In terms of medical devices, I believe accuracy determines how well the medical device functions to tackle the problem of treating the patient or problem it was made for. Precision is more of how finely correlated the medical devices are to each other: if they all have consistent results and results are reproducible across all medical devices, then this product has high precision. These factors are important to the FDA because the FDA has to regulate all of these products and make sure the medical devices are accurate and precise. In other words, the FDA has to regulate each medical device to make sure it functions to perform its intended purpose and is consistent along all medical devices. Throughout the phases of medical device development, Design Verification & Validation assist with the accuracy and precision of a medical device. Design verification is the process of deciphering if a medical device meets the specific requirements. Design validation is the process to determine if the medical device meets the customer's expectations and requirements.
With repeated use and over a period of time, all equipment tends to degrade which affects its accuracy and precision. In the medical device industry, a drift in the measurement is unacceptable. For medical device manufacturers, the precision and accuracy of a device is of utmost importance. So the medical device industry is regulated by strict standards by FDA.
In a nutshell, FDA guidelines for calibration of a medical device follows :
1. Equipment calibration must be carried out routinely, as per the company's written directions.
2. Calibration of every device that needs to be calibrated must be document.
3. Acceptable limits for accuracy and precision must be specific.
4. Calibration personnel must be trained.
5. Calibration standards must be traceable to the national standards, in-house standards (if necessary) or other acceptable standards have to be used.
6. Provisions have to be made for evaluating adverse effects caused by the defective equipment and corrective measures must be taken.
Precision and accuracy both separately or collectively play an important role in the the development of medical devices. For some medical devices one can play a more significant role than the other. For instance, a medical device used to collect data requiring post processing can be later calibrated, so precision would play a more important role here. On the other hand, a medical device requiring the display of live feedback would rely on both factors. On the other hand for other medical devices such as implants it would be important for the FDA to monitor the manufacturing processes to ensure that each unit is of high accuracy to a standard value. Therefore both are important factors that the FDA needs to monitor for the safety of a user’s health while for some scenarios one might play a greater role over the other.
Precision and accuracy are important when it come to developing medical devices because you are dealing with human. If something is not precise when it comes to medical device then you are risking someones life and that's why accuracy and precision are important to FDA. If FDA requires you to do clinical trials for your device then you should do it because they want to make sure that your device won't harm people and it will do what it is suppose to do.
Accuracy is how close the device's result is to that of a reliable “gold standard.” It is of prime importance because an inaccurate measurement or recording can lead to an inaccurate diagnosis which can definitely be fatal. The accuracy of the device qualifies how it performs in comparison to existing values. With precision, the FDA evaluates if the device is functioning as required and with the same accuracy every time it is tested repeatedly. Accuracy and precision are of the utmost importance for medical devices to be validated. There have been many instances where the FDA has ordered a recall of medical devices due to its lack of precision and accuracy.
Accuracy is defined as how well a value agrees with the a standard measurement of comparison. In regard to medical devices, accuracy can mean a few things. First, the accuracy that the product proves to be effective in its intended use. This is very important to the FDA because the device must be tested and proven safe for a specific application, but also proven to work every time it is used. For instance, it would be a large problem if a device was released on the market that was only effective 50% of the time. Secondly, accuracy of a medical device can also be in regard to the actual measurements the device is producing. If a blood pressure cuff were to constantly give a reading well over or under the actual measurement of the patient, well that device would not be very accurate. This is important to the FDA to prove that the device works every time and that readings are authentic measurements.
The same point in relation to accurate readings produced from a device can also be made for the importance of precision in a device. Precision is defined as how close values are to one another, and as for medical devices, precision can be in relation to how well the device the works on a consistent basis. What I mean by this is, if the same blood pressure cuff were used multiple times on the same person, it should produce consistent readings. This is important to the FDA in proving the device is consistent in usage and measurement.
let's make the question as, what does it mean to have an imprecise and inaccurate medical device?
The answer would be, that would not consider a medical device, it can count as a broken device. If the device does not give results that can give a meaning for the user that is a big problem.
for example if i am doing a CBC before a surgery, and the real result for my hg is 11, if the device was precise and inaccurate the reading might be around (6.5, 6.8, 7) or even (15, 15.5, 15.4) and if I have an accurate device but imprecise the first run i got 11.5 then second 9 or 10, but the thing is for a boarder line real result that will be huge misleading for medical decision.
So why it is important? my answer would be as simple as saving human life.
Precision and accuracy would be vital in the creation of an effective medical device. The comparison between precision and accuracy can sometimes be a bit tricky. During multiple tests if a product has similar outcomes then it can be considered precise. However, if these outcomes vary from the expected outcome, it would not be considered accurate. For a product to be accurate and precise, it must be able to repeat expected outcomes multiple times. When considering that with medical devices, it is vital that they are both. For example, there are some medical devices that are used for drug delivery. If the device administers a certain amount of the drug consistently, but the amount being administered is incorrect, that would be a major issue. This would mean the device is precise but not accurate. Similarly, if the device administers different amounts of a drug each time, the device would be considered imprecise, even if the average of all the drug administered is accurate. From this example alone, it can be seen how medical devices must be both accurate and precise. Otherwise, there could be disastrous consequences. For this reason, the FDA takes these aspects into account before providing a medical device with FDA approval.
Precision and accuracy are two important foundations of judgment that consumers sometimes neglect. The FDA's decision on any medical equipment, drug, or product is heavily influenced by how effectively these two requirements are satisfied. If a frequently used medical equipment fails to meet precision and accuracy standards, it might lead to patient misdiagnosis, which can be deadly. The FDA issued a recall on a 3D revascularization device made by Penumbra inc. on June 8th, 2017. There was a danger of the delivery wire breaking or detaching during the surgical insertion of this device. As a result, broken delivery wire fragments might end up into the patient's brain. This has a number of significant negative health consequences for the patients.
This example demonstrated that, although serving its job well, the gadget was unable to demonstrate its accuracy. Although not all cases of precision and accuracy are as serious as this, it demonstrates how critical it is for all medical equipment to adhere to their rules as closely as possible.
Precision and accuracy are very important to the scientific field. Accuracy is how close the value is to a standard while precision refers to how close the values are. What roles do precision and accuracy play into medical devices and how are they important to medical devices? Why are they so important to the FDA?
Accuracy and precision play an extremely important role! The exactness of clinical gear is particularly significant on the grounds that it impacts the general yield, identifying with both quality and productivity. This can basically interfere with the well-being of someone and either increase or decrease health. The FDA is responsible for ensuring the safety of medical devices. If they don't meet FDA standards it can cause trouble for doctors and patients.
Precision and accuracy are very important to the scientific field. Accuracy is how close the value is to a standard while precision refers to how close the values are. What roles do precision and accuracy play into medical devices and how are they important to medical devices? Why are they so important to the FDA?
Accuracy is important for medical devices because the purpose of the device to create an instrument to fulfill a purpose that provides the right results. Precision is important because you want the quality of your device to function as designed. These are both important roles for a medical device because these factors are what makes a device guaranteed to work. This is important to the FDA because, seeing how medical devices are used repeatedly, the equipment degrades in which the precision and accuracy becomes affected. Therefore it is important to keep devices serviced as needed.
Precision and accuracy are very important to the scientific field. Accuracy is how close the value is to a standard while precision refers to how close the values are. What roles do precision and accuracy play into medical devices and how are they important to medical devices? Why are they so important to the FDA?
Precision and accuracy play a very important role in the scientific field. As they are both needed and have roles to play. Precision can be used to attest to the quality of the product. Accuracy can attest to how the product is going to meet the needs of the user. Together they both will ensure that there is a quality product is on the field for clients and that it does what it is intended to do. Precision and accuracy are important to the FDA because without the two they can lead to a misdiagnosis and complications that can be prevented.
Precision and accuracy are very important measurements in science especially when dealing with medical devices and quality control systems. These two measurements have a direct impact on patient health. The FDA requires that medical devices should be precise producing the same results every time. This ensures that people are receiving effective care every time the device is in use. However, there could be limitations outside of the medical device company's control that could effect the precision of the device including environmental changes, a lower quality of the product, manufacturing defect, or simply due to wearing and tearing of the devices. Companies must be aware of these outside factors that could affect accuracy and precision and plan for them accordingly.
Precision and accuracy are essentially different ways of saying effective and safe. When something is precise you achieve a more predictable result. In terms of medical devices, if a 100 trials show that heart valve works perfect for only 6 months it is has a precise effect. If a patient only needed a heart valve for 6 months (unlikely), then these results would show effectiveness of the device through their precision to consistently achieve a desired result. Accuracy is whether your result is acceptable. If your heart valve should last 5 years and it only lasts 6 months, it is not accurately performing its purpose and therefore is not safe. In terms of the FDA, precision and accuracy are of utmost importance and should be at the core of every question and regulation.
@gaberuiz13 Great point here regarding the fact that precision requires devices to perform in a similar way consistently so that the same results are produced each time. Branching off of that, its especially crucial for validation or comprehensive checks where reproduction of the same result with little to no discrepancies is desired. Precision is most dependent on technique which has everything to do with automation of the product. Whist designing a product, trying to reduce the number of times a result is discrepant when trying to produce the same exact precise result would mean a minimized risk of possibly having to make a revision and adding a measurement step which is going to be costly and inefficient with regards to time. There is cost that it would add to the systematic approach to the product as well as adding cost with documentation and training.
