醫工證照上路前準備....點火了嗎?????

(http://bme.freebbs.tw 醫學工程論壇 同步發表)

今天收到一份文...

宜蘭縣衛生局的來文 :貴 院需定期執行院內醫療器材之維修、保養、校正、汰換等作業以及考量負責維修保養醫療器材之相關從業人員，是否亦應具備特定資格，本局(宜蘭縣政府衛生局)將納入醫療院所年度評鑑及抽查之重點考核項目。

這是發生什麼事呢

這是由食品藥物管理局建議衛生署上述的事情，衛生署回函說明,在評鑑時已列有相關條文，會作為以後評鑑的改進參考。同時將本文一併轉各縣市衛生機關，所以各位應該都會收到這份文。

汰舊換新這事，我知道是因應健保局前陣子抽審CT片時所引發的話題，

但”相關從業人員，是否亦應具備特定資格，”這指的是什麼事呢，證照嗎?還是指訓練?

我相信以地方衛生局的認知，應該不是對所謂的證照有很深入的了解，不過這也是好事一件，至少為證照開頭了。

不曉得各位所在的地方衛生機關，在醫政督導時，會不會提到這個話題，如果有的話，就請大家多多宣導證照的概念，開始點一下火吧。

一級回收 B. Braun, Outlook 400ES Safety Infusion System, Model Number 621-400ES

(http://bme.freebbs.tw 醫學工程論壇同步發表)

B. Braun, Outlook 400ES Safety Infusion System, Model Number 621-400ES(原文出處請點選)

衛署並無登記字號，國內應該沒引進。

Recall Class: Class I

Date Recall Initiated: August 24, 2010

Product: Outlook 400ES Safety Infusion System Model number 621-400ES

Manufacturing From: May 21, 2009 - June 23, 2009

Distribution From: July, 24, 2009 - December 31, 2009

The recalled products were upgraded from May 4, 2010 - June 21, 2010.

Use: The B. Braun Outlook 400ES Safety Infusion System is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid when the IV fluid container is lower than the pump and provides the accurate volume of all standard IV fluid, including blood, lipids, and Total Parenteral Nutrition (TPN).

Recalling Firm:
B. Braun Medical, Inc.
1601 Wallace Dr. Ste 150
Carrollton, Texas 75006

Reason for Recall: Infusion systems upgraded with the Motorola compact flash hardware and supporting software when used in a network environment that utilizes Temporal Key Integrity Protocol (TKIP) authentication can potentially induce a memory leak that can cause the Management Processor to become non-responsive.

This causes normal operation to stop, which is signaled by an audible backup alarm indicating that the pump is not delivering the medicine. There is no visual error warning to alert the user that the pump is not working.

經升級硬體(Motorola compact flash hardware快閃記憶體)後，在使用網路時利用軟體使用(TKIP) 作授權管制時會造成暫時的記憶體漏失，使得管理程式會無法回應操作。

這問題會迼成設備正常停止運作，同時會有警告聲響(backup)提示，但並沒在螢幕上警示使用者設備己停止運作。

Public Contact: Questions should be directed to B. Braun at 972-245-2243.

FDA District: Dallas

FDA Comments: On August 24, 2010, the firm notified its customers, by mail, about the problem. In the letter, the firm directed its customers to deactivate the wireless communication on their pumps and return them to the manufacturer.

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 adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experience using these products to the FDA's MedWatch Adverse Event Reporting Program¹ either online, by regular mail or by FAX.

Useful Links:

• MedWatch: The FDA Safety Information and Adverse Event Reporting Program