水銀血壓計回收貯放

(http://bme.freebbs.tw 醫學工程論壇同步發表)

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}