Infection Control & Hospital Epidemiology


ISO class 5 setting (eg, a pharmacy IV room) be for “immediate use” only, commencing within 1 hour of preparation and inter- prets “compounding” as including drawing medications from vials into syringes.28 Scientific literature is sparse pertaining to a 1-hour limit on the advance preparation of sterile drugs for injection in an “immediate use” setting. To the best of our knowledge, the “1-hour limit” from USP 797 is based on the underlying principle that drugs prepared outside of a properly regulated pharmacy IV “clean room” are more likely to become contaminated, and bacterial counts may increase over time.38 Austin et al39 performed a systematic review of the literature and found a significantly higher frequency of contamination of doses prepared in clinical than in 10 pharmaceutical environments (3.7% vs 0.5%; P=.007).39 A draft of the revision of USP Chapter 797 released in July 2018 contains language suggesting that pro- vider prepared drugs could be used until “the end of a case.”37 This draft is subject to change and will not be finalized until late in 2019.


Because no reliable method exists for knowing with certainty


whether the drugs or solutions have been used, the authors sug- gest designated healthcare personnel discard provider-prepared sterile injectable drugs and intravenous solutions at the end of each case, whether used or not. If the drugs or solutions have been used, they may be contaminated and subsequent use for another patient may result in transmission of organisms to that patient. The facility may consider returning to stock unused commercial prefilled syringes, which have not passed their “beyond use” date, have intact security locking caps, and have been present in the anesthesia work area during a case; however, consideration should be given to the possibility that the external surface of such syringes may become contaminated during a case and pose an infection risk if reused for another case. In addition to USP 797, the facility may consider the advice


of other authorities, which may be at variance with the 1-hour limit recommended by USP 797. For example, The Joint Commission’s recommendations for syringe labeling do not require labeling provider-prepared injectable drugs for “immediate use” with a date and time of expiration unless the expiration occurs within 24 hours of preparation, suggesting that “immediate use” may extendbeyond1hour.The Food and Drug Administration (FDA) “package insert” for propofol states that propofol has a 12-hour expiration time after being drawn up into a syringe; formulations of propofol without preservative may have a 6-hour expiration time after being drawn up into a syringe.40


How long can IV bags be spiked in advance of commencing use?


Recommendation: Anesthesia practitioners should minimize the time between spiking IV bags and patient administration; nevertheless, certain emergent or urgent circumstances may require advanced set-up of IV fluids and anesthesia providers should comply with their hospital protocols. Following spiking of an IV bag, administration should com-


mence as soon as possible. No specific time limit has been identified in the literature for advance preparation of IV bags. Rationale: Facilities should determine whether local regulatory authorities (eg, state boards of health or pharmacy) have rules regarding spiking of IV bags. Scientific literature pertaining to spiking IV bags is sparse. Haas et al41 found no bacterial growth


7


up to 8 hours in 80 bags of lactated Ringer’s solution spiked by a single provider following proper HH, but they did not address whether these results are replicable across multiple providers, in other settings, and with other types of IV solutions. Anesthesia providers occasionally spike IV fluids in advance,


especially in preoperative holding areas and in ORs that are reserved for emergencies. Providers should weigh the risks versus benefits of spiking IV bags that are not intended for immediate use. The authors encourage facilities to conduct a risk assessment in collaboration with their Infection Prevention and Control Departments.


Should syringes and medication vials be reused?


Recommendation: Single-dose medication vials and flushes should be used whenever possible. If multiple-dose medication vials must be used, they should be used for only 1 patient and should only be accessed with a new sterile syringe and new sterile needle for each entry. Syringes and needles are single patient devices and syringes should never be reused for another patient, even if the needle is changed. Rationale: The CDC established safe injection practices as part of its 2007 Guidelines for Isolation Precautions: Preventing Trans- mission of Infectious Agents in Healthcare Settings.42,43 Numer- ous authorities and organizations, including the Association for Professionals in Infection Control and Epidemiology (APIC), AANA, ASA, and the Joint Commission have issued guidelines and/or recommendations concerning injection safety and have referenced CDC safe injection practices.44–47 The Association of Anaesthetists of Great Britain and Ireland has also issued safe injection practices that mirror those of the CDC.48 The CDC recommendations are based on reports of outbreaks of pre- ventable healthcare-acquired viral and bacterial infections resulting from improper injection safety practices.42 Improper injection safety practices include: use of single-dose medication vials for multiple patients,49–54 improper use of multiple-dose vials,50,55,56 and use of a single syringe or needle to administer intravenous medication to multiple patients.42,44,53,57 Several groups of researchers have reported outbreaks of preventable healthcare-acquired viral and bacterial infections in inpatient operating suites, adult and pediatric medical-surgical wards, and outpatient endoscopy, surgery, infusion, myocardial perfusion testing, and pain centers.49–53,55–60


How should keyboards and touch screens in the anesthesia work area be cleaned and protected from contamination?


Recommendation: Facilities should require cleaning and disin- fection of computer keyboards and touchscreen computer monitors after each anesthesia case using a hospital-approved disinfectant consistent with manufacturers’ recommendations. Additionally, cleaning and disinfection should also occur every time there is obvious soiling or contamination of anesthesia work surfaces. Facilities should consider use of commercial plastic keyboard shields, sealed medical keyboards, or washable key- boards and touchscreens to facilitate thorough disinfection. Rationale: The problem of bacterial contamination of clinical and OR equipment is well documented as a host of bacteria such as coagulase-negative staphylococci, Bacillus spp, and even MRSA inhabit anesthesia surfaces, such as workspace computer


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