Pennsylvania Patient Safety Advisory Sterile Water Should Not be Given “Freely” ABSTRACT practitioners may have a knowledge deficit about the risks of IV administration of sterile water. For Severe hypernatremia can be challenging to treat. example, prescribers are ordering sterile “free water” There appears to be a failure among healthcare to treat hypernatremia. Free water refers to water not practitioners to recognize the danger of infusing plain associated with organic or inorganic ions. Because sterile water intravenously. Bags of sterile water for hypernatremia usually results from a loss of free water injection and inhalation also are being mistaken for relative to solute, it is likely that prescribers intend intravenous (IV) solutions. Sterile water is hypotonic to replace this deficit when writing these orders. (0 mOsm/L). Serious patient harm, including hemo- Water can be replaced by mouth or nasogastric tube; lysis, can result when it is administered by direct IV however, if given intravenously without additives to infusion. PA-PSRS and other medication error reporting normalize tonicity, hemolysis may occur. Second, programs have received reports of IV administration of inadvertent IV administration of sterile water is occur- sterile water to patients, some of which have resulted ring due to the look-alike nature of bags of sterile in patient deaths. Risk reduction strategies include water and other IV solutions. recognizing the problem, developing protocols to treat hypernatremia, establishing safeguards, assessing Errors in the Prescribing Phase for safe storage, and ensuring that sterile water bags In one particular event reported through PA-PSRS, a cannot be provided without prior pharmacy agree- physician ordered 2 L of sterile water for injection to ment and supervision. (Pa Patient Saf Advis 2008 treat an intensive care unit (ICU) patient’s elevated Jun;5[2]:53-6.) sodium level. Nurse was told to give the patient 2 L sterile water bolus IV for high sodium level. Nurse received IV sterile Severe hypernatremia, when the plasma concentra- water from pharmacy. Nurse hung 1 L sterile water tion of sodium is greater than 145 mEq/L,1 can be after getting order for doctor. Other doctor was aware challenging to treat, especially in patients with condi- of sterile water hanging. Nurse called pharmacist to tions such as hyperglycemia that may seem to limit receive second liter and was told it cannot be given IV. treatment options. It appears there is a failure among The infusion was stopped. The doctor was made aware. healthcare practitioners to recognize the danger of infusing plain sterile water intravenously to treat The infusion was stopped in time to prevent any hypernatremia. Also, bags of sterile water for injection harm to the patient. and inhalation are being mistaken for intravenous (IV) The Institute for Safe Medication Practices (ISMP) solutions when they are stocked on patient care units. has reported a similar event in which a physician Serious patient harm can result when sterile water is decided to give sterile water for injection intrave- administered by direct IV infusion due to hemolysis nously to an elderly patient who had been admitted related to the hypotonic nature of the product. to an ICU with pneumonia, congestive heart failure, Sterile water for injection is sterile water that is intended respiratory failure, severe hyperglycemia, and severe to be used by pharmacy to compound IV products hypernatremia.2 The physician was concerned about such as parenteral nutrition solutions. It also is used giving dextrose-containing fluids due to the patient’s in small quantities to solubilize drugs—the drug hyperglycemia. The physician contacted a pharmacist, solutes then contribute the osmotic pressure to the confirmed “large bags of sterile water for injection” solution to keep it safe. To prepare isotonic IV solu- were available, and changed the patient’s existing tions from sterile water for injection, solutes such as intravenous fluids to free water at 100 mL/hr. When sodium chloride or dextrose may need to be added. he received the order, the pharmacist entered it It takes 9 g of sodium chloride or more than 50 g of into the computer. A pharmacy intern retrieved a dextrose in a liter of sterile water to make it isosmotic bag from the sterile compounding area, placed the (about 308 mOsm/L) with blood. Potassium chloride pharmacy-generated label on the back of the bag, is similar to sodium chloride—about 154 mEq/L in and dispensed it to ICU. The nurse began the infu- sterile water for injection is needed to be nearly iso- sion without question because she was aware of the tonic. For cefazolin sodium, a 100 mg/mL solution patient’s hypernatremia and overheard the physician in sterile water for injection is nearly isotonic. Sterile ask the pharmacist if bags of sterile water were avail- water for injection is 0 mOsm/L, which can be fatal. able. She did not see red lettering on the bag that It should never be given intravenously to patients. stated “Pharmacy Bulk Package, Not For Direct Infu- sion” because the pharmacy label was on the opposite PA-PSRS and other medication error reporting pro- side of the bag. Another nurse noticed the statement grams have received reports of events involving the and stopped the infusion. The patient experienced a IV administration of sterile water to patients. There hemolytic reaction and acute renal failure, and died are two main reasons for these errors. First, healthcare after 550 mL had infused. Vol. 5, No. 2—June 2008 Reprinted©2008 Pennsylvania Patient Safety Authority Authority article - ©2008 Pennsylvania Patient Safety Page 53 Pennsylvania Patient Safety Advisory Error Related to Packaging, Labeling, and Hospital materials management departments may pro- Storage vide patient care areas with liter bags of sterile water. Bags of sterile water, especially 1 L size bags, can look One hospital reported through the ISMP-U.S. Phar- like and be confused with other IV solutions. For macopeia Medication Errors Reporting Program that example, a 1,000 mL bag of sterile water for injection their purchasing department stocked automated dis- was mistakenly dispensed by pharmacy to a dialysis pensing cabinets (ADCs) with IV solutions.4 In one unit and administered intravenously to a patient instance, a wholesaler mistakenly delivered 1 L bags instead of a 1,000 mL bag of 0.9% sodium chloride of sterile water for injection instead of 5% dextrose injection.3 The two products looked similar despite a solution. The error was not caught when the product red, boxed warning under the name on the bag of ster- was received nor when the ADC was restocked. A ile water (see Figure 1). The IV fluids were obtained by nurse accidentally retrieved and hung one of the ster- a pharmacy technician, checked by a pharmacist, deliv- ile water bags. A physician discovered the error when ered to the dialysis unit, and later taken from stock investigating the patient’s complaint of discomfort at and administered by the dialysis nurse. The error was the IV site. Sterile water was also found hanging on caught after 400 mL was administered. another patient, but only a small volume had infused. Both patients suffered no permanent harm. Sterile water bags are also being stocked in patient care areas. A pediatric patient was ordered 0.9% Emergency malignant hyperthermia boxes found in saline, according to a PA-PSRS report. the operating room and postanesthesia care unit can be another source of sterile water bags. Based on a Normal saline solution was ordered as a fluid bolus; recommendation from the Malignant Hyperthermia sterile water hung. Blood work was drawn, and no Association of the United States, these boxes often changes [were observed]. Sterile water in bags was are stocked with 1 L bags of sterile water to dilute removed from nursing units. dantrolene sodium for injection, a skeletal muscle No harm was noted. In order to prevent this error relaxant used to treat malignant hyperthermia.5,6 from occurring again, the facility removed IV bags of Unused or partially used bags of the solution may sterile water from nursing units. find their way into IV stock or be hung as an IV solu- tion during emergent treatment. Figure 1. Sodium Chloride Solution (Left) and Sterile Respiratory therapy staff may also store or bring bags Water for Injection (Right) of sterile water to patient care units for humidifica- tion devices used with ventilators or continuous positive airway pressure (CPAP) devices. Humidifica- tion of inspired gases helps prevent cilial damage as well as heat and water loss.7,8 While there are several ways to humidify the gases, a “wet” setup may require the use of a sterile water bag, which is attached to a humidification receptacle on the ventilator or CPAP device. For example, some units contain tubing that must be spiked into a water container with a tradi- tional IV-like port (see Figure 2). This means that only Figure 2. Sterile Water Bag Connected to a Humidification Unit Image provided courtesy of ISMP. Image provided courtesy of ISMP. Page 54 Reprinted©2008 Pennsylvania Patient Safety Authority Authority article - ©2008 Pennsylvania Patient Safety Vol. 5, No. 2—June 2008 Pennsylvania Patient Safety Advisory bags of sterile water can be used with these specific blood levels slowly. Too rapid correction of hyper- units to provide the humidification. natremia may result in cerebral edema, seizures, Sterile water for inhalation is available in 250 mL, and possibly death.2,10,11 500 mL, 1 L, 2 L, and 3 L bags that can be used for If concerns exist about using dextrose solutions, wet setups. Some of these bags not only look similar elevated blood sugars can be treated with insulin. to other IV solutions, but they can also be attached If there are concerns about fluid volume, patients to IV tubing (and may be listed for purchase as can be given diuretics.2 “IV solutions”). One hospital reported to ISMP that Program the pharmacy computer system to provide a respiratory therapist left a liter bag of sterile water an alert, “Use Only as a Diluent,” when these for inhalation unwrapped in the patient’s room to products are entered. Avoid offering sterile water replace the current bag attached to the ventilator.4 A for injection as a choice in prescriber order entry nurse, responding to an IV pump’s low volume alarm, systems.2 replaced the empty IV bag with the sterile water bag, believing it had been left as an IV replacement. The Clarify any order for sterile water with the pre- patient received 500 mL before the error was noticed, scriber as the order will likely will cause hemolysis.2 but he suffered no harm. Sterile water for inhalation Store sterile water bags away from medication sup- bags also may be stored on respiratory supply carts, plies. Never allow IV compounding products to right next to IV fluids, or hanging on an IV pole so leave the pharmacy’s sterile compounding area. Seg- the nurse could change the bag at night (see Figure 3). regate these solutions and store them with warnings to not distribute them outside the pharmacy.2,3 Risk Reduction Strategies Affix auxiliary warnings to both sides of sterile Sterile water for injection, inhalation, and irrigation water bags. (excluding pour bottles) has been added to ISMP’s Sterile water for injection is available in 2 L (or List of High Alert Medications.9 ISMP encourages larger) containers for IV compounding. The differ- healthcare organizations and practitioners to estab- ence in size of these larger bags can help reduce the lish special safeguards to reduce the risk of errors risk of confusion with other 1 L IV solutions.3 with high-alert medications. Below are a number of strategies that may be considered to reduce the risk For emergency malignant hyperthermia boxes, of IV administration of free water or sterile water for some hospitals have replaced the 1 L sterile water injection. bags with an adequate supply of 50 mL vials4 or 2 L bags of sterile water for injection. Alert practitioners to the danger—primarily hemo- lysis—of infusing sterile water. Educate clinicians If a wet setup is considered necessary to humidify about the physiology behind infusing hypotonic, inspired gases, humidification units that do not isotonic, and hypertonic solutions, especially in require the use of sterile water bags can be consid- relation to the patient’s electrolyte levels.2 ered. Some manufacturers offer wet humidification setups with self-contained plastic bottles of sterile Develop protocols to guide safe and effective water for inhalation, so bags of sterile water are not treatment of hypernatremia. Treatment of severe required. Heat and moisture exchangers, which are hypernatremia generally consists of infusions that self-contained disposable units that do not require contain smaller amounts of sodium to reduce a continuous flow of water, are another option. If these alternatives are not possible, establish guide- Figure 3. Sterile Water Bag On IV Pole lines for safe storage and handling of the sterile water for inhalation bags.4 Alert respiratory staff to avoid leaving bags of ster- ile water in medication rooms or patient rooms or hung on IV poles.4 Special poles that attach to the ventilator for the purpose of hanging sterile water bags for use with humidification units are available from some man- ufacturers. Consider using them when possible.4 Arrange for pharmacists and pharmacy technicians trained in safe drug storage to conduct regular rounds on patient care units, the respiratory department, and other areas where medications are stored or given so they can assess the storage of medications and solutions.4 Review the list of items that patient care units can order manually or automatically through materials Image provided courtesy of ISMP. management. Ensure that pharmaceutical products Vol. 5, No. 2—June 2008 Reprinted©2008 Pennsylvania Patient Safety Authority Authority article - ©2008 Pennsylvania Patient Safety Page 55 Pennsylvania Patient Safety Advisory (including sterile water bags) cannot be provided Available from Internet: http://medical.mhaus.org/index. without prior pharmacy agreement and supervision.2 cfm/fuseaction/OnlineBrochures.Display/BrochurePK/ B5DBDF12-20C3-4537-948C098DAB0777E3.cfm. Share information about these errors with purchas- ing staff to increase awareness of errors.2 6. Procter & Gamble Pharmaceuticals. Dantrium IV [package insert online]. 2007 Oct [cited 2008 Feb 15]. Notes Available from Internet: http://www.pgpharma.com/pi/ 1. Porter RS, Kaplan JL, Homeier BP, et al., eds. Hyper- US-DantriumIV.pdf. natremia. In: The Merck manual for healthcare 7. Chalon J, Patel C, Ali M, et al. Humidity and the professionals [online]. 2005 Nov. [cited 2008 May 3]. anesthetized patient [online]. Anesthesiology 1979 Available from Internet: http://www.merck.com/ Mar [cited 2008 Feb 14]. Available from Internet: mmpe/sec12/ch156/ch156e.html. http://www.anesthesiology.org/pt/re/anes/pdfhandler. 2. Institute for Safe Medication Practices. Water, water, 00000542-197903000-00005.pdf. everywhere, but please don’t give IV. ISMP Med Saf Alert 8. Forbes AR. Temperature, humidity and mucus flow in 2003 Jan 22;8(2):1-2. the intubated trachea. Br J Anaesth 1974 Jan;46(1):29-34. 3. Institute for Safe Medication Practices. Worth repeating: 9. Institute for Safe Medication Practices. ISMP’s list of avoiding mix-ups between sterile water and sodium chlo- high alert medications [online]. 2007 Aug [cited 2008 ? ride bags. ISMP Med Saf Alert 2007 Dec 13;12(25):3. May 3]. Available from Internet: http://www.ismp.org/ 4. Institute for Safe Medication Practices. How sterile water Tools/highalertmedications.pdf. SA bags show up on nursing units. ISMP Med Saf Alert 2003 Sep 18;8(19):1-2. 10. Kraft MD, Btaiche IF, Sacks GS, et al. Treatment of elec- trolyte disorders in adult patients in the intensive care 5. Malignant Hyperthermia Association of the United unit. Am J Health-Syst Pharm. 2005; 62:1663-82 States. Drugs, equipment, and dantrolene—managing MH 11. Kang SK, Kim W, Oh MS. Pathogenesis and treatment [brochure online]. 2004 Oct 1 [cited 2008 Feb 2]. of hypernatremia. Nephron 2002 Oct;92 Suppl 1:14-7. ? Self-Assessment Questions 1. Sterile water for injection is intended for all of the follow- ing EXCEPT? 5. All of the following steps would help to reduce the risk of inadvertent IV administration of sterile water EXCEPT? a. Compound intravenous (IV) products a. Stock sterile water for injection, irrigation, and inhala- b. Prepare parenteral nutrition solutions tion in 1 L bags c. Infuse intravenously b. Store sterile water bags away from medication supplies d. Solubilize small quantities of drugs c. Develop protocols to guide safe and effective treatment 2. Rapid correction of severe hypernatremia can result in all of hypernatremia. of the following EXCEPT? d. Avoid offering sterile water for injection as a choice in a. Seizure prescriber order entry systems b. High-output renal failure e. Pharmacists and pharmacy technicians trained in safe c. Cerebral edema drug storage make regular rounds on patient care units, d. Death respiratory department, and other areas where medi- cations are stored and given to assess the storage of 3. Sterile water for injection can cause hemolysis when medications and solutions administered intravenously. a. True b. False 4. All of the following factors contribute to errors involving sterile water for injection or sterile water for inhalation EXCEPT? a. Look-alike nature of bags of sterile water and other IV solutions b. Knowledge deficit about the risks of IV administration of sterile water c. Storage of bags of sterile water for injection in medica- tion rooms or patient rooms d. Humidification units with self-contained plastic bottles of sterile water for inhalation e. Bags of sterile water for injection from emergency malignant hyperthermia boxes find their way into IV stock Page 56 Reprinted©2008 Pennsylvania Patient Safety Authority Authority article - ©2008 Pennsylvania Patient Safety Vol. 5, No. 2—June 2008 pennsylvania Patient Safety Advisory This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 5, No. 2—June 2008. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). Copyright 2008 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. To see other articles or issues of the Advisory, visit our Web site at http://www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. the pennsylvania patient safety authority and its contractors The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the PA-PSRS program, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the PA-PSRS program or the Patient Safety Authority, see the An Independent Agency of the Commonwealth of Pennsylvania Authority’s Web site at www.psa.state.pa.us. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.