Air Contamination and SSI Risk in Implant Procedures

Air Contamination and SSI Risk in Implant Procedures August 16, 2018 Maureen Spencer, RN, M. Ed. , CIC, FAPIC Infection Preventionist Consultant www. maureenspencer. com 1

Disclosures Speaker provides clinical consulting services to Aerobiotix. 2

Learning Objectives 1. Explain why there is an increased risk of SSI from air contamination with implants. 2. List surgical procedure types that involve implants, and potential associated SSI. 3. List standard measures for ensuring safe OR air quality. 4. Describe adjunctive measures for improving OR air quality for implant procedures. 3

Potential for Surgical Wound Contamination From OR Air 4

Increased Risk of SSI in Implant Procedures From Contaminated Air • • • Procedures involving an implant pose the greatest risk of infection from the smallest inoculum. 1 A foreign body such as an implant can reduce the number of organisms needed to cause an infection by a factor of 100, 000. 2 Organisms, typically skin flora, are dispersed in the operating room on squamous epithelial cells that can settle in the open incision and adhere to the implant. 3 5

Air contamination and SSI: A proven relationship Nearly a century of peer-reviewed literature supports the relationship between airborne pathogen levels and SSI. 4 -6 Key SSI Risk Factors • Number of people in the room • Number of door openings • Facility risk factors • Length of procedure time • Instrument tray exposure • Procedural type Figure. Schematic of airborne pathogen environmental cycle. AORN’s Guidelines for providing a Safe Environment of Care (Part II) 6

Traffic Control and Opening Doors in Operating Rooms - Research • Mathijssen N et al. The Effect of Door Openings on Numbers of Colony Forming Units in the Operating Room during Hip Revision Surgery. Surgical Infections Nov 2016 • Hamilton W et al. Operating room traffic in total joint arthroplasty: Identifying patterns and training the team to keep the door shut. American Journal of Infection Control 46 (2018) 633 - • Teter J et al. Assessment of operating room airflow using air particle counts and direct observation of door openings. American Journal of Infection Control 45 (2017) 477 -82 • Andersson AE et al. Traffic flow in the operating room: An explorative and descriptive study on air quality during orthopedic trauma implant surgery. American Journal of Infection Control 40 (2012) 750 -5 • Edmiston CE, Sinski S, Seabrook GR, et al. Airborne particulates in the OR environment. AORN J. 1999; 69(6): 1169 -83. • Napoli C, Marcotrigiano V, Montagna MT. Air sampling procedures to evaluate microbial contamination: a comparison between active and passive methods in operating theatres. BMC Public Health. 2012; 12(1): 1. • Pedram P, et al. Operating Room Traffic is a Major Concern During Total Joint Arthroplasty. Clin Orthop Relat Res. 2012 Oct; 470(10): 2690– 2694. 7

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Elevated OR air bacterial level causes increased infection rates 2. 6 X <10 CFU >50 CFU A prospective randomized multicenter study shows that joint replacements in rooms with over 50 CFU bacteria were 2. 6 times as likely to have postoperative infection than those with 10 -20 CFU. 7 As airborne bacterial levels increase, infection rates increase. The relationship is linear. 14

Impact of SSI in General • SSIs are the most common type of hospital-acquired infection, accounting for 20% of all HAI. 20 • Patients with SSI have 2 - to 11 -fold increased risk of mortality. 21 • SSIs are the most costly of all HAI. With an annual estimated overall cost of $3 to $5 billion in the U. S. 22 • As many as 60% of SSIs are considered to be preventable. 23 • 45 million inpatient surgical procedures performed annually in US. 24 • Medicare no longer reimburses most SSIs. 25 15

Surgical Disciplines Placing Implants • • Breast Plastics Orthopedic Spine General – hernia mesh OB-GYN – pelvic floor mesh Cardiac – pacemakers, stents, valves, IADs. . 16

Just how small of an inoculum is required to cause an implant infection: A. 100 CFU B. 150 CFU C. 50 CFU 17

Just how small of an inoculum is required to cause an implant infection: A. 100 CFU 18

PJI (prosthetic joint infection) • 2. 18% of hip and knee implants become infected. 8 • A cost range for a single case of PJI using a one-way sensitivity analysis of $389, 307 to $474, 004. 9 • PJI is associated with a mortality rate of between 2 – 7%. 10 • Experts report that the fiveyear survival rate of patients with PJI is worse than with most cancers. 11 Figure: Historical and projected number of infected THA, TKA, and total (THA + TKA) procedures in the United States. 8 19

SSI from Bacteria Laden Skin Scales • Eight infections occurred after modified radical mastectomies in a tertiary-care hospital. Group A streptococci (GAS) was isolated from the patients. • This outbreak of GAS infection is believed to have occurred by airborne transmission, from scales of skin from colonized surgeon, shed and aerosolized, inoculating the operative field and leading to the infections. 33 20

OR Air Quality: How clean is clean enough? Air Scrubber Filter O. R. Ventilation Fan Air Scrubber Filter After 1 Month in OR Exhaust Vent Surface culture 21

European Air Quality Standards Already in Place 22

OR Air Quality: How clean is clean enough? Is typical O. R. air quality adequate for today’s O. R. environment? • More procedures per day and faster turnovers increase biological load in the O. R. • More personnel, activity and technology in the O. R. • Increased use of implants, particularly in orthopedics which have a higher risk for SSI • Older and more acute patient populations • Antibiotic resistant organisms • More revision procedures 23

Compounding Pharmacies • Unlike operating rooms, the pharmaceutical and computer industries enforce stringent air quality standard on their manufacturing processes. • Currently no air quality standard (bacteria and particle limits) nor standard methodology for testing OR air quality, as there are in compounding pharmacies. • Compounding pharmacies prepare sterile solutions to be introduced into the sterile vascular system. In OR, the majority of procedures involve entering a sterile organ space through an incision, which remains open to the OR air. 24

Number air particles per ISO class Compounding pharmacies must comply with International Standards Organization (ISO) class 5 standards for air quality. 26 25

Minimizing OR Air Contamination Standard Measures 1. Engineering air controls – dilution, filtration, pressurization and disinfection (AORN, CDC, ANSI/ASHE, ASHRAE standard 170 -2008)27 • Filtration: MERV (minimum efficiency rating value) 13 -14 required for OR, HEPA = 17 • Pressurization: air pressure (positive) • Dilution: air changes (20/hour) 2. Temperature and Humidity 3. Traffic control in OR – AORN, CDC 28, 29 4. Hair clipping outside OR - AORN 26

Minimizing OR Air Contamination Temperature and Humidity: 20% to 60% – Aids in controlling microbial growth, – Supports the shelf life and product integrity of sterile supplies, – Controlling relative humidity (RH) can reduce transmission of certain airborne infectious organisms, including some strains of influenza Temperature: 68 to 75°F – Location of lights can increase room temperature and also be an obstacle to the desired airflow pattern, – Patient hypothermia can contribute to increased risk of SSI. 27

Minimizing OR Air Contamination Airflow Systems for ORs 1. Turbulent flow: Airborne contaminants are controlled with dilution. This increases the effectiveness of air exchange and distribution, but can speed up microbial dispersion. 2. Unidirectional-flow (“laminar airflow or LAF”): Air travels in parallel lines and contaminants are carried away at the same velocity as the airflow towards the exhaust outlets. This system is designed to ensure airborne particles pass the operating area. 3. Laminar air-flow systems with HEPA filters (Ultra Clean air) is often used for orthopaedic and other implant surgery. 4. Mixed-flow: Unidirectional airflow regimes are only used to protect critical zones (e. g. the area surrounding the operating field). There is no consensus on the best airflow system for ORs 30 28

19 th Century Hospital Ward Design to Reduce Contaminated Air Transmission Octagon Ward at John Hopkins 29

21 st Century Operating Room Airflow Pattern 30

21 st Century Operating Room Airflow Pattern 31

21 st Century Operating Room Airflow Pattern Current systems, including laminar flow and positive pressure systems, do not deactivate pathogens, just displace pathogens. These pathogens are continuously being shed within the OR setting and contribute to the airborne pathogen concentration. 32

In one year, the average person will shed more than how many pounds of dead skin: A. 0. 5 pounds B. 3 pounds C. 8 pounds 33

In one year, the average person will shed more than how many pounds of dead skin: C. 8 pounds 34

Human Factors Affecting OR Air Quality 57 • Coughing, talking • Skin shedding • People moving in and out of room causing convective flows spreading bacteria • Heater Cooler exhaust 35

Minimizing Air Contamination with Surgical Attire Full coverage of hair and skin is required by AORN standards for all members of the surgical team due to: • On average, individuals shed more than 10 million particles from their skin every day. • Approximately 10% of skin squames carry viable microorganisms. • It is estimated that individuals shed approximately 1 million microorganisms from their bodies each day. 31 36

Human Factors Affecting OR Air Quality 57 • Not using smoke evacuators with laser and electrocautery • Hair clipping (consider vacuum assisted clipper “Clip. Vac” • Disconnecting forced air warmer (FAW) before turning blower off • Staff (anesthesia) using FAW to warm their body 37

Human Factors Affecting OR Air Quality In a teaching hospital at the end of a case: 1. The Surgeon leaves the room and the Resident, PA or NP closes the incision. 2. At the same time the following activities are creating air turbulence which could result in contaminants settling on operative site: • Circulating nurse counts sponges • Scrub tech prepares instruments for CSP • Anesthesia moves in and out of the room • Instrument vendor rep moves out of the room • Students and visitors move out of the room 38

Standard OR air flow results in a clean central area surrounded by a more contaminated area, driven by poor air flow, human activity, door opening, and floor contamination. This is the “DIRTY DONUT” where air contamination can be as much as 100 times greater than the cleaner center of the room. 39

The dirty donut can potentially contaminate people, surgical drapes, instrumentation, implants, gloves, and tables which are in direct communication with the patient. This phenomenon is called ENTRAINMENT, and is the most common way for bacteria to reach the surgical site. 40

2012 Outbreak Mycobacterium chimaera 45 41

2003 Outbreak Mycobacterium jacuzzi 42

Consequently. . Are adjunctive measures indicated to improve the quality of OR air? 43

Ultraviolet (UV-C) Germicidal Irradiation Upper room TB Water Environmental surfaces Hand held devices Ultraviolet germicidal products are common and have been used in hospitals for decades. The effectiveness of UV-C in eliminating microorganisms in air, water, on surfaces and instruments/ devices is well established. 6 44

Ultraviolet Germicidal Irradiation The most efficient way to inactivate airborne pathogens is to apply C-wavelength ultraviolet (UV-C) radiation, which disrupts the DNA of microorganisms. The germicidal ability of UVC is well known and documented. 56 45

Novel UV-C Disinfection System (UV Disinfection with Air circulating Fans and a Ceiling Light) Permanent fixture - white light disinfection 24/7 UV air disinfecting ceiling units 46

It is possible to remediate the dirty donut with adjunctive air filtration/ disinfection technology, located in the dirty area to create a secondary air flow to supplement the main system, replacing the dirty donut with a “clean donut. ” 47

Novel Air Scrubbing Technology (UV-C Disinfection plus HEPA Filtration) • Uses a proprietary ultraviolet technology combined with HEPA filtration to eliminate particulates and microorganisms. • Peer-reviewed studies report reduced air bacteria levels in operating rooms by 50 -60%. 43, 55, 58, 60 • Pending publication: study of >500 arthroplasty procedures found that the use of intraoperative air decontamination significantly reduced overall rates of PJI (p<0. 042) 48

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Conclusions 1. Current methods of providing OR air quality are limited to positive air pressure, 20 air changes per hour, long sleeves, traffic control and HEPA filtration in some ORs 2. Infection risk from contaminated OR air has been demonstrated most recently during the M. chimera outbreak associated with heater cooler devices 3. Air scrubbing technology (UV + HEPA) can serve as an adjunct for improving air quality for ORs where implant procedures are performed 51

THANK YOU!! maureenspencer@gmail. com Cell: (781) 864 -2130 52

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