What Is an Infusion Pump?.pdf
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An infusion pump is a medical device that delivers regulated fluids, medications, and nutrients to patients, with various types designed for specific uses such as ambulatory, enteral, and insulin delivery. Over time, these pumps have evolved from bulky early models to sophisticated, smart devices that enhance patient safety and efficiency while addressing design flaws through regulatory oversight. However, safety concerns remain, prompting the FDA to implement stricter standards to mitigate risks associated with these devices.
What Is an Infusion Pump?.pdf
- 1. What Is an Infusion Pump? An external Infusion Pump is a medical device that allows a patient to receive fluids in a regulated manner. Infusion pumps come in a range of shapes and sizes, and they’re utilized for a number of reasons and in a variety of settings. https://www.facebook.com/BLXMedical/photos/a.1027761811355497/1068526523945692/ Infusion pumps can supply large or little volumes of fluids, and they can be used to give nutrition or pharmaceuticals like insulin or other hormones, antibiotics, chemotherapeutic treatments, and pain relievers.
- 2. Some infusion pumps are intended for usage at the patient’s bedside alone. Ambulatory infusion pumps, for example, are meant to be portable or wearable. Several regularly used infusion pumps are developed for specific use. These include: Enteral Pump: A pump that delivers liquid nourishment and drugs to the digestive system of a patient. https://www.instagram.com/p/CYrlq5VIRxx/?utm_source=ig_web_copy_link Patient-controlled analgesia (PCA) pump: A pain medication delivery pump that has a function that allows patients to self-administer a predetermined dosage of medicine as needed.
- 3. Patient-controlled analgesia (PCA) pump Insulin pump: A pump that is generally used to administer insulin to diabetic patients. Insulin pumps are often used in households. Electrical or mechanical power can be used to power infusion pumps. Pumps function in a variety of ways. Insulin Pump For example: Fluid is retained in a syringe’s reservoir, while a moving piston regulates fluid delivery in a syringe pump. Fluid is kept in a flexible balloon reservoir in an elastomeric pump, and pressure from the balloon’s elastic walls drives fluid delivery.
- 4. A series of rollers clamps down on a length of flexible tubing in a peristaltic pump, pushing fluid ahead. Fluids can be supplied from several reservoirs at different rates using a multi-channel pump. A “smart pump” has safety measures including user-alerts that trigger when a danger of a hazardous medication interaction exists, or when the user alters the pump’s settings outside of predefined safety limits. https://www.youtube.com/watch?v=GGqtFormgXY&t=2s How have Infusion Pumps changed over time? Infusion Pump in 1930. Infusion pumps are being used in hospitals all around the world. These life-saving medical equipment are used to directly feed and medication patients. Infusion pumps, on the other hand, were not historically ubiquitous in hospitals. It wasn’t until 1970 that the first effective infusion pump was created. There were earlier versions, but they were clumsy, unavailable to most hospitals, and difficult to operate.
- 5. Infusion Pump in 1971. Thankfully, Modern infusion pumps are smaller, easier to operate, and more effective than ever before. Here’s how infusion pumps have progressed over time, as well as what the future holds for them. First Infusion Pumps:- Intravenous medication was first used in 1492, but it wasn’t until the 17th century that considerable progress was made. Christopher Wren (a prominent English architect) created the first IV infusion system in 1658. Infusion Pump in 1951. Scientists began researching methods to give fluids and drugs intravenously using needles after Wren’s device was
- 6. developed. Their studies, unfortunately, did not proceed as anticipated. As a result of these research, many individuals died, prompting the British government, the French Parliament, and the Vatican to prohibit blood transfusions. This prohibition lasted more than a century. It wasn’t until it was lifted that IV medication progressed again. Additional Innovation:- The beginning of progress occurred in the early 19th century. After learning from previous failed attempts, careful scientists decided to try again: The infusion procedure must be carried out slowly. They must get familiar with air embolism and how to avoid consequences. They must prevent overload. As a result, infusion pumps with regulated flow were developed. Intravenous medicine advanced significantly during World Wars I and II. Plastic tubing replaced rubber, vaccination bottles were designed to reduce the risk of air embolism, and subsequently, these vacuum bottles were completely replaced with plastic bags. Finally, Dean Kamen devised the
- 7. ambulatory pump in 1970, allowing patients to wander around during therapy. Kamen’s pump also delivered fluids and drugs at predetermined times. Other advancements in infusion pumps occurred in the 21st century. Pumps have become considerably easier to operate, more effective, and safer for patients thanks to smart pumps. The Future:- You might be wondering what infusion pumps will look like in the future now that you know how they’ve grown through time. Nobody knows what the future holds, but the all-in-one idea, an attempt to standardize infusion pump technology, is one initiative in the works. Scientists are developing a set of two pumps (volumetric and syringe) that may be implemented in a variety of situations. This will save hospitals time, money, and space while also speeding up and securing the infusion procedure. Medical practitioners may give their patients high-quality treatment by using Med One Group’s top-of-the-line medical equipment, such as external infusion pumps.
- 8. There are 3 Major Types of Infusion Pumps: Fluids are delivered into a patient’s body using infusion pumps. Infusion pumps have been used in hospitals since the late 1960s. These instruments provide medication and sustenance in precise doses. These devices are available for treatment in all medical institutions, and they are operated by trained medical personnel who know how to set the length and rate of fluid supply. Because they can give fluids at specific frequencies, quantities, and intervals, infusion pumps are preferable than manual fluid administration pumps. These pumps can be used to provide pain medicines, chemotherapeutic treatments, antibiotics, and insulin, among other medications. Infusion pumps are divided into several groups. Infusion pumps may be divided into several classes depending on a variety of variables. However, there are 3 different types of infusion pumps. Infusion pumps come in a variety of shapes and sizes: Infusion pumps are classified according to their purpose Infusion pumps are arranged according to the volume of fluid delivered
- 9. The mobility of infusion pumps is categorized IV pumps of various types based on mobility Ambulatory Infusion Pumps: Ambulatory infusion pumps are small, lightweight infusion pumps that are commonly used to treat persons with chronic diseases. Because they require medicine throughout the day, people with severe diseases may need to move around with their medical infusions. Such patients can be transferred while still getting their medication thanks to mobile and lightweight infusion pumps. This type of portable infusion pump overcomes the difficulty of administering medicinal infusions while on the road. Stationary infusion pumps: Because stationary infusion pumps do not require mobility, they do not need to be as small and light as portable infusion pumps. Patients with chronic diseases who are confined to their beds typically require
- 10. pharmaceutical or food infusions. For patients who require regular bedside feeding or medicine, the stationary pumps offer IV infusions at their bedside. Stationary pumps, unlike lightweight infusion pumps, do not need to be light. Infusion pumps are divided into two categories based on the volume of infusions they deliver. Syringe Pumps/Small Volume Infusion Pumps; These are infusion pumps that release little amounts of medicine in a brief amount of time. These are frequently used on newborns and young children. These infusion pumps are perfect for delivering little quantities of medicine, such as hormones, using a regulated motor mechanism that utilizes a plunger-style pumping device.
- 11. Large volume pumps (LVPs); The LVPs are infusion pumps that provide enormous amounts of sustenance or medicine. Electronic peristaltic pumps are frequently used by LVPs. The pump can be operated manually or by a computer-controlled roller. Classification of infusion pumps based on their functions. There are two types of infusion pumps when it comes to use. Specialty pumps and regular pumps are among them. Specialty Pumps: Specialty infusion pumps are created to satisfy the demands of certain medical situations. They are often used in the delivery of homecare or the treatment of certain conditions such as diabetes. Implantable, enteral, and
- 12. insulin infusion pumps are the three primary classifications of pumps in the specialty infusion pump category. Traditional Infusion Pumps: Traditional infusion pumps can be used in medical settings such as mobile, home, and long-term care. These pumps can be used to give pain medicine, antibiotics, chemotherapeutic drugs, and hydration fluids in both fixed and mobile settings. Traditional infusion pumps are further classified into four types, which include: Syringe Infusion Pumps Disposable Pumps Large Volume Pumps Elastomeric Pumps Do you or someone you know need an infusion system for medical reasons? Take your time to figure out what their medical needs are and which infusion pump would be best for them. A good option will ensure that medicine or food needs are delivered correctly and that the patient recovers quickly. A
- 13. customized infusion pump with a built-in heater can be utilized if a patient has a high fluid need or is chilled (hypothermic). This device is most commonly utilized in trauma patients who are chilly and require a lot of fluid and/or blood. FDA Calls for Reducing Infusion Pump Risks. Patient Safety The FDA stated that it is taking new steps to address safety concerns about external infusion pumps, including creating extra premarket standards for pumps used in all locations, including hospitals, clinics, and at-home settings. According to the FDA, they have been the source of “consistent safety problems”: Over 56,000 complaints of adverse occurrences have been received by the organization in the last 5 years. According to FDA statistics, 87 infusion pumps were recalled between 2005 and 2009 due to safety concerns. According to Jeffrey Shuren, MD, head of the FDA’s Center for Devices and Radiological Health, more than 700 deaths have been connected to infusion pump problems, although that number may be a “gross underestimate” because most deaths from the devices are not recorded as device malfunctions.
- 14. “Because these pumps frequently supply essential fluids to high-risk patients, failure has serious consequences,” Shuren explained. “It’s past time for a broader strategy than we’ve taken so far.” According to the FDA, infusion pump failures have been recorded from a variety of manufacturers and pump types, with many of the issues being linked to design and technical flaws. FDA is requesting that device makers disclose more design and technical information to the agency during premarket evaluation of infusion pumps in a new draft guidance and letter to device manufacturers. Additional risk evaluations were also required to support approval of new or modified pumps, according to the report. Defects in software, such as the failure of built-in safety alerts; Issues with the user interface, such as confusing on-screen instructions that result in dosage mistakes; and Components that break during ordinary usage, early battery failures, and sparks or pump fires are all examples of mechanical or electrical failures. The three most common causes of infusion pump failure, according to the FDA, are as follows: 1- Software Defects:
- 15. When difficulties develop, some pumps fail to trigger pre-programmed alarms, while others do so even when there isn’t a problem. Over- or under-infusion can be caused by other software faults. A software issue known as “key bounce” caused an infusion pump to occasionally detect one keystroke (e.g., a single zero, “0”) as several keystrokes (e.g., a double zero, “00”) in one instance. 2- . User Interface Issues: Numerous reports of muddled or unclear on-screen user instructions have resulted in incorrect drug dosages or infusion rates being programmed. The infusion pump screen, for example, may not make it apparent which units of measurement (e.g., pounds vs kilo-grams) should be used to enter patient data, resulting in incorrect dosage. 3- Mechanical or Electrical Failures: Other issues documented include components breaking under normal operation, such as pump housings; early battery failures; and sparks or pump fires. Each of these sorts of accidents poses a danger to patients, including the possibility of crucial fluids being over or under-administered.
- 16. However, what is the most prevalent cause of battery failure? This can involve batteries not being replaced during the suggested end-of-life regular maintenance, or when the patient forgets to plug in the infusion pump after ambulating, causing a low battery message and alarm to display, which is normally too quiet to be noticed. Is there an easy solution? Yes. Every one of the aforementioned difficulties, according to the ECRI Institute, may be avoided or at least managed with improved technology management. To begin with, electrical damages such as premature battery failures are perhaps one of the simplest to rectify provided the appropriate technology is used. Currently, healthcare staff frequently need to transfer patients with two devices since there is a continual fear that one would fail during transit by ambulance or hospital (source).
- 17. According to Smiths Medical warnings: 8 potential issues with infusion pumps. Regarding their Medfusion 3500 and 4000 infusion pumps, Smiths Medical and Hi-Tech Engineering issued an urgent field safety alert in Europe. The business sent out the letter to inform customers of eight possible problems with their pumps. False alarms, unexpected empty battery alerts, and irregular circuit board activity that compromise the internal clock system are some of the problems. For more: https://www.drugdeliverybusiness.com/smiths-medical-warns-infusion-pumps/ Additionally, problems with the clearing of programme volume given, erroneous bolus or loading dosage time display, and network design that affects pump communications all contribute to the possibility that infusion will continue even after a system failure. According to the letter, Smiths Medical has received reports of seven significant injuries and one fatality related to the eight possible concerns it identified.
- 18. There have been no recorded injuries or fatalities as a result of five out of the eight potential issues with the Medfusion 3500 and 4000 infusion pumps so far. The intermittent volume over time delivery mode problem, the unexpected depletion battery alerts, and the false main audible alarm (PAA) system failure are the three that have given rise to such reports. The Medfusion pumps start an alert with both visible and audio cues when the clinician has to be notified. A backup alarm is activated if the pump senses a problem with the audible element of the alarm, which results in a PAA system failure. Any active infusion is stopped by the pump in the event of PAA system failure. The pump may mistakenly identify a PAA system failure under some circumstances, including significant electrical interference. The pump emits an alarm both visually and audibly if the problem arises. Depending on the patient’s state, a delay in therapy or stoppage might cause major injury or even death. Smiths Medical has learned of two significant injuries and one death that may be connected to the problem thus far. For the depleted battery issue, the pump’s smart lithium-ion battery pack, which powers the device when it is not connected to AC power, may enter a state where it is unable to communicate the status of the battery to the pump under specific circumstances with excessive pump wireless network activity.
- 19. When a battery communication timeout alert occurs when the pump is powered by batteries, it assumes the battery is low and emits an unexpected depletion battery alarm, which might cause therapy to be interrupted or delayed. Four major injuries that may be connected to the problem have been documented thus far. If the pump doesn’t shut off in this situation, too much medicine may be delivered, which might be fatal or seriously harmful. There has been one complaint of a major injury that may be connected to the problem, according to Smiths Medical. For more articles and study material please visit on below link: https://www.hitech-ly.com/blogs/ For product updates and contacts visit on below link: https://www.facebook.com/BLXMedical/?ref=pages_you_manage https://www.linkedin.com/in/hi-techengineeringly/