租借物厂家完整处理流程--理念灭菌递送处理等课件.pptx

1、1.Discuss the current and future recommended practice and standards for accepting and processing loaner instruments.目前与未来的实施标准与建议（租借器械）2.Describe how sterilization practices in America and the world affect patient safety.美国灭菌的处理流程与病患保障 AAMI TIR63 Management of loaned critical and semi-critical medic

2、al devices that require sterilization or high-level disinfection高危险或者中度危险医疗设备，需使用灭菌或者高水平消毒Medical devices not owned by the health care facility that are loaned through a loan agreement with a vendor or another health care facility通过协议而租借的相关医疗器械，本身并不属于医院。A.Roles and responsibilities of the senderB.Ro

3、les and responsibilities of the receiver发送与接受者的相关准则要求A.Requisition 正式申请B.Scheduling 时间安排C.Receipt 收到相关协议D.Return 返还E.Tracking and documentation 追踪与文件3 Policy development3 Policy developmentConfirm availability on the date requested.确认需求的时间Assure complete shipping.确保完成运输Written documentation of medic

4、al devices inventory at the time of delivery.医疗器械的详细目录文件 Provide training 需要的培训An agreed-upon time and method of delivery 互相接受的递交方式与时间A means of traceability 追踪 Serial number 型号 Lot number 批号 Catalog number 目录好4.2 Roles and responsibilities of the sender4.2 Roles and responsibilities of the senderWr

5、itten IFUsPacking slip with the following information Purchase order number购买的合同数量 Shipment contents 运输内容 Item description and catalog number of each device.每一个装置的具体描述与它的相关序号Surgery date 使用时间Surgeon 医生Ship date 运输时间Sales representative or contact information 相关人员信息Shipping address 地址And specific del

6、ivery instructions 包括需要投递特殊的物件Information to be included with the device:4.2 Roles and responsibilities of the sender4.2 Roles and responsibilities of the senderCommunication Communication 沟通沟通Financial Responsibility Financial Responsibility 财务财务Device Responsibility Device Responsibility 器械器械Requi

7、sition Requisition 需求需求4.3 Roles and responsibilities of the sender4.3 Roles and responsibilities of the senderA procedure to ensure communication is clear and consistent to all involved.有整套流程确保沟通清晰，所有内容完整Included in the communication chain are:The surgeon 医生Operation room personnel 手术人员CSSD personn

8、el 供应室人员Health care technology management personnel(if an equipment safety check is required)相关技术人员Supply chain personnel 供应链人员The sender 服务运输人员4.3.1 Communication4.3.1 CommunicationSpecific Payment and financial responsibility for a loaned medical device,including:为了租借物品而特殊需要的财务和相关责任$Required proce

9、ss for payment to sender.运输者的相关费用$Documentation needed for payment.文件相关的费用$Who pays for replacement of lost or broken medical device.遗失或者使用损坏的费用支取4.3.2 Financial Responsibility4.3.2 Financial ResponsibilityThe healthcare facility should document its responsibility:Determining if a loaner is appropri

10、ate for use in the healthcare facility.确认如何正确的使用Be sure the healthcare facility is able to process the loaner instrumentation 确认有能力处理流程Keep agreements to the agreed upon time and method of receiving loaners 有协议确认收到时间与收取方式Reporting any damage or possible damage to loaners while at the healthcare faci

11、lity.相关报告损坏或者可能损坏的器械Decontaminate loaners before they are returned.返还之前是否需要消毒处理4.3.Device responsibility4.3.Device responsibilityPatient name病患使用者Loaner set(s)to be expecting 器械的预期使用Date and time of the procedure流程的具体日期与时间4.4 Requisition4.4 RequisitionThe healthcare facilities s policy should specif

12、y how the amount of time before the procedure should the device be delivered.医院需要确定多少时间在装置运送抵达之前This time should be agreed upon by all of those involved.所有的相关人员都需要知晓这个时间4.5.1 Delivery4.5.1 DeliveryThe loaner(s)should arrive at the time agreed upon.规定时间之前到达The healthcare facility should not accept lo

13、aner(s)if they do not arrive in sufficient time to follow its procedures(except in an emergency).如果没有准时到达，医院有权不接受这些器械4.5.3 Processing time4.5.3 Processing time4.5.2 Information from the receiver4.5.2 Information from the receiverExpected date and time of arrival of the loaner(s).时间与日期的到达If applicabl

14、e date and time of training.是否有时间可以进行培训Place BI s and CIS into area of package determined to the great challenge使用化学和生物监测Corner 角落处Different layers 不同层Next to heat sink(metal mass)According to FDA,“device that is placed into a surgically or naturally formed cavity of the human body if it is intended

15、 to remain there for a period of 30 days or more.FDA may,in order to protect public health,determine that devices placed in subjects for shorter periods are also implants Loads contain implantable devices should be quarantined until biological indicator results are available 植入物器械必须在生物指示剂结果出现后才能进行使用

16、 If documented medical exceptions dictate release of implant before BI PCD result 如果需要提前放行-Use implant log and an exception form Critical that documentation be fully traceable to the patient 具有全程追溯性PCD:Item designed to constitute a defined resistance to a sterilization process and used to assess per

17、formance of the process.BI should run daily,Implant every load.生物PCD每天使用 植入物每锅使用 The use of BIs provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores.使用生物指示剂，提供相关验证灭菌过程有效性Biological indicators provide the only direct measure of the letha

18、lity of the sterilization process.生物监测 是最直接的方式测试灭菌有效性Neither CI can be used to replace Bis没有任何化学指示物，可以取代生物指示剂Some facilities are moving to a higher standard of patient care by monitoring every sterilization load with a biological indicator.有一些机构使用更好标准，每一个锅次，都进行生物监测 Cost and impact of a recall 召回的成本分

19、析 Ensure every type of sterilization cycle used is monitored 确保每一钟灭菌循环方式都是有被检测的 Reduce risk and cost of healthcare-associated infections 减少感染的风险Porous Test PackHollow LoadORBI challenge test pack:AAMI ST 79 do not recommend hospital to use any hollow load/Helix test美国标准没有任何条款美国标准没有任何条款 推荐使用管腔装置推荐使用管

20、腔装置Test Periodic Annually年度使用Porous BD test everydayBD每天使用A.2 Hollow Load test was not performance qualification test.It means hospital need not do everyday管腔装置不是用来做质量验证 医院无需每天使用A.5 Porous BD test was the performance qualification test.hospital should do everyday BD是用来做质量验证 医院需每天使用ISO 17665-1,-2No N

21、o The hollow load test is a type test specified in EN 285:2006+A1:2008.It is not intended to be used other than as a type test by the sterilizer manufacturer.管腔不是为了最终的使用 而是为了灭菌器制造商的用来验证的装置The Bowie Dick test is a test that is intended to be performed daily by the end user.BD测试本身就是为了每天测试灭菌质量的表现AAMI S

22、T 79:Does NOT have a standard that calls out a specific helix 没有任何具体对管腔装置的标准ISO 17665:Hollow Load test was not performance qualification test.Hospital need not run Hollow load test湿热产品标准，管腔装置不是每日使用，医院并不需要使用管腔装置ISO 17665:Porous BD test was the performance and operation qualification test.Test Periodi

23、c Daily 辅料的BD测试，是灭菌器与运行的标准，每天进行操作ISO 11140-3,-4,-5,described linen PCD,no helixISO 11140-3,4,5中都是辅料PCD，没有管腔装置Patient safety is the main goal for all CSSD team members.It is and must be our fiduciary responsibility to produce a product free from bacteria to our customer.病人安全是整个CSSD工作的重要部分 我们的职责是提供无菌的

24、物品Patients enter hospitals,clinics,outpatient centers and doctors offices with problems.The patient does not need to contract an infection just from having a contaminated tray or instruments used during the procedure.让病患远离受过污染或者使用过的器械The team members in CSSD are not seen by the patient,yet they can

25、impact the outcome of a patients case if the tray or instrument used is not processed correctly.虽然CSSD的同事并不需要见到病患The patient enters the facility with the full confidence that the members of the CSSD are producing a quality product for their case each and every time.病患进入医院就是相信每一个器械都是安全的。HAIs(Health c

26、are acquired infections)are not to be tolerated in the CSSD environment due to inadequate care in the cleaning,reassembly and sterilization of instruments and products for the patient.在CSSD环境发生院内感染,是不能被接受的。Required certification is the hot item topic in the USA today 资质确认目前是美国的热点话题The state of New Y

27、ork just passed a law making it a rule that in order to work in a CSSD you must be certified.New Jersey is the only other state requiring certification.Forty-eight states to go!在纽约已经立法需要CSSD资质上岗Certification only means you have the basic minimum knowledge to provide the service of cleaning,reassembl

28、y,and sterilization 需要拥有最基本的相关知识By having this as a requirement each medical facility will have the consistency needed to give quality service.既然有这个规定，就需要提供相应的服务Certification also brings about continued education.Each certified technician must complete at least 12 CEUs(continuing education credit)pe

29、r year.持续性的教育This requirement gives you technicians that are aware of what is new and required in the industry.最新与行业的需求同时学习In the USA we presently have the option to follow the ANSI/AAMI ST79 recommended practice manual.按照指南的推荐手册进行操作In the future the verbiage will need to change to give some type of

30、 control over how CSSDs are managed throughout the USA.一些繁琐的东西将不断的简化改进This is called standardization.这就是标准化The future will bring standardization to all medical facilities in the USA thus giving each patient the same level of care.This new requirement will only serve to help CSSDs maintain the best p

31、ractice and stay aware of all new and improved processes.The future of CSSDs in the USA will require that we focus on patient safety while using best practice for each patient every time to control the spread of HAIs.通过每天正确安全的操作，为美国CSSD的未来 The added step of regulation will only serve to give consist

32、ent levels of sterilization practice to each and every medical facility.Looking back at the improvements that have evolved over the last fifty years serves only to show how important the work done is CSSDs has become.不断的提高，带来行业持续Looking toward the future out profession looks bright.Out patients will

33、 be far better off with out focus on their safety while hiring educated technician a field that has some standardization.The future CSSD in the USA can only get better!展望未来 一切会更好Relative Humidity Levels in the Operating Room Joint Communication to Healthcare Delivery Organizations AAMI TIR55:2015 Human factors engineering for processing medical devices AAMI TIR55:2015 Human factors engineering for processing medical devices Thank You!