pb7200呼吸機(jī)日常維護(hù)及保養(yǎng) - 國(guó)外醫(yī)療設(shè)備維修產(chǎn)業(yè)現(xiàn)狀一瞥

1、國(guó)外醫(yī)療設(shè)備維修產(chǎn)業(yè)現(xiàn)狀一瞥中國(guó)醫(yī)療維修產(chǎn)業(yè)論壇第二屆12th April 2007大連1摘要去年回顧國(guó)外醫(yī)療維修產(chǎn)業(yè)的發(fā)展國(guó)外是如何解決我們關(guān)心的幾個(gè)問(wèn)題2現(xiàn)狀3Alternate Site BurnPad Site Burn風(fēng)險(xiǎn)4去年回顧醫(yī)院的現(xiàn)狀和風(fēng)險(xiǎn)您正在使用的醫(yī)療設(shè)備安全嗎？什么是評(píng)估標(biāo)準(zhǔn)？您使用什么手段和工具？您真的知道醫(yī)療設(shè)備的壽命和使用，保養(yǎng)要求嗎？誰(shuí)來(lái)保證醫(yī)院設(shè)備長(zhǎng)期安全，穩(wěn)定，持續(xù)的運(yùn)行？如何改變頭痛醫(yī)頭，腳痛醫(yī)腳，缺乏計(jì)劃性維護(hù)的現(xiàn)狀配件的地位：至高無(wú)上！一把雙刃箭！追求廉價(jià)與忽視維修質(zhì)量、效率及安全的誤區(qū)醫(yī)院工程師缺乏專(zhuān)業(yè)培訓(xùn)5去年回顧維修服務(wù)商的現(xiàn)狀和風(fēng)險(xiǎn)沒(méi)有行業(yè)服務(wù)

2、標(biāo)準(zhǔn)！沒(méi)有制度保障！魚(yú)木混雜誰(shuí)真正了解GB9706?醫(yī)療設(shè)備的特殊性，它們不是家用電器！維修費(fèi)和勞務(wù)費(fèi)-讓我歡喜讓我憂(yōu)?產(chǎn)品維修資質(zhì)及培訓(xùn)完善自身維修管理，加強(qiáng)工程師培訓(xùn)，他們需要資質(zhì)和證書(shū)嗎？一個(gè)培訓(xùn)證書(shū)不可以包治百病6去年回顧一些建議和呼吁政府、醫(yī)療機(jī)構(gòu)、協(xié)會(huì)、學(xué)會(huì)、廠(chǎng)家、服務(wù)商建立設(shè)備安全責(zé)任的法律，法規(guī)。包括設(shè)備管理及持續(xù)安全性的評(píng)估制度及方法，出廠(chǎng)合格不代表永遠(yuǎn)合格。醫(yī)療行業(yè)維修服務(wù)標(biāo)準(zhǔn)和規(guī)范也許可以解決當(dāng)前的尷尬處境，建立專(zhuān)項(xiàng)資金（廠(chǎng)家及專(zhuān)業(yè)人士提供參考），用于醫(yī)院設(shè)備的日常預(yù)防性保養(yǎng)，延長(zhǎng)設(shè)備使用壽命和安全評(píng)估供方維修能力及可信度，如配件供貨，維修專(zhuān)用工具，設(shè)備，工程師的資質(zhì)提供

3、專(zhuān)業(yè)的，有效的產(chǎn)品安全指導(dǎo)，不僅僅是功能性的介紹提供多種服務(wù)供用戶(hù)選擇，保證售出產(chǎn)品得到良好的維護(hù)保養(yǎng)、定期檢驗(yàn)合理定價(jià)，制訂合理規(guī)范的報(bào)價(jià)體系7JACHO 報(bào)告Staffing Inadequate orientation/training process87 percent Insufficient staffing levels35 percentCommunication breakdown Among staff members70 percent With patient/family9 percentIncomplete patient assessment Room desig

4、n limits observation30 percent Delayed or no response to alarm22 percent Monitor change not recognized13 percentEquipment Alarm off or set incorrectly22 percent No alarm for certain disconnects22 percent Alarm no audible in all areas22 percent No testing of alarms13 percent Restraint failure (escape

5、)13 percentDistraction (environmental noise)22 percentCultural (hierarchy/intimidation)13 percent8本行業(yè)國(guó)外管理發(fā)展歷程1974年，醫(yī)院認(rèn)證委員會(huì)（JACHO)發(fā)布了所有交流供電設(shè)備的季度電氣安全測(cè)試規(guī)定1971到1975年，ECRI出版了醫(yī)療設(shè)備預(yù)防性維護(hù)操作流程1976年，美國(guó)議會(huì)通過(guò)醫(yī)療設(shè)備修正案，授權(quán)FDA管理醫(yī)療設(shè)備,包括:上市前的管理：510K上市后的監(jiān)督召回的跟蹤1984年，ECRI提出3級(jí)設(shè)備風(fēng)險(xiǎn)分類(lèi)9ECRI, July 1992; Bernzweig, 1996Liabilit

6、y in Tort民事責(zé)任There are two basic ways in which a person may be found legally responsible or liable for his actions. One, criminal liability, which deals with offenses against society as a whole. It is the domain of the police and prosecutors or district attorneys, while the other, civil liability, i

7、nvolves plaintiffs, defendants, and the “civil courts” (ECRI, OR Risk Management, Principles of Negligence Law, July 1992, p. 1; Bernzweig, 1996, p 13).Bernzweig, E. P. (1996). The Nurses Liability for Malpractice. St. Louis, MO: C. V. Mosby10ECRI Emergency Care Research Institute 風(fēng)險(xiǎn)等級(jí)分類(lèi)11本行業(yè)國(guó)外情況維護(hù)計(jì)

8、劃-當(dāng)前的狀況維護(hù)分類(lèi)非計(jì)劃性的維修更換部件計(jì)劃性的定期更換預(yù)防性維護(hù)報(bào)廢維護(hù)策略非計(jì)劃性維護(hù)：所有設(shè)備和相關(guān)設(shè)備計(jì)劃性維護(hù)：可針對(duì)選定的組別，如生命支持設(shè)備計(jì)劃維護(hù)過(guò)程PM: 為防止可預(yù)見(jiàn)的故障發(fā)生，定期更換易損件PVT: 定期的性能測(cè)試以確認(rèn)設(shè)備符合原來(lái)的技術(shù)指標(biāo)，排除相關(guān)的安全風(fēng)險(xiǎn)12本行業(yè)國(guó)外情況醫(yī)院日常維修活動(dòng)醫(yī)療器械監(jiān)管法規(guī)健全，醫(yī)院要求服務(wù)商提供他們所需的服務(wù)BME 執(zhí)行他們?nèi)粘５腜M計(jì)劃和性能，安全評(píng)估，選擇并與維修商簽署和評(píng)估維修協(xié)議，并確定詳細(xì)維修和服務(wù)內(nèi)容非計(jì)劃性維修的跟蹤或執(zhí)行維修報(bào)告和付款通知工時(shí)和勞務(wù)費(fèi)-主要的贏(yíng)利手段！同時(shí)促進(jìn)BME的發(fā)展維修服務(wù)商的信用及再評(píng)估參

9、加廠(chǎng)家的正規(guī)有償培訓(xùn)，拿到相關(guān)維修證書(shū)13本行業(yè)國(guó)外情況為什么醫(yī)院自己需要對(duì)設(shè)備進(jìn)行定期維護(hù)？JACHO 證書(shū)可以證明醫(yī)院的管理水平，ISO9001不一定適合其中要求對(duì)設(shè)備要進(jìn)行有效維護(hù)可被列入政府、醫(yī)療保險(xiǎn)指定的醫(yī)療機(jī)構(gòu)，保證醫(yī)院的收入?yún)⒄諛?biāo)準(zhǔn) IEC, ECRI, AAMI, JACHO etc參照廠(chǎng)家的要求醫(yī)院受訓(xùn)BME完成PM或簽保修、保養(yǎng)合同14醫(yī)療維修產(chǎn)業(yè)是否應(yīng)該打破壟斷？競(jìng)爭(zhēng)才有生命力壟斷不太可能帶來(lái)好的服務(wù)如何規(guī)范讓致力于服務(wù)的公司參與進(jìn)來(lái)？如何保證安全和正當(dāng)競(jìng)爭(zhēng)？服務(wù)分級(jí)？怎樣可以減少醫(yī)院的維修費(fèi)用并提高服務(wù)質(zhì)量？15本行業(yè)國(guó)外情況配件的銷(xiāo)售公平貿(mào)易法廠(chǎng)家的另一項(xiàng)收入來(lái)源質(zhì)量

10、保證及相關(guān)法規(guī)、政策支持16本行業(yè)國(guó)外情況第三方服務(wù)任何人均有權(quán)利去提供服務(wù)按設(shè)備分類(lèi)去選擇你的服務(wù)工程師培訓(xùn)證書(shū)告訴你他可以做什么定期需要再培訓(xùn)維修公司需要什么證書(shū)？不應(yīng)該是銷(xiāo)售許可證！17本行業(yè)國(guó)外情況培訓(xùn)提供服務(wù)的一種形式，可以贏(yíng)利臨床及使用培訓(xùn)安全注意事項(xiàng)及保養(yǎng)，維護(hù)培訓(xùn)開(kāi)放對(duì)第三方工程師培訓(xùn)？18Tyco Healthcare技術(shù)支持/維修事業(yè)部 閆亮長(zhǎng)江后浪推前浪19謝謝朋友們多年的支持！20Idc+4WK-hYeQZ+D(J-urkBCQCpHP7cq4PQBz6PUQ*#$-wE!+y*&3#-B5Hze7Keae(-#f&(UYCb&UonKCtUNqsaM8F5ueBbI8

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