Flash Sterilization By Colleen Landers Registered Nurse Consultant

2. Flash Sterilization By Colleen Landers Registered Nurse Consultant Surgical Suites & Sterile Processing Department

3. What is flash sterilization? Z314.13-01(CSA) – Emergency Sterilization – Which now will be replaced by CSA Z314.3 – Why? Flash sterilization - a special steam sterilization process designed and used for the emergency sterilization of surgical goods when proper sterilization cannot be done.

4. Flash Sterilization “Flash sterilization, if used by facility policy, shall be used only for emergency sterilization (for example when a dropped instrument requires immediate sterilization). Flash sterilization shall not be used to compensate for inventory shortages or scheduling problems. Flash sterilizers will be biologically monitored minimally daily and all items traceable to the patient.”

5. Current practice! Flashing total sets and implants is routine. Quick rinse in a sub-sterile room or scrub-sink area -Uniform or scrub suit + sink is now contaminated Excess flashing due to lack of inventory and scheduling practices. Flash Sterilizers with no preventative maintenance No verification of sterility of items being sterilized.

6. Where do we need to be? • Instrument sets should not be flash sterilized. Flash sterilizers are only validated for 1-2 instruments. • The following conditions shall be met if you are flashing: • a) there is an urgent unplanned need; • b) there are documented procedures for this practice • the physical layout and documented procedures assure direct delivery of the sterilized item to the point of immediate use. • d) The flash sterilizers has routine preventative maintenance that is documented. • e) Staff trained in reprocessing practices and yearly competency testing.

7. Where we need to be cont’d d. Proper decontamination of instruments; Performed in a separate room/environment by people who are properly attired with PPE (personal protective equipment). CSA Z314.8 e. Load documentation & monitoring system is in place. f. All flashed items tracked to the patient .

8. Measures to Avoid Flash Sterilization Measure to avoid flash sterilization: • maintenance of adequate inventories of medical devices; • coordinating device reprocessing with surgical schedules so that properly processed devices are available when needed; • adherence to policies and procedures for loaned and shared instrumentation (see Z314.22) so that devices arrive in time for proper reprocessing; and • education of medical staff and materials managers in the risks associated with flash sterilization • Computerized booking systems that cannot be converted to override inventory.

9. Why not Flash Sterilize? • Sterilization process itself can be similar to sterilization process performed in reprocessing department but the lack of pre- and post- sterilization precautions introduces additional risks to the use of flashed devices. • The facility has a responsibility to ensure that every patient receives the same level of care; therefore should endeavour to avoid the additional risks to patient safety associated with flash sterilization. • Remember that flash sterilizers are only validated for 1-2 instruments, and should only be used for life and death situations or loss of limb not routine for scheduling and lack of instrumentation. CSA Standard Z314.3 “Flash sterilization shall not be used on complete sets or trays of instruments.”

10. What can be done to change? Develop policies based on CSA standards that both SPD and OR staff could follow and live with! How do we do that? • Research the CSA documents which are best practices in reprocessing • Invite an expert to speak to the Peri operative Policy and Procedure Committee about the CSA Standards. • ORNAC Standards are based on CSA.

11. CSA Standards and ORNAC • Are they mandatory? • Why are they written if hospitals can’t follow? Why write a policy based on CSA Standard that can’t be upheld due to resources available? • Do we bend the Standard to fit resources of the hospital? • Lots of great questions!

12. What can be done to change practices? • Develop policies AND….. • Standardize practices throughout Canada for OR & SPD • Identify staff competencies • Develop an education plan • Decrease flash sterilization • Share our resources  • Be a leader! • Provide every patient with the same level of care

13. Policies and Procedures The requirements for policies, procedures, documentation and quality system are required. If a flash sterilized medical device is used in a procedure, an incident report shall be created that includes the following information: • patient’s name • physician’s name • date and time the of procedure using the flash sterilized device • procedure it was used for • reason that flash sterilization was needed • results of physical monitoring and biological / chemical indicator monitoring of the sterilizer and load. • Periodic review incident reports to help identify ways to reduce the need for flash sterilization.

14. Policies Flash sterilization process is composed of several phases that are critical to achieving and maintaining sterility. These phases include: • transport of contaminated devices to decontamination area • disassembly and decontamination c) preparation d) loading the sterilizer e) sterilization procedures f) monitoring and recording of cycle parameters f) unloading and aseptic transfer of items to the sterile field.

15. Personnel Requirements 1. All aspects of emergency steam sterilization require supervised staff that are knowledgeable, trained personnel wearing appropriate attire, including personal protective equipment. 2. Personnel must have demonstrated expertise in medical device reprocessing and in the use and application of the steam sterilization process. 3. Control of bio burden and containment of contaminants are essential to the sterilization process.

16. Personnel Requirements 4. The health care facility administration to ensure that operators of all steam sterilizers used for flash sterilization in the facility are trained. 5. Education documented with ongoing competency in the operation of steam sterilizers. 6. Staff are aware of the hazards associated with steam sterilizers. 7. Monitoring and maintenance of sterilizers required.

17. Flash Sterilization Personnel • Flash sterilization personnel must be responsible for verifying exposure time and temperature, and for aseptically transferring the sterilized items to the point of use. • Personnel engaged in the processing of items for flash sterilization require an initial orientation and on-the-job training, including instruction in the following; a) sterilizer operation and monitoring (sterility assurance) b) the parameters of steam sterilization c) basic microbiological principles d) the health care facility's infection control and prevention policies and procedures e) decontamination of medical devices

18. Flash Sterilization Personnel f) monitoring of sterilization g) preparation of the incident report h) action to be taken if there is a failure during reprocessing i) unloading and transfer to the sterile field. The facility shall assign specific responsibility to a staff member or position for the maintenance of quality system documentation relating to flash sterilization, including documentation of staff training, and the collection, review and retention of flash sterilization incident reports.

19. Work Area for Flash Sterilization • The steam sterilizer used for flash sterilization shall be located in a restricted-access area immediately adjacent to the area where the sterilized items will be used in patient care. • The sterilizer shall not be located in the operating room theatre, and shall not be near any potential source of contamination, such as sinks, hoppers, linen, or trash disposal areas. • Sterile storage shall not be located immediately adjacent to the sterilizer used for flash sterilization. • Flash sterilization must be carried out in a clean environment. • Devices processed by this method must be transferred and handled as little as possible as may not be protected by packaging before or immediately after the sterilization process.

20. Work Area • At least one flash sterilizer in the OR suite shall be on the emergency power system. • The facility shall have written validation from the sterilizer manufacturer that it is suitable for flash sterilization and specifying the size of loads for which it has been validated. • All instruments shall be cleaned and decontaminated prior to sterilization by trained staff wearing appropriate PPE. Refer to Z314.8. Saline shall not be used. Before they are cleaned, general operating instruments shall be separated from delicate instruments or devices requiring special handling.

21. Work Area Decontame • Soiled items shall be contained during the transport from the point of use to the decontamination area. • They shall be cleaned immediately. • Gloves and appropriate PPE shall be worn when handling soiled items. • Containment may be accomplished by any means that adequately prevents inadvertent personnel contact with or exposure to the soiled items during the transfer. • Reusable transportation containers shall be cleaned and decontaminated after each use.

22. Sterilization • High-temperature saturated steam must come into direct contact with all surfaces of all items. • Air removal, steam contact, and drainage of condensate are enhanced by proper positioning and by the use of perforated or mesh bottom trays. Items to be sterilized may be placed in (a) protective organizing cases (b) open trays (c) rigid sterilization container systems (d) single wrapped trays Closed container system is preferred, to minimize the chance of contamination occurring between sterilizer and patient.

23. STERILIZATION The health care facility shall follow the device manufacturer’s instructions, including those for • time and temperature • load size (including any necessary adjustments to time or temperature with relation to load size) • maximum loads (by weight or by number of instruments) • load configuration • Each flash sterilization cycle shall be verified by the health care facility through actual testing of loads configured as specified in the manufacturer’s instructions.

24. Sterilization If flashing will occur for life, limb or organ emergency disaster then after cleaning, items shall be placed in a perforated or mesh bottom instrument tray and arranged in the following manner: (a) instruments and devices with concave surfaces shall be positioned with the open side down; (b) all hinged instruments shall be opened, without engaging the ratchet, and shall be placed on racks or stringers as needed; (c) items with easily removable parts shall be disassembled; (e) for complex instruments (eg, air-powered instruments), the instructions of the device manufacturer shall be followed; (f) lumens of tubing, suction devices, and needles shall be moistened with pyrogen-free water immediately prior to steam sterilization.

25. Do Health Care facilities meet these requirements? Auditing of healthcare facilities across the nation will show that most do not meet these requirements. Most: • Wash instruments in scrub sinks or small sink in between OR theatres. • Decontame areas not under negative pressure Z314.8 • Maintenance on these sterilizers not done, sterilizers not cleaned, records not kept. Some so old should be replaced. • Staff not trained to reprocess and do not have competency testing or required education. It goes on and on!

26. Do you meet all these requirements? IF NOT YOUR FACILITY NEEDS TO TAKE ON A PROJECT TO IMPROVE PROCESS!

27. Implement to improve patient care!

28. Set up a Quality Improvement Project • Joint Quality Assurance/Accreditation Project – Sterile Processing Department and Surgical Suites Called The “Flash” Project • Must have buy in from all parties! • Why do it? Best Practices are provided in the CSA standards and every facility should be aiming for these practices. • Accreditation will now be examining flashing practices as a part of their review.

29. Perioperative Portfolio Meeting • Great idea / support evident • Invite Quality & Decision Support • Clerical support required. • Infection prevention and control and risk management involved.

30. The Project

31. Project Objectives • To determine frequency/reason for Flash sterilization • To determine staff competency with Flash sterilization. • To determine education required. • To incorporate Canadian Standards for Flash Sterilization • To develop a quality monitoring process • To improve the standard of patient care and improve patient outcomes • To share our resources and show you are a leader!

32. Goal ALL STAFF PRACTICING FLASH STERILIZATION TO THE CANADIAN STANDARDS

33. What can be done? • Project Map developed with Team in conjunction with Management Engineering. • Survey/OR Flash Record, developed with Quality & Decision Support, to obtain full understanding of current situation.

35. Survey Results • Ensure surveys were returned – response rate then reviewed and results documented. • These can be your support to proceed. • Staff identified competency re flash sterilizing as an issue: 79% of the staff felt somewhat or not at all confident in their knowledge re flash sterilizing. • Documentation was also an issue: 72% of the staff felt somewhat or not at all aware of the documentation required for flash sterilization.

36. Highlights - Survey Results • Only in preparing instruments or equipment for flash sterilization, do a slim majority of staff (56%) feel very competent and comfortable • Knowledge about Standards is not an issue • 65% of the staff indicated they felt their knowledge about Standards for flash sterilization is good or very good

37. Highlights - Survey Results • Staff identified two main reasons for flash sterilizing items: • Items dropped or contaminated during the case (10%) • Scheduling practices (56 %) • Lack of inventory (34%) Was this really the reason – data required!

38. Flash Sterilization Record

39. Purpose of the Flash record • Documents: • Why we are flashing? • Traceability to the patient! • Frequency of flashing!

40. Reasons for Flashing

41. Challenges to Documentation • Education to everyone in a timely manner • Completion of the form (Accuracy and completeness) • Timely follow up for omissions • Change from current practice • Working together so all items can be terminally sterilized in the reprocessing department.

42. Next Steps…Finalize policies and education modules! Implement policies and provide education to all!Evaluate education!Competency testing yearly! Document all flash sterilized items and meet to solve the issues that required this practice!Working together!Re-survey staffRe-audit documentation toolReport Data results to Leadership

43. Change can be accomplished! • Working together for the betterment of the patient we can all meet best practices in reprocessing as • Remember! You could be that patient having a surgical procedure and would you want a totally processed instrument or a flashed one? I know what I would want and so do you!

44. REMEMBER, THIS PATIENT COULD BE YOU!! WOULD YOU WANT THE INSTRUMENTS IN GOOD WORKING ORDER, CLEAN AND STERILE?

45. References • CSA Z314.3 Effective Sterilization in Health Care Facilities using the Steam Process • CSA Z314.8 Decontamination of reusable medical devices • CSA Z314.22 Management of Loaned, Shared, and Leased Medical Devices • Linda Jakeman’s presentation to Health Canada Scientif Advisory Panel on Flash Sterilization

46. Questions

47. Thank-you!