Documentation. It s Not Just Paperwork. Education & Training. by Martha Young, BS, MS, CSPDT

Documentation It s Not Just Paperwork by Martha Young, BS, MS, CSPDT Many thanks to the team at 3M Health Care for working with Managing Infection Control to provide the following accredited course. IAHCSMM has awarded one and one-half (1.5) contact points for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has preapproved this inservice for one and one-half (1.5) contact hours for a period of five (5) years from the date of publication, and to be used only once in a recertification period. This inservice is 3M Health Care Provider approved by the California Board of Registered Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five (5) years from the date of publication. Instructions for submitting results are on page 93. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. Objectives After completion of this self-study activity, the learner will be able to: 1. Develop a policy and procedure for documentation of sterilizer maintenance, product identification and traceability, and the results of wrapped and flash cycles. 2. Develop a policy and procedure for documentation of appropriate sterilization process parameters for medical devices being processed. 3. Develop a policy and procedure for documentation of implant loads. 4. Describe how to use documented results to do a recall and solve sterilization process failures. 76 MANAGING INFECTION CONTROL

Test Questions True or False 1. Documentation of the maintenance of each sterilizer and changes to utilities as necessitated by water-main breaks, annual boiler maintenance, additional equipment loads that place a strain on the utilities and installation of new boilers can assist in identifying the reasons for sterilization process failures and determining if sterilizer qualification testing needs to be performed. 2. Product identification and traceability is needed for stock rotation, real-time monitoring data, establishing that cycle parameters have been met, establishing accountability and assisting with recalls. 3. Document medical device manufacturers instructions for use to ensure the correct sterilization process and cycle parameters are being used. 4. Perform product quality assurance testing to verify that medical devices are being properly sterilized when the medical device manufacturers instructions for use are followed. 5. A load containing implants should be quarantined until the results of the BI testing are available. 6. The sterilization process monitoring results of an implant should be documented and fully traceable to the patient on whom it is used or in whom it is implanted. 7. Written documentation defining emergency situations in which an implant may be released before the biological indicator is available should be developed in consultation with infection prevention and control, the surgeon and risk management. 8. Documentation is the major ingredient for an effective and timely recall, beginning with lot control numbers and sterilization records to the recall report. 9. A computerized or electronic record keeping system can facilitate a recall and the investigation of a sterilization process failure. 10. A healthcare facility needs to document the recall of medical devices by manufacturers, including notifications or safety alerts. MANAGING INFECTION CONTROL 77

Documentation is essential in determining the reasons for sterilization process failures. Introduction The word documentation is defined in the dictionary as the act or an instance of the supplying of documents or supporting references or records and also the orderly presentation, organization, and communication of recorded special knowledge to produce a historical record of changes in variables. A document is a legal form which can be used to furnish decisive evidence or information and serves as evidence of proof. Each of you is responsible for providing records of the sterilization process to be used as history of the effectiveness of the process and as a legal document and proof of the outcome of that process. Thus, each of you involved with the sterilization process is a documentalist. Documentation is not just paperwork. It is an essential element in the Quality Control of the sterilization process. Documentation, commonly referred to as recordkeeping, makes an inventory of the materials that have been processed and the results of the sterilization process monitoring. All data is incorporated into a paper or electronic log system or filed as individual documentation records. This documentation is essential in determining the reasons for sterilization process failures that can be the result of human error, equipment failures, and/or poor sterilant quantity and quality. Documentation is used when products need to be recalled in the healthcare facility. One of the National Patient Safety Goals of the Joint Commission for Accreditation of Healthcare Facilities (JCAHO) is to have policies and procedures that improve the effectiveness of communicating recalls within the healthcare facility. These policies and procedures should be based on current scientific knowledge, accepted practice guidelines, and applicable laws and regulations as required. This in-service highlights the information needed in these policies and procedures to document the sterilization process, and to facilitate product recall of healthcare manufactured products. A brief discussion of the healthcare facility s response to medical device recalls, notifications or safety alerts is also included. The main references used for this in-service are: Association for the Advancement of Medical Instrumentation s (AAMI s) Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2006). 1 Association of perioperative Registered Nurses, Recommended Practices for Sterilization in Perioperative Practice Settings. AORN Standards, Recommended Practices, and Guidelines:2006. 2 Installation, care and maintenance of sterilizers A major part of recordkeeping is documentation of the maintenance of each sterilizer in a healthcare facility. This documentation should include information to identify the equipment and to establish a continuous history of all scheduled and unscheduled service. 1 This information is important because it can be used to verify that the sterilizers are working, have appropriate preventive maintenance, were repaired when a problem was identified, and assist in troubleshooting when a sterilizer malfunctions or a sterilization process failure occurs. For example, if a Bowie-Dick failure occurs or a positive biological indicator is obtained, the records can be reviewed to see when the last preventive maintenance occurred, when the sterilizer was last checked or repaired, the reason for the service, and the service history of the sterilizer. This information may provide clues for the investigation of sterilizer malfunction or sterilization process failure. In addition, sterilizer qualification testing should be conducted in the healthcare facility in cooperation with the sterilizer manufacturer when the following events occur. Sterilizer qualification testing using a biological indicator process challenge device (BI PCD) is performed after: sterilizer installation; sterilizer relocation; sterilizer malfunctions; sterilizer major repairs A major repair is a repair outside the scope of normal maintenance. This includes weld repairs of the pressure vessel, replacement of the chamber door or major piping assembly, or rebuilds or upgrades of controls. Normal preventive maintenance, such as the rebuilding of solenoid valves or the replacement of gaskets, is not considered major repair. Changes to the utilities that are considered major repairs to the sterilizer include a water-main break, annual boiler maintenance, additional equipment loads and installation of new boilers should be treated as major repairs. sterilization process failures. 1 Three consecutive empty cycles (except in tabletop sterilizers where this testing is done in a full load) should be run with a BI PCD. In dynamic-air-removal sterilizers, this testing is followed by Bowie- Dick test packs (BD PCDs) run in three consecutive empty cycles. For this testing, a cool loading cart should be used for each cycle to prevent superheating in the chamber (which can affect the test results) and more closely duplicates normal processing procedures. In addition, this qualification testing is also performed when changes are made to the utilities connected to the sterilizer that may affect its performance: 78 MANAGING INFECTION CONTROL

changes necessitated by water-main breaks; annual boiler maintenance; additional equipment loads that place a strain on the utilities; installation of new boilers. 1 Information identifying these events should be retained in the maintenance documentation. At a minimum, it should include the following information stated in AAMI ST79: 1. date on which service was requested; 2. model and serial number of the sterilizer; 3. location of the equipment (healthcare facility identification, if applicable); 4. name of individual from healthcare facility who requested and authorized service; 5. reason for service request; 6. description of service performed (e.g., calibration, repair); 7. types and quantities of parts replaced; 8. name of the person who performed the service; 9. date the work was completed; 10. handwritten or electronic signature and title of person who acknowledged completion of the work; and 11. results of any post-maintenance testing performed, if needed, before the sterilizer was returned to service. 1 These records must be maintained by the healthcare facility for the time determined by state and local regulations, legal considerations, individual situation, and according to the facility s policies and procedures. 1 These records should be kept by all of the following: supervisor responsible for the equipments (i.e., sterilizer processing, OR, etc); hospital engineering staff; service person; whomever deemed appropriate by the healthcare facility. 1 Product identification and traceability This part of recordkeeping documents each item or product processed, assists in proper stock rotation, ensures that cycle parameters have been met, establishes accountability and assists with recalls. Ideally, every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it is used or in whom it is implanted; such traceability can be accomplished by recording the sterilizer load identifier on the patient chart or the patient name on the load record. 1 Documentation should be maintained to allow for traceability of every load to the patient for who the instruments are used. 2 Sterilization quality control relies heavily on historical date, especially when quality assurance measures yield conflicting evidence. This data is used for both epidemiology tracking and ongoing assessment of the reliability of the sterilization process. 1 Lot control numbers Each item or pack should be labeled with a lot control identifier (sterilizer identification number or code), date of sterilization and cycle number. MANAGING INFECTION CONTROL 79

For flash sterilization, labels are not used, but the following information should be generated for each sterilization cycle using a load record: sterilizer identification and cycle number; contents of load; time and temperature of exposure phase of cycle; signature or identification of operator; date and time of cycle. Flash sterilization of implantable devices is not recommended; however, if it is unavoidable, full traceability to the patient should be maintained. 1 Sterilizer records Sterilization records for each cycle must be maintained either in a paper or electronic system, with electronic records recommended because they facilitate faster access to information for a quicker response when sterilization process failures occur. The information for each sterilization cycle includes: lot number; contents of load; exposure time and temperature if not on a recording chart; operator identification; results of BI testing; results of the Bowie-Dick testing; results of chemical indicator (CI) in the PCD (BI challenge test pack, BI challenge test tray, CI challenge test pack); any reports of inconclusive or nonresponsive CIs in the load. 1 In addition, the following documented information for BIs would assist with sterilization process failure investigation: BI catalogue number; BI lot number; Incubation time; Results of test and control BI (incubate a positive control BI from the same lot each day a test BI is incubated). Expiration dating For proper stock rotation each item should be labeled with an expiration date or statement. Each item in a load should be labeled with a control date for stock rotation and the following statement (or its equivalent): Contents sterile unless package is open or damaged. Please check before using. 1 Medical device manufacturer s instructions for use The instructions for use for all medical devices reprocessed in your sterile processing department should be part of the Quality Control documentation of the sterilization process. This ensures the correct sterilization process is being used and the sterilization parameters for that process are correct. If the correct process and parameters are not being utilized, you increase the risk that the medical device is not properly sterilized. AORN states for low temperature sterilization processes: 2 Follow the manufacturer s written instructions to determine if the item is compatible with EO and what the sterilization parameters are. Obtain documentation from the device and sterilizer manufacturer of items that can and cannot be processed in hydrogen peroxide gas plasma. Sterilization of devices to be processed in hydrogen peroxide gas plasma should be validated by the device manufacturer. Devices to be sterilized should comply with the sterilizer manufacturer s lumen claims relating to diameter and length of the device. Items that can and cannot be processed by liquid peracetic acid should be documented by the medical device and sterilizer manufacturer. The medical device manufacturer should validate the process using the sterilizer manufacturer s written instructions. Once this data is obtained, product testing should be performed to verify that the sterile processing department can effectively sterilize these medical devices using the instructions for use provided. This is discussed in the next section. Periodic product quality assurance testing of routinely processed items Product testing is recommended because the BI PCDs used for routine and qualification testing present a known challenge to the sterilization process but do not necessarily reflect the same challenge as items routinely processed. Therefore, product testing is recommended as part of a complete quality assurance program to ensure the effectiveness of the sterilization process and to avoid wet packs. 1 This testing needs to be part of the Quality Control of the sterilization process documentation. Routinely sterilized products should be tested periodically, and testing should also occur when major changes are made in packaging, wraps, or load configuration, such as dimensional changes, weight changes, or changes in the type or material of packaging or wrapper. 1 This testing procedure should be performed on each loaner tray before it is put into routine use and whenever the contents change. This testing should also be done when the medical device manufacturer s instructions for use are updated (see section on medical device manufacturer s instructions for use). 80 MANAGING INFECTION CONTROL

Figure 1. Placement of biological and chemical indicators for product testing. Product testing involves placing multiple BIs and CIs (Class 3, Class 4, Class 5 and/or enzyme-only indicators) within the product to be tested. 1,4 The number of BIs and CIs used will depend on the size and configuration of the pack being tested. See Figure 1 for examples of placement of BIs and CIs inside a multilevel instrument container. BIs and CIs are placed inside each layer in multiple locations, in corners and near the largest heat sink. The BIs and CIs should be labeled and their position in the product test sample documented. The product test samples should be labeled as such and placed among other products in a full load. After the sterilization process, the test BIs should be retrieved, incubated along with a positive control BI and the results documented along with the CI results. A photo of the placement of the BIs and CIs for your records would assist in documenting the results according to location of the BIs and CIs. The packages should also be inspected for evidence of moisture. If moisture is observed, steps should be taken to remedy the problem. 1 These include changing the packaging, adjusting the loading or decreasing the amount of metal in the load, selecting a longer sterilization and/or drying time, or adjusting the unloading and cooling procedure. If any test results indicate a problem, an investigation should determine the cause, the problem should be corrected, and the products retested. It might be necessary to change the configuration of the load and/or items within the package or to service the sterilizer. 1 Document in the sterilization records the test protocol, the initial test results, corrective actions taken and the final test results. Examples of product testing are: Wrapped textile packs Place BIs and CIs between multiple layers of draping material or surgical towels. Basin sets Place BIs and CIs in locations where air would be trapped, such as between nested basins. Instrument sets Place BIs and CIs at each end of tray, among instruments and next to the biggest heat sink (largest metal mass). Containment devices Place BIs and CIs in each corner, the center and any other areas recommended by the containment device manufacturer. 82 MANAGING INFECTION CONTROL

Multilayered instrument trays in containment devices Place BIs and CIs in the locations determined by the product manufacturer to create the greatest challenge to the sterilization process (corners, each layer, next to the biggest heat sink [largest metal mass]). Other types of items Place BIs and CIs in the area of the load least accessible to steam penetration. Implants The sterilization process monitoring results of an implant should be documented and fully traceable to the patient on whom it is used or in whom it is implanted. 1,2 The sterilizer operator should review and record the results of the physical monitors, chemical and biological indicators, and other data to determine if the results are appropriate and record the other data required in the sterilizer records listed in Annex L below. Patient safety could be adversely affected by the implantation of a nonsterile device. The sterilization of implantables should be closely monitored and each load containing implants should be quarantined until it is verified that BI testing has yielded negative results. 1 This is why each load containing an implant should be monitored with a BI PCD. The following explains the only exceptions to the rule. The load should be quarantined until the results of the BI testing are available (CDC, 2003a). Annex L (Informative) Example of documentation of premature release of implants This Annex provides an Implantable Devices Load Record and an Exception Form for Premature Release of Implantable Device/Tray, as examples of the forms recommended in Section 10.5.3.3. Implantable Devices Load Record Date Description Dept. Time Sterilizer # Load # Date/time Date/time Early Date/time Released of implants sterilized BI in and release? released by (specify incubator BI result to OR (full name) AM/PM) Figure L.1 Implantable devices load record 84 MANAGING INFECTION CONTROL

Exception Form for Premature Release of Implantable Device/Tray NOTE In a documented emergency situation, implantable devices will be released from quarantine in Central Service without the biological monitor result. This form should accompany the implant to the Operating Room. Operating Room personnel should complete this form and return it to Central Service within 24 hours. PLEASE COMPLETE ALL INFORMATION: DATE: SHIFT: TIME: AM PM PERSON COMPLETING THIS REPORT IN CENTRAL SERVICE: The following implantable devices/trays were prematurely released to the Operating Room: NAME OF OR PERSON REQUESTING PREMATURE RELEASE OF DEVICES: OPERATING ROOM REPORT: PATIENT NAME: SURGEON NAME: TIME OF PROCEDURE: AM PM DATE: REASON PREMATURE RELEASE WAS NEEDED: WHAT COULD HAVE PREVENTED PREMATURE RELEASE OF THIS DEVICE/TRAY? NAME OF OR PERSON COMPLETING THIS REPORT: DATE REPORT COMPLETED: RETURNED TO CENTRAL SERVICE ON: Figure L.2 Exception form for premature release of implantable device/tray Reprinted with permission from the Association for the Advancement of Medical Instrumentation, Inc. Copyright 2006 AAMI. www.aami.org. All rights reserved. When medical exceptions dictate (e.g., the need for traumarelated orthopedic screw-plate sets), it could be necessary to release an implantable device before the BI results are known. In this case, the release of the device before the BI results are known should be documented; the BI result obtained later should also be documented. (See Annex L for examples of an implant log and exception form.) It is critical that this documentation be fully traceable to the patient. Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule. Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon, and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release and that could be corrected. 1 Premature release of implants before the BI result is available is unacceptable and should be the exception, not the rule. Each exception should be documented using an implant exception form. This form (see Figure L.2) requires providing the following information each time an implant is prematurely released: Name of implant prematurely released, patient and surgeon; Reason for premature release; What could have prevented premature release of the implant. The 2006 Association of PeriOperative Registered Nurses (AORN) Recommended Practices 86 MANAGING INFECTION CONTROL

for Sterilization in Perioperative Practice Settings has a more stringent standard. Flash sterilization should not be used for implantable devices. Implants are foreign bodies, and they increase the risk of surgical site infections. Careful planning, appropriate packaging, and inventory management in cooperation with suppliers can minimize the need to flash sterilize implantable medical devices. When an implantable device is sterilized at a healthcare facility, a biological indicator should be run with the load and the implant should be quarantined until the results of the biological indicator are known. If an emergency situation makes flash sterilization unavoidable, a rapid-action biological monitoring device should be used along with a class V chemical integrator. The implant should not be released until the rapid-action indicator provides a negative result. After the rapid-action negative result is obtained, the implant can be released for use in the immediate situation. If the implant is not used, it cannot be saved as sterile for future use. Resterilization of the device is required. If the biological indicator is later determined to have a positive result, the surgeon should be notified as soon as the results are known. 2 Ramona Connor, RN, MSN, CNOR, who currently represents AORN on the AAMI Sterilization Standards Committee clarified how to quarantine the implant in the OR suite. She stated, The sterilized implant can be placed on a corner of the back table and segregated from the rest of the sterile field until the rapid-readout BI is ready to read. When the BI result is negative, then the implant can be placed in the patient. If the BI is positive, the implant hasn t been used and the rest of the sterile field hasn t been contaminated. Remember, the recommendation against flash sterilization is because of the increased risk of surgical site infection. This AORN recommended practice also states: Monitor the sterilizer function with mechanical (now referred to as physical), chemical and biological indicators to meet all monitoring standards. Record the physical parameters for each cycle, and verify the results before the item is transferred to the point of use. MANAGING INFECTION CONTROL 87

As soon as the BI is positive, recall all loads processed since the last negative BI. Monitor flash sterilization cycles daily with devices according to manufacturers written instructions. Use a sterilization process monitoring device with each load to be flash sterilized. Documentation should be traceable to each patient. Information on each load: 1. Device(s) processed; 2. Patient receiving item(s); 3. Reason for flash sterilization. Recall of products processed within a healthcare facility The objective of a recall is to expedite the retrieval of processed items that are suspected to be nonsterile and to ensure adequate follow-up actions such as quarantine of the sterilizer, notification of physicians and affected clinical departments, and surveillance of patients. 1 Each healthcare facility should have written policies and procedures for the recall of items from issued or stored sterilization process loads. These policies and procedures should be developed for compliance with the Safe Medical Devices Act of 1990 as it pertains to failures of reusable medical devices. 1 Documentation from the lot control numbers and sterilization records to the recall report is the major ingredient for an effective and timely recall. A computerized or electronic recordkeeping system can simplify the recall and the investigation of a sterilization process failure (see Figure 2. below) 5. Figure 2. Electronic recordkeeping system. With such a system, it is easier to review the various types of monitoring data and to identify items in the failure load, other loads from the specific sterilizer, and all loads recently processed by a particular operator. An electronic system may also permit access to sterilizer maintenance records, which may provide links to previous sterilization process failures, reasons for the failure, the resolution required, and the results of qualification testing of the sterilizer. When to recall In a healthcare facility, when a load of processed medical devices is released prior to obtaining the results of a biological indicator (BI) and the BI subsequently indicates a sterilization process failure (i.e., is positive), a recall must be initiated. At that time, all medical devices processed since the last load showing a negative BI should be considered nonsterile, retrieved and reprocessed. 1 The only exception would be if it was determined that the sterilization process failure was a result of operator error such as running the incorrect cycle for the load. A recall can also occur if, after the medical devices are released, a review of the monitoring data shows that the physical parameters were not met or internal chemical indicators from several packages from a load did not reach the desired end point. How to do a recall The key to an effective recall is immediate communications to appropriate personnel and departments responsible for retrieving the medical devices before they reach the patient. As soon as the BI is positive, recall all loads processed since the last negative BI. 1 Monitoring more frequently with a BI and obtaining results within a minimal incubation time (e.g., one or three hours) allows sterilization process failures to be identified much sooner, instruments to be turned around faster, costs associated with inventory and recall to be reduced, and patient outcomes to be improved. 6 Figure 3 on page 92 shows the recalls steps to take when a positive BI is obtained. How to avoid a recall In an ideal world you would purchase enough medical devices to allow for quarantine until the results of the BI are available. Quarantining 88 MANAGING INFECTION CONTROL

with a smaller inventory is more realistic if you can use an enzyme-based early-readout biological indicator (i.e., rapid readout BI) that provides results in one or three hours (steam sterilization). Edwin Ross stated in Surgical Services Management that in most cases, quarantine and every load biological monitoring are the most practical and least expensive operational processes that also meet your ethical responsibilities to the patient. 6 If the load is quarantined until the BI results are available (e.g., one or three hours), then a recall can be avoided. Medical device recalls, notifications or safety alerts A healthcare facility also needs to respond to medical device recalls, notifications or alerts that inform healthcare professionals of a risk of substantial harm from a medical device in commercial use. This information may be communicated by a manufacturer, distributor or other responsible party, or by the FDA. In all cases, the healthcare facility needs a policy and procedure in place to ensure that the healthcare facility responds appropriately and in a timely manner. The JCAHO Environment of Care Standard EC6.10 requires healthcare organizations to manage medical equipment risks by having processes for monitoring and acting on equipment hazard notices and recalls. An excellent source of information for this best practice is in OR Manager. 8 In this article, Jim Keller, director of the Health Devices Group at ECRI, an independent nonprofit organization that researches healthcare technology, describes the five best practices for managing device-related information. For more details read the OR Manager article, but briefly the five best practices Keller recommends are: 1. Have clearly defined roles and responsibilities about who is responsible for forwarding information to the relevant departments in the hospital. 2. Use consistent up-to-date terminology for devices so the facility can identify if those devices are within the system. 9 3. Have an approved list of sources for recall notices, hazard alerts, and other device-related information to assist staff in resolving reported problems. MANAGING INFECTION CONTROL 89

4. Have a process in place that ensures the correct information is sent to the right people so they can respond appropriately. 5. Have a follow-through process in place that documents what steps were taken in response to the notification. Summary Documentation provides supporting historical records of the outcome of the sterilization process, which is an important part of a Quality Control program. A healthcare facility needs clear policies and procedures in place that describe the documentation required for the sterilization process, product recall of healthcare manufactured products, and the healthcare facility s response to medical device recalls, notifications or safety alerts. It is the responsibility of the leadership of the healthcare facility to ensure that these policies and procedures are in place and followed so that patient safety is maintained. References 1. Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79: 2006. 2. Recommended Practices for Sterilization in Perioperative Practice Settings. Association of perioperative Registered Nurses. AORN Figure 3: Positive Biological Indicators (BIs) Results Action Steps to Take 1 1. Immediately verbally report the positive BI results to the appropriate supervisor and infection control department so they can implement the institution s recall policies and procedures, and recall items before the items contact the patient. If they determine that suspected nonsterile devices have been involved in patient use, follow-up surveillance of patients should be initiated as determined by the facility s policies and procedures. 2. Immediately initiate a recall order for all medical devices processed in the sterilizer since the last cycle that showed a negative biological indicator, even if other monitoring tools indicated a successful sterilization process. Communicate the following information to the affected departments: a) Why the medical devices are being recalled; b) Who authorized the recall; c) Who is responsible for reporting the results of the recall; d) Which medical devices are to be recalled (include load label information sterilizer load, load number and processing date); e) Which persons or departments the order is addressed to; f) The required method for recording the number and type of products recalled by location; g) Who, when and how to return the recalled medical devices to sterile processing. 3. Retrieve and reprocess all medical devices. 4. If using spore strip BIs that require sterile transfer to a media, subculture the biological indicator according tothe manufacturer s instructions. If using self-contained BIs, subculture if you suspect the BI was not correctly activated and incubated. Do not wait for the BI subculturing results to recall. 5. Determine the reason for the sterilization failure. 7 6. Correct the identified problem. 7. Verify the correction by retesting the sterilizer(s) as follows before placing back into routine use. 1,2 a) For dynamic-air-removal steam sterilizers, run three consecutive empty chamber cycles with BI PCDs followed by three consecutive empty cycles with BD PCDs. b) For gravity steam sterilizers, run three consecutive empty cycles with BI PCDs; c) For table-top steam sterilizers, run three consecutive full cycles with BI PCDs. 8. Follow with a written report of the recall order that includes: a) The circumstances that prompted the recall order; b) The total number of products intended to be recalled and the percentage actually recalled; c) Surveillance measures taken if affected devices could not be retrieved and have been in contact with patients; d) Verification that recalled items were reprocessed; e) Corrective action taken to prevent this situation from occurring again. 90 MANAGING INFECTION CONTROL

Standards, Recommended Practices, and Guidelines. 2006. 3. Young, Martha. Condensation of the AAMI Steam Sterilization Recommended Practices-Quality Control-Section 10 Part 1. Managing Infection Control. Sept:2006. 4. Young, Martha. Condensation of the AAMI Steam Sterilization Recommended Practices-Quality Control-Section 10 Part 2. Managing Infection Control. Oct:2006. 5. Prust, Janet. Solving Sterilization Process Problems Using New Tools. Managing Infection Control. July:2004. 6. Ross, Edwin. Using Biological Monitoring to Reduce Infection, Risk and Costs, Surgical Services Management. Vol. 4, No. 7, July 1998. 7. Havrilla, Gale, Hicks, Robin, Larson, Dorothy, and Young, Martha. Troubleshooting Steam Sterilization process Failures-A Series of Unfortunate Events. Managing Infection Control. Oct:2005. 8. Best practices for device recalls, alerts. OR Manager, Vol. 21, No. 6, June:2005. 9. http://www.fda.gov/opacom/enforce.html Martha Young, BS, MS, CSPDT, is a senior international technical service specialist in 3M Medical Products, St. Paul, Minn. She has more than 25 years of experience in the area of sterilization and disinfection. Ms. Young lectures around the world and has numerous publications on infection prevention with an emphasis on improving the performance of the sterilization process. She is a member of IAHCSMM, ASHCSP, AORN (Professional/ Practice Issues Chair for AORN speciality assembly for sterilization) and APIC and a certified Central Sterile Processing and Distribution Technician. In addition, she is a member of several AAMI working group committees that are developing recommended practices. Sterile Process and Distribution CEU Information CEU Applicant Name Address City State Zip Code The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this inservice for one and one-half (1.5) contact hours for a period of five years from the date of publication and to be used once in a re-certification period. Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individuals until re-certification is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding Certification contact: CBSPD, 2 Industrial Park Road, Suite 3, Alpha, NJ 08865 or call 908.454.9555 or visit Web site at www.sterileprocessing.org. IAHCSMM has awarded 1.5 contact points for completion of this continuing education lesson toward IAHCSMM recertification. Nursing CE Application Form 3M Health Care provider approved by the California Board of Registered Nurses, CEP 5770 for 1 contact hour. This form is valid up to five years from the date of publication. 1. Make a photocopy of this form. 2. Print your name, address and daytime phone number and position/title. 3. Add your social security number or your nursing license number. 4. Date the application and sign. 5. Answer the CE questions. 6. Submit this form and the answer sheet to: Workhorse Publishing Managing Infection Control PO Box 25310, Scottsdale, AZ 85255-9998 7. Participants who score at least 70% will receive a certificate of completion within 30 days of Managing Infection Control s receipt of the application. Application Please print or type. Name Mailing Address City, State, Country, Zip Daytime phone ( ) Position/Title Social Security or Nursing License Number Date application submitted ANSWERS 1. T 2. T 3. T 4. T 5. T 70-2009-7528-5 6. T 7. T 8. T 9. T 10. T Signature Offer expires March 2012 On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this program for the following: 1) Overall content 2) Met written objectives 3) Usability of content <03/07> Reprint with permission from Workhorse Publishing L.L.C. Copyright 2007/Workhorse Publishing L.L.C./All Rights Reseved. MANAGING INFECTION CONTROL 91