The disappearance of NRL-allergy in Germany and Europe

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1 The disappearance of NRL-allergy in Germany and Europe Apl. Prof. Dr. med. Henning Allmers, M.P.H. 1 2, Jörg Schmengler, M.D. 3, apl. Prof. Dr. med. Swen Malte John 1, apl. Prof. Dr. med. Christoph Skudlik 1 1 Dept. of Dermatology, Environmental Medicine and Health Sciences, University of Osnabrueck, Germany (Director: apl. Prof. Dr. Swen Malte John) 2 Dept. of Occupational Medicine University of Osnabrueck, Germany (Director: apl. Prof. Dr. med. Henning Allmers, M.P.H.) 2 Präventionsdienst der Berufsgenossenschaft für Gesundheitsdienst und Wohlfahrtspflege, Delmenhorst, Germany, (Director: Jörg Schmengler, M.D.) Correspondence: Apl. Prof. Dr. med. Henning Allmers, M.P.H. University of Osnabrueck Osnabrueck Germany Tel.: Fax

2 BACKGROUND: The increased adherence to the technical regulations prohibiting the use of powdered natural rubber latex (NRL) gloves has led to a decrease of new cases of type-i allergic diseases (asthma and urticaria) in German health care personnel. There was some concern that not only powdered NRL gloves were banned but that all NRL gloves might be avoided by administrators in charge of purchasing. OBJECTIVE: This paper assesses the effects of intervention to reduce the incidence of NRL allergy in personnel working in the German health care system by switching to powder-free NRL gloves on the glove purchasing practice in German hospitals. METHODS: We reviewed the annual numbers of the amount and type of gloves purchased/used in German acute care hospitals from to determine the powdered/powder-free ratio change and the glove materials (Original data provided by IMS Health - GPI Hospital Services, Frankfurt, Germany). RESULTS: In % of all surgical and examination gloves purchased were made from NRL. Of the 217 million gloves 19.5 % were surgical and 80.5 % examination gloves. The number of purchased examination gloves increased by 902 % between 1986 and The acquisition of surgical gloves only increased by 54.4% in the same period. Overall the total number of gloves used reached 1.8 billion in 2005, an increase of 737% from Only 2% of surgical gloves were made from non-nrl materials. The main non-nrl materials for non-sterile examination gloves (1.7 billion) were vinyl (10.9%), neoprene (3.8%) and poly-ethylene (1.0%). Only in the section of sterile examination gloves (23 million) there were more non-nrl material, mostly co-polymer (72.4) than NRL-gloves (27.6). In % of all gloves used in German hospitals were made from NRL, an increase of 84% from Approximately 10% of NRL gloves being used were powdered in DISCUSSION: The effect of increased recognition of NRL allergies, education about NRL allergies in healthcare facilities combined with the introduction of gloves with reduced powder and protein levels has not been associated with a decline in the number NRL-gloves. On the contrary the percentage of NRL material has steadily increased since The number of powdered gloves has decreased dramatically from 100% in 1994 to 10% in This decrease has caused a virtual disappearance of new NRL-allergy cases in German health care workers. 1

3 Introduction Recent investigations have shown that up to 17 % of healthcare workers (HCWs) (1-6) are sensitised to natural rubber latex (NRL) allergens. The proteins present in gloves and other products made of NRL and the inhalation and skin contact with this material are responsible for sensitisation (7, 8, 9). Even though there have been recommendations to use powder-free and low-allergen gloves as preventive measures there are few investigations that have studied the effects of interventions involving decreases in NRL protein over time (10, 11). Turjanmaa et a1. in Finland reported cessation or declines in sensitisation following changes in powder and/or a11ergen levels in gloves in hospitals (12). In a cross-sectional study Levy et al. found that no cases of sensitisation occurred among dental students using powder-free gloves while 5-15% of those using powdered gloves were sensitised (13). To our knowledge no reports on a nationwide level have been published. In a previous study we were able to show that by switching to powder-free NRL gloves detectable NRL aeroallergens were completely removed in a healthcare facility. Sensitised healthcare workers were able to remain at work by supplying them with NRL free gloves, thus showing that these simple and practical measures led to a successful secondary prevention of NRL allergy in HCWs. (14). The increased adherence to the technical regulations prohibiting the use of powdered natural rubber latex (NRL) gloves has led to a decrease of new cases of type-i allergic diseases (asthma and urticaria) in German health care personnel. There was some concern that not only powdered NRL gloves were banned but that all NRL gloves might be avoided by administrators in charge of purchasing. 2

4 Materials and methods An information leaflet concerning NRL allergy and stressing avoidance of powdered NRL gloves that was to be distributed by several semi-governmental statutory accident insurance companies responsible for any compensation claim by a worker was developed in 1996 and widespread distribution started in The greatest information campaign was carried out by the Berufsgenossenschaft für Gesundheitsdienst und Wohlfahrtspflege (BGW) the statutory accident insurance company for healthcare that is responsible for accident insurance, worker s compensation and preventive measures. All private physicians and dentists offices as well as all private and church-run hospitals (nearly 60% of all German hospitals with almost half of all hospital staff) are insured by the BGW (14). In the regulatory field a new version of the compulsory technical regulations for dangerous substances (TRGS 540) was published in December This explicitly stated that only low allergen powder-free NRL gloves should be used and that the use of powdered NRL gloves was not permissible in the workplace. Glove usage data We reviewed the numbers of gloves purchased and used for the period from 1986 until The numbers represent all acute care hospitals by projecting the sample of 280 hospitals. Data for the former East Germany have been incorporated since Separate numbers for powderfree NRL gloves became available in (Original data provided by IMS Health - GPI Hospital Services, Frankfurt, Germany). Epidemiological data regarding cases of suspected NRL allergies Every physician and dentist is required by law to report a suspected occupational disease to the appropriate statutory accident insurance company. The number of reported cases of suspected 3

5 NRL allergies (both skin and respiratory) became available from 1996 until 2002 for all HCWs insured by the BGW. A detailed analysis of the insurance data made it possible to determine the number of insured personnel and the number of suspected cases in all BGW insured acute care hospitals. Results The number of purchased non-sterile examination NRL gloves increased by 2,426 % between 1986 and 2007 reaching almost 1,7 billion per year. In contrast the number of purchased surgical NRL-gloves only rose by 56 % in the same period (Figure 1 and 2 ). Figure 1: Purchase of surgical and examination NRL-gloves in all German acute care hospitals from 1986 until In % of all surgical and examination gloves purchased were made from NRL. Of the 217 million gloves 19.5 % were surgical and 80.5 % examination gloves. The number of purchased examination gloves increased by 957 % between 1986 and The acquisition of 4

6 surgical gloves only increased by 58% during the same time period. Overall the total number of gloves used reached 1.9 billion in 2007, an increase of 737% from Only 4 % of surgical gloves were made from non-nrl materials. The main non-nrl materials for non-sterile examination gloves (1.8 billion) were vinyl (6%), neoprene/nitrile (5.2%) and poly-ethylene (0.4%). Only in the section of sterile examination gloves (26.6 million) more non-nrl material, mostly co-polymer (72.3%) than NRL-gloves (27.5%) was used. In % of all gloves used in German hospitals were made from NRL, an increase of > 80% from Approximately 1% of NRL gloves being used were powdered in Figure 2: Increase of glove use and decrease of non-nrl glove material from The incidence of suspected occupational allergy cases caused by NRL rose until 1997 (OA) and 1998 (skin allergies). ). By 2005 there was a 87 % decrease of new skin allergy cases and a 95 % reduction of reported new cases of OA (Figure 3). There was a positive linear correlation 5

7 between the declining purchase of powdered-nrl examination gloves and the reduction in new suspected occupational allergy cases. Figure 3: Purchase of non-sterile NRL examination gloves in all German acute care hospitals plus incidence of suspected cases of NRL-induced occupational asthma and contact urticaria per 1,000 insured healthcare workers in private and church-run acute care hospitals from Discussion The number of powdered NRL gloves purchased in acute care hospitals in Germany for use in operating theatres and for examination purposes has dramatically fallen since 1996 after a massive increase starting in It was interesting to note that it took two years longer to reduce the percentage of powdered sterile NRL gloves below the purchasing level of powderfree NRL gloves when compared to the decrease in powdered examination gloves. A similar observation was also made in a study of Liss and Tarlo who report that at the largest teaching hospital in Ontario, substitution of low protein, powder-free NRL gloves for non-sterile powdered gloves took place in 1995; whereas replacement of powdered sterile NRL gloves by lower protein, powder-free NRL gloves in 1997, two years later (16). 6

8 Before that time, NRL gloves were used mostly in operating rooms and for sterile procedures. Powder containing high levels of glove protein are suspected to trigger a sensitisation to NRL. The accepted secondary prevention in NRL sensitised individuals especially HCWs is to terminate any exposure to NRL products, because further persona1 use of latex products or bystander exposure from co-workers may result in maintaining or worsening of sensitivity and hea1th effects. It was our hypothesis that the use of powder-free low protein NRL gloves will reduce the incidence of sensitisation and asthmatic symptoms. A positive significant correlation between the use of powdered NRL gloves and the reported suspected occupationally caused cases of NRL allergy can be statistically confirmed by our data. (17). The first indication that reduction of powdered NRL gloves in a hospital environment led to a decrease in NRL allergy incidence was published in 1998 when no new cases of sensitisation among HCWs in a powder-free environment were found while two new cases of positive skin prick test could be documented where use of powdered NRL gloves had been maintained (7,8). The increase in reported cases from 1996 to 1998 is probably not only caused by an increase in the incidence of NRL allergies but also due to the information campaign that reached every physician s office in 1997 and Tarlo and Liss also reported that, despite the effect of increasing recognition, the introduction of gloves with reduced powder and/or protein, as well as other interventions have been associated with declines in the number of cases of NRLcaused occupational asthma in Ontario, Canada (9, 16). Recommendations to use powder-free, low-protein NRL gloves or non-nrl gloves have been available e.g. by the Occupational Safety & Health Administration (OSHA) in the USA and other organizations in many other countries (11, 18). Reports at the level of the individual patient or hospital have shown that these recommendations are successful (7, 9, 14, 19, 20, 21). 7

9 Conclusion The proposed measures led to a decrease of the incidence of NRL allergies in HCWs clearly indicating that primary prevention can also be achieved if these easily applied interventions are properly carried out and maintained (22, 23). These results indicate that enforcement of the regulations prohibiting the use of powdered NRL gloves did not lead to a decrease of purchasing/use of natural rubber latex gloves. Data available from other European countries has shown that NRL allergies in HCWs have decreased due to the reduction of powdered NRL gloves (24, 25). 8

10 References 1. Grzybowski M, Ownby DR, Peyser PA, Johnson CC, Schork MA. The prevalence of anti-latex IgE antibodies among registered nurses. J Allergy Clin Immunol 1996; 98: Arellano R, Bradley J, Sussman G. Prevalence of latex sensitization among hospital physicians occupationally exposed to latex gloves. Anesthesiology 1992; 77: Lagier F, Vervloet D, Lhermet I, Poyen D, Charpin D. Prevalence of latex allergy in operating room nurses. J Allergy Clin. Immunol. 1992; 90: Turjanmaa K. Incidence of immediate allergy to latex gloves in hospital personnel. Contact Dermatitis 1987; 17: Yassin MS, Lierl MB, Fisher TJ, O'Brien K, Cross J, Steinmetz C. Latex allergy in hospital employees. Ann Allergy 1994; 85: Kelly KJ, Kurup V, Zacharisen M, Resnick A, Fink JN. Skin and serologic testing in the diagnosis of latex allergy. J Allergy Clin Immunol 1993; 91: Liss GM, Sussman GL, Deal K, Brown S, Cividino M, Siu S, Beezhold DH, Smith G, Swanson MC, Yunginger J, Douglas A, Holness DL, Lebert P, Keith P, Wasserman S, Turjanmaa K. Latex allergy: epidemiological study of 1351 hospital workers. Occup Environ Med 1997; 54: Sussman GL, Liss GM, Wasserman S. Update on the Hamilton, Ontario latex sensitization study. J Allergy Clin Immunol 1998; 102: Tarlo SM, Easty A, Eubanks K, Parsons CR, Min F, Juvet S, Liss GM. Outcomes of a natural rubber latex control program in an Ontario teaching hospital. J Allergy Clin Immunol 2001; 108: Roy A, Epstein J, Onno E. Latex allergies in dentistry: recognition and recommendations. J Can Dent Assoc 1997; 63: Shoup AJ. Guidelines for the management of latex allergies and safe use of latex in perioperative practice settings. AORN J 1997; 66: 726, Turjanmaa K, Reinikka-Railo T, Reunala T, Palouso T. Continued decrease in natural rubber latex (NRL) allergen levels of medical gloves in nationwide market surveys in Finland and co-occurring decrease in NRL allergy in a large University hospital. (abstract) J Allergy Clin Immunol 2000, 104: S373p 13. Levy DA, Allouache S, Chabane MH, Leynadier F, Burney P. Powder-free protein-poor natural rubber latex gloves and latex sensitisation. (abstract) JAMA 1999; 281:

11 14. Allmers H, Brehler R, Chen Z, Raulf-Heimsoth M, Fels H, Baur X. Reduction of latex aeroallergens and latex-specific IgE antibodies in sensitized workers after removal of powdered natural rubber latex gloves in a hospital. J Allergy Clin Immunol 1998; 102: Baur X. Natural latex allergy. Recommendations of an interdisciplinary work group. (German) Anaesthesist 1996; 45: Liss GM, Tarlo SM. Natural rubber latex-related occupational asthma: association with interventions and glove changes over time. Am J Ind Med 2001; 40: Allmers H, Kirchner B, Huber H, Chen Z, Walther JW, Baur X. [The latency period between exposure and the symptoms in allergy to natural latex. Suggestions for prevention] German Dtsch Med Wochenschr Jun 21;121(25-26): Witt SF. Technical Information Bulletin Potential for Allergy to Natural Rubber Latex Gloves and other Natural Rubber Products. Occupational Safety & Health Administration (OSHA), April 12, Available from: URL: Tarlo, M. S., G. Sussman, A. Contala, M. C. Swanson. Control of airborne latex by use of powder free gloves. J Allergy Clin Immunol 1994; 93: Baur X, Chen Z, Allmers H. Can a threshold limit value for natural rubber latex be defined? J Allergy Clin Immunol 1998; 101: Saary J, Tarlo SM, Kanani A, Holnes DL. Reduction in rates of latex sensitivity among dental students and staff after changes in latex gloves. (abstract) Am J Respir Crit Care Med 2001; 163: A Allmers H, Schmengler J, Skudlik C. Primary prevention of natural rubber latex allergy in the German health care system through education and intervention. J Allergy Clin Immunol 2002; 110: Allmers H, Schmengler J, John SM: Declining incidence of occupational contact urticaria caused by natural rubber latex allergy in German healthcare workers J Allergy Clin Immunol 2004; 114: Vandenplas O, Larbanois A, Vanassche F, François S, Jamart J, Vandeweerdt M, Thimpont J. Latex-induced occupational asthma: time trend in incidence and relationship with hospital glove policies. Allergy Mar;64(3): Epub 2008 Dec LaMontagne AD, Radi S, Elder DS, Abramson MJ, Sim M. Primary prevention of latex related sensitisation and occupational asthma: a systematic review. Occup Environ Med May;63(5): Epub 2006 Feb 9. 10

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