Designed for Durability:
A Look at the Hardware Development of the Ivenix Large-Volume Pump
Designed for Durability: A Look at the Hardware Development of the Ivenix Large-Volume Pump
By Michael Scarsella, Director of Hardware Engineering
Durable medical devices are exposed to a constant onslaught of threats within the hospital environment – including harsh cleaning and disinfecting chemicals, liquid spills, drops, and bumps – and must continue to operate safely and reliably. Therefore, devices engineered for use in hospitals must be designed with consideration for these known vulnerabilities to avoid unwanted failures.
When designing the hardware for a new large-volume pump, the Ivenix team capitalized on a unique opportunity to learn about the common failures in the industry and reduce their occurrence to ensure the product can safely withstand the test of time. Here are a few of the hardware design considerations our team made during the development of the Ivenix Large-Volume Pump.
An accidental drop or impact is inevitable – but preventative design features can help keep things secure during equipment or patient transport. The Ivenix pump was designed to last. It includes a prominent handle, which extends the entire width of the top of the pump to provide users with a firm and stable means of carrying the pump. The pump can be easily moved by using the power grip handle when transferring a patient from a stretcher to a bed or when a patient moves. If there is an accident resulting in a drop or side impact, Ivenix has integrated a metal chassis into the enclosure which acts like a “roll cage” to protect the device and bolster its durability.
Doors, latches, and other means of loading administration sets into today’s infusion devices are often prone to fatigue, failure, or impact on device safety.1-3 The Ivenix pump was designed without the need for a door or complex cartridge loading system. The rigid loading system is constructed of strong metals to prevent premature wear or accidental damage, ensuring consistent performance over the life of the device.
Robust cleaning and disinfecting
Popular housing polymers are susceptible to mechanical and stress cracking which can sideline a fleet of pumps. The material chosen for the Ivenix infusion pump housing is an innovative technology in medical device housing materials. The chemically resistant co-polymers in the Ivenix pump maintain their impact-resistant properties over time when exposed to disinfectants. The material has no contraindications for commonly used cleaning or disinfection agents,4 which allows flexibility for hospitals as they become increasingly diligent in the effort to prevent the transmission of serious infections.
The Ivenix pump was also designed and tested to an ingress protection rating of IPX3, the only large-volume infusion pump in the U.S. market with this high rating.5 The ingress protection level gives clinicians peace-of-mind while used in environments that often see sprays, spills, or other inadvertent liquid exposure. In addition, a sealed device affords hospitals the choice to spray or wipe when cleaning and disinfecting to help harmonize, rather than define departmental protocols. The device is wipe-down friendly as well, as it provides easy access to its few crevices, and therefore fewer contaminants are trapped that could lead to hospital-acquired infections.
Protection of sensitive electronics
Infusion devices utilize sensors to detect the presence of air or to characterize fluid flow. These sensors are typically integrated into exposed areas of the pump that are susceptible to damage or the need for frequent repair or calibration. The Ivenix Infusion System has been designed to protect sensitive electronics within the walls of the enclosure thereby reducing the need for repair and preventative maintenance.
Connectors and electrical contacts are a necessity, but they are a vulnerable feature in modern hospital equipment. Devices are rendered unsafe or out of service due to corrosion or damage. The Ivenix pump has simplistically reduced its external contacts to three small pins necessary to dock to its accompanying pole-mounted battery charger. The charger has three mating contacts, which lay flat for easy cleaning and to prevent inadvertent damage.6
The Ivenix pump confidently provides eight hours of battery life, even when continuously delivering fluids or medications and connected to Wi-Fi. Dual battery packs enable plentiful runtime and also provide redundancy in the event of battery pack failure. The batteries are seamlessly recharged when the pump is mated to an Ivenix pole-mounted charging bracket.
The charger bracket has been designed to alleviate some of the issues found on other infusion devices to ensure pumps are fully charged and ready for use. An 8-foot long power cord is permanently attached to the charging bracket ensuring that the bracket and the power cord are never separated or misplaced. The power cord plug has been thoughtfully sized such that it does not impede use of neighboring outlets. And finally, a quick release button allows a pump to be easily disconnected from the charging bracket with a single hand, enabling a busy clinician to easily move or transport the pump.
The Ivenix pump was designed so that it takes benefit from considering the failure modes of currently marketed devices. The pump is strong and durable, has a highly chemically resistant housing, and has protected against or reduced the number of susceptible features.
These incremental hardware improvements position the Ivenix pump to withstand the environmental hazards of a hospital for years to come.
Michael Scarsella is Director of Hardware Engineering at Fresenius Kabi. He holds a Master’s Degree in Mechanical Engineering from Worcester Polytechnic Institute and has over 15 years of experience in medical device design, development, and manufacturing.
- Consult the Ivenix LVP Instructions for Use for device cleaning guidance
- IPX3 rating is among major competitors as of October 2022
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