Any medical device must be both accurate and precise. Lets take a simple blood pressure cuff. If I put it on my arm and test it 10 times there should only be slight differences between each of the measurements. The device must also be accurate. This is important for the FDA because if they are approving a device to be used on or in the body then it is their job to make sure that the device will be consistent in its reporting (precise) and will show the actual value it is testing (accurate). If we are designing a machine that will test someone's reflexes in terms of how fast they react the device must be precise in that when the same person is repeatedly tested in the same conditions their reaction time should all be measured as similar. and accurate in that the device must measure the reflex time correctly. If the device cannot do both of these consistently then what use is it? Accuracy and precision are important for the FDA because it is one of the ways they can determine if a device is going to be useful if it is approved for use.
Calibration is the most necessary thing that helps in minimizing the uncertainity in measurements. Because of that there are less chances for errors.Especially when it comes to medical devices safety is the priority for FDA so precision and accuracy is most important.Precision and Accuracy states that how close the instrument will work as per the standards. This is utmost important factors as wrong values would affect the diagnosis and would be hazardous for patients. As time goes by there are some differences in measurements of instrument so for this FDA has safety standards for calibration for maintenance of original standards. FDA might recall for drift in precision and accuracy.
It is very important that the medical devices actually do what it says it will do. This is one of the requirement in the medical device amendments of 1976 that the medical device must be safe, effective and labeled properly. The device should not kill people, it must do what it’s supposed to and the device can’t have false information. FDA takes this very seriously to prevent any health risk associated with the device and they inspects, evaluate and regulates all necessary documentation for medical device companies.
Accuracy and precision are crucial factors that must be considered when developing any medical device. Medical devices today typically consist of multiple parts and dimensions. In addition, these products are produced in large quantities. It is up to the accuracy of the machines and processes that create these parts to remain both accurate to the drawings, and consistent. Without accuracy, companies begin to produce products that were not initially intended to be created and as a result presents risks to the consumers. In addition, without precision, some products may be accurate, and some may not. This lack in consistency presents risks to some consumers. For these reasons, the FDA finds the accuracy and precision of all medical devices to be particularly important. Because no single machine or process is 100% accurate or precise, marginal errors must be determined so that there is a range of specifications that must be met in order to be considered acceptable. From my experience working in the industry, I've noticed a great amount of time and effort has been put into producing test samples of every aspect of every product to be measured and tested. Elaborate statistical analyses are then made with the data extracted from these samples in order to determine if what we are producing is acceptable. On top of that, both hardware and software that are used in the development of these products must also be tested in order to ensure the prolonged accuracy and consistency of the items created.
Accuracy and precision are defiantly important when it comes to medical devices. Accuracy is the target goal that the device has produce and precision is how close each outcome, are from each other when being used. Any miss calculation can injury or even kill the person that bought the device. All medical device should be safe for people and should do what it is supposed to do. Before the medical device is distributed to the world, FDA needs to test the product multiple times to make sure all of the outcomes are correct because they can’t risk release a product device that can cause harm than good.
I agree that accuracy and precision are so important to the FDA. They cannot have a drug or device not pass those regulations because they will be used for the general population. If they do not follow the the FDA regulations it could be harmful to the general public. Ofcourse there will never be a device or drug that is perfect but they want to lessen the complications as much as they can. They need to be as precise as they can when it comes to the devices because usually the device is to be used without the user having to do much. So also the accuracy has to be at the best it can be so the device can be used the best possible way. Same for drugs if the drugs does not follow the FDA regulations it could be potentially harmful for the public.
Precision and accuracy are both fundamental aspects of medical devices to not only the FDA but those developing the device as well. In order for a product to be functional and successful, one aspect cannot be without the other. If a device is precise but not accurate, then it is not performing at the level that it should be. In other words, it is not fulfilling the need it was meant to fulfill, instead it is doing some other purpose. If a device is accurate but not precise, then it is an inconsistent device, which is arguably a bigger problem. If you cannot predict how the device will act reliably, then it is really a liability, since you won't know if the device will work when you want it to. However, if you have both precision and accuracy, then the device performs at the level you want it to be fulfilling the need it is meant to fill, reliably. These characteristics are ones that are standard, meaning that one would expect a medical device to have them from the very start. In other words, having precision and accuracy is not a bonus but a prerequisite most times. This is true not only for medical devices, but for products in general.
In the medical field, both accuracy and precision are essential in order to ensure that results are valid. When one is not able to achieve either accuracy or precision requirements then a device is bound to fail tests or further calibration. These are among many reasons when a device or any drug are recalled or discontinued. The U.S. Food and Drug Administration has set a high standard regarding accuracy and precision to ensure that calibrated equipment meets certain requirements. Some errors for not meeting this accuracy and precision limits are a personal human error, method error or instrumental error. When these limits are not met, then they are re-evaluated and recalibrated to bring the potential results.
Accuracy refers to how a measurement is close to the right or acquired absolute value while precision how a measurement matches the same exact value being estimated. Both fields are independent. Which means a measurement may be highly precise but inaccurate, and vice versa.
Both accuracy and precision are essential to be insured in medical device development, which is the responsibility of FDA as well as the manufacturer. Device efficiency cannot be altered as any small error or uncertainty in calibrating a medical instrument or performing a lab test would lead to a deficiency in patient safety standards and to public risk.
All medical devices industry are controlled by FDA's 21 CFR Parts 11 & 820, Quality System Regulation (QSR) & ISO 13485 (Ref. medicaldesignbriefs website). Both accuracy and precession are important for FDA because maintaining human health and safety is their highest priority and main preference. This involves medical instrument calibration regulations which require any medical device industry to ensure device inspection and test it until it meets the acceptable standards to check the accuracy and precession of the device and efficiency level as many devices degrade by time. This includes stents inspecting, needles, catheters, Thermometers, etc. Failing in performing the appropriate inspection and the expected FDA compliance program and updating the Registration & Listing regulations every 6 months by any medical device company would lead to many complicated penalties including a device recall.
FDA compliance program stated that "manufacturers are expected to control their products from "cradle to grave" meaning from the design stage through post-market surveillance. Manufacturing processes, such as sterilization, are required to be implemented under appropriate controls. The MDR, Tracking and Corrections and Removals regulations involved activities with which manufacturers and importers are required to comply after the devices are distributed." (Ref. meddeviceonline website)
The FDA's main priority is to make sure all regulated products are safe and effective. A device that is both precise and accurate is necessary for both of these requirements.
Often, when a device is first conceptualized, it worth pursuing if it is at least one or the other. Maybe the device only works correctly half of the time so the precision needs to be worked on. Conversely, if the device is consistent but ultimately fails to complete the therapeutic treatment it must be fixed to be more accurate.
Both of these aspects will have to be rigorously tested to ensure the safety and efficacy of the device.
Precision and Accuracy of medical devices is carried out to minimize the uncertainty in measurements . It helps in reducing the errors and brings the measurement to an acceptable level. With repeated use and over a period of time, all equipment tends to degrade that affects its precision and accuracy. In the medical device industry regular maintenance and service are needed for an instrument to work accurately.
When it comes to a medical device, you can't really pick between accuracy and precision; you need both! A pacemaker can't be accurate without being precise as this would definitely cause a heart attack. You also don't want a pacemaker that is precise but not accurate inside your body. If you need a pacemaker, you probably already have one that is precise but not accurate, it's called your heart! (haha). But seriously, a medical device doesn't have much room to move in these categories. It must be able to sustain a human's life, and many times they are used because a human cant sustain their own life. Therefore it's a good thing the FDA cracks down on these devices before letting them into the market because the lives of the public lean on the accuracy and precision of these developed devices.
Precision and Accuracy are similar in context, but very different in definition, and equally important in the medical device field. Having one without the other is essentially useless, and will either cause harm to the consumer, cause the product to not function properly, or be shut down by the FDA. Take any kind of automated surgical tool for example, this product needs to be remarkably accurate in order to perform its required task. Additionally, if this product was 100% accurate, but not precise, the device will miss the target occasionally, while remaining close. In some instances, this is okay, but for most medical devices, this is definitely not acceptable. That is why it is necessary for this device, and any device to be both accurate and precise so that the target function is operated to the small fraction of a percent error every single time without fail.
Precision and accuracy are used interchangeably, but in science it has different meanings. Accuracy refers to closeness of the measured value to a standard or known value. But precision refers to the closeness of two or more measurements to each other. In the medical device examination, FDA has set its high standard for precision and accuracy ensuring for the safety of patients from instrumental error, human error. It checks, regulates and calibrates the devices multiple times before releasing in the outside world to prevent from potential threat of the human lives.
Accuracy and precision are the two important factors while taking data measurements. Both reflect how close a measurement is to an actual value, but accuracy reflects how close a measurement is a known or accepted value, while precision reflects how reproducible the measurements are, even if there are far from the accepted value. FDA concerns more over human lives and evaluates each and every medical device no. of times before causing harm or any accidents.
