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First generation product Before the 1980s, it was possi […]
First generation product
Before the 1980s, it was possible to intermittently enter the venous system by inserting an oblique hollow needle into a latex cap placed along the drug delivery device or at the end of the drug delivery device. The needle is usually fixed with a strap, which is easy to break. Soon after, emerging technologies were combined with the engineering controls required by the Boodborne Pathogens Standard of the U.S. Occupational Safety and Health Administration (OSHA) to produce a new generation of connectors.
The first-generation device had a split diaphragm and could be operated repeatedly with a blunt cannula. These connectors are designed to meet the need for intermittent access to the venous system while eliminating the hassle of using needles. Separate septum connectors are used in conjunction with other emerging technologies, including safety catheters that usually provide recessed or retractable needles. Although this new technology has not been immediately or universally adopted, and the costs associated with its use often provide barriers to implementation, these first-generation safety products have successfully reduced the exposure incidents reported by medical staff. 3 However, the first-generation split septum product did not solve the problem of catheter blockage. When the blunt needle is separated, the split septum connector generates negative pressure. Any negative pressure during disconnection will cause retrograde flow to flow into the catheter lumen, thereby endangering the patency of the device.
Second generation product
In the 1980s, technology continued to evolve. The second-generation needleless connector replaces the septum design by using a backflow prevention valve activated by a female/female Luer connector. The process of connecting Luer's components produces a locking effect that exceeds the possible connection stability of the split ept product. Since the female and male Luer mechanisms are already recognized concepts in medical device design, it is easy for clinicians to understand and accept the integration of the Luer into the connector.
Like the first-generation connectors, the Luer device allows intermittent access and eliminates the need for needles. However, its unique design is compatible with the use of most syringes and eliminates the need for blunt needles. In addition, the backflow prevention design of the Luer activation valve helps to counteract any negative pressure that occurs when the syringe (or other Luer device) is disconnected from the needleless connector, and when used according to the manufacturer’s instructions, these products do not Shows increased security risks.
Unfortunately, it has been proven that the Luer-compatible design poses other non-infectious safety hazards for patients. The serious incidents that have been reported all involve incorrect product use. For example, in 1996 and 2002, the Institute of Safe Medical Practice warned the medical industry about the possibility of connecting syringes containing oral medications to the venous system by connecting them to a needleless valve. 4 In 2003, the U.S. Food and Drug Administration (FDA) issued a safety statement that when oxygen was accidentally connected to a needleless luer device, an alarm was issued after the death of a patient. 5 However, during these years, the venous system has also continued to develop. An implantable infusion port is introduced for patients who require long-term treatment.
For patients who no longer need peripheral infusion, the tunnel-type central catheter has become a viable option. When treatment is expected to last more than a few days, a peripherally inserted central catheter (PICC) provides a safer option.
The third generation product
With more advanced catheter designs and clinical needs to extend catheter indwelling time, the need to maintain patency has become an issue of increasing clinical concern. The replacement of the coagulation catheter is expensive and traumatic for the patient. Stasis in the lumen can also increase the risk of infection. To address this need, many solutions have emerged, including the development of valved catheters, the use of fibrinolysis to clear the catheter, and the introduction of positive displacement connectors.
The third-generation connector combines the existing lueractivated valve concept with displacement. When the syringe used for flushing is disconnected from the leur, this action will discharge a small amount of solution for flushing the catheter. Displacement is a passive function and will happen automatically. Once this action occurs, the remaining solution (usually heparin or saline) will remain in the catheter and there will be no more positive pressure. The positive pressure Luer connector is designed to reduce backflow into the catheter more effectively than a diaphragm septum or standard Luer connector.
However, although third-generation connectors have advantages over previous designs, they cannot completely or in all cases prevent occlusion. However, positive displacement connectors are now widely used to help reduce central catheter complications. Nowadays, examples of detached diaphragm, luer activated and positive displacement luer connectors are on the market and are commonly used in intravenous systems.
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