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| What is a Single Use Medical Device?A single use medical device (SUD), also known as disposable medical device, is primarily designed for one time use.
By: David A single use medical device (SUD), also known as disposable medical device, is primarily designed for one time use. These products are designed with short-term convenience rather than long-term durability in mind and specifically made for critical performance and sterility. However, some medical devices will always remain multi use or reusable as producing them for single use may not be possible, economical or safe for human use. SUDs need to be inexpensive, as they are only for one use, hygienic, as they are sterilized once in the factory and usually cannot be sterilized again and safe, as they should cause any risks to human health, without compromising on functionality or usability. SUDs need to be efficiently designed for repeatable manufacturing. This requires understanding of the end user requirements and balancing it with cost, reliability and shelf life while considering appropriate materials and manufacturing processes for a given scale. Background: The first SUD was developed in 1948. Before this, medical devices were considered reusable. The practice of reusing SUDs initially was thought to be safe. However, after several reports of contracting fatal diseases or immune reactions, providers began resorting to single use of certain devices. During the 1970s and 1980s, technology resulted in usage of plastics in medical device designs and equipment manufacturers began to label single use only in order to prevent the potential harm to patients due to improper reuse. Usage & Applications SUDs are primarily used by hospitals and healthcare facilities to reduce cross contamination risks between patients, especially blood transmitted diseases like hepatitis and infections like human immune deficiency virus (HIV). Some of the commonly used SUDs include: • Needles, syringes and patches • Bandages and wound dressings • Infusion and transfusion catheters • Surgical gloves, masks, gowns and shoes • Surgical instruments such as graspers, hemostats, occluders, speculums and suctions devices • Urine bags and medical waste collectors • Applicator sticks for mouth care, dressing sets for mother and child, radiology sets, surgical accessories, suture sets, disinfection sets, hemodialysis sets, crepe and conforming bandages, stockinet and non-woven surgical unit wiping and sterilization sets. The latest trend is to reprocess some of the SUDs for reuse in order to reduce healthcare costs and to reduce pollution in the environment. Reprocessing can be beneficial only when undertaken under strict regulatory conditions, or else it may create a hazard affecting everybody involved with SUDs. A report on CBS Net indicates that with hospitals planning cost cutting measures, turned to reprocessing SUDs which has created an outside market of third-party reprocessors. # # # GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format. End
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