CT Power Injector

CLINICAL BACKGROUND (STATE-OF-THE-ART)

Clinical Background

Multi-Use Syringeless Injectors (MUSI) are advanced CT contrast media injection systems designed to enhance the efficiency and safety of contrast-enhanced computed tomography (CT) examinations. These systems utilize large-volume contrast media containers and peristaltic pump technology to deliver iodinated contrast media at controlled flow rates and volumes, improving image quality and diagnostic accuracy. (Toia et al. 2023)

MUSI systems are increasingly adopted in high-volume imaging environments where efficiency is crucial. They are particularly beneficial for patients with difficult venous access, where peripherally inserted central catheters (PICCs) may be used for contrast administration (Wortley and Almerol 2020). The clinical context for MUSI systems includes:

1. Growing demand for contrast-enhanced CT examinations, with over 50% of CT procedures requiring contrast media administration (Kemper et al. 2022).
2. Emphasis on patient safety, particularly regarding air embolism prevention and PICC tip positioning (Kemper et al. 2022) (Wortley and Almerol 2020).
3. Increasing focus on environmental sustainability and waste reduction in radiology practices (Toia et al. 2023).

MUSI systems often incorporate advanced features such as proactive air management, which aims to reduce the risk of air embolism during contrast injection (Kemper et al. 2022). They also allow for multiple patient use without changing the contrast media container, potentially improving workflow efficiency and reducing waste (Toia et al. 2023).

Alternative Options

Single-Use Syringe-Based Injectors (SUSI) are a traditional method for CT contrast media administration. These systems use disposable syringes and tubing for each patient, typically with separate syringes for contrast media and saline. SUSI systems often incorporate air detection sensors but use a reactive approach to air management. They generally result in higher waste generation compared to newer technologies (Toia et al. 2023) (Kemper et al. 2022).

Manual injection of contrast media is sometimes used, particularly for central venous catheters. However, a study at a children’s hospital found that hand injection of IV contrast material led to damage of central venous catheters in 0.3% of cases over a 6-year period. The study suggests that hand injection can generate high and inconsistent pressures, potentially leading to catheter damage. Unlike power injection, the pressure and rate of injection during hand administration are unknown and uncontrolled. This evidence challenges the assumption that manual injection is necessarily safer than power injection for central venous catheters (Donnelly, Dickerson, and Racadio 2007).

Clinical Benefit

–        Improved workflow efficiency
–        Enhanced safety and system features
–        Optimized contrast usage
–        Lower Adverse Event rate and extravasation rate

Table below summarizes the need for performance and safety parameters of the device under evaluation and its technology that requires clinical data. The performance and safety endpoints are established for the clinical claim.

Performance and Safety Endpoints Table

Claims	Outcome Parameters	Acceptance Criteria
Performance
Improved workflow efficiency	Patient changeover times	15.4s ± 8.7s
	Day setup times	138.1s ± 92s
	Workflow efficiency improvement (time savings)	> 40%
Enhanced safety and system features	Allowable injected air volume	< 0.017 mL
	Air detection accuracy	> 96% at 2ft distance
	Successful injection completion rate	> 98.9%
Optimized contrast usage	Contrast volume reduction	> 18%
Safety
Lower Adverse Event rate and extravasation rate	Overall adverse reaction rate	< 0.7%
	Minor contrast reactions	< 0.9%
	Extravasation Rate	< 0.6%
	Device-related complications	< 0.9%

The selected safety and performance endpoints are widely recognized by radiologists and technologists to evaluate CT contrast media injection systems. Based on the State-of-the-art (SOTA) literature articles, the following key performance and safety metrics have been established:

Workflow Efficiency:

MUSI systems reduce overall time spent per exam compared to Single-Use Syringe-Based Injectors (SUSI):

40.5 seconds less time spent per exam with MUSI (p < .001). 40-63% time savings. (Toia et al. 2023)

Patient changeover times show significant improvement:

15.4s ± 8.7s for newer systems compared to 53.7s ± 19.6s for conventional systems (p < .001). (Kemper et al. 2022)

Day setup efficiency:

138.1s ± 92s for setup time with projected workflow efficiency improvement of 40-63%. (Kemper et al. 2022)

System Performance & Safety Features:

MUSI systems significantly reduce contrast media waste:

• Significant reduction in iodinated contrast media waste with MUSI compared to SUSI. (Toia et al. 2023)
• Weight-based protocols demonstrate 18-28% reduction in contrast volume while maintaining image quality  (Yap et al. 2021); (Zeng et al. 2023)

High reliability in completing programmed injections:

• 100% successful injection completion rate. (Kemper et al. 2022)
• 98.9% successful injection completion rate (534/540 examinations). (Son et al. 2020)

Proactive air management systems demonstrate superior performance:

• Average injected air volume: 0.005 mL ± 0.006 mL (maximum 0.017 mL) with proactive systems;
• Compared to reactive systems: 0.130 mL ± 0.082 mL and 0.106 mL ± 0.094 mL. (McDermott, Barone, and Kemper 2021)

Adverse Events

Low overall adverse event rate:

0.7% of total procedures (Wang et al. 2022)

Contrast extravasation rates:

• 0.3% with warmed contrast
• 0.6% with non-warmed contrast (Mahajan et al. 2024)

Minor contrast reactions:

0.9% (Son et al. 2020)

Device-related complications:

• Device disconnection: 0.9% (Son et al. 2020)
• Catheter leakage: 0.2% (Son et al. 2020)

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Literature Search Period: 2020 – 2024 | Search Time: Oct. 2024 | Next review/update: Oct. 2025