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    Diabet es Research md Chi cal Practice, 16 ( 1992) 209-212SC 1992 Elsevier Science Publishers B.V. All rights reserved 016%8227/92/$05.00

    DIABET 00645

    209

    Is the reuse of needles for insulin injection systems associatedwith a higher risk of cutaneous complications?Giinther Schuler 3, Klaus Pelz b and Lothar Kerp a

    Deptrrrmetlt cf Etldocrinol og~~ and hDeparfment of Microbiolo gy, and Hy giene, Albert- Ludw igs-Univ ersitiit . Freiburg. German),(Received 14 May 1991)

    (Revision accepted 19 February 1992)

    SummaryTwenty diabetic patients participated in a study to assess if multiple use of needles for insulin injectionsystems (Pens) is safe under normal daily conditions. The previous mean duration of Pen therapy was16.3 months. During this time, the 20 patients carried out altogether more than 33 000 injections withoutany sign of local infection despite needle reuse. Patients were told to use needles if possible for 1, 3, 6,9, and 12 injections before bacteriological assessment. Bacteriological investigation of these needlesshowed no contamination, except with one needle used three times, which was colonized with coagulasenegative Staphylococcus. In contrast, half of the needles plastic ground points which touched the skinwere contaminated. No signs of infection were observed at the injection sites throughout the study. Weconclude that, based on the bacteriostatic effects of commercially formulated insulin and on the siliconi-sation of needles surfaces, bacterial growth is sufficiently prevented. Therefore, we can recommend thereuse of pen needles as a simple, safe and cost-beneficial procedure.Key words: Insulin injection system; Needle colonization; Bacterial contamination; Skin infection

    IntroductionInsulin injection systems called Pens have beenused in the treatment of diabetes since 1984 [ 11.These systems simplify daily insulin therapy whenmultiple insulin injections are necessary becausethe carriage of both vials, syringes and needles isreduced to one complete system which is as safeas and simpler to use than traditional syringes.

    Correspondence to : G. Schuler, Dept. of Endocrinology,Albert-Ludwig+Universit%t. Hugstetter Str. 55, D-7800Freiburg, FRG.

    Although only single use of pen needles is pre-scribed, most diabetic patients have used them formultiple insulin injections. This procedure isknown to be safe when plastic insulin syringeswith fixed needles are stored dry and in a refrigera-tor [2,3].

    However, pens cannot be stored at a !ow tem-perature because variations in temperature maycause loss of insulin which falsifies the correctinsulin dosage. Since no data about bacterial con-tamination of needles which have been usedseveral times have yet been reported, we investi-gated both skin inflammation at the injection sitesin a retrospective study and needles reused by

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    patients as described in a fixed schedule by col-lecting them for culture experiments.

    Materials, Patients, and MethodsMaterialAll patients examined in this study used eitherOptiPen lR, OptiPen 2R or OptiPen 4R (HoechstAG, FRG) as an insulin injection system (Fig. 1).The prefilled disposable insulin cartridges neces-sary for these Pens contain 300 IU of insulinformulated at a strength of 100 IU/ml. Regularhuman insulin, NPH insulin and premixed insulinpreparations consisting of soluble human insulinand isophane human insulin in a ratio of 15 : 85,25 : 75, and 50 : 50 are available in such cartridges.Regular human insulin is preserved with 0.27%meta-cresol and the other contain 0. 15y0 meta-cresol and 0.06% phenol. Since the characteris-tics of these insulin preparations are comparableto those of other origin and all other pen modelsavailable are similarly constructed, it is justified togeneralize the following results.

    lower case+

    PatientsThirteen type I diabetic patients and seven insu-lin-requiring type II diabetic patients (8 male and12 female) were recruited for the study from theoutpatient clinic. Mean age was 35 years (range,18-74 years); mean duration of insulin therapywas 9.6 years (range, 1-31 years). The previousmean use of such insulin injection systems was16.3 months (range, 2-57 months). Sevenpatients used these insulin injection systems twicea day, four patients injected insulin three timesdaily, seven patients carried out four injections aday, and five injections per day were made by twoof the patients. The mean total daily insulin dosewas 43 IU (range, lo-72 IU); the average singleinsulin dose was 13.4 IU (range, 4-40 IU). Beforeparticipating in the experiment, 9 of 20 patientshad reused the needles between two and fivetimes, nine other patients had used them for 5 to10 injections and two patients had reused thesame needle for more than 10 injections.

    upper case4

    t tinsulin cartridge dosage knob

    protective caps4 4 needle

    needles plasticground pointFig. 1. Insulin injection system (OptiPen).

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    Methods211

    ResultsStu& design The study was subdivided in to twoparts. Informed consent was obtained from allpatients. All patients attended the outpatientclinic five times during a 2-4 week period. At thefirst visit, printed forms were supplied to recordthe following retrospective topics: duration ofprevious pen therapy, number of injections, doseand formulation of the insulin, location of theinjection sites, frequency of needle reuse and com-plications associated with the injection proce-dure, i.e. redness, swelling, tenderness or anyother sign of local infection or haematomas.

    In the prospective part of the study each patientreceived five sterile, numbered needles which hadto be used for one, three, six, nine, or twelveinjections if possible. Pens had to be stored atroom temperature. As the last injection was to bemade in the morning, the first use of every needlewas different for each patient and dependent onthe number of injections prescribed in the proto-col and the number of daily insulin injections.After the last injection, patients had to store eachneedle together with the outer protective cap in asterile container and hand them over to the doctorduring the next few hours together with a detailedprotocol containing date, time, and dose ofinjected insulin. No detailed information wasgiven to the patients about the aims of the studyto avoid them using more caution concerning thecorrect use and storage of the pens and needles.Injection sites were to be shown to the doctor ifpatients recognized any conspicuous signs and ateach clinic attendance.Culture experiments After last use, each needlewas carefully drawn several times through aColumbia-Blood-Agar as a culture medium at thetime when patients would have reused the needles(4-12 h). Bacterial contamination of the needlesplastic ground points was tested by contact withthe culture medium. This medium was chosenbecause it inactivates traces of phenol or cresol byprotein denaturation. Incubation was carried outover 72 h at 37C.

    Seven patients completed the protocol and usedsingle needles repeatedly up to 12 times beforebacteriological assessment. All other patients(five male, eight female) reused several needles upto nine times because dullness of the needle mademore injections impossible. No signs of localinfection were reported or could be recognized bythe doctor. A total of 87 needles was investigated:20 needles were used for one, three, six, or nineinjections, and seven needles were reused twelvetimes. Coagulase negative Staphylococcus wasdetected after an incubation period of 72 h on thesurface of a single needle, which had been usedthree times, while the cultures of all other needlesremained sterile. However, half of the needlesplastic ground points tested (see Fig. 1) were con-taminated (50.6,), either with coagulase negativeStaphylococcus, Corynebacterium or x-hemo-lytic Streptococcus (see Table 1). No relationshipcould be demonstrated between contamination ofthe plastic ground points and the frequency ofdaily insulin injections or between contaminationand the kind of insulin administered or the loca-tion of the injection sites.

    In the retrospective part of the study, pen-associated complications in the past were ana-lyzed. Patients had used these insulin injection

    TABLE IResults of the bacterial cultures taken from the needlesexterior surfaces and the needles plastic ground points after

    I. 3. 6. 9 or I2 injectionsTotal number of injections: 6 9 12(Ill: ,z:,, (2:) (20) (?(I) (7)Culture from needles exterior surface

    No growth 70 19 70 20 7Coagulase neg. Staphylococcus, 0 I 0 0 0

    Culture from plastic ground pointNo growth II 12 H 7 4Coagulase neg. Staphylococcus X 7 I I I I 2Corynebacterium spp: 0 I 5 4 Ix-Hemolytic Streptococcus, 7 II I II (I

    : Multiple microbial contamination possible.

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    systems previously for between 2 and 57 months(average, 16.3 months). They had carried outmore than 33000 injections (range, 120-6840;mean, 1657) with these systems. During this timenobody had recognized any sign of local infection,and neither local infections nor insulin therapy-related systemic infections had been documentedin the medical histories. Of 20 patients, fivereported that the incidence of haematomas wasslightly higher than with traditional syringe use.

    Bacterial cultures taken from another needlenot used in this study, which was used for 193injections during 6 months by a 69-year-oldwoman who visited our outpatient clinic for thefirst time, remained sterile too.

    DiscussionPrevious studies have validated the clinical obser-vation that reuse of plastic syringes and needles isonly possible when they are stored in a refrigera-tor [2,3] or wiped with alcohol [4] after use. Inthis study we could demonstrate no infectioncomplications in a group of 20 diabetic patientsusing the same pen needles for up to nine injec-tions or for 12 injections at room temperature in7 of 20 cases. As already demonstrated in theretrospective part of the study the reuse of needlesis limited after 5 to 10 injections because multipleuse make the needles point blunt, which wouldcause pain during the following injections. Bac-terial contamination of reused needles surfaceswas observed in only one of our cases, but withoutany sign of infection at the injection site.

    These data are in accordance with those ofWhyte et al. who found bacterial contaminationin 3.89/; of needles exterior surfaces [ 51. The riskof cutaneous infection is known to be low, sinceElek [6] stated that at least 7.5 x 10h coccus arenecessary for pus formation after intradermalinjection, and Koivisto and Felig [7] found nomore than 3.0 x lo4 bacteria/5.3 cm2 skin in dia-betic patients. In addition, we could demonstratethat the siliconisation of pen-needles, which wasintroduced to minimize the pain of injection, iseffective in reducing bacterial needle colonization

    (unpublished data). Besides the preservativesadded to commercially formulated insulins, insu-lin itself has antibacterial properties [ 81. For thesereasons no cutaneous complications were foundthroughout the whole study, which included morethan 33 000 single insulin injections.

    We conclude that the storage of Pens at roomtemperature as well as the multiple use of penneedles is safe and not associated with a higherrisk of cutaneous infections when they are reusedfor a limited number of injections. Multiple use ofneedles is limited because needles become moreand more blunt. The reuse of needles is con-venient in everyday life, especially when travelling,because fewer materials have to be carried. At thesame time the reuse of pen needles can lowersome of the costs of diabetes care.

    AcknowledgmentsWe wish to thank Daniela Larch for skillful tech-nical help and Ulrike Schuler for secretarialassistance.

    ReferencesWalters, D., Smith, P., Marteau, T., Brimble, A. andBorthwick, L. (1984) Patientsexperience with, and accept-ance of, multiple insulin injections using cartridge-packedinsulin in a novel injection pen. Diabetologia 27,344A-345A.Lester, E., Woodroffe, F.J. and Grant, A.J. (1984) Ex-perience with routine reuse of plastic insulin syringes. Br.Med. J. 289, 1498-1499.Collins, B.J., Richardson, S.G., Spence, B.K. and Hunter,J. (1983) Safety of reusing disposable plastic insulinsyringes. Lancet i, 559-561.Aziz, S. (1984) Recurrent use of disposable syringe-needleunits in diabetic children. Diabetes Care 7, 118-120.Whyte, W., Hilditch, T.E. and Bell, N.D.S. (1984) Micro-bial contamination of pharmaceutical injections at the siteof administration. J. Clin. Hosp. Pharmacol. 9, 61-67.Elek, SD. (1956) Experimental staphylococcal infectionsin the skin of man. Ann. N.Y. Acad. Sci. 65, 85-90.Koivisto, V.A. and Felig, P. (1978) Is skin preparationnecessary before insulin injection? Lancet i, 1072-1073.Schade, D.S. and Eaton, R.P. (1982) Bactericidal proper-ties of commercial U.S.P. formulated insulin. Diabetes 3 I,36-39.


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