Human Factor Analysis of Humira Auto-Injectors - Article Example

Human Factor analyzes of Humira auto injectors Insert Insert INTRODUCTION Background Information Humira auto-injector pen is an integrated medical device that is designed for delivering a single dose of a particular drug and is mostly used for self-injection. It is used in the treatment of Rheumatoid arthritis, Juvenile idiopathic arthritis and Psoriatic arthritis by use of a biological disease modifier known as Humira autoinjector pen. This Humira auto-injector controls the above diseases and other chronic diseases that result due to tumor necrosis factor. The Humira auto-injector pen is self-administered, and this makes it more advantageous over other injectors since is portable and enhances convenient and flexible scheduling. The patients affected by these chronic diseases require self-administration of medication, which is easy to use and available through the use of the convenient device, which adheres to therapy and reduces the pain. This Humira pen offers all these requirements, which make it more preferred by patients compared to other prefilled syringes. (Simons, 2007). The Humira auto-injector is made such that it can facilitate self-administration effectively to untrained personnel. It is mostly injected into the thigh or the buttocks, and its design makes the injection effective. It has a lower protective cap that ensures the needle tip is shielded by injection and Upper protective cap that play an important role in ensuring no accidentally firing. It also has a yellow bar that acts as an indicator to show that the full dose has been delivered. It also has the Firing button that when pressed the needle is inserted automatically, and the drug is delivered. This makes the Humira auto-injector pen effective in drug delivery. (Nussbaum, 1999). Problem Statement Although the performance of the HUMIRA auto-injector pen is easy to use and more convenient to use, it has shortcomings that need to be analyzed to prevent side effects it can cause to the patients. The shortcomings that are caused by the design and its components may be overlooked or put under serious consideration depending on the effects it can cause to the patients that use it. One of its shortcomings results due to the HUMIRA auto-injector containing a glass syringe, which may result in contamination of the drug. The glass syringe is prone to contamination, and this can cause serious negative effects to the patients using the device. (Lin, 2001). The high dexterity required when using the autoinjection pen is also a problem as many users of the device may vibrate during the administration of the medication thus resulting to effective administration of the drug. In addition, the high dexterity may break the glass syringe, which is fragile and requires great care while handling it. This becomes a shortcoming of the device, which needs to be looked at. HUMIRA auto-injector pen also has small inspection window for checking whether the entire drug have been delivered. This makes the patients strain very much to check resulting to others unable to find whether all drugs have been delivered or not. This results to improper medication, which may result in serious side effect to the users of the device. The inspection window, therefore, needs to be made more visible to the users for effective use of the device by the patients. (Nuts, 2004). Such issues about the HUMIRA auto-injector pen should be put into consideration to enhance effectiveness and success of the device in medication delivery. Methods of data collection 1. Direct interviews To test the effectiveness of the auto-injector HUMIRA pen, I choose 20 participants comprising of 10 men and 10 women aged between 18-40 years. I used the usability testing method in my testing of the HUMIRA pen. The twenty participants were family members, neighbors, and friends. Everyone was educated, therefore; I gave each a written instruction on how to use the Humira pen. They were then to perform a test on how to use the pen and they had to do the injection into a small pillow. Each had to do at a time, and I observed each participant keenly and took notes on the same. I also checked and noted if they followed instructions correctly and performed the task properly and finally evaluated all the participants. (Lin, 2001). Below is the procedure that the participants were to take to enhance the effective use of the auto-injector pen to enhance medication delivery. 1. First, ensure the pen has the drug you want to inject. 2. Then hold the pen in your hand firmly and make it come into contact with the area of injection (it should be either thigh or buttock but for the experiment was the pillow) 3. Ensure the pin is at an angle of 90 degrees to the point of injection. 4. Ensure no trembling or your hand is not shaking. 5. Then press the firing button and the drug is delivered. 6. Ensure all the drug is delivered by checking from the inspection window then remove the pen from the injection area. I also used two types of questionnaires, which included paper pencil questionnaires and web-based questionnaires. 2. Paper-pencil-questionnaires I also used this type of questionnaire where I asked questions pertaining the HUMIRA pen and out of the 50 questionnaires, I had distributed only twenty were completely answered. Among those, I issue were 20 patients aged 23 to 60 years who had used the pen for more than one month the various users outlined their views about advantages and challenges they faced while using the pen. Results Direct interview results From the 20 participants, I noted that most of the participants had activation problems were some took much time. The firing button also made greater noise that terrified the users making them not to apply it effectively. Some of the participants, I also found they activated the injector even before placing it on the pillow and activated it even when the cap was still on. Some also twisted the pen during injection and bend it that making it unable to make an angle of 90 degrees with the pillow. The participants committed these only possible errors. Below is a table showing the results. Participants Men women observation 7 6 Twisting pen during injection 6 5 Removing firing button 5 7 Not making an angle of 90% during injection 4 6 Activating device before placing on pillow 5 4 Activating device when cap is still on 6 3 Long activation time 6 7 Overall activation error 5 6 Difficulty in finding if all drug is delivered The above results showed that the participants did not follow effectively follow the instructions leading to the various also difficulties in observing if all drug was delivered emphasized on more analysis of the device to make it more effective. Paper pencil questionnaire Results The device satisfied most of the feedback from the questionnaire showed most of the people, but some amendments needed to be made to make effective. Some said it was more portable and less painful compared to other syringes. The feedback from the 20 patients showed that although the device was better it had some complications while using it. The table below shows the advantages and issues that needed to be analyzed as per the 20 patients went through. Patients Their view 14 Device was more effective compared to other syringes 12 Easy to find out when the delivery is complete 7 Inspection window is too small and needs to be enlarged 8 High click noise when activated which made the patients lose control while injecting 9 Pinching skin with one hand and injecting with another hand was a great challenge mostly to females 12 There were stains in the glass syringe. Apart from the advantages the participants outlined it is evident that more analysis was required to make an improvement on the syringe. Analysis I did analysis based on the feedback to enhance the effectiveness of the device. Below are the criteria I employed in the analysis. 1. Design and Evaluation method The information about the usability testing where I used 20 participants could be used to evaluate the design and evaluation of the device. The design of the Humira auto-injector has led to the availability of advanced injection device that has led to great benefit to many patients and medication in general due to its self-administration and easy to use. Its design also makes it have broader use of drug and user requirements through simple adaptation. Unfortunately, there is a lack of detailed information and knowledge on how the key design parameters affect the overall performance of the injector. This has led to difficulties and problems by patients to meet their new medication needs. (Lin, 2001). I have done one mathematical modeling to provide a clear analysis of the design and evaluation of the device. This modeling has led to important design parameters like the injection time, injection force and shear stress on the drug, which can be determined. Injection time, for instance, should be short, as many users prefer it to be short. This is made possible by changing the needle diameter. Thus, I increased the diameter of the needle by 5% of nominal, which reduced the injection time by 23%. (Lin, 2001). The figure four below shows how the length and diameter of the needle affected the patients. FIGURE 3 also is a sketch graph representing the same whereby in the two increase in diameter lowers injection time. Figure 3 Y-axis Time Taken For Injection Diameter of needle X-axis 1. Engineering Anthropometry and Biomechanics Design I also analyzed on the specific sizes and how the device needed some amendments on the sizes of its components to make it more effective. The inspection window was small, many patients were unable, and others trained to know when the entire drug was delivered. The diameter of the needle and length also needed some amendments. The length of the needle is very crucial since it has to deliver the drug to the respective place in the body. According to my research, many auto-injector needles are very short thus unable to deliver the drug effectively. This has affected mostly women in preference to men. I made my pen with a longer needle of 12.7mm, and this is to curb the problem of incomplete administration of the drug. The needle also has the required length thus cannot cause injuries to the users. The diameter of the needle was also another area I analyzed as patients required less time in the delivery of the drug, and this could be possible by increasing the diameter of the needle by 5% which reduced the delivery time of the drug. I also enlarged the inspection window by 5% which could make it easier for users to know when the delivery was complete. The figure four above shows the effects. (Shang, 2014). 2. Human cognition and decision-making From the feedback I got from different participants, many people who were affected by the biological diseases had interest for the use of the Humira autoinjector pen. They viewed it as better compared to other ordinary syringes. However, they also outlined some challenges that resulted from the device. From the results of the 20 Participants, it was evident that the users would face challenges while doing the injections thus calling for more attention while performing the same. In addition, their arguments on certain issues I analyzed to fit their requirements and decision. (Nussbaum, 1999). 3. Human sensory systems design I also analyzed on the human and the device interactions and made the possible adjustments to ensure the interaction was an effective one. I increased the inspection window to curb the vision issue where the patients strained to determine when the delivery was complete. Also ensured the firing button did not produce much noise thus ensuring the comfort of the patients. The pen was also portable which made it convenient for patients. These adjustments made the interactions between the users and the device a better one for effective self-administration. (Nuts, 2004). 4. Workload and human error The human errors that resulted from a failure to the user the correct procedure and others resulting from the device I analyzed and came up with the possible solutions. The activation time, which was long, could be reduced by increasing the needle diameter; only one cap could be used to avoid user confusion. (Decker, 2008). The size of inspection window could be enlarged to avoid straining in determining drug delivery. This could ensure effective administration of the drug to the body. The patients could also follow carefully as errors such as twisting pen and placing at wrong angle occurred due to carelessness. The high noise of the firing solutions could be minimized to enhance comfort to the patients. If the above errors could be viewed carefully and the possible solutions employed, then the workload and human error could be minimized and eventually eliminated. (Lin, 2001). Recommendations I recommend the design of Direct interview which involved usability testing results and other designs to enhance the effectiveness of the device. From the feedback and findings from the analysis, I recommend the following to ensure effectiveness in self-administration of the drug by patients. (Simons, 2007). I recommend the dexterity effects to be reduced as the high dexterity affected the patients negatively. The long activation time could be reduced by enlarging the diameter of the needle and reducing the strength required to hold the firing button. The inspection window should be increased to curb the patients’ problem in determining the delivery of the drug. The length of the needle also needed to be increased to ensure the drug reached the respective tissues in the body more so to the women and children. The pen is not that stable that I recommend for a holder to be made to enhance stability. (Robert, 2002). The table below also shows some recommendations for the device to enhance effectiveness. The adjustments I recommend for the HUMIRA autoinjector pen. Should have only one cap To reduce the instructions to follow. Should have reduced injection force To take care of rheumatic and arthritic patients It should have holder To increase stability Inspector window should be larger For easy monitoring of drug delivery Use of plastic syringe instead of that of glass It will reduce chances of contamination of the drug. Minimize loud click on firing button This will ensure comfort of patients The figure below shows the HUMIRA pen design I recommend. If the above recommendations are put into consideration, then the device will be of great help, and various challenges will be minimized and eventually eliminated. The price should be patient friendly too. References 1. Robert, l. (2002) Drug delivery. Chemical & Engineering article vol.80 (34), pp.39-47. Retrieved 2015-06-07 2. Wang, N.X & Von, H.A. (2011). ‘’affinity-Based Drug Delivery”, micro mol Biosci vol. 11, pp. 321-332 3. Shang, S. (2014) United States Patent. US 8758301B2. Retrieved from https://www.google.com/patents/US8758301 4. Nussbaum, M., Kroemer, K., Wojcik, L., (1999) Figure Force Capability: Measurement In addition, Prediction Using Anthropometric and My electric Measures. Angela DiDomenico Astin. 5. Decker WW. (2008). The Etiology and Incidence of Anaphylaxis in Rochester, Minnesota: a Report from the [PMC free article] [PubMed ] 5. Gosbee LL. Nuts (2004). .! I Can’t Figure Out How to Use my Life-Saving Epinephrine Minnesota: a Report from the [PMC free article] [PubMed ] 6. Simons F. (2007). . Self-inject able Epinephrine for First-aid Management of Anaphylaxis. Pediatrics. [PubMed] 7. Lin L. (2001). The Role of Human Factors Engineering in Medical Device and Medical System Errors. Clinical Risk Management: Enhancing Patient Safety. London, England. Appendix Read More