Where the Microbes are Lurking: Preventing Cross Contamination via Medical Devices

1. Where the Microbes are Lurking: Preventing Cross Contamination via Medical Devices Kathleen Meehan Arias, MS, CIC Arias Infection Control Consulting, LLC This educational activity is supported by an education grant from Philips Healthcare, LLC

2. Continuing Education Credits • At the end of this webinar you can obtain 1.0 contact hour by going to www.saxetesting.com/bo • Complete the post-test and evaluation form. • Upon successful submission, you will be able to print out your certificate of completion. • Provider (Saxe Communications) is approved by the California Board of Registered Nursing. Provider # 14477 • This program has been approved for 1.0 contact hour of CRCE by the AARC. • No off-label use of products will be discussed. • Disclosure: Ms. Arias did not disclose any conflicts of interest in relation to this presentation.

3. Our Speaker Ms. Kathleen Arias, MS, CIC President, Arias Infection Control Consulting, LLC

4. Objectives • List the pathogens linked to transmission from medical devices and equipment • Describe the financial and clinical implications of contamination of medical devices and equipment • Discuss prevention strategies for reducing risk of transmission, including use of both reusable and single-use medical devices and supplies

5. Why Talk About Microbes? • The hospital environment, including medical devices and equipment, becomes contaminated by a variety of organisms • There is documented evidence that: • Hands and gloves of healthcare workers readily acquire pathogens after contact with contaminated inanimate surfaces • Healthcare workers can transfer these organisms to subsequently touched patients and inanimate surfaces • Contaminated medical devices and equipment have transmitted pathogens and infections to patients

6. Why Talk About Microbes? • These findings emphasize the importance of cleaning and disinfecting of hospital surfaces, medical devices, and medical equipment • This presentation will discuss: • Several pathogens that have been associated with transmission from medical devices • Strategies for reducing the risk of transmission of pathogens from semicritical and noncritical medical devices and equipment

7. Microbes are everywhere…

8. Clinically Relevant Organisms Can Be Found on Dry Hospital Surfaces and Medical Equipment These organisms frequently cause healthcare-associated infections (HAIs) Table adapted from: Kramer A, Schwebke I, Kampf G. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infect Dis. 2006;16(6):130. Used with permission.

9. The Burden of HAIs Human Cost Financial Cost $35.7 to $45 billion (estimated 2007 dollars) added to U.S. annual healthcare costs to treat2 Lost wages and productivity for patients and families • Account for 1.7 million infections and 99,000 deaths in U.S. each year1 • 4.5 infections for every 100 hospital admissions • Physical and mental suffering Klevens RM, Edwards JR, Richards CL Jr, et al. Estimating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Rep 2007 Mar-Apr; 122(2):160-6. Scott RD. The direct medical costs of healthcare-associated infections in U.S. hospitals and the benefits of prevention [report online]. 2009 Mar http://www.cdc.gov/ncidod/dhqp/pdf/Scott_CostPaper.pdf.

10. How Microbes Can Be Transmitted from Inanimate Surfaces to Susceptible Patients Contaminatedinanimatesurface Direct transmission Susceptiblepatient Hands of healthcare worker Compliance in hand hygiene: ~ 50% Kramer A, Schwebke I, Kampf G. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infect Dis. 2006;16(6):130.

11. Question: The major mode of transmission of healthcare associated pathogens to patients is via: 1. Treatment with improperly disinfected semi-critical medical devices 2. Direct contact with colonized or infected patients 3. Contact with inadequately cleaned hospital environmental surfaces 4. Transiently colonized hands of healthcare workers*

12. Many Factors Involved for Infection to Occur Microbe (bacteria, fungi, viruses) Infection Patient Environment (hospital surfaces, devices, equipment)

13. Why focus on contaminated medical devices and equipment?

14. The Patient Care Environment: Medical Devices and Equipment

15. Equipment Contamination in an Emergency Department Clinically significant organisms isolated: • MRSA • VRE • Gram Negative rods Obasi C, et al. Contamination of equipment in emergency settings: An exploratory study with a targeted automated intervention. Annals of Surgical Innovation and Research 2009; 3:8

16. Many organisms isolated from contaminated medical equipment and devices are pathogens that frequently cause healthcare associated infections

17. Implications of Using Contaminated Medical Devices and Equipment (1) • Contaminated medical devices have resulted in healthcare associated infections 1 • These HAIs resulted in morbidity, mortality and increased healthcare and patient costs • Millions of patients exposed to medical devices and equipment each year • More than 20 million GI endoscopic procedures alone are performed annually in the United States2 • Many patients at risk for HAI 1. Rutala WA, Weber DJ. New developments in reprocessing semicritical items. Am J Infect Control 2013; 41:S60-S66. 2. Everhart JE. The burden of digestive disease in the United States. NIH publication no. 09–6443. Washington (DC): U.S.Department of Health and Human Services; 2008.

18. Implications of Using Contaminated Medical Devices and Equipment (2) • Hands of personnel can transfer pathogens from contaminated hospital surfaces to patients1 • Patient can subsequently develop an HAI • Contaminated hospital surfaces can transmit pathogens to patients1 • Outbreak investigation and control is disruptive, time consuming and expensive • HAIs and outbreaks can result in adverse publicity and lawsuits • Medical device reprocessing errors result in patient lookback and patient notification re: potential exposure2 • Otter JA, et al. Evidence that contaminated surfaces contribute to the transmission of hospital pathogens and an overview of strategies to address contaminated surfaces on hospital settings. Am J Infect Control 2013;41(5):S6-S11. • Rutala WA, Weber DJ. New developments in reprocessing semicritical items. Am J Infect Control 2013; 41:S60-S66

19. Types of Medical Devices and Equipment: Critical Items Critical Items: • Enter sterile tissue or the vascular system • Must be sterile because of high risk for infection if contaminated • e.g., surgical instruments, vascular catheters Image provided by K. Arias Rutala WA, Weber DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. US Dept of Health and Human Services, Centers for Disease Control and Prevention; 2008.

20. Types of Medical Devices and Equipment: Semicritical Items • Come in contact with mucous membranes or non-intact skin (e.g., laryngoscope blades, bronchoscopes, GI endoscopes and some ultrasound transducers) • Should be free of all microorganisms • small numbers of bacterial spores permissible • Must be cleaned meticulously and disinfected with high-level disinfectant between uses • Can readily transmit infectious agents Rutala WA, Weber DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. US Dept of Health and Human Services, Centers for Disease Control and Prevention; 2008.

21. Types of Medical Devices and Equipment: Noncritical Patient Care Items • Come in contact with intact skin but not mucous membranes during routine use (e.g., ECG leads/cables, blood pressure cuffs, stethoscopes, pulse oximetry sensors, some ultrasound transducers) • Pose little risk when used as noncritical items and do not contact nonintact skin and/or mucous membranes • Should be cleaned and disinfected with low- or intermediate-level disinfectants between patient use Rutala WA, Weber DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. US Dept of Health and Human Services, Centers for Disease Control and Prevention; 2008.

22. Question: Which of the following items is most likely to transmit a healthcare associated infection if it is not properly cleaned and disinfected between patients: 1. Pulse oximetry sensor 2. Laryngoscope blade* 3. Stethoscope 4. Blood pressure cuff

23. What We Know… • Semicritical medical devices have long been associated with transmission of pathogens and subsequent development of healthcare-associated infections (HAI) • Noncritical medical equipment can serve as fomites harboring microorganisms which can be transmitted and contribute to HAIs

24. Let’s Look at semicritical devices

25. Examples of Semicritical Medical Devices • Bronchoscopes • GI endoscopes • Laryngoscopes • Nasopharyngoscopes • Cystoscopes • Respiratory therapy and anesthesia equipment • Tonometers • Vaginal specula • Endocavitary probes • Prostate biopsy probes • Infrared coagulation devices • Diaphragm fitting rings • Esophageal manometry probes • Anorectalmanometry catheters

26. Many Semicritical Medical Devices Difficult to Clean and Disinfect: e.g., Bronchoscopes • Lumens, ports and channels difficult to decontaminate • Many outbreak/pseudo-outbreak reports1 • Contamination commonly resulted from failure to adhere to appropriate procedures for cleaning, disinfection, rinsing, drying and/or storage • Pseudomonas aeruginosa most common organism reported 1. Weber DJ, Rutala WE. Lessons Learned From Outbreaks and Pseudo-Outbreaks Associated with Bronchoscopy. Infect Control Hosp Epidemiol 2012; 33: 230-234.

27. Many Semicritical Medical Devices Difficult to Clean and Disinfect: e.g., Tonometers • Sensitive, easily damaged • Outbreaks of epidemic keratoconjunctivitis associated with tonometers • Transmission occurred from contaminated tonometer to patient's eye • Contamination commonly resulted from poor disinfection procedures • Typically caused by adenovirus types 8, 19 and 37 Viney KA, et al. An outbreak of epidemic keratoconjunctivitis in a regional ophthalmology clinic in New South Wales. Epidemiol. Infect 2008;136:1197–1206.

28. Ultrasound Probes/Transducers: What’s the Infection Risk? • Can be considered semicritical or noncritical, depending on use • Risk of transmitting infection via ultrasound transducer related to: • Presence of micro-organisms (number and virulence) • Body site explored (mucosal or intact skin) • Type of procedure (invasive or non-invasive) • Can become contaminated during use (e.g. vaginal probe with human papilloma virus, hepatitis B virus) • Low level vs. high level disinfection? • Probe covers often compromised Casalegno J-s, et al. (2012) High Risk HPV Contamination of Endocavity Vaginal Ultrasound Probes: An Underestimated Route of Nosocomial Infection? PLoS ONE 7(10): e48137.

29. Let’s Look at noncritical devices

30. Examples of Noncritical Medical Devices and Equipment • ECG leads and cables • Electronic thermometers • Blood pressure cuffs • Stethoscopes • Pulse oximetry sensors • Some ultrasound transducers • Bedpans • Blood glucose meter

31. Electronic Thermometers Implicated in Infection Transmission • Livornese LL, et al. Hospital-acquired infection with vancomycin-resistant Enterococcus faecium transmitted by electronic thermometers.Ann Intern Med 1992;117(2):112-116. • Porwancher R, et al. Epidemiological study of hospital-acquired infection with vancomycin-resistant Enterococcus faecium: possible transmission by an electronic ear-probethermometer. Infect Control Hosp Epidemiol 1997;18:771-773. • Brooks SE, et al. Reduction in the incidence of Clostridium difficile-associated diarrhea in an acute care hospital and a skilled nursing facility following replacement of electronic thermometers with single-use disposables. Infect Control Hosp Epidemiol 1992;13(2):98-103.

32. Blood Glucose Meter: a Noncritical Item? • Can become contaminated with blood • Known risk for hepatitis B and C transmission • Hepatitis B virus (HBV) has been transmitted when device used for more than one person without cleaning and disinfecting between uses • If meter shared, it should be cleaned and disinfected after every use, per manufacturer’s instructions to prevent carry-over of blood and infectious agents • If manufacturer does not specify how device should be cleaned and disinfected, it should not be shared http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html

33. Some noncritical items may be used on nonintact skin: e.g., reusable ECG leads • ECG leads become contaminated during use1 • Can serve as reservoir for pathogens • Must be properly cleaned and disinfected before use on another patient • ECG leads pose little risk when used as a noncritical items and do not contact skinnonintacthowever….ECG leads and cables sometimes used on or near nonintactskin • Reusable ECG equipment not always properly disinfected2 • Patients at risk for acquiring nosocomial pathogens • Risk increases if skin not intact 1.Jancin, B (2004). “Antibiotic-Resistant Pathogens Found on 77% of ECG Lead Wires.” Cardiology News: Vol. 2, No. 3 2. Albert, NM et al (2009). “Multicenter Study of Bacteria on Reused Clean Electrocardiography Lead Wires: Are Monitoring Patients at Risk for Nosocomial Infections?” [abstract RES29]. Am J Crit Care. Vol.18 (3): e11-e12.

34. Cross Contamination Risk Factors for Reusable ECG Cables/Lead Wires • Difficult to clean and disinfect • Cannot be submersed • Multiple surfaces make it difficult to effectively disinfect between patient use • Nooks and crannies provide environment for bacterial growth and protection from cleaning • Cleaning/disinfection agents can degrade items • Decreased efficacy and functionality over time • Direct contact with patient’s skin • Can come in contact with blood/body fluids, wounds, surgical incisions, drainage tubes, nonintact skin, IV sites/catheters MRSA

35. ECG cables/leads: Many chances for cross contamination during hospital stay EMS → Emergency Department → Transport Monitor → Cardiac Cath Unit → Transport Monitor → Operating Room → Transport Monitor → Critical Care Unit → Transport Monitor → Step Down Unit → Transport Monitor → Telemetry Unit → Med/Surg Unit Patient exposed to multiple reusable lead sets

36. Question: Which item has been demonstrated to have the greatest risk of transmission of infection? • Vaginal speculum • Blood pressure cuff • Bronchoscope* • Ultrasound transducer

37. Lurking Microbes • Pathogens linked to transmission via contaminated medical devices and surfaces include: • Vancomycin resistant Enterococcus (VRE)1 • Methicillin resistant Staphylococcus aureus2 • Clostridium difficile3 • Acinetobacter spp4 • Hepatitis B virus5 • Pseudomonas aeruginosa6 • Adenovirus7 • The above bacteria pose clinically important antimicrobial resistance problems and are common causes of HAIs Livornese LL, et al. Ann Intern Med 1992;117(2):112-116. Dancer SJ. Importance of the environment in methicillin-resistant aureus acquisition: the case for hospital cleaning. Lancet 2008; 8: 101-113 3. Brooks SE, et al. Infect Control Hosp Epidemiol. 1992;13(2):98-103. 4. Villegas MV,Hartstein AI.Acinetobacter outbreaks, 1977-2000.Infect Control Hosp Epidemiol.2003;24(4):284-295 5. http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html 6. Weber DJ, Rutala WE. Infect Control Hosp Epidemiol 2012; 33: 230-234 7. Viney KA, et al.. Epidemiol Infect 2008;136:1197–1206

38. Question: Transmission of this organism to patients has been linked to contaminated electronic thermometers used for obtaining rectal temperatures. 1. Norovirus 2. Vancomycin resistant Enterococcus (VRE)* 3. Acinetobacter baumannii 4. Staphylococcus aureus

39. Cross Contamination Risk for Reusable Medical Equipment “Multiple studies have demonstrated that portable healthcare equipment, such as stethoscopes, tourniquets, sphygmomanometer cuffs, electronic thermometer handles, otoscopes and pagers also become contaminated, like hands, and can serve as a potential vector for antibiotic-resistant pathogens to patients, either via direct contact or by contamination of clinicians hands.”1 Studies also show that personnel do not always effectively clean and disinfect healthcare equipment2 Muto CA et al. SHEA Guideline for Preventing Nosocomial Transmission of Multidrug-Resistant Strains of Staphylococcus aureus and Enterococcus”. Infect Control Hosp Epidemiol 2003;24(5):362-386. Alfa M. Monitoring and improving the effectiveness of cleaning medical and surgical devices. Am J Infect Control 2013;41:E56-S59

40. What You Can Do About These Microbes… Infection Prevention Measures for Reducing Risk of Transmission

41. Semicritical Medical Devices:Ensure Cleaning and Disinfection • Use high-level disinfectant or sterilizer • Implement protocols based on evidence-based guidelines1,2 • Protocol must be device-specific • Follow manufacturer's instructions for use (IFU) • Sometimes ineffective and confusing • Use appropriate cleaners and disinfectants • U.S. Environmental Protection Agency (EPA) registered disinfectant 2 • Must be both effective and compatible with device Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Petersen B, et al. Multisociety Guideline on Reprocessing Flexible GI Endoscopes. Infect Control Hosp Epidmiol 2011;6:527-537.

42. Noncritical Medical Items:Ensure Cleaning and Disinfection • Implement protocols based on evidence-based guidelines1,2 • Clean and disinfect with an EPA-registered low- or intermediate-level disinfectant on a regular basis, and when visibly soiled1 • Use disinfectant active against pathogens most likely to colonize or infect patients2 • Bleach recommended for items potentially contaminated with C difficile or HBV1 • Assign cleaning and disinfection responsibilities and hold personnel accountable Who cleans this? Must have a system to ensure that reusable equipment is cleaned and disinfected before use with another patient Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, June 2007.

43. Hand Hygiene • Hand hygiene is THE single most important measure to prevent infection • Appropriate use of gloves is integral part of hand hygiene • CDC1 and WHO2 published evidence-based guidelines for hand hygiene • We know when we should clean our hands…however adherence to effective hand hygiene practices remains low 1. John M. Boyce JM, Pittet D. Guideline for hand hygiene in health-care settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Infect Control HospEpidemiol. 2002;23(13):S3-S40. 2. WHO Guidelines on Hand Hygiene in Health. World Health Organization; 2009 Available at: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf.

44. For Patients on Contact Precautions…… “Use disposable noncritical patient-care equipment (e.g., blood pressure cuffs) or implement patient-dedicated use of such equipment. If common use of equipment for multiple patients is unavoidable, clean and disinfect such equipment before use on another patient.” Must have a system to ensure that reusable equipment is cleaned and disinfected before use with another patient Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, June 2007. http://www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf .

45. Reusable vs. Disposable? • Compliance with cleaning and disinfection protocols is often poor • Disposable recommended for contact precautions • Consider disposable item if used on or near nonintact skin or on mucous mebranes • Need to evaluate cost of disposable item vs. cost of reprocessing reusable items • Examples : • ECG leads and cables • Pulse-oximeter sensor • Blood pressure cuff • Thermometer • Vaginal speculum

46. Reusable vs. Disposable? Pros Cons Used once and discarded (environmental concerns) Costs Item Waste disposal Disposable item may not be as acceptable/accurate as reusable • Reduced risk of infection transmission if used on one patient • Eliminates concerns of : • Poor adherence to cleaning/disinfection protocols • Ineffective decontamination protocols

47. Reusable vs. Disposable? • Costs associated with HAIs • A hospital acquired infection increases hospital care cost of a patient by $10,375 and I ncreasesthe length of stay by 3.30 days. • An institution must evaluate the cost associated with a HAI versus the use of a single-patient use devices. Hassan M, Tuckman HP, Patrick RH, Kountz DS, Kohn JL.. Cost of hospital-acquired infection. Hosp Top. 2010 Jul-Sep;88(3):82-9. doi: 10.1080/00185868.2010.507124.

48. Monitor Effectiveness of Cleaning/Disinfection Process • Visual inspection alone is not adequate • Automated washers • Check fluid flow through lumen connectors • Adenosine triphosphate (ATP) • Check presence of enzymatic detergent • Manual cleaning • ATP • Checks for organic residuals Alfa M. Monitoring and improving the effectiveness of cleaning medical and surgical devices. Am J Infect Control 2013;41:E56-S59

49. Question: This organism forms spores that are resistant to alcohol and many disinfectants: 1. Staphylococcus aureus 2. Norovirus 3. Clostridium difficile* 4. Enterococcus faecalis

50. Measure and Ensure Adherence to Infection Prevention Practices • Measure adherence to infection prevention measures and provide personnel with information on their performance • To ensure consistency, use standardized checklists for monitoring practices • Conduct rounds to monitor adequacy of cleaning/disinfection of semicritical and noncritical items • Ensure that disposable items are used when specified by protocol