Automated testing of auto-injectors. Frew. Department of Respiratory Medicine, Royal Sussex County Hospital, Brighton, UKSearch for more papers by this author. Edited by: Hans- Uwe Simon. Prof. Frew, Department of Respiratory Medicine, Royal Sussex County Hospital, Brighton BN2 5. BE, UK. Tel.: +4. Fax: +4. 4 1. 27. E- mail: anthony. Abstract. To cite this article: Frew A. J. Allergy 2. 01. Abstract. Anaphylaxis is a systemic allergic reaction that often involves respiratory symptoms and cardiovascular collapse, which are potentially life- threatening if not treated promptly with intramuscular adrenaline. Owing to the unpredictable nature of anaphylaxis and accidental exposure to allergens (such as peanuts and shellfish), patients should be prescribed intramuscular adrenaline auto- injectors and carry these with them at all times. Patients also need to be able to use their auto- injectors correctly while under high stress, when an anaphylactic attack occurs. Despite this, an alarming number of patients fail to carry their auto- injectors and many patients, carers of children with known anaphylaxis and healthcare professionals do not know how to use the device correctly, despite having had training. Currently available auto- injector devices have various limitations that may impede their use in the management of anaphylaxis. There is also a lack of validated assessment criteria and regulatory requirements for new devices. This review describes the different delivery systems used in currently available auto- injectors and discusses the key barriers to the use of adrenaline auto- injectors, with the goal of identifying the . Recently, the National Institute of Allergy and Infectious Disease and Food Allergy and Anaphylaxis Network convened a meeting to agree on a definition of anaphylaxis and criteria for its diagnosis. Key outcomes of this meeting included consensus agreement on the definition of anaphylaxis as . Diagnostic/clinical criteria for accurate identification of anaphylaxis were also set out (3, 5, 6). Epidemiology of anaphylaxis. Despite the establishment of clinical criteria for anaphylaxis, it remains difficult to ascertain the true frequency of anaphylaxis because patients vary in the symptoms with which they present, and whether they end up in clinical care. A recent review of the available epidemiological evidence has estimated a lifetime incidence rate of 5. Annual incidence rates vary between countries. For example, in the United Kingdom (UK), it has been estimated that the annual incidence of anaphylaxis is 1. England has experienced anaphylaxis at some point in their lives (1. The estimated prevalence of severe anaphylaxis ranged from 0. Switzerland and the United States of America (USA), while in Sweden, Budapest, Barcelona and Bombay a slightly higher figure of 1. An auto-injector automatically dispenses a predetermined dose of medicament upon activation. The auto-injector includes a. The biasing force for the cover 150 is less than the activating force of the auto. These properties include activation force. Next-generation EpiPen. Fatal anaphylaxis was reported to occur in 0. The estimated death rate from food- induced anaphylaxis in children < 1. United Kingdom is approximately 1 per 2. However, food is not the only cause of anaphylaxis. The cause of anaphylaxis remains unidentified in approximately one- third of cases (6) and of those cases with a known cause, food (such as peanuts, tree nuts, fish, shellfish, milk and egg) accounted for one- third of the cases (1. Pathogenic mechanisms and triggers have been described in detail elsewhere (5, 1. Management of anaphylaxis. Adrenaline is the drug of choice for the treatment of anaphylaxis (1, 3, 1. Anaphylaxis often presents in the community setting. In such an event, patients need to be able to recognize what is happening, rapidly self- administer intramuscular (i. When patients get to a clinical setting, healthcare professionals should carry out rapid assessment of the airways, breathing, circulation and orientation, followed promptly by further i. Immediate intervention Assessment of airway, breathing, circulation and adequacy of mentation Administer adrenaline intramuscularly every 5–1. Possibly appropriate, subsequent measures depending on response to adrenaline: Place patient in recumbent position and elevate lower extremities Establish and maintain airway Administer oxygen Establish venous access Normal saline intravenously for fluid replacement. Specific measures to consider after epinephrine injections, where appropriate: Consider adrenaline infusion Consider H1 and H2 antihistamines Consider nebulized . Owing to the unpredictable nature of anaphylaxis, the random occurrence of accidental exposures to allergens, and the short median time to respiratory or cardiac arrest (reported to be 3. Moreover, the possibility of anaphylaxis has a substantial adverse impact on quality of life if no first- aid package is provided. Therefore, after resolution of the acute episode, all patients should be given at least two adrenaline auto- injectors and trained on how to use them in the event of future episodes (1). In addition, every patient should receive an individualized Anaphylaxis Emergency Action Plan (1, 2. A systematic review has highlighted the importance of early self- administration of adrenaline because fatalities have been associated with significant delays or failures in administration (8, 2. Moreover, early and appropriate intervention with i. What is auto injector? Auto injector is specially designed to auto inject by automatically insert the needle and inject the contents. Fusion capable of delivering a wide range of pharmaceuticals with consistent and adjustable speed and force. The naloxone auto-injector for intramuscular or subcutaneous injection was fast-tracked approved by the Food and Drug Administration. Upon activation of the naloxone auto-injector by. Despite this, 3. 0–7. Several issues have been identified that may impede the use of currently available auto- injector devices in the management of anaphylaxis (3. The present review describes the delivery systems adopted by currently available auto- injectors and discusses the key barriers to the use of adrenaline auto- injectors, with the goal of identifying the . An auto-injector for dispensing a predetermined dose of medicament is disclosed. The auto-injector includes a needle cover that is configured to move from a retracted position to an extended locked position. Automatic injector with kickback. When the openings are aligned prior to activation of the auto-injector. The biasing force for the cover 150 is less than the activating force of the auto-injector 100. The premeasured auto- injector design allows those without formal medical training to use it as it does not require medications to be drawn up via a conventional syringe. This is of great importance, especially in high- stress medical emergencies, such as during an anaphylactic attack, and particularly for children who may find assembling a traditional ampoule/needle/syringe difficult, let alone having to inject themselves. Currently available auto- injectors require a simple multi- step technique, with instructions printed on the package inserts . The main difference between the auto- injector devices is in the type of delivery system, which is either cartridge- based or a syringe delivery system. One disadvantage inherent with syringe delivery systems (Fig. An extra operational step may increase the risk of misuse because patients have to memorize and undertake the correct operational sequence at a time of high stress and urgency. After thumb activation, the released spring moves the prefilled syringe to its end position, at which point the needle pierces through the tissue. The piston rod is also moved to its end position, and the position of the end stop determines the volume of medication ejected. Therefore, with a syringe delivery system, delivery of adrenaline may start as soon as pressure is applied to the piston rod. This may result in deposition throughout the needle track, resulting in loss of some or all medication before reaching the target muscle. Design overview of currently available auto- injectors for emergency self- administration of adrenaline in the treatment of anaphylaxis. The effective penetration depth is a component of spring force applied, needle length, bore diameter and how easily the tissue is penetrated by the adrenaline solution. The glass syringe is a limiting factor in the design and limits the force that can be applied by the spring compared to cartridge- based systems. In contrast, with a cartridge- based device, after the safety cap has been removed, the injector is activated by holding the outer housing and pressing the device tip onto the tissue, allowing the outer housing to move against the inner housing (black tip; Fig. After activation, the released spring moves the cartridge and the attached needle to its end position, which then pierces through the rubber closure and into the tissue. Because of the high power of the remaining spring force, the sealing disc of the cartridge (closure) bursts and opens the fluid pathway. Only then is the adrenaline released. The ejected volume is determined by the end stop on the attached piston rod. Therefore, in addition to having one less operational step, the adrenaline is only released once the needle is fully deployed into the tissue. This helps to ensure minimal loss of medication and delivery of adequate levels of medication to the correct location (i. Application of an adequate activation force applied to the device and maintaining this throughout injection compresses subcutaneous (s. An ultrasound investigation into the role of compression has shown that an 8 lb (3. Ana. Pen, based on the s. Three forms of this product are available, named Ana. Pen 5. 00, Ana. Pen 3. Ana. Pen 1. 50; which contain 0. Both Ana. Pen 1. 50 and Ana. Pen 3. 00 have been licensed for use in the UK since 2. EU since 2. 00. 3, with Ana. Pen 5. 00 licensed in 2. Epi. Pen is a single use, cartridge- based adrenaline auto- injector. The device was released in the EU in 1. Epi. Pen Junior, which contains 0. Both Ana. Pen and Epi. Pen are also produced as training devices. These are needleless replicas of the actual devices that patients can use to practice using the device with a trainer (3. However, these current training devices only replicate the sequence of administration steps and do little to provide the patient with any of the sensation of an injection by auto- injector. A third adrenaline auto- injector, Twin. Ject, is available in the USA only. Twin. Ject is a syringe- based device that, unlike Ana. Pen, contains two doses of adrenaline. The first is injected in the traditional manner. To access the second dose, the patient unscrews the needle end of the device and removes the adrenaline- filled syringe from within the device. If symptoms have not improved within 1. Two forms of this device are available: one containing 0. Problems with the use of adrenaline auto- injectors.
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