Medical Device

REPROCESSING Issues & Solutions

Objectives At the end of this program, participants will be able to: • identify recent CDC and FDA alerts regarding improper reprocessing of reusable medical devices in healthcare facilities, • explain the CDC and FDA recommendations for what actions healthcare facilities should take, • discuss issues and solutions for healthcare facilities complying with these recommended actions.

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Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices 9/11/15 - The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. 3

Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.

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Recent Media Reports Recent media reports describe instances of patients being notified that they may be at increased risk for infection due to lapses in basic cleaning, disinfection, and sterilization of medical devices. These events involved failures to follow manufacturers’ reprocessing instructions for critical[1] and semicritical[2] items and highlight the need for healthcare facilities to review policies and procedures that protect patients. 5

CDC HEALTH ADVISORY 9/11/15 - The advisory comes following numerous reports over the past several months of facilities struggling with cleaning, disinfection and sterilization of medical devices, particularly duodenoscopes. Several deaths have occurred as a result of highly resistant bacteria that were transmitted from patient to patient. 6

IN THE NEWS Twenty-one people have died and dozens more were sickened by scope-related infections in LA, Pittsburgh, Seattle, and Washington, D.C. Other outbreaks have been reported in Philadelphia, Milwaukee and Worcester, MA, according to USA Today. A U.S. Senate report found in January that major duodenoscope maker Olympus and FDA failed to alert the U.S. public, even as superbugs infected hundreds. Drug-resistant bacterial strain carbapenem-resistant Enterobacteriaceae (CRE), implicated in the illnesses and deaths, kills almost half of those infected. 7

Olympus Duodenoscope (Used in ERCP procedures)

Did You Know? This device has many difficult to clean areas and the MFR’s IFU has over 60 cleaning steps! 8

CDC Recommendations Healthcare facilities should arrange for a healthcare professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assessment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer.

The following actions should be performed: 9

TRAINING Healthcare facilities should provide training to all personnel who reprocess medical devices. Training should be required and provided: • Upon hire or prior to provision of services at the facility, • At least once a year, • When new devices or protocols are introduced, including changes in the manufacturer’s instructions for use during the device’s life cycle.

Personnel should be required to demonstrate competency with device reprocessing (i.e., trainer observes correct technique) prior to being allowed to perform reprocessing independently. 10

TRAINING Healthcare facilities should maintain current documentation of trainings and competencies. If the healthcare facility hires a contractor for device reprocessing, the facility should verify that the contractor has an appropriate training program and that the training program includes the specific devices the healthcare facility uses. Copies of manufacturers’ instructions for operating and reprocessing each type of reusable device should be readily available to staff and inspectors. This file should include instructions for use of chemical disinfectants. 11

Audit and Feedback Healthcare facilities should regularly audit (monitor and document) adherence to cleaning, disinfection, sterilization, and device storage procedures. Audits should assess all reprocessing steps, including: • Performing prompt cleaning after use, prior to disinfection or sterilization procedures • Using disinfectants in accordance with manufacturers’ instructions (e.g., dilution, contact time, storage, shelf-life) • Monitoring sterilizer performance (e.g., use of chemical and biological indicators, read-outs of sterilizer cycle parameters, appropriate record keeping) • Monitoring automated endoscope reprocessor performance (e.g., print out of flow rate, time, and temperature, use of chemical indicators for monitoring high-level disinfectant concentration) 12

Audit and Feedback Audits should be conducted in all areas of the facility where reprocessing occurs. Healthcare facilities should provide feedback from audits to personnel regarding their adherence to cleaning, disinfection, and sterilization procedures.

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Common errors in the reprocessing of Surgical instruments Point of Use and Transport • Failure to wipe off gross soil and/or flush lumens with sterile water, • Delay in transporting soiled (and opened) items to the decontamination area, • Failure to use a pre-soak solution on soiled items prior to transport, • Transporting items without using a closed container and/or without a biohazard symbol. 14

Common errors in the sterilization of Surgical instruments Reprocessing area (Decontamination) • Not donning and/or doffing PPE properly • Not having enough sinks to soak-wash-rinse • Not having all the MFR’s written IFUs • Not following all the MFR’s written IFUs • Not using ultrasonic cleaner(s) properly • Testing some, but not all mechanical cleaners

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Common errors in the reprocessing of Surgical instruments Reprocessing area (Prep & Pack) • Not inspecting 100% of instruments, • Not using inspection lamps and/or lens, • Cleaning instruments and/or rigid containers, • Assembling hinged instruments in the closed position, • Using improper materials (i.e. marking pens, sterilization tape and/or wrap inside trays, sterilization tape on rigid containers, peel pouches and/or count sheets inside trays). • Trays exceeding 25 lbs. weight limit. 16

Common errors in the reprocessing of Surgical instruments Sterilization & Storage • Improper loading of sterilizers and/or PCD, • Incorrect sterilization mode and/or parameters, • Not enough dry time for type of load, • Placing steam sterilized carts near an AC vent, • Not allowing steam sterilized items time to cool to room temperature (24°C/75°F), • Not storing sterile items in a separate, controlled area, • Stacking wrapped trays which causes compression. 17

Solution is…

BEST PRACTICES Point of Use • pre-clean and spray instruments to prevent soil from drying before transport Reprocessing Area • clean & disinfect in Decontam area • inspect & assemble in Prep & Pack • package & sterilize in Sterilization • maintain sterility in Sterile Storage Quality Assurance • document, document, document! 18

Common errors in the reprocessing of Flexible Endoscopes Point of Use (Procedure Room) • Not wearing proper PPE • Not having MFR’s IFUs • Reprocessing delay (multiple procedures and/or with procedures performed at night or on the weekend) • Failure to clean all channels (even if unused, fluid and debris can enter channels at the distal tip) • Transporting without using a closed container and/or not labeled with biohazard id 19

Common errors in the reprocessing of Flexible Endoscopes Leak Testing • Not having the MFR’s IFU available • Use of damaged water resistant cap • Overlooking pressurization of scope prior to immersion • Incomplete angulation of the distal tip in all directions during leak test • Not following the MFR’s IFUs for reprocessing a damaged scope 20

Common errors in the reprocessing of Flexible Endoscopes Manual Cleaning and Rinsing • Failure to fully submerge endoscope • Failure to submerge for the required length of time • Neglecting to dilute the detergent per the MFR’s IFU • Using worn, damaged or improper brushes • Failure to use MFR’s validated cleaning adapters • Damaged/improperly reprocessed cleaning adapters • Failure to thoroughly rinse off soil and/or detergent residue 21

Common errors in the reprocessing of Flexible Endoscopes Manual HLD and Rinsing • Using a sink or basin of insufficient dimensions • Using a solution after it’s expiration date • Not MRC testing prior to each use • Failure to thoroughly rinse off HLD in all channels • Failure to dry all channels Automated HLD • Failure to manually clean and/or rinse channels prior to placing inside automated endoscope reprocessor (AER) 22

Common errors in the reprocessing of Flexible Endoscopes Storage • Oversight in removing all valves and water resistant cap when storing the endoscope • Neglecting to ensure that scopes are hung with all locks in the free position • Crowded and unsecured scope storage areas 23

IMPORTANT UPDATE regarding storing flexible endoscopes SGNA now supports a 7 day storage interval for reprocessed endoscopes-but only if they were reprocessed and stored according to professional guidelines and manufacturer instructions. AORN Guidelines for Perioperative Practice no longer recommends a 5 day storage interval and the VA follows a directive to process unused endoscopes after 12 days hang time. 24

Solution is …

BEST PRACTICES Point of Use • pre-clean to prevent soil from drying during transport.

Reprocessing Area • perform leak test, • manual cleaning & rinsing, • HLD (manual or automated), • rinsing, drying and storage. Quality Assurance • documentation & record keeping. 25

Infection Control Policies and Procedures Healthcare facilities should allow adequate time for reprocessing to ensure adherence to all steps recommended by the device manufacturer, including drying, proper storage, and transport of reprocessed devices. • Considerations should be made regarding scheduling of procedures and supply of devices to ensure adequate time is allotted for reprocessing.

Healthcare facilities should have protocols to ensure that healthcare personnel can readily identify devices that have been properly reprocessed and are ready for patient use (e.g., tagging system, storage in a designated area). 26

Infection Control Policies and Procedures Healthcare facilities should have policies and procedures outlining facility response in the event of a recognized reprocessing error or failure. Healthcare personnel should assess the cause of the error or failure and the exposure event in order to determine the potential risk of infection. The procedure should include how patients who might have been exposed to an improperly reprocessed medical device would be identified, notified, and followed.

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Infection Control Policies and Procedures Individuals responsible for infection prevention and reprocessing at the healthcare facility should be consulted whenever new devices will be purchased or introduced to ensure that infection control considerations are included in the purchasing decision, as well as subsequent implementation of appropriate reprocessing policies and procedures and to ensure that the recommended reprocessing equipment is available at the healthcare facility.

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Infection Control Policies and Procedures Healthcare facilities should maintain documentation of reprocessing activities, including maintenance records for reprocessing equipment (e.g., autoclaves, automated endoscope reprocessors, medical washers and washerdisinfectors, water treatment systems), sterilization records (physical, chemical, and biological indicator results), and records verifying high-level disinfectants were tested and replaced appropriately.

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Infection Control Policies and Procedures Healthcare facilities should follow manufacturer recommendations for maintenance and repair of medical devices that are used to perform reprocessing functions as well as medical devices that are reprocessed. If healthcare facilities contract maintenance and repair of these devices to third-party vendors, healthcare facilities should verify that these vendors are approved or certified by the manufacturer to provide those services. NOTE: The CDC has removed this recommendation, after push back from industry and healthcare facilities. 30

Additional Information Examples of relevant guidance include CDC’s Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 available at www.CDC.gov and guidance from AAMI at www. AAMI.org. Healthcare administrators should work with their infection prevention personnel and accreditation organizations to ensure that all recommendations are properly implemented to protect patients and personnel.

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Additional Information Problems with medical device reprocessing should be reported to the FDA's MedWatch Adverse Event Reporting program either online at https://www.accessdata.fda.gov/scripts/medwatch/, by regular mail, or by fax.

Download the form at

http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/de fault.htm or call 1-800-332-1088 to request a reporting form,

then complete and mail to address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. 32

Additional Information Healthcare personnel employed by facilities that are subject to the FDA's user facility reporting requirements (see:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Post marketRequirements/ReportingAdverseEvents/ucm2005737.htm)

should follow the reporting procedures established by their facilities. [1] Critical items (e.g., surgical instruments) are objects used to enter sterile tissue or the vascular system and must be cleaned and sterilized prior to reuse. [2] Semi-critical items (e.g., endoscopes for upper endoscopy and colonoscopy, laryngoscope blades) are objects that contact mucous membranes or non-intact skin and require, at a minimum, cleaning and high-level disinfection prior to reuse. 33

FDA Safety Communication - All flexible bronchoscopes 9/17/15 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm462949.htm

The FDA recommends that facilities that reprocess flexible bronchoscopes take the following precautions: • Strictly adhere to the manufacturer’s reprocessing instructions. It is critical that staff responsible for reprocessing bronchoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling. • Do not skip steps. Be sure to follow all pre-cleaning, manual cleaning and HLD or sterilization steps. • Ensure that staff who reprocess soiled bronchoscopes understand the importance of manually cleaning the scope thoroughly before it is disinfected or sterilized. Meticulous cleaning is an essential part of endoscope reprocessing. Failure to perform adequate cleaning may result in failure of HLD or sterilization. • Use only bronchoscope manufacturer-specified cleaning accessories, highlevel disinfectants, enzymatic cleaning agents and detergents and follow their directions for use. 34

FDA Safety Communication – All flexible bronchoscopes 9/17/15 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm462949.htm

• Immediately remove from service for assessment and repair or replace any bronchoscope that fails a leak test (performed to assess scope integrity after every procedure), or shows visible signs of damage. Examples of damage may include: loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, or other signs of wear or damage. • Follow the manufacturer’s recommendations for preventive maintenance and repair of the device. For additional information on maintenance and repair services, refer to the manufacturer’s information provided with your bronchoscope or directly contact the manufacturer. • Implement a comprehensive reprocessing quality control program. Your reprocessing program should include written procedures for monitoring, training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure. • After reprocessing, store bronchoscopes in a manner that will minimize the likelihood of contamination or collection and retention of moisture, according to manufacturer’s instructions. 35

Reprocessing Issues Both the CDC Health Advisory and the FDA Safety Communication raise a number of issues regarding sterilization and HLD, such as… 1. 2. 3. 4. 5. 6. 7.

Are all your reprocessing personnel trained properly? Do you provide regular audits of personnel and processes? Are Policies & Procedures consistent with current Standards? Do you have all your device manufacturer’s IFUs? What is your policy regarding conflicting IFUs? Do you have the resources to comply with device IFUs? Is documentation complete, accurate and presentable (CAP)? 36

Solutions Personnel Training: • Require all reprocessing personnel to be certified as a condition of employment or within two years of hiring. Include a requirement for annual competency check and minimum of 10 CEUs each year. – www.iahcsmm.org (CSSD certification) – www.sterileprocessing.org (CSSD and GI Scope certification) – http://shop.csa.ca/en/canada/personnel-certificationprograms/certified-medical-device-reprocessing-techniciancmdrt/invt/2703373 (Canada MDR certification) 37

Solutions Personnel Training: • Initial training and annual training competency records - Hire a full-time Educator who can observe correct technique - Include training records and annual competency documentation of any 3rd party contractors

Regular audits: – Educator should monitor and document compliance with all reprocessing steps, equipment maintenance and sterilization or HLD processing results. 38

Solutions Policies & Procedures: • Establish a P&P that states you have to review the written IFU prior to purchase, borrowing (e.g. loaner trays) or trialing any new reusable medical device. • Establish a P&P that requires your device manufacturers to update you as to any changes made to their current IFUs. • Enforce all P&Ps, especially when it comes to loaner trays arriving on time and with IFUs. 39

Solutions Manufacturer’s IFUs: • Confirm that you have all your IFUs and if not, have your Educator secure those that are missing or outdated: – Sales Reps (Corporate 800# and name of QA/RA person) – www.OneSourcedocs.com (access data base for a fee)

• Review all IFUs and confirm there are no conflicts with your current reprocessing steps: – Highlight any conflicting steps – Identify resources needed to comply with all reprocessing steps (e.g. space, equipment, supplies, personnel, TIME) 40

Instructions For Use (IFU) Everyone knows how important it is to follow the instrument MFR’s IFU, but are these instructions being followed? For complex devices, specific times will be validated for the soaking, ultrasonic cleaning and/or rinsing. Let’s look at a few examples… 41

EXAMPLE - MFR’s Cleaning IFU

SYMMETRY Orthopedic Instruments 1. 2. 3. 4. 5. 6. 7.

Submerge in enzymatic detergent. Flush port with 50 ml enzymatic detergent. Soak for 10 min in protein soluble detergent. Scrub with soft bristled brush (agitate instrument while scrubbing). Rinse with warm tap water (38-49°C) Flush port with 50 ml warm tap water. Place in bath of warm water (agitate by hand for at least 1 min). Repeat this process 2 additional times. 42

EXAMPLE - MFR’s Cleaning IFU

SYMMETRY Orthopedic Instruments 8.

Ultrasonic for 10 min with neutral pH detergent (flush port with 50 ml prepared detergent before sonication).

9.

Flush port with clean tap water (3 times).

10. Rinse for at least 1 min with tap water. 11. Dry with clean, lint free cloth. 12. Inspect. 13. Lubricate tip mechanism and finger slot (do not lubricate flush port). 43

EXAMPLE MFR’s Cleaning Zimmer Orthopedic Surgical Instruments

1. Completely submerge instruments in enzyme solution and allow to soak for 20 min. 2. Rinse in tap water for minimum of 3 min. 3. Ultrasonic clean for 10 min. 4. Rinse in purified water for at least 3 min. 5. Repeat sonication and rinse steps. 6. Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe. 44

EXAMPLE - MFR’s Cleaning IFU

BAUSCH + LOMB Storz Ophthalmic Instruments Bausch + Lomb is pleased to announce the availability of new cleaning instructions for our surgical instruments marketed under the Storz Ophthalmic Instrument and Bausch + Lomb Instrument brands.

Manual Cleaning 1. Disassemble the instrument as applicable and inspect the instrument for damage or corrosion. 2. Pre-rinse the instrument by holding it under cold running water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water. Additional rinsing may be necessary depending on the size and extent of soiling of the instrument. 3. Place the instrument into a suitable clean basin filled with fresh neutral pH cleaning solution prepared according to the directions of the solution manufacturer. Use only cleaning solutions that are labeled for use with medical devices or surgical instruments. 45

EXAMPLE - MFR’s Cleaning IFU BAUSCH + LOMB Storz Ophthalmic Instruments Ensure that the instrument is fully immersed in the cleaning solution. The following conditions were validated using a neutral pH detergent (Steris ProKlenz NpH) and a severe organic soil challenge (Biomedical Instrumentation and Technology 2007;41(4):324-331). 4. Using a soft cleaning brush gently scrub all surfaces of the instrument while keeping the instrument submerged in the cleaning solution for at least 5 minutes. Clean the instrument until all visible soil has been removed. 5. Rinse the instrument by holding it under cold running water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water. Additional rinsing may be necessary depending on the size of the instrument and the amount of soil. 46

EXAMPLE - MFR’s Cleaning IFU BAUSCH + LOMB Storz Ophthalmic Instruments 6. Place the instrument in an ultrasonic bath filled with fresh neutral pH cleaning solution and sonicate for 5 minutes. Use only cleaning solutions that are labeled for use with medical devices or surgical instruments. Ensure that the instrument is fully immersed in the cleaning solution. Do not overload the ultrasonic bath or allow instruments to contact one another during cleaning. Do not process dissimilar metals in the same ultrasonic cleaning cycle. 7. WARNING: Do not process powered instruments in an ultrasonic cleaner. 8. The cleaning solution should be changed before it becomes visibly soiled. The ultrasonic bath should be drained and cleaned each day it is in use or more frequently if visible soiling is evident. 47

EXAMPLE - MFR’s Cleaning IFU BAUSCH + LOMB Storz Ophthalmic Instruments Follow the instructions of the manufacturer for the cleaning and draining of the ultrasonic bath. 9. Repeat steps 4-6 as necessary if visible soil remains on the instrument. 10. Rinse the instrument by holding it under warm (27˚C – 44˚C; 80˚F – 100˚F) running water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water. Additional rinsing may be necessary depending on the size of the instrument. 11. If the instrument has lumens the lumens should be flushed using a syringe filled with 50cc of warm distilled or deionized water using a stopcock as follows: 48

EXAMPLE - MFR’s Cleaning IFU

BAUSCH +

LOMB Storz Ophthalmic Instruments a. Place syringe tip into a beaker of warm (30˚C – 40˚C/85˚F – 105˚F) distilled or deionized water and fill to the 50cc mark. b. Connect the end of the syringe to the center stopcock fitting. c. Rotate the stopcock lever to the male Luer fitting (irrigation) or to the female Luer fitting (aspiration) to allow fluid flow to the appropriate Luer fitting. d. Connect the stopcock to the appropriate Luer connector on the instrument. e. Push on the syringe plunger to force fluid through the lumen into another beaker for proper disposal. Do not draw flushing fluid back through the lumen. Disconnect the syringe. Disconnect the syringe/stopcock from the instrument. 49

f. Repeat steps A-E at least three times, for each lumen. g. Fill the syringe with 50cc of air, reattach the stopcock, and push on the plunger to force air through each lumen. Disconnect the syringe/stopcock from the instrument. NOTE: The CX7120 Universal Maintenance Kit contains a syringe and stopcock suitable for cleaning instrument lumens.

12. Immerse the instrument in clean basin containing fresh deionized or distilled water and soak for at least three minutes. 13. Immerse the instrument in second clean basin containing fresh deionized or distilled water and soak for at least 3 minutes. 14. Perform a final rinse of the instrument with sterile distilled or deionized water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water. 50

• Do you have an ultrasonic cleaner? • Do you know if it is being used? • Do you know for how long?

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Do you know how many devices require ultrasonic cleaning? Do not forget loaners!

Knowing this information, will tell you if you have the right type and right amount of equipment?

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What if you cannot comply? If this is an issue, you must secure the proper resources, or you must contact the device manufacturer and ask them to revalidate to your standard reprocessing procedures. Not complying with device a patient safety issue and could cause you to lose your accreditation.

MFR’ IFU is

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What about manufacturers who will not revalidate? Your only solution: Use their IFUs to justify purchasing the additional resources. Explain that non-compliance is not an option, for the following reasons: - patient safety, - maintaining your facility’s accreditation, and - media attention, as it only takes one (1) bad outcome to ruin your healthcare facility’s reputation. 54

CONCLUSION Reprocessing complex medical device requires a lot of resources and the future of healthcare is more and more complex devices. Therefore, healthcare facilities must provide reprocessing personnel education and training, along with the proper environmental controls, space, equipment, water quality, supplies and TIME to comply with each IFU.

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Thank You! Chuck Hughes VP, Infection Prevention Consulting Services SPSmedical Supply Corp. now part of Crosstex International, a Cantel Medical Company E-mail: [email protected] Certified as a Health Education teacher, Chuck has worked for over 25 years in the manufacturing industry in areas of Regulatory Affairs, R&D, Marketing, Microbiology and Sterilization Training. He is a corporate member AORN, AST, IAHCSMM, SGNA and numerous other organizations, including AAMI and CSA where he contributes to sterilization standards. A popular speaker at regional, national and international healthcare conferences, Chuck has visited thousands of healthcare facilities during his career providing sterilization consulting services that include fee based and complementary audits of instrument reprocessing areas. 56

References & Resources Association for the Advancement of Medical Instrumentation (AAMI) 1110 North Glebe Road, Suite 220 · Arlington, VA 22201-4795 www.aami.org Association of periOperative Registered Nurses (AORN) 2170 South Parker Road, Suite 300 · Denver, CO 80231-5711 www.aorn.org Centers for Disease Control and Prevention (CDC) 71600 Clifton Road · Atlanta, GA 30329-4027 www.cdc.gov U.S. Food and Drug Administration (FDA) 10902 New Hampshire Avenue · Silver Spring, MD 20993 www.fda.gov SPSmedical Supply Corp. 6789 W. Henrietta Road · Rush, NY 14543 www.SPSmedical.com/education

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