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Safe Injection Practices for Administration of Propofol

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Safe Injection Practices for Administration of Propofol Safe Injection Practices for Administration of Propofol CECIL A. KING, MS, RN; MARY OGG, MSN, RN, CNOR ABSTRACT Sepsis and postoperative infection can occur as a result of unsafe practices in the administration of propofol and other injectable medications. Investigations of infec- tion outbreaks have revealed the causes to be related to bacterial growth in or contamination of propofol and unsafe medication practices, including reuse of syringes on multiple patients, use of single-use medication vials for multiple pa- tients, and failure to practice aseptic technique and adhere to infection control practices. Surveys conducted by AORN and other researchers have provided addi- tional information on perioperative practices related to injectable medications. In 2009, the US Food and Drug Administration and the Centers for Disease Control and Prevention convened a group of clinicians to gain a better understanding of the issues related to infection outbreaks and injectable medications. The meeting participants proposed collecting data to persuade clinicians to adopt new practices, developing guiding principles for propofol use, and describing propofol-specific, site-specific, and practitioner-specific injection techniques. AORN provides resources to help perioperative nurses reduce the incidence of postoperative infection related to med- ication administration. AORN J 95 (March 2012) 365-372. © AORN, Inc, 2012. doi: 10.1016/j.aorn.2011.06.009 Key words: sterile injectable medications, propofol, sepsis, safe injection prac- tices, safe medication administration. uring the past 10 years, there has been In 1990, one year after propofol was ap- growing concern regarding postoperative proved for use, the Centers for Disease Control Dinfections associated with the handling of and Prevention (CDC) investigated four clusters injectable medications; more specifically, clusters of postsurgical infections and hyperthermic re- of sepsis and postoperative infections have oc- actions.4 The investigators traced the infections curred related to the use of propofol.1 Propofol is and reactions to several factors, including ex- a sterile, IV, lipid-based, emulsive anesthetic trinsic contamination of the agent that resulted agent. It was approved by the US Food and Drug from lapses in aseptic technique during the han- Administration (FDA) in 1989 and has been dling of the medication, use of propofol by in- widely used in the United States since that time.2 fusion pump, and preparation of the infusion As a lipid-based emulsion, this medication is pump by one anesthesia provider. The same known to support bacterial growth.3 infusion pump, syringe, and provider were doi: 10.1016/j.aorn.2011.06.009 © AORN, Inc, 2012 March 2012 Vol 95 No 3 ● AORN Journal 365 March 2012 Vol 95 No 3 KING—OGG TABLE 1. Propofol Handling Guidelines1 US Food and Drug Administration recommendations General product insert guidelines Vials of propofol and prefilled syringes are intended Strict aseptic technique must always be used when handling for single (ie, one patient) use. sterile injectable medications. Begin infusion immediately after drawing up or Propofol should be inspected before use for particulate opening the vial of medication. matter, discoloration, or evidence of separation of the Infusion from prefilled syringes or vials must begin emulsion. within 6 hours of opening/filling the syringe. Do not use if contaminated. Propofol that is infused directly from a large volume Fill syringes or spike the vial immediately before administration (eg, 100 mL) vial is to be limited to one patient and to each patient. must be infused within 12 hours of opening the vial Disinfect the rubber stopper with 70% isopropyl alcohol. or spiking the stopper. Discard unused portions within 6 hours of filling syringes or 12 hours after spiking a large volume vial for infusion. 1. DIPRIVAN® (propofol) Injectable Emulsion. 451094A/Issued: February 2008. US Food and Drug Administration. http://www.accessdata.fda.gov/ drugsatfda_docs/label/2008/019627s046lbl.pdf. Accessed December 8, 2011. identified as risk factors in two of the infected During a 10-year period from 1998 to 2008, 35 patients.4 documented outbreaks of hepatitis occurred in These outbreaks of infection prompted the nonhospital health care facilities (eg, pain clinics, pharmaceutical company that manufactures propo- endoscopy clinics, hemodialysis centers), which fol to add language to the product circular stating put more than 60,000 patients at risk for develop- that “strict aseptic technique must always be ing bloodborne pathogen infections.11 These out- maintained during handling . .”5 and preparation breaks were traced to of propofol for injection. The FDA issued propo- reuse of syringes on multiple patients, fol administration guidelines based on recommen- single-use medication vials used for multiple dations from the CDC,4 the American Society of patients, Anesthesiologists,6 and the Anesthesia Patient failure to practice aseptic technique, and Safety Foundation7 that are similar to the failure to follow fundamentals of infection manufacturer’s recommendations summarized in control practices.11 Table 1. All recommendations were based on the following facts: In 2002, the Oklahoma State Department of Health investigated an unexplained outbreak of Propofol is a lipid-based emulsion that sup- hepatitis C (HCV).12 All the infected patients had ports bacterial growth.8 been treated for pain at the same outpatient clinic. Bacterial contamination increases rapidly over The Oklahoma health department was able to test time.9 795 (88%) of the patients who had been treated Disinfection of propofol ampules or vials be- since the clinic opened and found that 71 patients fore opening considerably reduces the risk of had contracted HCV and 31 had contracted hepa- bacterial contamination of the medication.8 titis B during 2002. Interviews with staff mem- Disodium edetate, which inhibits bacterial growth, bers regarding injection practices revealed that was added to propofol in 1996; as a result, the care providers used a single needle and syringe incidence of propofol injection infections was to administer three different sedation medica- reduced but not eliminated.10 tions. In addition, these providers used the 366 AORN Journal SAFE INJECTION PRACTICES www.aornjournal.org same needle and syringe to administer these has led to outbreaks of serious postoperative medications to all of the patients treated that health care-associated infections. day. Results of the investigation suggest that It is essential to use strict aseptic technique the infections were transmitted from patient to when handling propofol, as mandated by the patient after a provider used a syringe and nee- manufacturer’s written instructions. dle on a patient positive for hepatitis and then used the same syringe and needle to administer MEDICATION PRACTICES SURVEYS medication to subsequent patients. The outbreak In July 2009, AORN conducted a random elec- stopped when the practice of reusing syringes tronic survey of 500 of its 40,000 members to and needles stopped.12 determine their current practice for handling In 2007, investigation of an outbreak of HCV propofol. A total of 410 members completed the at an endoscopy center revealed that five of the survey for a response rate of 82%. Seventy-two six infected patients had undergone procedures on percent of the respondents practiced in a hospital the same day.13 Direct observation of the center’s setting (ie, academic, community, rural), and 28% personnel demonstrated that they inappropriately of the respondents practiced in ambulatory sur- reused syringes and used single-dose medication gery centers or endoscopy units. The highest per- vials on multiple patients. Clean needles and sy- centage of respondents (ie, 36%) worked in facili- ringes were used to withdraw medication from a ties with five to 10 ORs (Figure 1), and most single-use bottle of propofol. The medication was respondents worked in ORs in which an average injected through the patient’s IV. If more propo- of 51 to 100 surgical procedures were performed fol was needed, then the same syringe with a per week (25%) (Figure 2). The majority of the clean needle was used to withdraw more medica- respondents (87%) reported that, in their facilities, tion. Investigators theorized that backflow from anesthesia providers (eg, physicians, certified RN the patient’s IV or the needle may have contami- anesthetists) draw up propofol medication prod- nated the syringe with HCV, thereby contaminat- ucts for administration (Figure 3). When asked ing the vial. The remaining medication was used how often the vial of propofol was typically ac- on subsequent patients.13,14 cessed, 50% reported once, whereas 44% reported The findings of the investigations into these witnessing the same vial being accessed two to various outbreaks of postoperative infections may three times. Six percent of respondents reported be summarized into four major points that relate seeing the same vial of propofol being accessed to safe injection practices. more than four times (Figure 4). When asked if Propofol is a lipophilic IV injection that is known to support AORN Resources the growth of AORN guidance statement: safe medication practices in periopera- microorganisms. tive settings across the life span. In: Perioperative Standards and The addition of a preser- Recommended Practices. Denver, CO: AORN, Inc; 2011:605-611. vative to propofol only inhibits microbial growth, Watch for these new
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