Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 2 (June 2004) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority HIDDEN SOURCES OF LATEX IN HEALTHCARE PRODUCTS Over the past decade, considerable scientific and that may be less well-known. The information is not clinical information has been acquired and strate- comprehensive, but is designed to pique interest gies have been implemented to reduce allergic re- and spark further inquiry, as protocols and actions to latex in healthcare settings. Despite this staff/patient education programs are reviewed and effort, however, reports submitted in the PA-PSRS updated. system indicate that latex exposure and allergic re- actions continue. The following examples were re- Since September 1998, the Food and Drug Admini- ported to PA-PSRS: stration (FDA) has required labeling of the presence of latex on all medical equipment that may come in • A condom catheter was placed on a patient contact with humans, as well as latex packaging with a documented latex allergy. The patient materials that come in contact with the product.6 developed dermatitis. While the labeling requirement is helpful, there may be many products currently in use that were manu- • A surgeon used latex gloves while performing factured prior to the implementation of this labeling an invasive procedure on a patient with a requirement. For example, providers may use latex- documented latex allergy. During recovery, containing personal stethoscopes or reflex ham- the patient became short of breath, and oxy- mers that were acquired many years ago. In addi- gen saturation decreased. The patient was tion, the ruling does not include pharmaceuticals or treated until symptoms resolved. items not regulated by the FDA. Also, individual components within a larger package may not be Patients with latex allergy may experience reactions labeled.7 ranging from minor rashes to anaphylaxis.1 The more exposures a latex-sensitive patient experi- The following products may contain latex: ences, the more severe their reactions may be- come.2 Hospital supplies: blood pressure cuffs; tubex sy- ringes; ECG wires; pulse oximeters and cables; Now that latex allergy protocols are implemented in vascular compression stockings; ready-to-use ene- the healthcare community, the new frontier may be mas; Ace bandages; spacers for multi-dose inhal- to assure that such interventions are updated, effec- ers; adhesive tapes; tourniquets; CPR mannequins; tive, and fully implemented by the staff. Latex is ex- condom catheters; wheelchair cushions; oxygen tremely common in healthcare and consumer prod- masks/cannulas; incentive deep breathing exercis- ucts. Approximately 40,000 products contain natural ers; fitted hospital bed sheets; IV injection latex rubber proteins.3 Approximately 2,000 of these ports/tubing; disposable syringes with rubber plung- products are used in healthcare settings.4 Identifying ers; ostomy pouches and straps; disposable incon- which products contain latex and which are latex- tinence pads; washable underpads; latex-stoppered free can be a tremendous challenge. multidose vials; nasogastric tubes (silastic-covered latex); certain dressings. To prevent latex sensitization in high-risk groups or to prevent serious allergic reactions in those sensi- tized to latex, the most effective method is avoid- This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 1, No. ance of contact with latex-containing materials.5 It is 2—June 2004. The Advisory is a publication of the Pennsylvania Patient important that healthcare providers recognize that Safety Authority, produced by ECRI & ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). some products may contain latex and that appropri- ate alternatives may be available. In addition, up- Copyright 2004 by the Patient Safety Authority. This publication may be re- dated information about latex-containing products printed and distributed without restriction, provided it is printed or distributed in can be integrated into patient education programs. its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This article presents selected information from the To see other articles or issues of the Advisory, visit our web site at clinical literature about latex-containing products www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2004 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 2 (June 2004) Hidden Sources of Latex (Continued) Personal protective equipment: goggles; masks; mation about latex allergy to both healthcare provid- gloves; respirators. ers and patients. Many are accessible on the Inter- net. Such information can be invaluable when up- Operating room: drapes with adhesive strips; bouf- dating protocols and educational programs. fant caps and shoe protectors; surgical wound drains; instrument mats; mesh; electrode grounding Available Resources pads; anesthesia machine reservoir bags; anesthe- sia masks; body positioning/holder devices; fiberop- • Mitchell N. Latex Allergy: accessing infor- tic/video scopes; eye shields; laparoscopy insuffla- mation of the Internet. J Emerg Nurs. 1007; tion hoses; needle counting systems; rubber breath- 23:51-52. ing circuits and ventilation bellows; teeth protec- tors/bite blocks; bronchoscopy components (T- • American College of Allergy, Asthma, and piece, saline injector, suction tubing). Immunology. www.allergy.mcg.edu/physicians/ltxhome.html. Critical care/Emergency Departments: Ambu • American Latex Allergy Association, bags; endotracheal tubes; cervical spine collars; ALERT. www.latexallergyresources.org Swan-Ganz catheters. • National Institutes for Occupational Safety Physical Therapy: exercise bands and balls; crutch and Health. www.cdc.gov/NIOSH/latexalt.html pads (axillary and arm grips); cold/hot packs. • Nurses World, Latex Free Information. www.nursesworld.com/latex.htm Medical Imaging: rubber aprons; positioning blocks; head straps. • Pryor JP, Vonfricken K, Seibel R, Kauder DR, Schwab CW. Anaphylactic Shock from Dietary: latex gloves (may contaminate food served a Latex Allergy in a Patient with Spinal to patients and employees).8 Trauma. Journal of Trauma Injury, Infection, and Critical Care 2001 May; 50(5): 927-930. A review of the clinical literature identifies common elements in protocols related to the latex allergic • Latex Allergy News. CETRA Latex-Free patient: Information Services. www.latexallergyhelp.com • Coordination by a multidisciplinary commit- • Spina Bifida Association of America. tee/task force. www.sbaa.org • Assessment/identification of those at risk. • Latex Allergy Links. www.latexallergylinks.org • Communication among staff about the al- lergy. • Thurlow KL. Latex Allergies: Management • Strategies to eliminate/minimize latex expo- and Clinical Responsibilities. Home Health- sure. care Nurse 2001 Jun; 19(6):369-371. • Maintaining lists of latex-containing and la- • Safety and Health Topics: Latex Allergy. tex-free products, using brand names. U.S. Department of Labor, Occupational • Latex-free carts/kits. Safety & Health Administration. www.osha.gov/SLTC/latexallergy/index.html • Latex-safe procedures for specific patient care areas/departments. • Holmes SA. Looking Out for Latex. Science • Ongoing education programs for healthcare and Children 1999 Feb; 21-25, 52-53. providers and patients/families. • Binkley HM, Schroyer T, Catalfano J. Latex • Identification of symptoms and being pre- Allergies: A Review of Recognition, Evalua- pared to provide interventions. tion, Management, Prevention, Education, • Reviewing/monitoring data concerning latex and Alternative Product Use. Journal of Ath- reactions to assess program effectiveness letic Training 2003; 38(2):133-140. and to take corrective actions.9 Several resources compile and communicate infor- Page 2 ©2004 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 2 (June 2004) Hidden Sources of Latex (Continued) USE OF MULTIDOSE MEDICATION VIALS AND LATEX ALLERGY One latex avoidance strategy suggested in the literature relates to multidose vials. It was thought that the solution in such vials contained latex allergen from the stopper, or that the allergen could enter the needle used to puncture the vial stopper. It has been suggested that multidose vials with latex stoppers be replaced with glass ampules or latex-free vials.1 Another proposed strategy was to remove latex stoppers from multidose vials to draw up medications, rather than puncturing the stopper with a needle in order to obtain the medication.2 A review of the literature, however, indicates that the risk of latex exposure from the use of multidose vials with latex stoppers is not clear.3 The level of latex allergen in such vials has been determined to be extremely low. In one study, the amount of latex protein found in medication vials was not detectable when the rubber stopper was punctured up to 40 times.4 Also, studies have indicated that there was no difference in measurable allergen of the solution when puncturing rubber stopper, compared to when latex stoppers were removed.5 The Johns Hopkins Hospital, which uses multidose vials widely, indicates the following in its Interdisciplinary Clinical Practice Manual: “When drawing up medication, it is not necessary to remove the stopper from the vial. Multidose vials should only be punctured once and then discarded, unless using the Clave multidose vial adaptor. Use IV tubing sets with synthetic ports to eliminate allergen exposure.”6 Isolated cases, however, continue to be reported of allergic reactions associated with use of multidose vials.7 Coring may occur with repetitive puncturing of a stopper on a multidose vial. This may result in microscopic rubber particles that may contaminate the medication or be injected into subcutaneous tissue.8 It is, therefore, incumbent upon each healthcare institution to decide whether and/or how to use multidose vials in the care of the latex-sensitive patient. In determining such a policy, institutions may wish to balance the potential for latex exposure by withdraw- ing a medication through a latex-stoppered vial with other considerations, including the patient’s degree of latex hypersensitivity and the potential for errors in dosage, dilution, contamination, and waste.9 Notes 1. Latex Sensitivity. ECRI Healthcare Risk Control 1996 Jan; Environmental Issues 18:1. Also AORN Latex Guideline. AORN Journal 2004 Mar; 79(3):653-672. 2. Davis BR. Perioperative Care of Patients with Latex Allergy. AORN Journal 2000; 72:47-54. 3. Senst BL, Johnson RA. Latex Allergy. Am J Health Syst Pharm 1997; 54:1071-5. 4. Yunginer et al. Latex Allergen Contents of Medical and Consumer Rubber Products. Journal of Allergy Clinical Immunology 1993; 91:241. 5. Thomsen DF, Burke TG. Lack of Latex Allergen Contamination of Solutions Withdrawn from Vials with Natural Rubber Stoppers. Am J Health Syst Pharm 2000; 57:44-7. Also Yunginger JW, Jones RT, Fransway AF, Kelso JM, Warner MA, Hunt LW. Extractable Latex Allergens and Proteins in Disposable Medical Gloves and Other Rubber Products. J Allergy Clin Immunology 1994; 93:836-42. 6. Brown RH, Hamilton, RG, McAllister MA. How Health Care Organizations Can Establish and Conduct a Program for a Latex-Safe Environment. Joint Commis- sion Journal on Quality and Safety 2003; 29(3): 113-123. 7. Vassallo SA, Thurston TA, Kim SH, Todres ID. Allergic Reaction to Latex from Stopper of a Medication Vial. Anesth Analg 1995; 80:1057-8. 8. Primeau MN, Adkinson NJ, Hamilton RG. Natural Rubber Pharmaceurical Vial Closures Release Latex Allergens That Produce Skin Reactions. Journal of allergy and Clinical Immunology 2001 Jun; 107:958-962. Also Asakura T, Seino H, Noxaki S, Abe R. Occurrence of Coring in Insulin Vials and Possibility of Rubber Piece Contamination by Self-Injection. Journal of the Pharmaceutical Society of Japan 2001 Jun; 121 (6): 459-463. 9. Senst BL, Johnson RA. Latex Allergy. Am J Health Syst Pharm 1997; 54: 1071-1075. Notes 1.Sussman GL, Beezhold DH, Liss G. Latex Allergy: Historical Perspective. Methods 2002 May; 27(1):3-9. Also Leby DA, Leynadier F. Latex Allergy: Review of Recent Advances. Current Allergy Reports 2001; 1:32-38. Also Sussman G, Gold M. Guidelines for the Management of Latex Allergies and Safe Latex Use in Healthcare Facilities. American College of Allergy, Asthma & Immunology 1996 Aug. alergymcg.edu/physicians/latex.html. Also Patriarca G, Nucera E, Buonomo A, Roncallo C, DePasquale T, Pollastrini E, Schiavino D. New Insights on Latex Allergy Diagnosis and Treatment. J Investig Allerg Clin Immunol 2002; 12(3):169-176. 2.Charous BL. The Puzzle of Latex Allergy: Some Answers, Still More Questions. Ann Allergy 1994; 73(4):277-281. Also ECRI. Ad- dressing Latex Allergy in Healthcare. ECRI. The Risk Management Reporter 1997 Oct. p.13. Also Lenehan GP. Latex Allergy: Sepa- rating Fact from Fiction. Nursing 2004 Feb; Suppl 12-18. Also U.S. Department of Labor. Occupational Safety and Health Administra- tion 4/12/99. Technical Information Bulletin: Potential for Allergy to Natural Rubber Latex Gloves and Other Natural Rubber Products. Also Muller BA. Minimizing Latex Exposure and Allergy. Postgraduate Medicine 2003 Apr; 113(4):91-97. ©2004 Pennsylvania Patient Safety Authority Page 3 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 2 (June 2004) Hidden Sources of Latex (Continued) Notes (continued) 3. Gritter M. Latex Allergy. Lippincotts Primary Care Practice 1997 1(2):142-151. Also Johnson G. Avoiding Latex Allergy. Nursing Standard 13(31):12,21,49-56. 4. Dyck RJ. Historical Development of Latex Allergy. AORN Journal 2000 Jul; 72:27-29, 32-33, 35-40 5. Poley GE, Slater JE. Latex Allergy. J Allergy Clin Immunol 2000; 105:1054-1062. 6. Jezierski M. Creating a Latex-safe environment: Riddle Memorial Hospital’s Response to Protect Patients and Employees. J Emerg Nurs 1997; 23: 191-198. Also AORN Latex Guideline. AORN Journal 2004 Mar; 79(3): 653-672. 7. Elliott BA. Latex Allergy: The Perspective from the Surgical Suite. J Allergy Clin Immunol 2002 Aug; 110 (2Suppl);117-120 8. Latex in the Hospital Environment. Spina Bifida Association of America. 2003 Summer. www.sbaa.org. Also Tidwall J. About Latex Allergy. allergies.about.com/cs/latex/a/aa080999_p.htm. Also Binkley HM, Schroyer T, Catalfano J. Latex Allergies: A Review of Rec- ognition, Evaluation, Management, Prevention, Education, and Alternative Product Use. Journal of Athletic Training 2003; 38(2):138- 140. Also Hees A, von Hintzenstern J, Peters KP, et al. Allergic and Irritant Reactions to Rubber Gloves in Medical Health Services: Spectrum, Diagnostic Approach, and Therapy. J Am Acad Dermatol Con;t 8) 1991; 26(3 pt 2): 831-839. Also Young MA, Myers M, McCullock LD, et al. Latex Allergy: A Guideline for Perioperative Nurses. AORN Journal 1992; 56(3):488-502. Also Latex Allergy News. CETRA Latex-Free Information Services. www.latexallergyhelp.com. Also Schumann L, Buhr V. Screening Patients for Latex Allergies. J Am Acad Nurse Pract 2000 Sep; 12(9)380-385. Also Adkins D. Latex Products in the Hospital Environment. J of Emergency Nursing 1997; 23(2):135-138. Also Hamman CP, Rodgers PA, Sullivan K. Management of Dental Patients With Allergies to Natural Rubber Latex. Gen Dent 2002 Nov-Dec; 50(6):526-536. Also Brehler R, Kutting B. Natural Rubber Latex Allergy. Archives of Internal Medicine 2001 Apr; 161(8):1057-1064. Also Kramper MA. Latex Allergy: A Nursing Update. ORL Head Neck Nurs 2000 Summer; 18(3):7-11. Also Engelken GJ. Heighten Your Response to Latex Allergy. JAAPA 1999 Aug; 12(8):53-65. Also Guidelines for Preventing Sensitivity and Allergic Reactions to Natural Rubber Latex in the Workplace. Society of Gastroenterology Nurses and Associates. Revised 2004. www.SGNA.org. 9. ECRI. Sample Policies and Procedures: Latex Sensitivity in Patients and Healthcare Workers. Healthcare Risk Control. Environ- mental Issues 18.2. 1998 Nov; 3:1-27. Also Stenst BL, Johnson RA. Latex Allergy. American Journal of Health Systems Pharmacy 1997 May; 54(9):1071-1075. Also Gehring LL, Ring P. Latex Allergy: Creating a Safe Environment. Dermatol Nurs 2000 Jun; 12(3):197-201. Also Jennings LM. Latex Allergy: Another Real Y2K Issue. Rehabilitation Nursing 1999 Jul-Aug; 24(4):140, 142. Page 4 ©2004 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 1, No. 2 (June 2004) An Independent Agency of the Commonwealth of Pennsylvania 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, as contractor for the PA-PSRS program, is issuing this newsletter 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 Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. 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 non-punitive approach and systems-based solutions. ©2004 Pennsylvania Patient Safety Authority Page 5