The user interface allows the user to receive information from GIIP output devices and input data/commands through GIIP user input devices.The environment (cloud) is constrained to physical properties such as temperature, pressure, sound, and radiation energies. A pump delivery mechanism provides the force for moving insulin from the pump to the user at a prescribed rate and for a prescribed duration.The user/patient interacts with the GIIP through the GIIP user interface. The drug delivery interface represents a segment of concealed tubing connecting insulin flow from the reservoir to the infusion set. Along this path, the drug reservoir acts as a built-in storage unit for insulin that will be monitored and administered. Generic Insulin Infusion Pump ArchitectureThe GIIP administers insulin to the user via a delivery path, composed of a drug reservoir, a drug delivery interface, and the infusion set. Manufacturers claiming to use this preliminary hazard analysis in their design process still have to establish sufficient evidence to the FDA that their device is safe and effective. However, these activities are beyond the scope of this article.Manufacturers who reference this generic analysis in their design process may benefit from checking their results against this independent work. It is imperative that the diabetes community and insulin pump manufacturers work together to comprehensively address foreseeable risks and establish risk control measures (i.e., process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels ) that reduce overall risk to an acceptable level.We believe it would be helpful to the diabetes community to establish a common insulin pump safety reference model. Food and Drug Administration (FDA) indicates that there were over 5000 adverse events reported for insulin pumps in the year 2008. These risks are rooted in the complex technology itself, development and manufacturing errors, individual differences in physiology and lifestyle, and because the devices are operated by patients themselves, on a daily (24/7) basis, and in diverse environments.The Manufacturer and User Facility Device Experience database maintained by the U.S. Pumps used for subcutaneous insulin delivery not only provide patients with increased convenience and flexibility, but also provide the potential for greater dose precision, more reliable insulin action, and relatively quick dosing adjustments for different lifestyle activities.While insulin pump technology has helped patients lead a more normal, healthy life, the devices do present risks (i.e., combination of the probability of occurrence of harm and the severity of that harm ) to the patient or user of the device. These pumps are typically used to help maintain blood glucose (BG) levels by delivering rapid-acting insulin through a catheter placed under the skin. IntroductionInsulin pumps play an important role in modern diabetes treatment. This is useful for determining the best course of action when selecting materials, developing monitors, controls, and other design features for the product. This method is based off of logic gates to target all causation events or “gates”, are necessary to make the top level event occur.In the initial steps of development, it can be difficult to know specific hazardous events that might occur, but there are still high-cost baseline hazardous events that could pose risk during development that must be considered. At the top of the tree lies the hazardous event that poses a risk, which then branches down to various levels of factors that cause this event to happen that need to be addressed. The two are similar in approach, but visually FTA is seen as a convenient way to estimate probabilities of frequency.
Methodology of hazard analysis in medical device developmentThe most common approaches to top-down hazard analysis in medical device development include Fault Tree Analysis (FTA) and Hazard Analysis and Critical Control Point (HACCP). On the other axis there is the evaluation of the severity of the event, or how risky the consequences are.
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