Evaluation of a safety-engineered peripherally inserted intravenous catheter with multiple access blood control: clinician acceptability and ease of use

It is well established that peripheral intravenous catheter (PIVC) insertion is one of the most common and essential interventions in the health care system.^1–3 While intravenous (IV) catheters are considered non-significant risk devices and IV catheter insertion has immediate benefits to the patient,⁴ health care workers (HCWs) are vulnerable to blood exposure and needlestick injuries (NSIs) as a result of these procedures.³

The risk of NSI from IV catheters has been studied extensively; less attention has been paid on characterizing and reducing the overall blood exposure sustained by HCWs during PIVC insertion or removal.⁵When blood exposure occurs on non-intact skin or mucous membranes, bloodborne pathogen transmission may occur. Indeed, the Centers for Disease Control and Prevention (CDC) reported that IV insertion was the second highest source of human immunodeficiency virus (HIV) exposure for HCWs, even though IV catheter needles account for a small fraction of sharps used in health care settings. In a 2012 survey conducted among 350 HCWs, respondents reported mucous membrane or skin contact with blood during insertion (46%) and removal (42%) of a PIVC.⁵

The Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030), as amended pursuant to the 2000 Needlestick Safety and Prevention Act, serves to protect United States HCWs from bloodborne pathogens.^{6, 7} Amid legislation aimed to increase HCW safety, the most impactful reduction in sharps injury risk and blood exposure came from the development and implementation of safety-engineered devices designed to reduce the occurrence of sharps injuries from users.⁷ Safety-engineered IV catheters have been used for decades, with some safety-engineered PIVCs designed to include blood control valves to prevent blood exposure. While numerous safety designs of IV catheters are available, devices with passive safety features are designed to automatically cover the needle after removal and are associated with low NSI incidence rates compared with semiautomatic or automatic devices.⁸

In a previously published study, this research group demonstrated protection from blood exposure during insertion as well as high levels of acceptability and ease of use of a well-established passive safety-engineered PIVC with blood control at insertion time among a population of experienced clinicians.⁹ In this study, we continue our investigation into the prevention of blood exposure with a new multiple access septum on the same, well-known, passive safety-engineered PIVC in healthy participants and in a simulated use environment.

Acceptability of a new safety-engineered PIVC with multiple access blood control (MBC) was evaluated by the clinicians’ ability to access the catheter multiple times without blood exposure from the catheter hub at any point during the procedure, insert this new IV catheter, and maintain their usual insertion technique. Blood leakage was defined as any visible blood exterior to the catheter coming from the catheter hub after withdrawal of the needle.

Methods

Clinician and participant selection

Clinicians and participants were recruited for the study using the contract research organization's (CRO) database (TKL Research, Inc. Fair Lawn, NJ); they were informed about the study and provided written informed consent before participation and were reimbursed for their participation in this study.

Thirty-one clinicians with current nursing licenses were enrolled and completed the study. Demographic information was collected for clinicians: clinician ages ranged from 24.9 to 74.6 years (mean=39.5 years) and were predominately: gender: female (n=24, 77.4%); race: Caucasian (n=24, 77.4%); ethnicity: non-Hispanic or Latino (n=19, 61.3%); and handedness: right-handed (n=27, 87.1%; Table 1). Most clinicians performed IV insertions using a 1-handed technique (n=18, 58.1%), while 13 clinicians (41.9%) used a 2-handed technique.

Clinicians were from various work locations including local hospitals and surgical centers, with experience using IV catheters, had a minimum of 3 years of clinical experience, and performed ≥3 PIVC insertions per week (range=3–100 insertions).

Clinicians were excluded if they had physical conditions making them unable to perform the study procedures, discussed the details of this study or the test product with B. Braun Medical staff or other study clinicians outside of the study, or if they worked for a medical device company.

Ninety-two participants were enrolled and completed the study. Participants were ≥18 years of age; had ≥2 accessible veins on the hand, forearm, or antecubital fossa with intact skin at the site of insertion; and provided written informed consent to participate in the study. Participants ages ranged from 18.9 to 77.7 years (mean=54.2 years) and were predominately: gender: female (n=69, 75.0%); race: Caucasian (n=67, 72.8%); and ethnicity: non-Hispanic or Latino (n=64, 69.6%; Table 2). Participants were excluded if they were self-reported to have hepatitis B, hepatitis C, HIV or acquired immunodeficiency syndrome; taking any medication(s) or had a medical condition that increased the risk of bleeding; self-reported IV drug use; participating in another medical device or pharmaceutical study; or were an employee or family member of the investigator, study center, a medical device company, or B. Braun Medical.

Clinicians and participants received a stipend for their participation in the study; there were no additional direct, indirect, or implied benefits provided to the clinicians or participants based on their responses.

Materials

The PIVC with MBC for this study was the Introcan Safety^® 2 IV Multiple Access Blood Control Catheter (B. Braun Medical, Inc.), a safety-engineered PIVC with multiple blood control septum. A diagram of the PIVC with MBC is presented in Figure 1.

Statistical methods

The sample size of 30 evaluable clinicians was selected to yield approximately 180 study catheter insertions for assessment of the study objectives. This sample size was adequate to obtain at least 70% agreement of each of the primary and secondary objectives with at least 90% power. Due to the nature of this study, blinding was not possible.

Clinician and observer questionnaires

The source data consisted of observer and clinician questionnaire responses following clinicians’ use of the PIVC with MBC. Likert-scale questionnaire responses were analyzed using topbox analysis and binomial statistics. The yes-or-no ratings were tabulated with a summary of the frequency and percent of responses. Within-treatments analysis was conducted using binomial statistics.

A 4-point scale was used for Likert-scale questionnaire responses: strongly disagree, disagree, agree, or strongly agree. Agreement responses were defined as strongly agree and agree.¹⁰ The percentages of agreement responses required to consider each objective successfully met was set at 70%.

Study design

This study was run according to Food and Drug Administration (FDA) regulations, the ethical principles of the Declaration of Helsinki, the International Conference on Harmonization accepted standards for Good Clinical Practice, and all applicable standard operating procedures of TKL Research, Inc. The guidelines set forth by the FDA for applying human factors and usability engineering to medical devices, medical device reporting for manufacturers, and medical devices with sharps injury prevention features were adhered to throughout the design and conduct of the study.^11–14 Using these guidelines, we designed the study to assess multiple connections and disconnections (syringes, extension sets) as well as flushing of the device to simulate the clinical practice of flushing a catheter to ensure patency of the device. A local institutional review board approved this study.

Screening, enrollment, and clinical procedures occurred during a single study visit for each clinician and participant. Observers and clinicians were trained before participation in the study to standardized study procedures and assure that the skills and competences of the nurses were appropriate. Multiple observers were trained on the study procedures to allow for simultaneous use of multiple study procedure stations. All observers were given the same training by a single individual from the CRO. Observers monitored the clinicians during each procedure to verify proper use and function of the PIVC with MBC.

The study was divided into 3 parts (Figure 2).

• Part I: Screening and enrollment: After signing the consent, clinicians and participants who met all eligibility criteria were enrolled. Clinician and participant demographic information and clinician background information were collected.
• Part II: Observation: each clinician conducted 6 PIVC with MBC insertions on 2–3 participants using a new device each time, for a total of approximately 180 PIVC insertions. Each participant received 2–4 study catheters. Video recordings were used to observe procedures and to verify if there was any blood leakage from the catheter hub.

The following steps were completed by the clinician. The occurrence of blood leakage was documented by the observer approximately seconds after each step was completed.

• Insert the catheter and remove the needle.
• Attach a disposable syringe, withdraw approximately 1cc of blood, and remove the syringe.
• Attach a flush syringe, flush with 1mL normal (0.9%) saline solution (NSS), and remove the flush syringe.
• Attach a NSS preprimed extension set, flush with a syringe containing 1 mL of NSS, and removed the extension set.
• Attached a disposable syringe, withdraw about 1 mL of blood, and remove the syringe.
• Attach a preprimed NSS extension set, flush with 1mL of NNS, and remove the extension set.

After the clinician completed each catheter insertion, 2 blood draw and flush procedures, and removal of the PIVC with MBC, he or she completed the appropriate questionnaire page of the case report form (CRF). If for any reason the device did not function properly, including that the clinician did not follow the study procedures, the clinician would have documented this on the CRF and put the device in a separate container for return to B. Braun Medical for analysis.

• Part III: End of study: Clinician assessments were reviewed by study site personnel to ensure completion. Participants were discharged after their last procedure and received a safety follow-up phone call 5–7 days later.

Results

Clinician and participant background and demographic information are presented in Tables 1 and 2, respectively. All clinicians and participants were compliant with the study protocol. All enrolled clinicians and participants completed the study as designed.

Observers documented if there was any blood leakage through yes-or-no responses to the questions: ‘Was there any blood leakage from the catheter hub within 15 seconds?’ after any of the study steps: removing the needle from the catheter hub, removing the first disposable syringe, removing the flush syringe, removing the first primed extension set, removing the second disposable syringe, and removing the second primed extension set. There was no visible blood leakage from the catheter hub within 15 seconds of any of the listed procedures for any of the PIVCs with MBC evaluated (Table 3).

Observers recorded the number of attempts made by clinicians to achieve a successful stick. Of the 186 stick attempts documented by observers, 178 attempts (95.7%) achieved firststick success (Figure 3). Eight insertion attempts (4.3%) were unsuccessful. At least 2 insertion attempts were performed before determining that a given stick was unsuccessful. All unsuccessful sticks were considered technique related or difficult insertions, and none affected clinician or participant safety or the outcome of the study.

After the clinician completed each PIVC with MBC procedure, he or she rated the function and ease of use of the product using 4-point Likert scales or yes-or-no responses (Figure 4). Agreements ranged from 83.3% to 98.9%. Clinicians rated the overall acceptability of the PIVC with MBC a single time, on a 4-point Likert scale. Overall, 93.6% (n=29) of clinicians considered the PIVC with MBC acceptable (Figure 4).

Based on the success criteria of this study, the primary and secondary objectives were successfully met, with >70% agreement.

Discussion

In this study, we evaluated a new safety-engineered PIVC with a MBC septum that prevents accidental blood exposure by preventing blood flow from the catheter hub once the needle is withdrawn and during multiple connections and disconnections of other devices to the catheter hub. It has a passive safety-engineered feature designed to automatically engage upon needle withdrawal. Together, these 2 safety features prevent blood exposure and NSI during catheter insertion and needle removal, and the connection and disconnection of medical devices like syringes and extension sets. Advantages of passive safety-engineered IV catheters are extensive and well documented. For this reason, in the current study, we continue our investigation into the clinician acceptability and ease of use assessment of a well-known safety PIVC with a multiple access septum for the prevention of blood exposure.

Blood exposure can occur any time a catheter is placed, connected, or disconnected to other Luer devices, or removed. Blood leakage during catheterization interrupts the clinical process, causing a major inconvenience for HCWs and patients, and poses a significant risk for HCWs through the potential for exposure to bloodborne pathogens including HIV, hepatitis B, and hepatitis C. When using conventional catheters, blood leakage can occur in up to 61.2% of cases during insertion and in up to 74% of cases during connections and disconnections.¹⁵ Clinicians are required to use a specific technique after the catheter is threaded, by pressing the skin proximal to the catheter tip to prevent blood leaking from the catheter hub. These devices directly impact HCW safety by reducing both blood exposure during insertion and eliminating the need for vein compression, saving cleaning time and supplies.¹⁶ Safety-engineered devices also reduce NSIs,^{3,7–9,17,18} reduce patient complications while increasing indwell time,² save time and money involved in cleanup and prophylaxis,^{16, 19, 20} and have high levels of clinician acceptability.^{9, 17}

Blood control is essential for clinician safety during all stages of the IV catheterization process.²⁰The multiple access septum in this PIVC with MBC controls the flow of blood coming out of the catheter hub and can be accessed multiple times, allowing for multiple accesses of the hub for blood collections, boluses, extension set changes or other procedures when needed, without blood leakage. The study device performed as intended, and the septum of the device prevented blood leakage from the catheter hub after each hub access (Table 3).

A benefit of blood control catheters is the reduction of the potential for blood exposure without the need to perform vein compression.^{15, 17, 21} The passive safety mechanism on the PIVC with MBC ensures clinician compliance with the safety feature. Indeed, the safety shield activated when the needle was withdrawn in 100% of the devices that were used.

The PIVC with MBC has a similar handling technique to other safety IV catheters, allowing the clinician to transfer his or her IV insertion technique to this new device with little to no learning curve. Most clinicians agreed that they did not have to change their PIVC insertion technique to use the device (83.3%), it was easy to insert the catheter, and easy to remove the needle from the catheter hub (92.5%–93.0%).

Failed PIVC insertions occur routinely in clinical settings. Authors of studies have shown over 27% of PIVC insertions required 3 or more attempts.¹ First-stick success was achieved by clinicians in 95.7% of procedures in this study (Figure 3). Though clinician assessments are subjective by nature, the wide range of clinician experiences (ie, work location, years of experience, PIVC insertions/week) are considered to be representative of this user population. Participants were healthy and presented with ≥2 easily accessible veins in this simulated use environment. No adverse events (AEs) were reported by the clinicians or participants during the study nor at the safety follow-up call.

Limitations

There were several limitations to the study that may have impacted the results. Clinicians and participants were advised of the procedures and the fact that they would be observed during the study. Thus, it was not possible to eliminate the Hawthorne effect. This study was performed by experienced clinicians, in healthy participants and in a controlled clinical setting.

Thirty-one clinicians completed a total of 186 procedures with the PIVC with MBC. Each procedure was treated independently for analysis. Because the clinicians were able to contribute to the endpoints multiple times, the clinician assessments may have been skewed. The clinician population was made up largely of white, female, right-handed individuals. These demographic variables were not expected to contribute to clinicians’ use of the device and therefore not normalized. Lastly, participants were selected based on the availability of ≥2 accessible veins on the hand, forearm, or antecubital fossa. In a real-world setting, patients may not present with easily accessible veins.

Recommendations for practice

Clinicians should always follow universal precautions (gloves, gowns, masks, etc.), yet accidental bloodborne pathogen exposure could occur during insertion and access of a PIVC due to NSIs or blood spillage. Safety-engineered PIVCs are readily available, but institutions should consider using passive safety-engineered PIVCs with MBC to prevent unintended blood exposure and NSIs. As multiple hub connections are usually required, blood control via a multiple access septum can provide protection against accidental blood exposure to HCWs, and because of the first-stick success, this study catheter can help decrease the number of catheters required for clinical procedures, resulting in an improvement in patient safety and satisfaction.

PIVC insertions may interfere with patient comfort by causing pain and anxiety.²² First-stick success is critical in the reduction of pain and thus reducing anxiety.²³

Conclusions

No blood leakage was observed from the catheter hub at any point during the procedures, and most clinicians achieved firststick success when using this product. Overall, 93.6% of the clinicians rated this PIVC with MBC acceptable. Clinicians were able to visualize the double flashback, easily insert the catheter and remove the needle, and attach and disconnect multiple syringes and extension sets without blood leakage from the hub, maintain their current PIVC insertion technique, and felt protected from blood exposure during insertion and use of the catheter. No AEs were reported by the clinicians or participants during the study nor at the safety follow-up call.

Disclosures

B. Braun Medical Inc. funded the research. Angela Karpf, MD, Diana Valencia, MD, Susan Ballek, RN, and Christopher R. Curtin, are employees of B. Braun Medical Inc. TKL Research conducted the study. JessonYeh, MD, Allyson Marshall-Hudson, PhD, and Michael Tuley, PhD are employed by TKL Research Inc, B. Braun Medical Inc, and TKL Research Inc., were involved in the preparation of this manuscript.