ACOMED 多功能型手術檯 AT-6600G 動作異常。

(http://bme.freebbs.tw 醫學工程論壇同步發表)

名稱:ACOMED 多功能型手術檯 AT-6600G
故障情形：動作異常。
故障原因：搖控器接線受潮。

這手術台剛推下來時，真的有點像是中風的病人，頭板會一直上升，腳板則一直下降，還往側翻...，大家的直覺就是...搖控器按鍵有問題。

換了一個還是一樣，也因為己經都動作到底了，所以怎按都沒反應，而且按鍵對應的動作，也都不對，再換掉連接線，還是一樣；開始動起電路板的念頭了，把僅剩可以動作的電磁閥跳接到頭、腳側的電磁閥，先把台子的形狀恢復到正常平衡的樣子，這樣也好看是那個電磁閥在作亂。

就在這時發現一樣特別的事，線一接，搖控器還沒接上，就會開始亂動了。當下就懷疑電路板上的relay有問題，拆下板子檢查看看，Relay似乎沒什麼大礙裝回去，線一接，搖控器還沒接上，還是開始亂動了。

這時同事想到了，板子沒問題，線也換了，該不會是接點吧，他的用的是15P D型接頭，就是電腦早期用的搖桿接頭那種，

拿起了祕密武器.....吹風機！沒錯就是吹頭髮用的吹風機，慢速熱風吹了2~3分鐘，一切恢復正常...

最近天氣乾燥，嗯....應該是有液體去滴到吧。

TOP 10 HEALTH TECHNOLOGY HAZARDS FOR 2011 (ECRI 2011 十大醫療技術危害 )

(http://bme.freebbs.tw 醫學工程論壇同步發表)

TOP 10 HEALTH TECHNOLOGY HAZARDS FOR 2011 (ECRI 2011 十大醫療技術危害 )

原文出處 原文下載

TOP 10 HEALTH TECHNOLOGY HAZARDS FOR 2010~11

(IT的問題首次列入在醫療技術危害)

	2011	2010
1.	Radiation Overdose and Other Dose Errors during Radiation Therapy 放射治療過程中，輻射劑量超標或錯誤	Alarm Hazards 各種不適當警報造成的問題
2.	Alarm Hazards 各種不適當警報造成的問題	Needlesticks and Other Sharps Injuries 針刺或尖銳物刺傷問題
3.	Cross-Contamination from Flexible Endoscopes 軟式內視鏡使用時的交叉感染	Air Embolism from Contrast Media Injectors 造影劑注射器造成的空氣栓塞
4.	The High Radiation Dose of CT Scans CT高輻射劑量造影	Retained Devices and Unretrieved Fragments 體內遺留器械及未處理妥當的碎片
5.	Data Loss, System Incompatibilities, and Other Health IT Complications 資訊系統中的資料遺失或不相容問題	Surgical Fires 手術室火災
6.	Luer Misconnections Luer連結頭漏	Anesthesia Hazards due to Inadequate Pre-Use Inspection 不當的使用前檢查所造成的麻醉機問題
7.	Oversedation during Use of PCA Infusion Pumps PCA幫浦使用中造成Oversedation 問題	Misleading Displays 螢幕顯示資訊不易了解
8.	Needle sticks and Other Sharps Injuries 針刺或尖銳物刺傷問題	CT Radiation Dose CT造影劑量問題
9.	Surgical Fires 手術室火災	MR Imaging Burns MR檢查時物品起火
10.	Defibrillator Failures in Emergency Resuscitation Attempts 急救時電擊器失效問題	Fiberoptic Light-Source Burns 軟式內視鏡光源起火問題

TOP 10 HEALTH TECHNOLOGY HAZARDS FOR 2011 (ECRI 2011 十大醫療技術危害 )

(http://bme.freebbs.tw 醫學工程論壇同步發表)

 

TOP 10 HEALTH TECHNOLOGY HAZARDS FOR 2011 (ECRI 2011 十大醫療技術危害 )

 

原文出處    原文下載

 

1. Radiation Overdose and Other Dose Errors during Radiation Therap

2. Alarm Hazards

3. Cross-Contamination from Flexible Endoscopes

4. The High Radiation Dose of CT Scans

5. Data Loss, System Incompatibilities, and Other Health IT Complications

6. Luer Misconnections

7. Oversedation during Use of PCA Infusion Pumps

8. Needlesticks and Other Sharps Injuries

9. Surgical Fires

10. Defibrillator Failures in Emergency Resuscitation Attempts

2010 年度召回總清單(List of Device Recalls)

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2010 年度召回總清單(List of Device Recalls)

FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.
Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products.
Please note that FDA now lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. You can find the date that a firm initiated a recall in the text of the recall notice.
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2010 Medical Device Recalls
Listed by date posted on FDA website
Device Name
Date
Penumbra System Reperfusion Catheter 032
12/08/10
Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps - Recall, Refund and Replacement
11/30/10
B. Braun addEASE Binary Connector
11/30/10
WalkMed, Inc. Triton Pole Mount Infusion Pump
11/24/10
Micromedics, Inc., Surgical Sealant Dispensers, Micromedics Nasal Septal Buttons, and Otological Ventilation Tubes – Sealed in Pouches
11/23/10
SIGMA Spectrum Infusion Pump Model 35700
11/12/10
bioMérieux, Inc., VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP)
11/10/10
Hospira Symbiq One and Two Channel Infuser
11/04/10
Medtronic Octopus Nuvo Tissue Stabilizer, Model TSMICS1
11/02/10
Excelsior Medical Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe)
10/26/10
CareFusion Corporation, Alaris PC Units (Model 8015)
10/15/10
Westmed Inc., BagEasy Manual Resuscitation Devices
10/13/10
Multi-Med, Inc. Huber (Non-coring) Needles and Finished Devices Containing Huber Needles Labeled as "All-Med Medical Products, Inc." and "Marquette Medical, Inc." Brands and Provided to Some Consignees in Bulk Without Labeling
10/12/10
Symbiq One and Two-Channel Infusers
09/21/10
AngioScore Inc. - AngioSculpt "EX" PTCA Scoring Balloon Catheter
09/08/10
Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls)
08/26/10
Ikaria Holdings, INOMAX DS Drug Delivery System
08/23/10
St. Jude Medical 6 French Engage™ Introducer Devices
08/13/10
Cook Medical - Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube
08/04/10
Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System
07/20/10
Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser
07/15/10
Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System
07/02/10
Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors
07/02/10
Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED® Semi-automatic External Defibrillators
06/14/10
Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol
06/10/10
GE Healthcare Aisys and Avance Anesthesia Systems
05/17/10
Certain Cuffed Shiley Tracheostomy Tubes
05/17/10
Cardiac Science Corporation, Powerheart, CardioVive, Nihon Kohden, and GE Responder Automated External Defibrillators (AEDs)
04/30/10
Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator
04/22/10
Teleflex Incorporated - Arrow International Custom Intravenous (IV) Administration Products (IV Tubing Sets and Accessories) and Certain Arrow Arterial Embolectomy Catheters
04/08/10
Four Class I Recalls: Becton, Dickinson (BD) and Company, Q-Syte Luer Access Split Septum and Numerous Products Containing the Q-Syte Luer Access Split Septum Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.
03/30/10
Gyrus ACMI, Inc. Micron Bobbin Vent Tube T, 1.27 mm
03/17/10
Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath
03/11/10
Beckman Coulter Inc., UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell
03/10/10
Abiomed, Inc., AB5000 Circulatory Support System
03/10/10
Cardiac Science Corporation - Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs)
03/08/10
Thomas Medical Products Inc., Transseptal Sheath Introducer Kits
03/08/10
Baxter HomeChoice and HomeChoice PRO
03/03/10
Exelint International Inc. - Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion Sets
02/26/10
StatSpin, Inc., doing business as IRIS Sample Processing, StatSpin Express 4 Centrifuges, Model #510
02/26/10
Thomas Medical Products Inc., Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport
02/04/10
Hettich Instruments Management I, Hettich Centrifuges with 2050 and 2076 Plastic Rotors
01/28/10
Edwards Lifesciences Inc., Aquarius Hemodialysis System
01/28/10
ev3 Endovascular, Inc., Trailblazer Support Catheter
01/05/10
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Additional Resources
Medical Device Recalls
Recalls Database
Alerts and Notices (Devices)
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
FDA 101: Product Recalls - From First Alert to Effectiveness Checks

年度保養計劃的擬訂

(http://bme.freebbs.tw 醫學工程論壇同步發表)

又到了年底了，新年度即將來到，換句話說，所有工作都得作個總結，其中最重要的還是度的保養計劃了。

評鑑要求跟重視的就是PDCA，就我們自己的業務來說，現在就是P的階段了。

如果您也是要排定明年的保養計劃，確有點複雜無頭緒，參考我們的方法吧

P:計劃

計劃就是保養計劃，原則上目標物就是醫工所管理的所有的醫療儀器，不過就這幾年的方向，大概是以風險管理為主要的分類依據

先把所有設備依風險分類分級及保養分級:

1. 風險分類

風險分類	法規分類
風險1		未直接使用於病人儀器或簡單接觸病人皮膚表面不具治療或診斷功能者
風險2	低風險	儀器故障時不會直接或間接造成病人傷害者
風險3	中風險	儀器故障時會直接或間接造成病人傷害者,或數據不準會造成臨床誤判
風險4	高風險	儀器故障時會直接或間接造成病人死亡者

2. 保養分級

保養分類	執行內容	保養週期	負責單位
一級保養	依使用手冊執行清潔及功能測試，並作相關配件點檢。	日檢查、週檢查、月檢查	使用或保管單位
二級保養	定期耗材更換、設備調校、檢查	月保養、季保養、	醫工或廠商
三級保養	依原廠規範執行保養調校	半年保養、年度保養	醫工或廠商
合約保養	依原廠規範執行保養調校並與廠商簽訂合約(或保固內)執行		廠商

D:執行

1. 自行保養者，依所訂定的保養基準執行，如無保養基準，自行訂定或請廠商提供後修訂。

2. 確認保固內、租賃、合約保固及自行保固的範圍。

3. 保固內、租賃、合約保固等是以負責follow廠商處理為原則，並要求廠商要開具工單(含保養基準及耗材)。

4. 依所需保養的技術或設備可自行處理或申請洽商處理。

5. 自行保養者，如需更換耗材，可先申請，並列入保養基準記錄。

6. 建檔時，保養記錄需以定期清潔保養或合約保養建檔，以利統計。

C:檢核

1. 保養達成率設定為每季>25%

2. 建議每季保養會議:，於每季最後一月的第二個週五，並做會議記錄。

3. 每季保養會議中提出請各工程師提出保養達成率

4. 如有資產不明或己報廢經行政助理盤點確認或確認設備閒置超過一年，請當成異常提出，於每季保養會議中提出。

A:改善

1. 如有資產不明或己報廢，請將資料移轉行政助理作後續盤點確認。

2. 依開箱日期，確認是否為新增的設備並訂為保固內及新增保固週期後納入清單

3. 將一級保養及上年度保養有異常，如閒置、不明、報廢等無法保養的資產剔除。

4. 依上次保養人，預排為本次保養人，再平均各工程師的負荷。

5. 如有資產不明或己報廢經行政助理盤點確認或確認設備閒置超過一年，當成異常提出，並會資材課財產組及使用單位上層主管，並由行政助理做follow，並留記錄。