The impact of guidelines on sterility precautions during indwelling urethral catheterization at two acute-care hospitals in Sweden - a descriptive survey

The aim of the study was to investigate the nurses´ self-reported sterility precautions during indwelling urethral catheterization at two acute-care hospitals in Sweden, where the local guidelines differ in their sterility requirements. The study also aimed to analyze factors affecting the participants´ conformity with sterility precautions recommended in the EAUN-guidelines for indwelling urethral catheterization on adults.

The study had a descriptive design and was based on a structured questionnaire, with 19 questions in total. Nine questions concerned the participant and the working conditions (profession, graduation year, years in profession, department, years at present department, ward, work shift, origin of the insertion technique, frequency of IUC-insertion) and ten questions concerned the indwelling urethral catheterization procedure (insertion technique, sterility of the IUC during insertion, hand hygiene prior to preparing for procedure, solution for periurethral cleaning, area for preparing equipment prior to IUC-insertion, sterility of the set for catheterization if used, sterility of dressing on insertion area if used, sterility of utilities used for IUC-insertion, disposable/reusable equipment used for IUC-insertion, fluid for urinary washouts if used).

The questionnaire was constructed by the researchers in collaboration with expertise in urology nursing and infection control and the questions concerning sterility precautions during IUC-insertion procedure were based on the EAUN-guidelines for indwelling urethral catheterization in adults [12]. The questionnaire was pilot tested for comprehensiveness on healthcare-personnel in urology at another hospital in Sweden prior to the study. Each person taking part in the pilot test was instructed to read the questions and describe thoughts and associations for each question and the corresponding answer options by thinking aloud. After completed questionnaire each person was interviewed about the need of any additional questions to describe the IUC-insertion procedure. The pilot test did not result in any changes of the questions or answer options.

The study was conducted at two acute-care hospitals, hospital A and hospital B, with approximately 600 and 500 beds respectively, both situated in Stockholm County, Sweden. Wards for in-patient care at the departments for general surgery, cardiology and general internal medicine were chosen for the study as they had a similar level of care and urethral catheterization was performed regularly in all those wards by registered nurses and assistant nurses. At the time for the survey each hospital had local guidelines for indwelling urethral catheterization. The local guidelines at hospital A were launched in 2006 and updated in 2011. The local guidelines at hospital B were launched in 2011 and updated in 2013. See Table 1 for an overview of the required sterility precautions for indwelling urethral catheterization according to the EAUN-guidelines and both local hospital guidelines. EAUN used the term “sterile procedure” to summarize their requirements whereas hospital A used the heading “sterile technique” for their procedure and hospital B called their procedure “non-sterile technique”. At both hospitals it was possible for the newly employed nurses from the included wards to practice their IUC-insertion procedure at the hospital clinical training centers, but none of the wards required repeated training to keep up skills.

Head Nurses at all 28 wards for in-patient care at departments for surgery, cardiology and internal medicine at both study hospitals were asked about taking part in the study after verbal and written information. At hospital A fourteen of 15 eligible wards (3 wards at the department for surgery, 4 wards at the department for cardiology and 7 wards at the department for internal medicine) accepted participation in the study. One Head Nurse (a ward at the department for surgery) declined study participation due to other ongoing studies and workload at the ward. At hospital B, all 13 eligible wards (3 wards at the department for surgery, 3 wards at the department for cardiology and 7 wards at the department for internal medicine) accepted participation. The participants were registered nurses and assistant nurses. Employees on sick leave, parental leave and temporary staff were not included.

Verbal and written information was given by the study conductor to the nurses and assistant nurses at the participating wards during ward meetings. The voluntary participation in the study was emphasized and the printed questionnaires were distributed by the study conductor or the Head Nurse to the employees fulfilling the inclusion criteria. The participants were instructed not to discuss the questions in the questionnaire during the study period. The Head Nurses reminded the staff about the questionnaire at ward meetings. Consent was implied when nurses voluntarily returned the answered questionnaires to the study conductor in preaddressed and sealed envelopes within 2 weeks after distribution. At hospital A, 563 questionnaires were distributed during December 2015–March 2016. At hospital B, 368 questionnaires were distributed during May 2016–January 2017. The answers in the returned questionnaires were anonymized prior to data analysis. See Fig. 1 for flowchart of the study inclusion process.

Differences in background characteristics and indwelling urethral catheterization procedure of the participants were evaluated with Chi-square test, Fisher’s exact test and Mann-Whitney U-test. Continuous variables were expressed as medians (IQR) and categorical variables as numbers (%).

Binary logistic regression was used to identify variables associated with practicing the sterility precautions for indwelling urethral catheterization required in the EAUN-guidelines. The dependent variable was performing in agreement with all the five components of the sterility precautions in the EAUN-guidelines as described in Table 1 (bactericidal alcohol hand rub, sterile catheter, on a clean trolley, with sterile gloves, sterile fluid). Thirteen explanatory variables were tested, among these eight background factors (hospital, department, profession, years in profession, years at present department, work shift, frequency of IUC-insertion, origin of the insertion-technique) and five technique-related factors (type of insertion-technique, periurethral cleansing solution, use of set for catheterization, dressing on insertion area and disposable vs reusable equipment) which could affect the sterility during IUC-insertion.

We categorized the following variables into two groups: department (internal medicine and cardiology/surgery), years in profession (0–2 years and > 2 years), work shift (day/evening/alternating shift and night shift), frequency of IUC-insertion (each week or month and less than each month), origin of the insertion technique (according to the hospital guidelines and other answers), insertion technique (sterile technique and non-sterile technique), use of set for catheterization (sterile set and non-sterile set/no set used), dressing on insertion area (sterile drapes and non-sterile drapes/no drapes) and equipment for catheterization (disposable and reusable/don’t know). Periurethral cleansing solution was categorized into three groups (soap/tap water, sterile normal saline and other solutions) to reflect to participants´ choices for periurethral cleaning prior to IUC-insertion. First, univariable analyses was used to study crude associations of each explanatory variable with the odds (OR) of factors affecting the participants´ conformity with the sterility precautions required in the EAUN-guidelines. Secondly, multivariable logistic models were used in a backward and forward procedure to study the adjusted associations. Variables with a p-value < 0.10 in the univariable analyses were included in the multivariable analyses. The associations are presented as odds ratios (OR) with 95% confidence intervals (CI). Finally, Hosmer-Lemeshow goodness-of-fit test was used to assess the adjusted model, with a p-level above 0.05 indicating an acceptable fit. The IBM Statistical Package for the Social Sciences (SPSS) version 26.0 (IBM Corp., Armonk, NY, USA) was used for all analyses and a two-sided p-value of < 0.05 was considered statistically significant.

Answers were obtained from 518 of 563 included persons (92%) at hospital A and from 334 of 368 included persons (91%) at hospital B. Among the respondents at both hospitals 33 of them (26 at hospital A, 7 at hospital B) answered that they never inserted indwelling urinary catheters and were excluded from analysis. Not all questions were answered by every participant, thus leading to different numbers of analyzed answers for each question.

In total, answers from 492 participants at hospital A and 327 answers from participants at hospital B were analyzed.

The characteristics of the participants from both study hospitals are displayed in Table 2.

The participation is described on department level hence ward is not included in Table 2.

At hospital A, a higher proportion of participants worked at the department of cardiology, worked alternating shifts (both day, evening and night shifts) and had longer professional experience compared to the participants at hospital B.

The participants’ answers about their denomination of the insertion technique – sterile or non-sterile – and sterility precautions during indwelling urethral catheterization are presented in Table 3.

Although a majority of the nurses at both study hospitals answered that the IUC should be kept sterile during insertion (hospital A 82.2%, hospital B 78.2%), nurses at hospital A more often inserted the IUC with sterile gloves or a sterile forceps or by holding the catheter’s inner plastic cover (hospital A 68.6% vs hospital B 61.7%, p-value 0.042). During the procedure use of disposable equipment was more common at hospital A (hospital A 97.1% vs hospital B 92.6%, p-value 0.004).

Irrespective of insertion technique a sterile set for catheterization was used by over half of the participating nurses from both study hospitals. Only 16–20% of nurses claimed using sterile drapes for dressing on the insertion area in efforts to create a protective field and prevent contamination of the IUC during insertion. Dressing on insertion area was not required in neither of the local hospital guidelines.

The univariable analysis identified four explanatory variables that were significantly associated with performing in agreement with the five components of the sterility precautions in the EAUN-guidelines (see Table 1). After performing a multivariable logistic regression analysis to study the adjusted associations for those four variables the significant associations remained. The four variables were: working at department for surgery and cardiology (OR 2.35, 95% CI 1.69–3.27), use of sterile set for catheterization (OR 2.06, 95% CI 1.42–2.97), use of sterile drapes for dressing on insertion area during procedure (OR 1.91, 95% CI 1.24–2.96) and using the term “sterile technique” for indwelling urethral catheterization (OR 1.64, 95% CI 1.11–2.43).

See Table 4 for details in the univariable and multivariable analyses.

Maintaining the sterility of the IUC during insertion is one of the cornerstones in evidence-based international guidelines for prevention of HAUTI among patients in need of an IUC. The sterility of the catheter is kept by using sterile equipment, lubricants and solutions, by proper hand hygiene and by skills in ensuring not to contaminate the IUC during the whole procedure [8‐12]. In this study it was mostly considered by the participants that the IUC should be kept sterile during insertion (hospital A 82.2%, hospital B 78.2%) which is in accordance with the EAUN-guidelines but not required by the local guidelines at hospital B. Despite of that only 62–69% of the participants used sterile gloves/forceps for catheter insertion or practiced a non-touch technique by keeping the catheter sterile within its inner plastic cover during insertion. The nurses at hospital A reported higher adherence to those techniques compared to hospital B (p-value 0.04).

Sterile drapes on the insertion area could be used to protect a catheter from unintended contact with the patient’s legs or bed linen. This is not required in the EAUN-guidelines but is advocated in national guidelines from for example the United States of America and Ireland [8, 10]. Only 16–20% of the participants at both study hospitals used sterile drapes on the insertion area to protect the sterile catheter from contamination during catheterization.

A standardized set for urethral catheterization, including all necessary sterile equipment, such as gloves, forceps, fenestrated drapes, gallipots and swabs can both facilitate a uniform behavior when performing indwelling urethral catheterization and secure sterility of the IUC throughout the whole procedure. A pre-prepared set ensures that no necessary item is forgotten. The facilitating effect of a pre-prepared set for aseptic IUC-insertion is also reported in a study by Mizerek et al. [14]. In our study almost 83% of the participants used a pre-prepared set for catheterization though only 57% used a sterile set.

The use of the term “non-sterile technique” for the procedure irrespective of how it actually was performed might originate from the introduction of “non-sterile technique” in the Swedish national guidelines for indwelling urethral catheterization during the 1990s. Those guidelines were influenced by a small randomized clinical trial conducted by Carapeti et al. in 1994. In this study the authors compared “sterile technique” with “non-sterile technique” for short-term indwelling urethral catheterization on patients undergoing elective general surgery [15]. The study found no statistically significant difference in UTI incidence between the compared insertion techniques, (11% with “non-sterile technique”, 9.5% with “sterile technique”, p-value > 0.1) and the authors recommended the cheaper “non-sterile technique”. Important to notice is however, that the IUC was kept sterile during both procedures by holding the sterile IUC within its inner plastic cover during insertion. “Non-sterile technique” was introduced in the revised Swedish national guidelines launched in 1994 and included use of soap and tap water for periurethral cleaning, no dressing on insertion area, use of non-sterile equipment and non-sterile gloves when inserting the IUC [16]. Unfortunately, the emphasis on not touching the sterile IUC was left out. This opinion of the proper way to perform indwelling urethral catheterization has dominated in Sweden and thus influenced what nurses have been taught during education and professional work until an updated version of the national guidelines based on same sterility precautions as in the EAUN-guidelines was launched in 2015. This return to an earlier approach to the principles of keeping the sterility of the IUC during insertion in the national guidelines does not seem to have had an impact on what the participants in this study called their insertion technique.

A variety of terms for IUC-insertion techniques are found in scientific and educational literature. Further, healthcare settings can have different interpretations of a specific insertion technique. For example, EAUN stresses that “non-sterile technique” is applicable only for a patient performing intermittent self-catheterization at home [17]. The inconsistent use of different terms for insertion technique during urethral catheterization and uncertainties in understanding how proper aseptic insertion of the sterile catheter is accomplished by nurses has also been reported by others [18‐21].

National and local hospital guidelines for indwelling urethral catheterization should use a harmonized description of the term “sterile technique” accompanied with an explanation of what necessary sterile equipment to use for successful aseptic procedure, with the emphasis on the use of a sterile set for catheterization and sterile drapes on the insertion area to create a protective field for the sterile urinary catheter so that it is not accidentally contaminated during procedure.

The different requirements for keeping the catheter sterile in the local hospital guidelines from hospital A and hospital B did not affect the adherence to the EAUN-guidelines (OR 0.99, 95% CI 0.72–1.34).

An association with performing according to the EAUN-guidelines was also found for the use of sterile set for catheterization (p-value < 0.001) and sterile drapes for dressing on insertion area during procedure (p-value 0.004). There was also an association between adherence to the EAUN-guidelines and using the term “sterile technique” for indwelling urethral catheterization (p-value 0.014). A possible explanation for this may be that the term “sterile” is easier to relate to an aseptic performance than the term “non-sterile”.

On an overall level we believe that the association between those variables and performing according to the EAUN-guidelines demonstrates the knowledge and understanding of aseptic technique by the individual nurse. This knowledge could have been achieved during education or employment and is obviously more influential for the actual behavior than a written hospital guideline.

We have chosen to analyze association of the explanatory variables and performing in accordance with all the five components of sterility precautions in the EAUN-guidelines as we believe that the five components act like a bundle. When urinary catheterization is performed all the five components should be kept to.

Different requirements on sterility and equipment in the local hospital guidelines, combined with the lack of a detailed description of the IUC-insertion process are factors that counteract a uniform performance of indwelling urethral catheterization. This may jeopardize the patient safety.

In addition to harmonized guidelines the need for training in aseptic preparation of sterile equipment is stressed by the EAUN-guidelines and other international guidelines [8‐12]. Lo et al. states that only nurses passing competence assessment in aseptic IUC-insertion should perform indwelling urethral catheterization and the nurses´ competencies should be reassessed on a regular basis [22]. According to Walsh et al. “computer-assisted learning” is as effective as “expert-assisted learning” for basic knowledge and skills training in aseptic IUC-insertion [23]. In an experimental study conducted by Todsen et al. they found that the obtained skills in aseptic IUC-insertion during a theoretical course combined with a practical training on mannequins were still retained when the participants´ performances were reassessed 6 weeks later when performing IUC-insertion on real patients in a clinical setting [24].

Furthermore, in a multi-modal study conducted by Ara et al. with several activities including for example theoretical education and practical training in standard precautions and aseptic technique, visual reminders, monitoring and feedback on a regular basis resulted in a significant overall improvement of aseptic maintenance of sterile equipment [25]. This multi-modal intervention approach for prevention of HAI is also advocated by the World Health Organization (WHO) in Guidelines on Core Components of Infection Prevention and Control Programmes at the national and acute health care facility level [26].

The results from our study support the need for the healthcare-settings to have a strategy regarding repeated training of the staff in aseptic IUC-insertion procedure and how to implement changes in updated guidelines for urethral catheterization.

A limitation of our study is that it is based on self-reported description of practice and not observation of the actual performance during indwelling urethral catheterization. Using a questionnaire, however, made it possible to cost-efficiently reach many more nurses from different departments at two hospitals, with different sterility requirements in local hospital guidelines, than observation would have done. A validation of the procedure described by the participants requires an observational study of the practiced skills such as conducted by Manojlovich et al. [21]. Another limitation may be that the study did not include physicians. Although IUC-insertion can be performed by physicians, urethral catheterization in Sweden is performed mostly by nurses hence the focus on nurses in the study. The guidelines for catheterization are usually written by registered nurses.