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How Safety Features Make Or Break Infusion Pump Design

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How Safety Features Make Or Break Infusion Pump Design Expert View HOW SAFETY FEATURES MAKE OR BREAK INFUSION PUMP DESIGN In this article, Charlotte Harvey, Medical Sector Manager, and Tim Frearson, Senior Consultant, both of Sagentia, overview the safety systems required when designing an infusion pump system, with a focus on free-flow prevention, occlusion detection and air-in-line detection. Infusion pumps are complex New entrants to the world of infusion pumps electromechanical devices used to deliver will find that safety features are a major fluids into a patient’s body in a controlled driving force behind their design, as they manner. They typically serve the needs of control every aspect of a user’s interaction hospital-bound patients, where life-saving with the device and have the potential to make medication is normally delivered via it unusable when things go wrong. This article intravenous infusion. With the desire for reviews different pump types, their typical patients to be able to manage their own safety features, and the implementation of conditions outside of a hospital setting, three of the most important safety features in together with the trend towards continuous infusion pump design. drug delivery, the use of at-home, ambulatory and wearable infusion pumps is on the rise. IDENTIFYING THE DIFFERENT TYPES OF INFUSION PUMP “Many of the learnings There are several types of infusion device. The type of pump used is dependent on from volumetric and the patient’s needs, such as the required syringe pumps are also volume and the speed of the desired relevant to ambulatory or infusion. And different types of pump are more or less suited to hospital, at-home or wearable pumps, as they ambulatory usage. are typically based on In hospital settings, volumetric, syringe the larger volumetric or and gravity pumps are the most popular choices. Volumetric pumps (Figure 1), syringe devices.” sometimes referred to as large volume pumps (LVPs), are the preferred choice Ms Charlotte Harvey Medical Sector Manager E: [email protected] Mr Tim Frearson Senior Consultant E: [email protected] Sagentia Ltd Harston Mill, Harston Cambridge CB22 7GG United Kingdom Figure 1: A typical volumetric infusion pump. www.sagentia.com 74 www.ondrugdelivery.com Copyright © 2019 Frederick Furness Publishing Ltd Expert View Figure 2: A typical syringe pump. for medium and high flow rates and large elastomeric balloon reservoir that empties to a single drug. Size and usability volume intravenous or enteral infusions. itself with a fixed pressure. They are become larger concerns and significantly They use a pumping action (typically linear generally designed for use by a patient at impact the device design. or rotary peristaltic) to pump fluid into the home as they are small, lightweight, easy Other types of infusion devices not patient under pressure and resistance. An IV to use and are easily portable. They are included here are pneumatic, clockwork bag can be used, or the device may employ a primarily intended to deliver antibiotics, and spring. However, these are significantly dedicated cassette. chemotherapy and analgesics where a high less common than volumetric and syringe For lower volume delivery and lower degree of accuracy is not required. The pumps, which will be the focus of discussion infusion rates, syringe pumps (Figure 2) are downside to these types of pump is they in the rest of the article. Many of the usually the preferred option. They work by have no built-in alarms or event log. Both learnings from these types of pumps are also pushing the plunger of a disposable syringe temperature and the fill volume of the relevant to ambulatory or wearable pumps, along at a predetermined rate. This rate reservoir (under- or over-filling) can affect as they are typically based on the larger can be continuous or in steps, delivering the intended delivery rate. Conversely, the volumetric or syringe devices. several boluses in a given time. Pumps for fixed volume and flow-rate reduce the risk delivering anaesthesia for sedation are based of user error. DESIGNING FOR SAFETY on the syringe mechanism. They are specially Patient-Controlled Analgesia (PCA) designed so that the rate can be adjusted, and pumps allow a patient to control the delivery The reliability of medical devices such as other functions accessed, during infusion. of pain-relieving medication. Typically, infusion pumps is extremely important These pumps allow for a higher flow rate, the syringe pump design allows patients because they are used on patients likely to be so that the induction dose can be delivered to deliver a bolus themselves. Protection in a critical condition. For this reason, they quickly in a single operation. against free-flow is especially important typically incorporate warnings and alarms. Some infusions are given using gravity with PCA pumps due to the nature of the Many of the safety features common to rather than a device to deliver the fluid. medication involved (pain relief) and risk of infusion devices are particularly susceptible Gravity pumps rely on the head height of overdose, particularly if the patient may be to tolerance variation of components and the fluid bag relative to the point of delivery unsupervised for some of the time. assembly processes. Therefore, a large to the patient. A gravity-controlled infusion There are also pumps specifically part of designing these features must be employs a clamping action to vary the flow designed to allow patients to continue dedicated to fully understanding their of liquid. The speed of delivery is dependent receiving treatment or therapy away from intended use, clinical environment and on pressure differential, which can be a hospital, thereby leading a normal life potential variations in manufacturing. limited, but the volume is almost limitless. during treatment. These are usually referred Getting the design right upfront is critical A gravity infusion would be employed when to as ambulatory pumps and have a size to ensuring that the design is robust in the the rate of infusion can be imprecise and and design that makes them wearable. field. Some design issues may not present large volumes are required. Wearable solutions vary from ones that themselves until the product is released Pump types that are more suited to adhere to the skin, to ones supplied in a into manufacturing where the extreme of at-home or mobile use are elastomeric, backpack or shoulder-bag. These pumps tolerance variation is encountered. Due to patient-controlled analgesia (PCA) and usually use the volumetric or syringe pump the adverse events that can occur in the “wearable” pumps. Elastomeric pumps are models as a basis for the technology, but field, there is heavy regulatory focus on non-electronic single use pumps, with an are often designed to be more specific their design. Copyright © 2019 Frederick Furness Publishing Ltd www.ondrugdelivery.com 75 Expert View Box 1 shows a list of typical safety features in descending order of importance. BOX 1: TYPICAL SAFETY FEATURES Note that a number of these safety features are usability based, to protect against misuse. FOR INFUSION DEVICES Note also that the importance of these features does not always correlate with the • Anti-free-flow device in • Syringe barrel clamp alarm, ease of implementation during device design administration set door open alarm or equivalent and development. In the rest of this article • Free-flow clamp in pump when door • Syringe plunger disengagement the focus will be on free-flow protection, opened (volumetric pump only) alarm or equivalent occlusion detection and air-in-line. • Air-in-line detection (volumetric • Automatic switching to keep the pump only) vein open (KVO) rate at the end ASSESSING FREE-FLOW • Detection of an empty drug/fluid of infusion PROTECTION FEATURES reservoir • Pre-set control of the total volume • Occlusion detection to be infused and digital read-out • Provision against accidental of volume infused Over-infusion is known to be a major modification of settings • Patient history log and technical cause of fatal adverse events when • Two distinct actions to change rate history back-up considering infusion pumps. There are a • Two distinct and/or simultaneous • Battery back-up (automatic switching few key differences between free-flow in a actions to initiate bolus to battery when mains power fails) syringe pump and in a volumetric pump. In volumetric pumps, free-flow may occur if the disposable tubing is not correctly fitted, or if the fluid is under the action of “The active pumping mechanisms used in syringe gravity without the tubing being correctly pinched or clamped. In either of these cases, and volumetric pumps generate high pressures to there are device alarms which can be used overcome this resistance, and therefore the pressure in to alert the user or caregiver. If free-flow the line will increase further when an occlusion occurs. becomes an issue in a syringe pump, the syringe plunger or barrel must not have Thus, occlusion detection devices typically use force been correctly loaded, with the pump at measurement to detect this increase in pressure.” a height sufficient to generate a pressure that overcomes the venous pressure and the friction between the plunger and barrel. patient’s condition can deteriorate rapidly by coupling a force sensor directly to the Warnings and alarms will typically be used if the infusion stops. However, occlusions wall of the disposable pumping segment. to alert the user or caregiver to incorrect also introduce the risk of a post occlusion As the internal fluid pressure increases or syringe loading. Other precautions may bolus, where the pressure in the line builds decreases the tubing will exert more or less include positioning the pump level with the behind the occlusion and releases suddenly force on the sensor (Figure 3). To ensure patient and use of an anti-siphon valve.
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