Glass ampules and filter needles: an example of implementing the sixth ‘R’ in medication administration
Heidi G. Stein
The use of filter needles is not often considered when discussing medication preparation from glass ampules. Fundamentals of nursing references prior to 1999 typically do not acknowledge this as an important component of safe medication administration. Safe medication administration traditionally has been regarded as adhering to five rights (5Rs): right medication, dose, patient, route, and time. Adding a sixth right may be appropriate–the right technique in medication preparation.
The use of filter needles in aspirating parenteral medications from glass ampules was first recommended by Katz, Borden, and Hirscher (1973). This recommendation came from their observations during their anesthesia clinical practice that intravenous medications packaged in glass ampules often became contaminated with glass particles when opened. The American Society of Health System Pharmacists (ASHP) and the Infusion Nurses Society (INS) also offer current recommendations regarding the use of filter needles to remove tiny glass particles that result when glass ampules are opened (ASHP, 2000; INS, 2002). Glass particulate and bacterial contamination have long been recognized as hazards associated with ampules (Stehbens & Florey, 1960). IV administration of glass particles may lead to complications, including pulmonary thrombi and microemboli, infusion phlebitis, end-organ granuloma formation, and inflammation (Furgang, 1974; Garvin & Gunner, 1964; Rodger & King, 2000; Shaw & Lyall, 1985; Waller & George, 1986; Zacher, Zornow, & Evans, 1991).
The hazards of glass particulate contamination associated with glass ampules and the effectiveness of filter needles in decreasing such contamination are discussed. Strategies for compliance with filter needle use are highlighted.
Parenteral Medication Administration
The fundamentals. The knowledge and skills needed to prepare medication from glass ampules are taught early in nursing curricula. A review of several nursing fundamentals and basic skills textbooks revealed different perspectives regarding the use of filter needles to withdraw medications from glass ampules. Textbooks written from 1992 to 1998 (Baer & Williams, 1992; Craven & Hirnle, 1996; Elkin, Perry, & Potter, 1996; Kozier, Erb, Blais, Wilkinson, & Van Leuven, 1998; Perry & Potter, 1998; Taylor, Lillis, & LeMone, 1993) indicated that use of filter needles was optional. Books written from 1999 to 2005 (DeLaune & Ladner, 2002; Perry & Potter, 2002; Potter & Perry, 1999, 2003, 2005) recommended filter needle use when aspirating medication from glass ampules. This change may not have been communicated clearly to practicing nurses, who may consider use of a filter needle to be discretionary.
Even nurse educators and leaders do not seem to perceive the importance of filter needle use. During hospital orientation, the use of filter needles is not validated as a core competency, perhaps because of the assumption that students have already mastered this skill (Hadaway, 2003). A systems issue may also exist with regard to availability of filter needles in the clinical setting. Nurses who were taught to use filter needles in school often find themselves ignoring this practice because of the unavailability of filter needles at the point of service (Taxis & Barber, 2003). Seasoned nurses just may be learning about the use of filter needles. A nurse educated in the mid-70s who recently attended an intravenous (IV) education class stated, “I first learned about the use of filter needles with glass ampules a few years ago when I attended an IV education class. It struck me that there was no nursing policy and procedure regarding their use, and they were not available on my unit” (C. Rivera, personal communication, November 13, 2005).
Beyond the Basics: Standards of Care and Continuing Education
The role of nurses in medication administration has changed tremendously over the past 3 decades because of the increased number of patients requiring intravenous therapy in the clinical setting (Ingram, 2005). The routine nature of intravenous administration might make nurses less mindful of the risks involved (Ingram, 2005; Pepper, 1995) but as professionals, nurses follow standards of care. In the hospital setting, the best resources for standards of care are policies and procedures developed to comply with regulations mandated by the Joint Commission on Accreditation of Healthcare Organizations, Occupational Safety and Health Administration (OSHA), and the individual state’s Nurse Practice Act. Standards also may be developed by health care institutions in response to negative events that occur in the clinical setting to prevent their recurrence (Ashley, 2004).
Nurses should be proactive in seeking continuing education to remain aware of rapid advances in pharmacology and technology changes related to IV therapy. They may become involved at the national policy level in decisions affecting medication administration accuracy through membership in professional organizations, such as the Infusion Nurses Society or the Association for Vascular Access. Standards of care have been established by the INS, with recommended policies and procedures in IV therapy including use of filter needles (INS, 2002). Nurses must ensure that filter needles are stocked routinely on their units. Filter needles cost approximately $30 per box of 100 filter needles. In comparison, central venous catheter-associated blood stream infection is $25,000 per episode (Kluger & Maki, 1999).
Hazards Associated with Glass Ampules
Glass particulate contamination. Glass ampules are effective in preserving the purity and shelf life of liquid parenteral medications. Powdered preparations are rarely packaged in ampules. The composition of glass ampules is type 1 grade borosilicate glass, which can be clear or amber, and is scored either chemically or by metal etching (Sabon, Cheng, Stommel, & Hennen, 1989). Prescored ampules, which are usually colored around the neck, break easy without filing. They are available in a variety of sizes (1-10 ml), and with different types of stems (straight and closed) and tips (funnel, double, or fine) (DeLaune & Ladner, 2002).
Research confirmed the multiple potential problems associated with the use of ampules. After an ampule is broken, glass particles can contaminate the solution in the ampule (Furgang, 1974; Gillies, Thiel, & Oppenheim, 1985; Kempen, Sulkowski, & Sawyer, 1989; Preston & Hegadoren, 2004; Turco & Davis, 1972), causing inflammatory changes in both animals (Dorris et al., 1977; Stehbens & Florey, 1960) and humans (Garvan & Gunner, 1964). Glass ampules are not only a potential source of glass fragments but also a source of infectious agents which can contribute to granulomatous lesions in the lung, brain, spleen, and kidney (Garvan & Gunner, 1964). Studies using the animal model also have identified inflammatory changes in the venous endothelium (Dorris et al., 1977; Stehbens & Florey, 1960). With increased infusion time and concentration of particulate matter, reactions can become severe.
Bacterial contamination. Identifying bacteria-contaminated glass fragments (Kempen et al., 1989) prompted the recommendation for filter needles even though it was known that their use would not eliminate the problem entirely. A study by Zacher and coauthors (1991) identified that bacterial contamination through introduction of glass fragments into the drug solution can be minimized by swabbing the neck of the ampule with alcohol before breaking it. Microbial contamination also can occur when using ampules stored in dusty shelves, touched by dirty hands, or held in unsterile gauze, and from needles that come in contact with the external surface of the ampule during the process of withdrawing the drug (Kempen et al., 1989).
Ensuring Medication Administration Safety with Filter Needles
The use of filter needles was recommended by Hahn (1990) and McConnell (1993) when aspirating from ampules to prevent introduction of glass particles. Filter needles, which have a screening device in the hub to remove minute particles or foreign materials from liquid solutions, are effective in removing glass particles from broken ampules (Preston & Hegadoren, 2004). Five-micron particulate ampule filter needles reduce the potential for glass particle injection and the introduction of contaminants when using single-dose glass ampules (Katz et al., 1973; Preston & Hegadoren, 2004; Sabon et al., 1989). Two kinds of 5-micron filter needles comply with the Needlestick Safety and Prevention Act and OSHA standards: the blunt filter needle and the filter straw.
Review of policy for medication preparation from glass ampules using filter needles and competency validation should be done initially during new employee orientation and annually thereafter. For example, staff must be aware that filter needles should be removed from the syringe and discarded to the sharps container after the withdrawal of medication.
They should never be used for injection (Engstrom, Giglio, Takacs, Eillis, & Cherwenka, 2000; Workman, 1999). The steps in withdrawing medication from a glass ampule appear in the competency checklist are provided in Table 1.
Strategies for Implementing the Sixth ‘R’ of Medication Administration
Institutions should define strategies to implement the sixth “R” of medication administration, and every practicing nurse should make a commitment to contribute to this end. An adaptation of Rich’s “corkscrew model” of error reduction in medication administration (Rich, 2005) can be used to define these strategies (see Figure 1). The model is a complex circular model with the “blunt end” made up of nurse leaders and the “sharp end” made up of nurses administering medications. The circularity of the model represents the interdisciplinary nature of medical systems.
[FIGURE 1 OMITTED]
The Blunt End: The Role of Nursing Leadership
Nurse leaders in academic and practice settings should be congruent in their perspectives regarding safe IV medication administration. Increased attention to intravenous therapy in undergraduate nursing curricula will establish a seamless transition from academic education to clinical practice. INS standards of practice, as well as policies and procedures in intravenous therapy, should be taught consistently in nursing schools and implemented consistently in the clinical setting. The following are recommendations to increase compliance with the use of filter needles (Wolf, 2005):
* Assess and validate nursing knowledge and skills in IV therapy on a yearly basis.
* Educate and enforce written policies and procedures regarding use of filter needles to improve compliance with patient safety standards.
* Require preparation of parenteral medications only in designated areas, such as medication rooms, and make filter needles available in those places.
* Empower nurses to promote safe medication preparation by performing peer education and use of posters as reminders, and using quality improvement tools to show improvement in practice.
* Recognize and reward nurses who value further education and promote best practice standards.
The Sharp End: The Role of Nurses at the Point of Care
Successful incorporation of the use of filter needles into practice will depend on commitment, compliance, education, and skills validation of nurses who administer medications. Interdisciplinary collaboration also is essential, including the following activities (Heiss-Harris & Verklan, 2005; Taxis & Barber, 2003):
* Explore the process of filter needle use with pharmacy and materials management staff.
* Load filter needles to accompany ampules in electronic medication-dispensing machines.
* Include filter needles in emergency response carts.
* Implement consistent policies and procedures in allied departments (for example, endoscopy, special procedures, radiology, operating room, post-anesthesia care unit).
Safety in medication administration is paramount. Prudent practicing nurses should be aware that glass contamination is a real hazard. Best practice includes use of filter needles when withdrawing medications from glass ampules. Collaboration among academic nurse educators, staff nurse educators, nursing administrators, pharmacists, materials management personnel, and bedside nurses is crucial to ensure implementation of the sixth “R” in medication use.
Acknowledgment: The author would like to thank Dr. Elaine Slocumb and Liw Villagomeza for assisting with the editing of this article.
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Heidi G. Stein, MSN, RNC, CRNI, is a Telemetry Nurse, Morton Plant Mease Health Care, Safety Harbor, FL; Clinical Instructor, BayCare Education, Clearwater, FL; and an Adjunct Faculty Member, St. Petersburg College of Nursing, St. Petersburg, FL.
Competency Checklist for Withdrawing Medication from Ampule
Equipment: Medication Administration Record (MAR), sterile syringe,
extra needle of proper gauge and length according to site (IM/SC),
needleless system (IV), medication ampule, sterile gauze, alcohol
swab, blunt filter needle (FN) or filter straw (FS).
Critical Elements Rationale Met Met
order, check MAR.
Wash hands. Reduces microorganism.
Tap the top of Moves liquid to bottom.
the ampule gently
Cleanse ampule Reduces contamination.
neck with alcohol.
Snap neck using Protects from broken glass.
Discard neck in Protects personnel from
sharps container. injury.
Apply FN/FS to Ensures airtight system.
syringe, remove shield.
Hold syringe with Promotes dexterity and
dominant hand. access to medication.
Stabilize the ampule with
non-dominant hand, either
by holding the ampule upside
down or laying it on a flat
Insert FN/FS to Prevents contamination
center of ampule of needle tip or shaft and
Tip or shaft must not air from entering syringe.
touch rim, aspirate gently.
Replace FN/FS with needle.
Expel air by holding Prevents injecting air.
Discard ampule and blunt Protects personnel from
FN in sharps container. injury.
Wash hands. Reduces microorganisms.
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