租借物厂家完整处理流程---理念灭菌递送处理课件

1、“What will become the main focus of this important department?”Sharon Greene-Golden, CRCST,FCS1. Explain the importance of following the recommended practice guidelines as in the AAMI/ST79.2. Discuss the current and future recommended practice and standards for accepting and processing loaner instru

2、ments.3. Describe how sterilization practices in America and the world affect patient safety. ObjectivesAAMI TIR63 Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfectionWhat are Loaned Medical Devices?Medical devices not owned by the hea

3、lth care facility that are loaned through a loan agreement with a vendor or another health care facilityRoles and responsibilities of the senderRoles and responsibilities of the receiverRequisitionSchedulingReceiptReturnTracking and documentation3 Policy developmentLoaner PolicyConfirm availability

4、on the date requested.Assure complete shipping.Written documentation of medical devices inventory at the time of delivery.Provide trainingAn agreed-upon time and method of deliveryA means of traceabilitySerial numberLot numberCatalog number4.2 Roles and responsibilities of the senderRoles and respon

5、sibilities of the senderRoles and responsibilities of the senderWritten IFUsPacking slip with the following informationPurchase order numberShipment contentsItem description and catalog number of each device.Surgery dateSurgeonShip dateSales representative or contact informationShipping addressAndy

6、specific delivery instructionsInformation to be included with the device:4.2 Roles and responsibilities of the senderCommunicationFinancial ResponsibilityDevice ResponsibilityRequisition4.3 Roles and responsibilities of the senderRoles and responsibilities of the health care facilityA procedure to e

7、nsure communication is clear and consistent to all involved.Included in the communication chain are:The surgeonOperation room personnelCSSD personnelHealth care technology management personnel (if an equipment safety check is required)Supply chain personnelThe sender4.3.1 CommunicationCommunication

8、Healthcare FacilitySpecific Payment and financial responsibility for a loaned medical device, including:$Required process for payment to sender. $Documentation needed for payment. $Who pays for replacement of lost or broken medical device. 4.3.2 Financial ResponsibilityFinancial ResponsibilityThe he

9、althcare facility should document its responsibility:Determining if a loaner is appropriate for use in the healthcare facility.Be sure the healthcare facility is able to process the loaner instrumentationKeep agreements to the agreed upon time and method of receiving loanersReporting any damage or p

10、ossible damage to loaners while at the healthcare facility.Decontaminate loaners before they are returned.4.3. Device responsibilityDevice ResponsibilityLoaner RequisitionPatient nameLoaner set(s) to be expectingDate and time of the procedure4.4 RequisitionDeliveryThe healthcare facilities s policy

11、should specify how the amount of time before the procedure should the device be delivered.This time should be agreed upon by all of those involved.4.5.1 DeliveryProcessing TimeThe loaner(s) should arrive at the time agreed upon.The healthcare facility should not accept loaner(s) if they do not arriv

12、e in sufficient time to follow its procedures (except in an emergency).4.5.3 Processing timeSender Communication4.5.2 Information from the receiverExpected date and time of arrival of the loaner(s).If applicable date and time of training.Product TestingPlace BI s and CIS into area of package determi

13、ned to the great challengeCornerDifferent layersNext to heat sink (metal mass)Every Pack should be monitored with External and Internal CIsImplant/Implantable deviceAccording to FDA, “device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain the

14、re 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 implantsRelease for Implant LoadsLoads contain implantable devices should be quarantined until biological indicator results are availableIf documente

15、d medical exceptions dictate release of implant before BI PCD result- Use implant log and an exception form Critical that documentation be fully traceable to the patientProcess Challenge Device BI (PCD)PCD: Item designed to constitute a defined resistance to a sterilization process and used to asses

16、s performance of the process.BI Monitoring FrequencySome facilities are moving to a higher standard of patient care by monitoring every sterilization load with a biological indicator.Cost and impact of a recallEnsure every type of sterilization cycle used is monitored Reduce risk and cost of healthc

17、are-associated infectionsPorous Test Pack Or Hollow Load Test? Porous Test PackHollow LoadORPreparation of 16 towel PCD BI challenge test pack: AAMI ST 79 do not recommend hospital to use any hollow load/Helix testISO 17665-1, -2Test Periodic AnnuallyPorous BD test everydayA.2 Hollow Load test was n

18、ot performance qualification test. It means hospital need not do everydayA.5 Porous BD test was the performance qualification test. hospital should do everydayISO 17665-1, -2Is a Hollow Lumen test the same as a Bowie and Dick test ?No The hollow load test is a type test specified in EN 285:2006+A1:2

19、008. It is not intended to be used other than as a type test by the sterilizer manufacturer. The Bowie Dick test is a test that is intended to be performed daily by the end user.Sterilization GuidelinsAAMI ST 79: Does NOT have a standard that calls out a specific helixISO 17665: Hollow Load test was

20、 not performance qualification test. Hospital need not run Hollow load testISO 17665: Porous BD test was the performance and operation qualification test. Test Periodic DailyISO 11140-3, -4, -5, described linen PCD, no helixPatient safety is the main goal for all CSSD team members. It is and must be

21、 our fiduciary responsibility to produce a product free from bacteria to our customer.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 proced

22、ure.The team members in CSSD are not seen by the patient, yet they can impact the outcome of a patients case if the tray or instrument used is not processed correctly.Patient SafetyThe patient enters the facility with the full confidence that the members of the CSSD are producing a quality product f

23、or their case each and every time.HAIs (Health care 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.Patient SafetyRequired certification is the hot item topic in the

24、USA todayThe state of New York 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!Certification only means you have the basic minimum knowledge to provide the service of cleani

25、ng, reassembly, and sterilizationRequired CertificationBy having this as a requirement each medical facility will have the consistency needed to give quality service.Certification also brings about continued education. Each certified technician must complete at least 12 CEUs (continuing education cr

26、edit) per year.This requirement gives you technicians that are aware of what is new and required in the industry.Required CertificationIn the USA we presently have the option to follow the ANSI/AAMI ST79 recommended practice manual.In the future the verbiage will need to change to give some type of

27、control over how CSSDs are managed throughout the USA.This is called standardization.Department RegulationThe 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 practice and stay aware of all new and improved processes.Department RegulationThe future of CSSDs in the USA will require that we focus