1、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 instruments.3.Describe how sterilization practices in America and the wo
2、rld affect patient safety.AAMI TIR63 Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfectionMedical devices not owned by the health care facility that are loaned through a loan agreement with a vendor or another health care facilityA.Role
3、s and responsibilities of the senderB.Roles and responsibilities of the receiverC.RequisitionD.SchedulingE.ReceiptF.ReturnG.Tracking and documentation3 Policy development3 Policy developmentConfirm availability on the date requested.Assure complete shipping.Written documentation of medical devices i
4、nventory at the time of delivery.Provide trainingAn agreed-upon time and method of deliveryA means of traceability Serial number Lot number Catalog number4.2 Roles and responsibilities of the sender4.2 Roles and responsibilities of the senderWritten IFUsPacking slip with the following information Pu
5、rchase order number Shipment contents Item description and catalog number of each device.Surgery dateSurgeonShip dateSales representative or contact informationShipping addressAndy specific delivery instructionsInformation to be included with the device:4.2 Roles and responsibilities of the sender4.
6、2 Roles and responsibilities of the senderCommunicationCommunicationFinancial ResponsibilityFinancial ResponsibilityDevice ResponsibilityDevice ResponsibilityRequisitionRequisition4.3 Roles and responsibilities of the sender4.3 Roles and responsibilities of the senderA procedure to ensure communicat
7、ion 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 Communication4.3.1 CommunicationSpecific Pay
8、ment 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 Responsibility4.3.2 Financial ResponsibilityThe healthcare facility should docu
9、ment 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 possible damage to loaners whi
10、le at the healthcare facility.Decontaminate loaners before they are returned.4.3.Device responsibility4.3.Device responsibilityPatient nameLoaner set(s)to be expectingDate and time of the procedure4.4 Requisition4.4 RequisitionThe healthcare facilities s policy should specify how the amount of time
11、before the procedure should the device be delivered.This time should be agreed upon by all of those involved.4.5.1 Delivery4.5.1 DeliveryThe loaner(s)should arrive at the time agreed upon.The healthcare facility should not accept loaner(s)if they do not arrive in sufficient time to follow its proced
12、ures(except in an emergency).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).If applicable date and time of training.Place BI s and CIS into area of package determined to the great chal
13、lengeCornerDifferent layersNext 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 to remain there for a period of 30 days or more.FDA may,in order to protect public health,determine that devices placed in
14、subjects for shorter periods are also implants Loads contain implantable devices should be quarantined until biological indicator results are available If documented medical exceptions dictate release of implant before BI PCD result-Use implant log and an exception form Critical that documentation b
15、e fully traceable to the patientPCD:Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.Some facilities are moving to a higher standard of patient care by monitoring every sterilization load with a biological indicator.Cost and im
16、pact of a recall Ensure every type of sterilization cycle used is monitored Reduce risk and cost of healthcare-associated infectionsPorous Test PackHollow LoadORBI challenge test pack:AAMI ST 79 do not recommend hospital to use any hollow load/Helix testTest Periodic AnnuallyPorous BD test everydayA
17、.2 Hollow Load test was not 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,-2No No The hollow load test is a type test specified in EN 285:2006+A1:2008.It is not intended to be used
18、 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.AAMI ST 79:Does NOT have a standard that calls out a specific helixISO 17665:Hollow Load test was not performance qualification test.Hospital need not run Ho
19、llow 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 our fiduciary responsibility to produce a product free from bacteri
20、a 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 procedure.The team members in CSSD are not seen by the patient,yet they can i
21、mpact the outcome of a patients case if the tray or instrument used is not processed correctly.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.HAIs(Health care acquired infections)are not to be t
22、olerated in the CSSD environment due to inadequate care in the cleaning,reassembly and sterilization of instruments and products for the patient.Required certification is the hot item topic in the USA todayThe state of New York just passed a law making it a rule that in order to work in a CSSD you m
23、ust 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 cleaning,reassembly,and sterilizationBy having this as a requirement each medical facility will have the consis
24、tency needed to give quality service.Certification also brings about continued education.Each certified technician must complete at least 12 CEUs(continuing education credit)per year.This requirement gives you technicians that are aware of what is new and required in the industry.In the USA we prese
25、ntly 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 control over how CSSDs are managed throughout the USA.This is called standardization.The future will bring standardization to all medical facilities in th
26、e 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.The future of CSSDs in the USA will require that we focus on patient safety while using best practice for each patient
27、every time to control the spread of HAIs.The added step of regulation will only serve to give consistent 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
28、 CSSDs has become.Looking toward the future out profession looks bright.Out patients will 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!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!
