Risk Reduction Strategies for Operating Room Personnel

1. Risk Reduction Strategies for Operating Room Personnel Robert D. Auerbach, M.D. FACOG Senior Vice President & Chief Medical Officer CooperSurgical, Inc.

2. The Goal Gershon, R. R., C. D. Karkashian, J. W. Grosch, L. R. Murphy, A. Escamilla-Cejudo, P.A. Flanagan, E. Bernacki, C. Kasting, and L. Martin. 2000. Hospital safety climate and its relationship with safe work practices and workplace exposure incidents. Am.J.Infect.Control 28:211-221.

3. Introduction* • Health care is the second fastest growing sector of the U.S. economy • Employing over 12 million workers • Women represent nearly 80% of the health care work force • OR workers face a wide range of hazards on the job • Needle-stick injuries • Latex allergy • Anesthesia gases • Toxic fumes/smoke • Rates of occupational injury to health care workers have risen over the past decade. *National Institute for Occupational Safety and Health (NIOSH) October 22, 2009

4. The Operating Room • Occupational blood exposure is influenced by numerous factors • Staffing levels and characteristics • Type of procedure (complexity, planned vs. elective) • Devices and equipment • Patient characteristics • The core surgical team consists of • Surgeon, surgical assistant, circulating nurse, scrub nurse or surgical technician, and anesthesia care provider • In a teaching setting, surgeries are attended by residents and medical students

5. Needle-Stick Injury

6. Needle-stick injury • The highest proportion of percutaneous injuries occurred in OR settings - 30% of all reported hospital sharps injuries* • ORs had the second highest rates of non-percutaneous exposure, at 16.5% of the total exposure rates* • Exposure rates for operating room technicians were nearly eight times the average rate for all occupational groups combined • *Perry, J., G. Parker, and J. Jagger. 2006. EPINet Report: 2003 Percutaneous Injury Rates. Advances in Exposure Prevention 7:42-45. • **Dement, J. M., C. Epling, T. Ostbye, L. A. Pompeii, and D. L. Hunt. 2004. Blood and body fluid exposure risks among health care workers: results from the Duke Health and Safety Surveillance System. Am.J.Ind.Med. 46:637-648.

7. Needle-stick injury • Scrub nurses have the highest rate of percutaneous injuries and operating surgeons have the second highest injury rate* • Resident surgeons had the highest frequency of percutaneous and mucocutaneous exposures, accounting for over 50% of all exposures in the OR setting** *Cardo, D. M., and D. M. Bell. 1997. Bloodborne pathogen transmission in health care workers. Risks and prevention strategies. Infect.Dis.Clin.North Am. 11:331-346. **Jagger, J., M. Bentley, and P. Tereskerz. 1998. A study of patterns and prevention of blood exposures in OR personnel. AORN J. 67:979-4, 986.

8. Needle-stick injury • In the OR, the highest proportion of percutaneous injuries are from suture needles • Other sources of OR exposure include scalpels, hypodermic needles, stylets, scissors, wire sutures, orthopedic equipment (drill bits, screws, pins, saws), needle point cautery tips, skin hooks, towel clips, and forceps • The National Institute for Occupational Health and Safety (NIOSH) has estimated • 600,000 to 800,000 needlestick and other percutaneous injuries occur annually in hospitals in the United States • Combined medical and work productivity costs in 2004 was $188.5 million Leigh, JP, Gillen, M, Franks, P, et al. Costs of needlestick injuries and subsequent hepatitis and HIV infection. Curr Med Res Opin 2007; 23:2093.

9. Needle-stick injury • The most important pathogens are hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) • In the year 2000, percutaneous injuries led to 16,000 cases of hepatitis C, 66,000 cases of hepatitis B and 1,000 cases of HIV • The most recent data from 2006 revealed that the overall rate for percutaneous sharp object injuries was 16.88 per 100 occupied beds per year for non-teaching hospitals and 44.32 injuries per 100 occupied beds per year for teaching hospitals *Pruss-Ustun, A, Rapiti, E, Hutin, Y. Estimation of the global burden of disease attributable to contaminated sharps injuries among health-care workers. Am J Ind Med 2005; 48:482. **Perry, J, Parker, G, Jagger, J. 2006 percutaneous injury rates. International Healthcare Worker Safety Center, January 2009; 1. http://www.healthsystem.virginia.edu/internet/epinet/2006-EPINet-Needle-Stick-Data.pdf.

10. Risk of acquisition of bloodborne pathogens Hamilton, RG. Latex Allergy: Epidemiology, clinical manifestations, and diagnosis. In: UpToDate, Boschner, BS (MD), UpToDate, Waltham, MA, 2009

11. Minimizing risk • Healthcare workers must • Receive yearly education on the epidemiology of bloodborne pathogen transmission and means of minimizing such risks • Be offered hepatitis B immunization at no cost to the employee • Be provided with certain engineering controls proven to reduce exposure to risk (e.g. leakproof secondary containers and needle disposal containers) • Be provided Personal Protective Equipment (PPE) - PPE consists of gloves, impervious gowns and face/eye shields • "Standard" precautions (formerly called universal precautions) should be used for the care of all patients • All healthcare facilities are required by OSHA to undertake measures to reduce the occupational exposures to bloodborne pathogens including the use of engineering controls that minimize the risk of sharp injuries

12. Other measures • Healthcare facilities should consider implementing other strategies • Double gloving for high risk surgical/obstetrical procedures • Blunted suture needles • Self sheathing needles • According to surveys conducted in 6 EPINet hospitals, 39% of accidental exposure to bloodborne pathogens were unreported.* • Example - If the obstetrician experiences a needle stick during episiotomy or laceration repair, the patient’s record is typically checked for HIV or HCV. If the patient is not infected the needle stick is not reported. Annual Number of Occupational Percutaneous Injuries and Mucocutaneous Exposures to Blood or Potentially Infective Biological Substances, http://www.healthsystem.virginia.edu/internet/epinet/estimates.cfm, revised 6/15/98

13. Example – Episiotomy/OB laceration retractor • Repair typically compromised • Poor lighting • Digital retraction method • Blood obstructing view • Results in • Poor tissue approximation • Increased risk of needle-stick injury • Specifically designed retractor • Reduces risk of needle-stick injury • Superior visualization for optimum repair

14. Needle-stick summary

15. Needle-stick summary

16. Needle-stick summary

17. Latex Allergy

18. Latex Allergy - introduction • Rubber is a natural resource that is used in the manufacturing of a wide variety of commercial products • 90% of natural rubber comes from the sap-like fluid (latex) of the commercial rubber tree, Hevea brasiliensis (Hev b) • Contributing factors • Significant increase in the use of latex gloves by clinicians and other healthcare employees occurred • In 1992, the United States Occupational Safety and Health Administration (OSHA) issued the Bloodborne Pathogens Standard that required protective glove use • This increased demand for natural rubber latex came at a time when the supply of latex was limited • Latex was collected from increasingly younger trees that had been treated with stimulants to produce higher levels of latex per tree • The latex was processed without delay, minimizing the extent of protein denaturation

19. Latex allergy - prevalence • Prevalence of latex allergy • General population - fell to <1 percent by 2006 in countries where latex avoidance was promoted • Healthcare worker • Latex allergy achieved epidemic proportions in the medical community by the mid 1990s. An estimated prevalence of sensitization among the general healthcare worker population in one study was 12% • Rates fell to approximately 4% with the introduction of powder-free gloves; it can be assumed that rates have decreased even further with the increased use of non-latex gloves • Patients who undergo multiple surgeries - most high profile group was children with spina bifida • Estimated that 1/3 – 2/3 of children who underwent their surgeries in the 1990s became sensitized Kelly, KJ, Pearson, ML, Kurup, VP, et al. A cluster of anaphylactic reactions in children with spina bifida during general anesthesia: epidemiologic features, risk factors, and latex hypersensitivity. J Allergy ClinImmunol 1994; 94:53.

20. Latex allergy • 13 latex proteins (Hev b) are known to be potent allergens: • Elicit human IgE antibody • Leading to sensitization in exposed individuals • Allergic reactions upon subsequent exposure • Hevea indicator allergens • Hev b 1 (rubber elongation factor) and Hev b 3 (prenyltransferase) - most commonly induce IgE antibody responses in individuals who become sensitized through direct mucosal exposure to Hevea rubber products. • Hev b 5 (acidic protein) and Hev b 6.02 (mature hevein) - released from dipped rubber products, mainly latex gloves, and transported via aerosolized powder used for glove donning, or sloughed directly into the environment. Exposure to these allergens through direct contact or inhalation occurs most frequently in occupations in which protective rubber gloves are frequently worn.

21. Clinical manifestations • Symptoms depend upon the route of exposure, the amount of allergen in the natural rubber product, and the underlying mechanism of the reaction (irritant, non-IgE mediated, or IgE-mediated) • Most common symptoms Contact Dermatitis • Presents as skin rash and itching one to four days after direct skin contact • Initial appearance of the rash is frequently an acute eczematous dermatitis • Takes on a more dry, crusted, lichenified appearance with continued latex exposure Weber, DJ. Management of healthcare workers exposed to hepatitis B virus or hepatitis C virus. In: UpToDate, Bartlett, JG (MD), UpToDate, Waltham, MA, 2009

22. Clinical Manifestations • Most common symptoms (con’t) Allergic contact urticaria • Contact urticaria is the most common allergic reaction reported by healthcare workers who use latex medical gloves • Redness, itching, and wheal and flare reactions occur at the site of rubber-skin contact within 10 to 15 minutes Rhinoconjunctivitis and asthma • Manipulation of powdered latex gloves produces an aerosol of Hevea allergens that can trigger rhinitis and asthma symptoms in latex sensitive individuals • Pre-existing asthma is not a prerequisite for the development of latex-related asthma Anaphylaxis - Anaphylactic reactions have occurred after use of various latex-based products in both medical and nonmedical settings

23. Clinical manifestations • Diagnosis • The most reliable indicator of allergy is a strong clinical history, associating exposure and symptoms • Confirmatory tests (skin tests, serology, and provocation) are limited by reagent availability, varying reagent sensitivity/specificity and composition, and significant potential risks for triggering serious reactions • In the United States, serology is the test of choice • Measurement of Hevea latex-specific IgE antibody in serum • Incubation of test human serum with a Hevea latex allergen-containing reagent • Bound IgE antibody is detected with an enzyme-labeled anti-human IgE reagent • Provocation testing is generally not recommended

24. Strategies to combat latex allergy • Institutional avoidance • Recognizing the importance of controlling latex exposure for allergic patients and healthcare workers • Establishment of latex safe environmental policies • Replacing Hevea latex containing products with non-Hevea based synthetic products • Using powder-free latex products if no alternative non-latex available • Powder-free natural rubber latex products undergo a final chlorination step that removes a large percentage of Hevea allergenic protein • Individual avoidance • Use only non-Hevea medical gloves • There are as many as 40,000 consumer products in home and medical/dental environments that may contain latex – they need to be avoided • In the United States, Hevea latex-containing medical devices must be labeled "containing natural rubber latex" with a medical alert black box warning

25. Anesthetic Gases

26. Anesthetic gases • Workplace exposures to anesthetic gases occur in hospital-based and stand-alone operating rooms • Inhaled anesthetic agents include two different classes of chemicals • Nitrous oxide • Halogenated agents - halothane (Fluothane®), enflurane (Ethrane®), isoflurane (Forane®), desflurane (Suprane®), and sevoflurane (Ultane®) • It is estimated that more than 200,000 health care professionals are potentially exposed to waste anesthetic gases and are at risk of occupational illness* *http://www.osha.gov/dts/osta/anestheticgases/index.html#A

27. Health effects • Nitrous oxide • Mutagenicity testing – negative • Studies demonstrate reproductive and developmental abnormalities in animals exposed to high concentrations of N2O • Reduced fertility • Female dental assistants exposed to unscavenged N2O for 5 or more hours per week had a significantly increased risk of reduced fertility compared with non-exposed female dental assistants • For dental assistants who used scavenging systems during N2O administration, the probability of conception was not significantly different from that of the non-exposed assistants Rowland, A.S., Baird, D.D., Weinberg, C.R., Shore, D.L., Shy, C.M., and Wilcox, A.J. 1992. Reduced Fertility Among Women Employed as Dental Assistants exposed to High Levels of Nitrous Oxide. N Engl J Med 327: 993-997.

28. Health effects • Nitrous oxide (con’t) • N2O and spontaneous abortion • Women who worked with N2O at least 3 hours per week in offices not using scavenging equipment had an increased risk of spontaneous abortion • Relative risk = 2.6, 95% confidence interval [CI] = 1.3-5.0 • Halogenated agents • Halogenated agents are used with and without N2O • Studies documenting a statistically significant excess of spontaneous abortions in exposed female anesthesiologists: • Cohen, E.N., Bellville, J.W., and Brown, B.W., Jr. 1971. Anesthesia, Pregnancy and Miscarriage. A Study of Operating Room Nurses and Anesthetists. Anesthesiology 35: 343-347 • Tomlin, P.J. 1979. Health Problems of Anaesthetists and Their Families in the West Midlands. Br Med J 1: 779-784

29. Health effects • Halogenated agents (con’t) • Association between anesthetic exposure and congenital anomalies is less consistent • Only a few studies in some subpopulations of exposed workers found a positive association* • Other studies reported no association with congenital anomalies** • There is evidence that halothane is mutagenic in certain in vitro test systems*** *Pharoah, P.O.D., Alberman, E., Doyle, P., and Chamberlain, G. 1977. Outcome of Pregnancy Among Women in Anaesthetic Practice. Lancet 1: 34-36. **Axelsson, G., and Rylander, R. 1982. Exposure to Anaesthetic Gases and Spontaneous Abortion: Response Bias in a Postal Questionnaire Study. Int J Epidemiol 11: 250-256. ***Garro, A.J., and Phillips, R.A. 1978. Mutagenicity of the Halogenated Olefin, 2- Bromo- 2 - Chloro - 1,1-difluoroethylene, a Presumed Metabolite of the Inhalation Anesthetic Halothane. Mutat Res 54: 17-22.

30. Anesthetic gas scavenging • Removal of excess anesthetic gases from the anesthesia circuit can be accomplished by either active or passive scavenging • Active systems • Excess anesthetic gases may be removed by a central vacuum system (servicing the ORs in general) or an exhaust system dedicated to the disposal of excess gases • Waste anesthetic gas scavenging system is connected to the central vacuum system • Passive systems • Non-recirculating systems take in fresh air from the outside and circulate filtered and conditioned air through the room. Whatever volumes of fresh air are introduced into the room are ultimately exhausted to the outside. Waste anesthetic gases can be efficiently disposed of via this nonrecirculating system • Recirculating HVAC/ventilation systems return part of the exhaust air back into the air intake and recirculate the mixture through the room. Adsorbers can also trap most excess anesthetic gases

31. Anesthetic gases - summary • Significant improvements in the control of anesthetic gas pollution in health-care facilities • Improved design of scavenging systems • Installation of more effective general ventilation systems • Increased attention to equipment maintenance and leak detection

32. Toxic Fumes

33. Toxic fumes/smoke - introduction • The standard surgical mask provides minimal protection against surgical aerosols, particulates and vapors • Standard surgical mask is effective against particles 1.1 microns and larger • 77% of particulate matter generated during surgery is smaller than 1.1 microns* • Energy sources that generate smoke during surgery: • Monopolar and bipolar electrosurgery units • CO2, Nd:YAG, KTP, and argon lasers • Electrosurgery forceps • Ultrasonic devices • Mechanical morcellators *Tomita Y,Mihashi S,Nagata K, et al. Mutagenicity of smoke condensates induced by CO2-laser irradiation and electrocauterization. Mutat Res. 1981;89:145–149.

34. US Occupational Safety and Health Administration (OSHA) • OSHA* conclusions • Smoke plume may contain toxic gases and vapors such as benzene, hydrogen cyanide, and formaldehyde, bioaerosols, dead and live cellular material (including blood fragments), and viruses • Smoke may irritate the eyes and upper respiratory tract and interfere with vision • Smoke may contain toxic gases that could be mutagenic and carcinogenic *Occupational Safety and Health Administration, US Department of Labor.  Hospital eTool. Surgical suite module. Available at: http://www.osha.gov/SLTC/etools/hospital/surgical/surgical.html#LaserPlume

35. The risks of surgical smoke • Health care workers who are regularly exposed to surgical smoke may complain of: • Bronchial problems • Upper respiratory difficulties such as chronic cough • Adult-onset or worsening asthma • Headache • Fatigue • Throat irritation • Congestion • Vaporization of 1 gram of tissue* • CO2 laser exposes a healthcare worker to the equivalent of 3 cigarettes of smoke in 15 minutes • Electrosurgery exposes a healthcare worker to the equivalent of 6 cigarettes of smoke in 15 minutes *Tomita Y,Mihashi S,Nagata K, et al. Mutagenicity of smoke condensates induced by CO2-laser irradiation and electrocauterization. Mutat Res. 1981;89:145–149.

36. AORN – Association of periOperative Registered Nurses

37. Recommendations • Advocates of the use of local exhaust ventilation (LEV) during surgical procedures in which smoke is generated • American National Standards Institute (ANSI) • AORN • Emergency Care Research Institute (ECRI) • Among the options to improve air quality in the OR are • Improved ventilation in the OR • A suction device • An in-line filter with a suction canister • A trocar-attached filter

38. System analysis • Active systems • Aggressive smoke removal capabilities via suction and attached filters which need to be replaced • Utilize on-off controls • Commonly utilized for laparotomy procedures • During a laparoscopic procedure, pneumoperitoneal pressure falls and CO2 must be quickly replaced to continue the procedure – devices with a closed loop system minimize loss of pneumoperitoneum • Passive systems • Ideal for laparoscopy as they utilize differential in pressure to generate gas/smoke and fume flow through a filter mechanism • Some devices regulate flow based on filter characteristics to automatically maintain pneumoperitoneum

39. Example – active systems • Designed to attach to an electrosurgical pencil • Eliminates the need for surgical technician or nurse to hold tubing

40. Example – passive system • Passive disposable multi-stage filter systems • ULPA filter traps smoke, particulates and aerosolized pathogens • Activated charcoal membrane absorbs odors and chemical toxins • Elevated intraperitoneal pressure pushes out the smoke, etc. along with the CO2 • Flow rates are pre-set to optimize smoke removal without losing pneumoperitoneum

41. Compliance - many operating rooms see less than universal use • Duke University study • The survey involved 623 respondents • Represented all 50 states and Canada • Found that many surgical facilities fail to use LEV consistently Smoke evacuation or wall suction was used “always or often” in only: Edwards BE,Reiman RE. Results of a survey on current surgical smoke control practices. AORN J. 2008;87:739–749.

42. Toxic fumes/smoke - summary • Surgical smoke created during laparoscopy is hazardous to the OR staff and to the patient • Health hazards to the operative staff • Potential for diseases (bacteria and viruses) being transmitted in surgical smoke • Some of these gases are known carcinogens • Small smoke particles are inhaled which can end up in the alveoli of your own lungs • The mask does NOT offer complete protection against inhalation of these particles • Health effect to the patient* • Research has shown that the patient absorbs byproducts of tissue destruction when smoke is not evacuated during laparoscopy • Smoke absorption leads to increased methemoglobin and carboxyhemoglobin in the patient’s blood, potentially causing symptoms of nausea, headaches, and vision problems in the post-anesthesia care unit Ott, D. E. Smoke and particulate hazards during laparoscopic procedures. Surgical Services Management, 1997; 3(3): 11-13.

43. Toxic fumes/smoke - summary • Benefits of smoke evacuation during surgery • Maintains a clear field of vision • Facilitates the procedure technique • Safely minimizes plume exposure to patients and surgical team members • Laparotomy • Active devices with an inline filter work best • Laparoscopy • Passive devices ideal • Preserve pneumoperitoneum and provide improved visualization

44. Risk reduction strategies for operating room personnel • OR workers face a wide range of hazards on the job including • Needle-stick injuries • Latex exposure • Anesthesia gas in the operating room • Toxic fumes/smoke generated during surgical procedures • Methods to mitigate risk exposure include • Education regarding risk • Evaluation of the operating room environment • Utilization of mitigation devices