APIC position paper: Safe injection, infusion, and medication vial practices in health care SusanA.Dolan,RN,MS,CIC,a Gwenda Felizardo, RN, BSN, CIC,b Sue Barnes, RN, BSN, CIC,c Tracy R. Cox, RN, CIC,d Marcia Patrick, RN, MSN, CIC,e KatherineS.Ward,RN,BSN,MPH,CIC,f and Kathleen Meehan Arias, MS, CICg Washington, DC Outbreaks involving the transmission of bloodborne pathogens or other microbial pathogens to patients in various types of health care settings due to unsafe injection, infusion, and medication vial practices are unacceptable. Each of the outbreaks could have been prevented by the use of proper aseptic technique in conjunction with basic infection prevention practices for handling par- enteral medications, administration of injections, and procurement and sampling of blood. This document provides practice guid- ance for health care facilities on essential safe injection, infusion, and vial practices that should be consistently implemented in such settings. Key Words: Bloodborne pathogens; injection; infusion; medication vial practices; aseptic technique; parenteral medications; administration of injections; procurement of blood. Copyright ª 2010 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved. (Am J Infect Control 2010;38:167-72.) The transmission of bloodborne viruses and other in the exposure of .100,000 individuals to viral hepa- microbial pathogens to patients during routine health titis and the transmission of either hepatitis B virus care procedures continues to occur because of the (HBV) or hepatitis C virus (HCV) to more than 500 pa- use of unsafe and improper injection, infusion, and tients.13 The unsafe practices used by health care per- medication vial practices by health care professionals sonnel in these outbreaks can be categorized as (1) in various clinical settings throughout the United syringe reuse between patients during parenteral med- States.1-13 Breaches in safe injection, infusion, and ication administration to multiple patients, (2) contam- medication vial practices continue to result in unac- ination of medication vials or intravenous (IV) bags ceptable and devastating events for patients. More after having been accessed with a used syringe and/ than 35 outbreaks of viral hepatitis have occurred in or needle, (3) failure to follow basic injection safety the United States over the past 10 years because of practices when preparing and administering parenteral these unsafe practices and other breaches of infection medications to multiple patients, and (4) inappropriate prevention procedures. These outbreaks have resulted care/maintenance of finger stick devices and glucome- ter equipment between use on multiple patients. In 2001, an anesthesiologist at a New York endos- From the Department of Epidemiology, Children’s Hospital, Aurora, copy clinic infected 19 patients with HCV by improp- a CO ; Infection Preventionist, Group Health Coopertive, Tacoma, erly reusing syringes and contaminating a multi-dose WAb; National Infection Prevention Leader, Kaiser Permanente, San Mateo, CAc; Infection Control St. Mary’s Hospital, Decatur, ILd; Infec- anesthesia medication vial subsequently used for mul- 3 tion Control, Multicare Health System, Tacoma, WAe; Infection Con- tiple patients. A similar HCV outbreak because of un- trol, Roper Hospital, Mount Pleasant, SCf; Arias Infection Control, safe injection practices occurred in New York in 2002 g Crownsville, MD. and 2007, affecting a total of 102 patients.13 In 2002, Conflicts of interest: None to report. nearly 100 Nebraska hematology oncology clinic pa- Address correspondence to Denise Graham, APIC (Association for tients contracted HCV after a health care worker Professionals in Infection Control and Epidemiology), 1275 K St, Suite (HCW) responsible for medication infusions routinely 1000, Washington, DC 20005-4006. E-mail: [email protected] used the same syringe and needle from a HCV- 0196-6553/$36.00 positive patient’s blood draw to obtain saline flush so- Copyright ª 2010 by the Association for Professionals in Infection lution from an IV bag. As a result, the patient’s blood Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved. on the needle of the syringe was inoculated into the IV bag, which was then used as flushing solution for doi:10.1016/j.ajic.2010.01.001 several other patients.9 One of the most recent HCV 167 168 Dolan et al. American Journal of Infection Control April 2010 outbreaks occurred at an endoscopy center in Nevada the preparation and safety of the compounding per- in 2008, again because of unsafe injection practices in- sonnel. HCWs who prepare medications outside of volving reusing syringes and sharing single-use medi- ISO class 5 settings do so in environments with envi- cation vials between patients. This outbreak received ronmental particulates and microorganisms. Such set- significant media attention because, in part, of the tings and immediate-use preparation practices can fact that 63,000 persons were identified as being at po- potentially cause contamination of vials, IV solutions, tential risk for acquiring hepatitis. More than 12,000 and syringes from both airborne and direct contact patients have been tested to date, and at least 115 sources. For example, clinicians who prepare injec- patients have been found to be infected with HCV. tions and infusions may perform hand hygiene but The investigation is ongoing.12 not wear sterile gloves and a mask or contain their The Association for Professionals in Infection Con- hair during preparation. When they remove the cap trol and Epidemiology (APIC) recognizes these out- from the needle and insert it into the vial while breath- breaks as unacceptable. Each of the outbreaks could ing over the sterile needle and vial stopper, they create have been prevented by the use of proper aseptic tech- the potential for microbial contamination. Spiking a nique in conjunction with basic infection prevention bag, vial, or bottle with a 1-way device and leaving it practices for handling parenteral medications, adminis- in place also increases the microbial contamination tration of injections, and procurement and sampling of risk. The spike collects microorganism contamination blood. Responsibility for the oversight and monitoring from the environment, and the sterile solution is then of patient safety must be clearly designated in health poured out or withdrawn from a contaminated spout. care settings to ensure that staff education is available For this reason, spiking any solution with a 1-way de- for all health care professionals providing such services vice and leaving it in place for multiple entries puts pa- to patients. Furthermore, periodic monitoring for abso- tients at risk for infection and is strongly discouraged. lute adherence to safe injection practices in health care According to USP ,797., immediate-use CSPs (pre- settings is vital to ensure effective engineering of and pared outside the ISO 5 environment) are exempted adherence to safe practices in everyday patient care. from the rigorous environmental purity standards and In 2008, the United States Pharmacopeia (USP) pub- personnel cleansing and garbing practices that are re- lished a revised USP General Chapter ,797. Pharma- quired for all other categories of CSPs in USP ceutical Compounding—Sterile Preparations.14 These ,797..14 Immediate-use CSPs allow for certain sterile standards apply to compounded sterile preparations products to be prepared (compounded) without the (CSPs), which include compounded biologics, diagnos- need for special facilities (eg, clean room or ISO class 5 tics, drugs, nutrients, and radiopharmaceuticals, in- hood) and practices (eg, full cleansing or gowning). Dis- cluding but not limited to the following dosage forms solving, diluting, measuring, and mixing non-nutrient that must be sterile when they are administered to pa- sterile injections using sterile devices (eg, ampuls, tients: aqueous bronchial and nasal inhalations, baths bags, needles, syringes, and vials) in clinical practice fa- and soaks for live organs and tissues, injections (eg, col- cilities (eg, patient care areas in hospitals, clinics, and loidal dispersions, emulsions, solutions, suspensions, physician offices) typify the conditions of what USP irrigations for wounds and body cavities, ophthalmic ,797. calls ‘‘Immediate-use CSPs.’’ USP ,797. re- drops and ointments, and tissue implants). This in- quires a 1-hour limit from completing preparation (eg, cludes manufactured bags or bottles of intravenous or spiking an IV bag) until beginning administration of irrigation fluid that may or may not contain additives the immediate-use CSPs to patients. Their rationale is and any solution drawn into a syringe for injection. that the 1-hour limit is expected to preclude microbial USP ,797. applies to the pharmacy setting as well population increase when accidental contamination of as to all persons who prepare medications that are ad- such drugs occurs with small quantities of microorgan- ministered and all settings in which they are prepared isms. Once microbial contamination occurs, the (eg, hospitals, other health care institutions, patient organism replication can begin within 1 to 4 hours treatment clinics, physician’s offices, and others). with exponential growth occurring rapidly afterward. This chapter includes the standards for preparing, la- For settings that prepare and use immediate-use beling, and time frames for discarding