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KMID : 1142220230180010081
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 1 p.81 ~ p.89
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A Strudy on Improvement Methods for use Errors through Needle-free Injector Risk Management
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Lee Hyeon-Woo
Kim Sung-Min
Kwon Ji-Yun
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Abstract
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Needle-free injector were developed for various reasons, including the fear of needles, possibility of proliferation of disease through reuse, unintended pricking of the needle, and possibility of infection. Although needle-free technology reduces the patients’ concerns on the use of a needle, it is not possible to fully guarantee that safety issues such as negligence by the user will not occur. The safety and applicability of the use have become an important issue due to the advancement of medical devices. As such, the appropriate use by the patient is required due to the increase in medical device accidents arising from the negligent use. Therefore, this study researched the means of improving the error in the use through the evaluation of risk-management based appropriateness with a Needle-free injector. The needle-free injector is a medical device that injects liquid by passing it through the skin by means of micro-spraying, using the magnetic force and spring. The risk is evaluated after having performed the identification of factors and harmful situations in order to identify the error in the use of the needle-free injector by applying an advisory group review technique. Based on outcome of the evaluation, a formative evaluation is executed by assessing the software and hardware user interface requirements. By applying the brainstorming technique, a scenario for the use related to harmful factors is identified. which will then be used to deduce a scenario for the use for the summative evaluation. The intended user is professional medical personnel, and the evaluation of appropriateness of the use was executed in the operating room, which is the actual environment for the use. Lastly, opinions of the developers were asked by applying FMEA (Failure Mode and Effect Analysis) to the review opinions on the outcomes of the appropriateness of the use evaluation and the outcome of the risk evaluation conducted for the details of the identification predictable for harmful factors and situations. As a result, the means of the improvement of risk-management based appropriateness of the use was deduced by reflecting the opinions of 15 intended users and 5 developers for the 17 errors by the of a needle-free injector. It is anticipated that the development of needle-free injector will be helpful in improving the safety of and appropriateness of the use by the users.
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KEYWORD
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Needle-free injector, Usability, Use error, Risk management
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