The Current Challenges in the North American Reprocessing Field and Proposed Solution!

1. The Current Challenges in the North American Reprocessing Field and Proposed Solution! By Colleen Landers Registered Nurse Consultant

2. Objectives • Define the major issues facing reprocessing departments. • Provide options to solve these issues. • Refer to the standards that reprocessing departments require to solve these issues.

3. Challenges • Cleaning and sterilization instructions. • Turn around demands. • Sterilization extended cycles. • Staff orientation, education and competency testing. • Weight of Sets. • Loaner Sets. • Flash Sterilization

4. Medical Procedures: • First: Do no Harm • New Millennium:Age of the Internet and Litigation!!(The Public are informed and demanding more of HealthCare).

5. Cleaning and Sterilization of Medical Devices • Medical Devices have become increasingly complex as more sophisticated and less invasive surgical procedures are developed. • The manufacturers’ validated reprocessing instructions for these devices have not kept pace with the requirements listed in the Canadian and American standards.

6. Cleaning and Sterilization of Medical Devices • Along with this issue, the increased demand to do more surgical procedures, requires faster turn around of instruments to meet the surgical demand. • Concern regarding the safety of patients receiving healthcare in North America has required the standards to be reviewed and requirements increased.

7. Cleaning of Medical Devices: Who is responsible for What?? • Manufacturer’s validate that instrument can be reliably cleaned and sterilized/disinfected and is therefore re-usable. • Users verify that cleaning & sterilization equipment is working properly and that in-hospital cleaning & sterilization methods are consistently performed and verified.

8. Medical Device Specific Instructions for Reprocessing What you don’t Know?

9. Manufacturer recommended cleaning that is not validated! • “Ivory Snow”! • “No detergent”! (only sterile distilled water) • “Use regular hospital cleaning protocol”!

10. “Crud” Issue Patient-used (no side-panel): un cleaned Patient-used repeatedly; side-panel removed

11. “Show Me the MONEY”!! • STERILE Crud???- Acetabular reamers- Electronic drill Hand pieces • No “infection” risk ?  What is the issue? • Cost/Benefit: What is realistic???

12. Sterile Crud ??? • Foreign organic material- Endotoxin (LPS) from dead bacteria- blood and other organic debris from previous patient or from cleaning process (e.g. enzymatic detergent residuals, water organisms etc). • Adverse antigenic reaction to foreign organic material (e.g. implants & LPS). • Foreign body: “Nidus” for endogenous infection. [Xing et al. Accumulation of LPS by polyethylene particles decreases bone attachment to implants. J Orthopedic Res 2006;24:959-966]

13. Cleaning and Sterilization of Medical Devices • Health Care Facilities need to make sound decisions when purchasing a reusable medical device. • Documents that guide you are; • ISO 17664 Information to be provided by the manufacturer for reprocessing of a resterilizable medical devices. (CSA Z17664) • AAMI ST:81 Sterilization of medical devices; Information to be provided by the manufacturer for the processing of resterilizable medical devices.

14. Comply with ISO 17664 & AAMI ST81Validated Cleaning Methods Coiled reamer shafts Alternative: solid shaft Crud from between coils

15. Information provided by manufacturers • Adequate and appropriate cleaning and sterilization. • Instruments with cannulation (lumens or holes) – these instructions need to be device specific – include ultrasonic. If the device retracts or requires disassembly – include pictures. • Instruments with crevices (i.e. nuts, bolts, broaches, cutting blocks) device specific. • Instruments that are hinged – (i.e. pliers, cutters, forceps) – instructions to include: • Cleaning brush size and type • Ultrasonic • Lubrication if required – type of lubricant that is recommended.

16. Information provided by manufacturers • Flexible reamers – Instructions need to be device specific including pictures. • Manufacturers to give maximum number of reprocessing times for implants (i.e. screws, plates) – how to identify when replacement is required. • Manufacturers to review design. Cleaning tools should be provided by manufacturers. • Ensure that when manufacturers update, revise and/or change sterilization instructions for medical devices the new procedures are communicated to the current users in a systematic documented fashion.

17. WHY? • Health Care facilities require a policy and procedure requiring all information on reprocessing from the manufacturer of the device prior to reprocessing; cleaning, decontamination, wrapping and sterilization. • Required prior to purchase, lease, trial or evaluation or purchase. • Why? To protect the facility from error and protect patients from risk.

18. POLICY PROCEDURE FOR ORDERING REUSABLE MEDICAL DEVICES Requires the following; • Purchase approved by the Reprocessing Manager and Infection Prevention and Control prior to evaluation, consignment, loaned/leased or purchases. • Written manufacturer’s instructions for cleaning, wrapping and sterilization reviewed and attainable by Central Processing department before purchase. • In-service for cleaning and sterilization shall be provided to all staff, prior to the medical device being placed in circulation for use on a patient.

19. POLICY PROCEDURE FOR ORDERING REUSABLE MEDICAL DEVICES • The decisions to make changes to cleaning products, purchases of new equipment for surgical procedures, etc., shall be performed by a “Product Evaluation Team” endorsed by the OEM. • All medical devices that will be loaned/leased, used on consignment, evaluated or purchased will be reviewed and a decision made by the Product Evaluation Team.

20. Why? • To determine if the medical device can be cleaned and sterilized in the facility before evaluation, consignment, loaned/leased or purchased in the healthcare facility. • To ensure that the reprocessing will meet the requirement for organism kill. • To prevent risk to patients and staff.

21. Solution • If healthcare facilities require staff to reprocess medical devices then clearly written instructions with pictures are required. • In service of all medical devices given to the reprocessing staff on the cleaning, wrapping and sterilization prior to the implementation of the device in the health care facility. • Sound decisions, when purchasing the medical device, to ensure it can reprocessed in the facility to meet the best practices required in the standards.

22. Solution • If increased numbers of surgical procedures are required then increase in instrumentation to meet these demands is required. • Short cuts in reprocessing are a risk to patients! They are are not a means to meet the demand. • All patients have the right to the same level of care and the same level of reprocessed instrument. • ST79 covers these requirements as does CSA Z314.3 and Z314.8.

23. EXTENDED CYCLES

24. Sterilization Cycles Typical steam sterilization method used in health care are the dynamic air removal cycles. Typical cycles are: • 3 Minutes at 135 degrees C (275°F) • 4 Minutes at 132 degrees C (270° F) Cycle is dependent upon specific sterilizer manufacturer. Hospital sterilizers are only validated for these hospital cycles. Gravity cycles rarely used today in healthcare facilities.

25. Extended Cycles • Up to 10 different extended cycle times exist and the number grow daily! • These cycles are greater than the standard hospital cycles. • Extended cycles are now being recommended by various device manufacturers. e.g. Range of 5 to 40 minutes

26. Sterilizer Manufacturer Validated Cycles *This table represents the variation in sterilizer manufacturers’ recommendations for exposure at different temperatures. For a specific sterilizer, consult only that manufacturer’s recommendations. Dry times have not been indicated as this varies substantially depending upon the sterilizer manufacturer, season and/or other site specific issues. Note: Extracted from AAMI DS2/ST79/2005-02-07

27. Problems Large sterilizers are designed to accommodate loads of multiple devices with similar requirements for sterilization. • Having only a small number of sets in a large sterilizer chamber increases the challenge to sterilization and the likelihood that air will not be completely removed from the set being reprocessed. This may compromise sterilization. • It is inefficient to run a load with a single device that requires a different sterilization cycle. • Sterilizing items in multiple loads does not allow departments to meet the daily sterilization demands.

28. Problems Changing the settings on sterilizer equipment, for each load, can lead to human error resulting in the wrong cycle being selected. • This can lead to devices being weakened, destroyed or incorrectly sterilized in subsequent loads.

29. Problem Packaging for containment of devices or sets has not been validated for use in extended cycles e.g. reusable and single use wraps, pouches, rigid containers and their filters. • May not maintain sterility . • May not allow sterilization of all device surfaces due to tightness of fitting, excessive metal mass or layering of devices.

30. Recommended Solution Standardize to a minimum number of cycles e.g. one extended cycle, the length of time to be determined, in addition to the 3 or 4 minute cycle routinely used. • to allow BI and CI manufacturers to develop products specific to these cycles. • to decrease likelihood of human error. • to increase productivity. • to decrease likelihood of sterilization failure.

31. Recommended Solutions • When a device manufacturer develops extended cycle recommendations, the type of appropriate packaging to be used for the extended cycle (reusable or single use wrappers, rigid containers or pouches) should be included in the validation process. • Packaging manufacturers should validate their products for extended cycle times.

32. AAMI TIR 31- Process Challenge Devices/test packs used for healthcare facilities. • The standard extended cycles has been addressed in this AAMI TIR. • They include: • Pre Vacuum cycles 270 – 274 degrees at 10 or 20 minutes. • Gravity 250 degrees 40 or 60 minutes. • Recommend Solid Load PCD and Hollow Load PCD for each recommended cycle.

33. Proposed Chart for Extended Cycles

34. Recommended Solution • This will allow PCD manufacturers to develop PCDS for these cycles. • Adopted by the ST 8 - Hospital Steam Sterilizers so sterilizers validated for these cycles. • Adopted as hospital cycles in ST79 –Comprehensive Guide to steam sterilization and sterility assurance in health care facilities. • Wrapping manufacturers can then test their wrap at these cycles. • CSA in Canada has agreed to also adopt these cycles recommended.

35. Conclusion Extended Cycles • Device manufacturers must work together, with other manufacturers, to ensure that the recommended extended cycle meets capabilities of the sterilizer, the packaging, and process monitors to be used. • Health Canada and the FDA, when reviewing pre market applications for devices will require the medical device manufacturer to provide appropriate Validation • Packaging will be validated for these cycles. • Process monitoring device will be available for these cycles. • Healthcare sterilizers will be validated for all of the hospital cycles recognized as healthcare steam sterilization cycles.

36. Staff Orientation, Training and Competency Testing.

37. Reprocessing Staff • Since the 1990’s with the advent of “Minimal Invasive Surgery”, instruments became complex and more difficult to clean. • Simple instruments like kockers and criles made of stainless steel are no longer the norm. • These changes brought larger challenges for cleaning, requiring knowledgeable staff that are current and trained. • Staff now require greater education and critical thinking abilities in order to do the cleaning and reprocessing safely. • Reprocessing departments require a Quality System which requires monitoring and documentation.

38. Quality Control Standards require • Continuous supervision of personnel performance. • Competency testing. • Supervision of work practices. • Ongoing verification of adherence to policies and procedures. • Verification of reprocessing practices.

39. Quality Systems • Deviations from normal operating procedures are identified, investigated and evaluated. • Corrective action required. • Audits: • Internal audits by knowledgeable staff to verify effectiveness of system. Audit reviews documented and corrective action taken. • Periodic external reviews to measure progress are recommended. • Contractors or other organizations that perform functions that could effect quality systems then they must demonstrate they will have adequate control and supervisions so as not to effect quality system.

40. This Requires Educated Staff with Critical Thinking Skills! • Challenge is to find these people and then to maintain them in the field. • Orientation after they obtain a formal course requires months of supervision before they can function alone. • Due to the complexity of the instruments and vast numbers of sets to master, this does not occur overnight. • Ongoing education, competency testing of staff yearly, in service on all new medical devices is costly and time consuming. • Staffing compliments must address release time for this to occur and is rarely considered when financial allocations are given to reprocessing areas.

41. Proposed Solutions • Require formal education as hiring practice. • Ensure the staff have job satisfaction. • Provide ongoing education opportunities for staff. • Have internal audits be opportunities for improvement. • Staff that know why they are required to do something do a better job. • Ensure you have detailed procedure cards for all cleaning and reprocessing practices for all medical devices that are current and have pictures to facilitate processes. • Provide opportunities for open houses in the department so users understand the complex tasks the reprocessing staff deal with on a daily basis.

42. Proposed Solutions! • Offer opportunities for user staff to spend time in reprocessing. • Offer opportunities for reprocessing staff to view surgical procedures so they understand the use of medical devices. • Celebrate success! • Teach staff to understand that an error is a learning opportunity as long as corrective action results. • Do customer service surveys and involve staff in the results and solutions. • Liaison staff between the operating room and reprocessing is a requirement, in order to solve issues rather then let them become issues that break relationships.

43. Proposed Solutions! • Reprocessing budgets must include release time for training and ongoing education. • Auditing must be scheduled & documented! • Recommendations must be documented, and addressed to improve process and action taken!

44. Why knowledge is Important?

45. Weight of Sets! Imagine working in a Reprocessing Department or Operating Room where there is a maximum weight limit on instrument trays! Imagine that this maximum weight limit policy is routinely enforced! Picture your staff no longer complaining about having to repeatedly lift heavy trays! Imagine if you did not have to deal with wet pack problems or other sterilization concerns due to heavy trays! This vision can come true by just saying “NO” to instrument trays that are too heavy!

46. WEIGHT OF SETS

47. Heavy Sets! • No matter what the reason for an instrument set being on the heavy side, it can be a problem when it comes to the sterilization process. • Overweight sets and sets that do not have the metal mass evenly distributed can create concerns with adequate steam contact with all surfaces. • In addition, a problem with drying may result in the potential for wet packs. • The Association of Preoperative Registered Nurses (A O R N ’s) 2006 recommended practice for Packaging Systems states rigid container systems should be used according to manufacturers’ instructions. The approved sterilization method and cycle exposure times for each rigid container system should be provided in the manufacturers’ data and instructions. • Your sterilization standards state “weight of a wrapped instruments set should be no more then 16 pounds! • The sterilizers are validated for this weight.

48. Heavy Sets • Why? The more mass metal the more steam forms water thus drying issues & wet packs. • The new CSA Z314.3 states the total weight with container cannot be over 10 kg/22 pounds. • Sterilization cannot occur unless the steriliant can reach all surfaces of the instrument. With multi layer sets users must verify that the steriliant will sterilize all medical devices in all areas. • Testing with BI’s has been done and failure has occurred. (User Alert- Problems with process monitors for extended cycles)

49. Instrument sets; excessive weight & mass • If failure of any BIs: report to medical device manufacturer • Break down set to smaller tray sets and re-test

50. Ergonomic Concerns with Heavy Sets • In the hospital setting we see many injuries of staff due to repeated lifting of heavy instrument containers. • The health and safety of healthcare workers should be protected through reasonable weight restrictions, especially when these trays must be lifted an average of 12 to 15 times each time the set is used and reprocessed. • Instrument sets used for a surgical procedure are lifted on and off case carts, on and off surgical areas, in and out of instrument washers, onto and off of processing tables, lifted to be wrapped or containerized, into and out of the sterilizer, on and off storage shelves, etc. • This repetitive lifting can be an ergonomic nightmare, particularly when the set weight exceeds 10kg/22 pounds or if there are several heavy sets. • Studies have shown that repetitive lifting greater then 9kg will cause injury to staff such as shoulder, arm, back, neck. • The statistics are showing that these heavy sets are making patients of our reprocessing and operating room staff.