3M Sterile U Network 3M Sterile U Web Meeting January 16, 2014 Today s meeting times: 9:00 a.m., 11:00 a.m. and 1:00 p.m. CST To hear audio, call 800-937-0042 and enter access code 7333633 Phone lines are muted. Audio will commence when the webinar begins.
Welcome! Topic: Don't Borrow Trouble: An Approach to Managing Loaner Trays Speaker: Lisa Spence Huber, BA, CRCST, ACE, FCS Facilitators: Diane Koch, 3M Susan Flynn, 3M Housekeeping Questions Mute feature (*7 = unmute; *6 = mute) Chat feature Technical difficulties Post session follow-up For more information: 3M www.3m.com/3msterileu Infection Prevention Solutions
How do I get a CE Certificate? Next week, all of today s meeting participants will be sent an email containing instructions for obtaining a CE Certificate for today s meeting. The email will be sent to the email address you provided when you logged-in to today s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate email to them.
Disclosures Lisa Spence Huber, BA, CRCST, ACE, FCS Educational Consultant to 3M Health Care 3M 2014. All rights reserved.
Learning Objectives 1 Describe the impact that loaner instruments have on Sterile Processing Departments 2 3 Discuss recommended practices for managing, processing, and monitoring loaner instruments Discuss IAHCSMM s position paper and sample policy & procedure on the management of loaner instrumentation 3M 2014. All rights reserved.
Don't Borrow Trouble: An Approach to Managing Loaner Trays
Yikes! We just got 24 loaner trays!!
Why is there a need for Loaners? New technology Patient specific instruments Trials Multiple cases Insufficient storage or inventory
Loaner Instruments Present Many Challenges Unexpected instruments that arrive when you are least prepared Expected instruments that don t arrive Not sure who to call if there is a problem Delays in instrument processing system overload Inadequate staffing for workload Inadequate, unclear or unavailable reprocessing instructions Communication barriers between CS and OR and Instrument rep Stress!!
Loaner Instruments Should Arrive With Sufficient Time To: Inspect and inventory Clean and decontaminate Assemble and package Terminally sterilize Cool prior to use Quarantine until negative BI results are known Document and track to the patient We can not take shortcuts
Implants Present Additional Challenges AAMI is very clear on this point Every sterilization load containing implants should be monitored with a PCD containing a BI (a BI challenge test pack). A Class 5 integrating CI should be included in this PCD. Implants should be quarantined until the results of the BI testing are available (CDC, 2008). Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule. Late arrivals do not allow for proper processing and can have a serious impact on patient outcomes and facility disruption. Reference: AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.6.1 and 10.6.3
Reasons for Last Minute Deliveries (as told to me by reps) The doctor s office forgot to tell me what he wanted to use This is the only set of these instruments in this area and they are being used somewhere else this afternoon The doctor looked at the patient s x-ray at 10:30 p.m. and changed his mind about the procedure for 9:00 this morning I was in a case in, then I had to go to the office to pick up the instruments and then I can bring them to you I just found out about this case and I got here as soon as I could
It isn t easy to get all team members together The Team Members The Surgeon The OR Team RN Scrub Tech CS Staff Instrument Company Rep The Patient
The Joint Commission National Patient Safety Goals NPSG.07.05.01 Implement evidence-based practices for preventing surgical site infections Element of Performance 3 Implement policies and practices aimed at reducing the risk of surgical site infections. These policies and practices meet regulatory requirements and are aligned with evidence-based guidelines (for example, the Center for Disease Control and Prevention [CDC] and/or professional organization guidelines). Reference: The Joint Commission 2014 Hospital Accreditation Standards (HAS)
Evidence-Based Guidelines Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79: 2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Association of perioperative Registered Nurses (AORN), 2013 AORN Recommended Practices for Sterilization in Perioperative Practice Setting Recommended Practices for Selection and Use of Packaging Systems for Sterilization
AORN 2013: Sterilization RP A formalized program between the health care organization and health care industry representatives should be established for the receipt and use of loaned instrumentation. (XIV) Personnel requesting loaned items should specify quantities, estimated time of use and return, and restocking requirements to circumvent the need for IUSS. (XIV.d.1.) Late receipt of loaned instruments should not be used to justify IUSS. (XIV.d.2.)
AORN 2013 Sterilization RP Loaner Manufacturer s Instructions For Use (IFU) AORN: IFU should be obtained before loaned items are received (XIV.c) Device manufacturer provides validated instructions for all processing steps in the IFU Cleaning solutions, brushes, rinses, sonic, mechanical or manual washing Packaging wrapped method or container Sterilization sterilization method, exposure time, dry time and aeration time, if applicable
IAHCSMM Position Paper on the Management of Loaner Instrumentation NOTE: IAHCSMM is not a standards-making group; therefore, the position paper is not a standard, but rather a tool to provide and help facilities develop their own loaner instrument-related policies and procedures. The position paper is based on established best practice and regulation from» The Joint Commission» AAMI» AORN» CDC
IAHCSMM Position Paper on the Management of Loaner Instrumentation Healthcare facilities that borrow surgical instruments should have a well-developed loaner program and written policy that establishes standardized receipt and use of all loaner instrumentation. This policy should be established with input from CSSD, OR and various departments such as, Infection Prevention and Control (IPC), Administration, Materials Management, Risk Management (RM), and surgeons.
The Loaner Instrumentation Program Should Include Policy/Procedure for: Requesting loaner instrumentation Facility time requirements for delivery and pick-up Obtaining FDA-cleared written IFUs Inservicing if necessary Processing instrumentation (cleaning, decontaminating, packaging, sterilization, storage and transport) Maintaining records of the transactions
Loaner Instrumentation Checklist CS notified of loaners prior to receiving them Received in facility (decontamination) at least two working days (48 hours) for existing loaner sets and three working days (72 hours) for new sets before scheduled case Inventory list and IFUs provided/available Inventory and quality checks completed Multiple trays numbered and labeled (patient name, surgeon) Trays do not exceed 25 pounds All instruments in good condition Container in good condition, with no rusting, tape, residue, etc.
IAHCSMM Sample P&P for Loaner Instrumentation OR Responsibilities Required loaner instruments should be requested when surgery is scheduled (delivery expectations should be communicated) IUSS should not be a substitute for sufficient instrument inventory resulting from late delivery of loaner instruments Sales Rep Responsibilities Provide written inventory sheets and IFUs Deliver instruments per hospital policy Tray weights not to exceed 25 pounds Inservice staff on instruments as required
IAHCSMM Sample P&P for Loaner Instrumentation CS Department Responsibilities Clean, decontaminate and sterilize instruments according to FDA-cleared manufacturers IFUs Inspect for cleanliness, defects, etc. Maintain records according to facilities policies Decontaminate instruments post procedure Maintain inventory sheets for verification post procedure
In addition Each facility should have a strong policy regarding using IUSS for implants Biological monitoring for all implant loads Items quarantined until BI results known Only released prior to known results in defined emergency situation Premature release form completed and signed by physician Reference AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013
Now what?... It takes much more than supporting standards, recommended practice and policies/procedures to manage a successful loaner instrument program! In addition to these tools there is one key to success
Define and Share Expectations Provide access to your facilities loaner policy to all members of the team Surgeons Instrument Company Reps OR and CS Staff Keep statistics to identify problems Let team members know when improvements are needed
Designate Go-To Person(s) For Ease of Communication Saves time everyone knows who to talk to Ensures communication is coordinated Relationships can be developed with instrument company reps Aids the sharing of information -Arrival times -Number of trays
Orthopedic Specialist Super-User Knows the instrumentation well so that instrumentation can be properly identified Improves communication with the instrument reps Saves time Increases trust Provides training for other staff
Plan Ahead Use the surgery schedule to anticipate future needs Huddle with OR staff (at least twice daily) to discuss future needs Eliminates surprises Provides status updates Keeps everyone informed of changes
Problems and Solutions Problem Inadequate documentation Solution Developed a Loaner Documentation Form. Filled out at time of delivery. All pertinent information in one place Form used later for statistical data collection for policy compliance
Problems and Solutions Problem Loaner instruments on multiple case carts separated in OR. Solution Loaner trays labeled with bright pink labels
What are the Take-Aways? A successful loaner management program requires input from all team members A successful program is based on established standards and best practice A successful program requires constant communication among all team members A successful program is patient focused
Thank you! Next 3M Sterile U Web Meeting When: Thursday, February 20th Topic: In Case of Emergency: The appropriate use of IUSS Register at www.3m.com/sterileu
References 34 3M 2014. All rights reserved.
References The Joint Commission. 2014 Hospital Accreditation Standards (HAS) International Association of Healthcare Central Service Materiel Management www.iahcsmm.org Association of perioperative Registered Nurses (AORN), 2013 AORN Recommended Practices for Sterilization in Perioperative Practice Setting Recommended Practices for Selection and Use of Packaging Systems for Sterilization Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Available free at: http://www.cdc.gov/hicpac/pubs.html Association for the Advancement of Medical Instrumentation (AAMI) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text)
Thank you 36 3M 2014. All rights reserved.