therapy is dependent upon the underlying condition of the patient and the treatment being prescribed.  A delay/interruption in therapy has a worst case potential to result in significant injury or death.
• Depending on the drug and the dosage delivered, over-infusion has the worst-case potential to result in significant injury or death.

Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies.  Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption in therapy or an over-infusion could result in significant injury or death.
Public Contact: Call Hospira Advanced Knowledge Center at 1-800-241-4002, option 4 if you are unsure if the pressure sensor in your device has been replaced since January 1, 2009.
FDA District:  Chicago District Office
FDA Comments:

On March 15, 2013 Hospira sent its customers of record who purchased the device directly from them an "Urgent Device Field Correction¹" letter.  

Required Actions:

• Immediately perform proximal and distal occlusion tests as defined in the GemStar Technical Service Manual. If the device fails either of the tests, remove it from clinical service. Contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM Central Standard Time) to report the issue and arrange for the return of the device for recalibration.
• Add the performance of a proximal and distal occlusion test to your yearly GemStar maintenance schedule.
• Complete and return the attached reply form and return it to the fax number or email address on the form, even if you do not currently have the impacted devices. Contact Stericycle at 1-866-606-8264 (Monday- Friday, 8 AM - 5 PM Eastern Standard Time) to obtain additional copies of the reply form.
• Notify your accounts who may have received these devices from you if you have further distributed them and ask that they contact Stericycle at 1-866-606-8264 (Monday- Friday, 8 AM - 5 PM Eastern Standard Time) to receive a reply form.

（可以要求代理商 請先依原廠維修手冊，進行近遠端壓力sensor阻塞測試，並列入年度保養維護項目，並將檢測結果回傳Hospira公司)

Hospira Actions:

• Hospira is modifying the GemStar Technical Service Manual to add proximal and distal occlusion tests annually to confirm that devices do not require recalibration.

For further inquiries, contact Hospira using the information provided below.

Hospira Contact	Contact Information	Areas of Support
Hospira Global Complaint Management	1-800-441-4100 (8AM-5PM CST, M-F) (ProductComplaintsPP@hospira.com)	To report adverse events or product complaints
Hospira Advanced Knowledge Center	1-800-241-4002, option 4 (Available 24 hours a day/7 days a week)	Additional information or technical assistance

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 adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program² either online, by regular mail or by FAX.

TOP 10 HEALTH TECHNOLOGY HAZARDS FOR 2012~2014 (ECRI 2014 十大醫療技術危害 )

(http://bme.freebbs.tw 醫學工程論壇同步發表)

Top_10_Hazards_Executive_Brief.原文網址

Alarm hazards、Pump,輻射、內視鏡問題及IT相關問題  己經連續三年蟬聯囉

手術機器人的問題第一次出現，看來醫生對使用Robot要有重新的認知跟訓練，
可能較少打電動玩具吧  ^^

	2014	2013	2012
1	Alarm hazards   各種不適當警報造成的危害	Alarm hazards  各種不適當警報造成的危害	Alarm hazards 各種不適當警報造成的危害
2	Infusion pump medication errors 點滴幫浦的給藥錯誤	Medication administration errors using infusion pumps 點滴幫浦給藥量錯誤	Exposure hazards from radiation therapy and CT 放射治療及電腦斷層輻射曝露危害
3	CT radiation exposures in pediatric patients 在兒科患者的CT輻射暴露	Unnecessary radiation exposures and radiation burns during diagnostic radiology procedures 非必要輻射曝露及檢查過程中輻射灼傷	Medication administration errors using infusion pumps 點滴幫浦給藥量錯誤
4	Data integrity failures in EHRs and other health IT systems 電子健康檔案和其他醫療IT系統的資料整合失敗	Patient/data mismatches in EHRs and other health IT HIT systems 電子病歷及其他健康資訊資料錯誤	Cross-contamination from flexible endoscopes 軟式內視鏡的交叉污染
5	Occupational radiation hazards in hybrid ORs 混合式手術室的職業輻射危害	Interoperability failures with medical devices and health  IT systems 醫儀與資訊系統連線管理疏忽	Inattention to change management for medical device connectivity 醫儀與資訊系統連線管理疏忽
6	Inadequate reprocessing of endoscopic devices and surgical instruments 內視鏡設備和手術器械再處理的不足	Air embolism hazards 空氣栓塞危害	Enteral feeding misconnections 餵食管的錯誤連接
7	Neglecting change management for networked devices and systems 忽略聯網設備和系統的變更管理	Inattention to the needs of pediatric patients when using "adult" techniques 用成人治療技術未注意小兒病患的差別需求	Surgical fires 手術室火災
8	Risks to pediatric patients from "adult" technologies 使用"成人"技術時導致的兒科患者的風險	Inadequate reprocessing of endoscopic devices and surgical instruments 軟式內視鏡及手術器械的交叉污染	Needlesticks and other sharps injuries 針頭或其他銳器傷害
9	Robotic surgery complications due to insufficient training 由於訓練不足所導致的機器人手術併發症	Caregiver distractions from smartphones and  other mobile devices 智慧型手機或行動裝置造成醫護人員分心	Anesthesia hazards due to incomplete pre-use inspection 檢查疏失造成的麻醉意外
10	Retained Devices and Un-retrieved Fragments 遺留的物件和無法恢復的碎片	Surgical Fires 手術室火災	Poor usability of home-use medical devices 家用醫療器材可用性不佳造成的意外