I think that any when any product is launched in the market, the tests and all the certain documents are already verified. However, when issues start with those products, they cannot recall just from one error found because it can be updated without machines or product recall. The FDA cannot predict every possible outcome of product or drug after it is out in the market. Some possible results are already quality tested and verified. Only after then it is out in the market. However, it is possible for a machine to be used differently than the normal way of using it, which causing the malfunction or creating issues with hardware. When the complaints are going beyond the limit and turn into life-threating, the manufacturer and the FDA both recalls the device or product to prevent the worst possible outcomes
Recalls can be delayed to due to insufficient evidence to pull a product off of the shelves. The company itself can often be biased and try to prolong the time it has on the market to increase sales. Often, they are not reprimanded for this practice to the point that they would actively try to avoid putting out products prematurely. There is too much incentive for them to keep ineffective products on the market for them to make the right choice
I was wondering that why are the recall either made by company or made my FDA are of items which have been in the market for at least 5-8 years after the launch in market. Why cant they be either verified at first with proper precaution and even if they come in the market why would they wait till the customer complains reached a certain point too react on to it. Can you list the reasons and ways this can be avoided
Recalls don't always take 5-8 years, sometimes they can happen within a year or two of product launch. Nevertheless, companies will create design documents to make sure their products are meeting the design requirements set forth by the FDA, and also risk documents to identify the potential risks involved with releasing that specific product. Companies will most likely also have trending limits for complaints - in other words, they'll set an acceptable limit based on the number of devices sold in which a failure can occur. So, if a company receives one complaint on a device but they've sold thousands of those devices, that is a limit of risk the company is willing to accept. However, if that trend continues and they keep receiving more and more complaints but don't continue selling as many devices, then that may exceed their acceptable limit and trigger a recall. To receive that many complaints though takes time.
In recalls issued long after the product launch (ex: 5-8 years), the recall is usually not of serious health risk to the user (unless the product malfunction was due poor durability). Most recalls are initiated by the company itself, and if not forced by the FDA to recall, the company may try to delay or avoid recall if the complaints aren't sufficient to hurt sales and aren't hazardous in nature. Recalling will cost the company a lot of time and additional resources in order to initiate recall, notify the FDA and consumers, and either correct or completely destroy devices of a certain model or product line. While pre-clinical and clinical trials can test one batch of devices, there may be issues in certain individual devices during mass production. Some companies may also be required to adhere to a strict deadline that doesn't allow time to accurately test long-term wear and tear of the device in live experiments. As strict as the FDA is, it cannot foresee all the negative outcomes or increasing risk of a device after years of use.
https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall
I think the main reason for the FDA's recall of a device is that it has unexpected problems. In most cases, the company will find defects or problems and take the initiative to contact the fda. Although not all potential problems can be completely eliminated, if we want to avoid this situation, we can only improve the quality of products by doing more quality control and control experiments. This can improve product quality performance, although not perfect, but can reduce quality risks as much as possible. At the same time, when using medical devices, users should not only standardize the use of medical devices, but also do the quality control and maintenance, which can also extend the service life of devices.
All medical device companies go through several precautionary phases of medical device development in order to prevent a non-conformance or recall. A product's non-conformance can be easily overlooked by the quality department of the company itself or it could be just an engineering mishap which can, again, be overlooked by quality. I believe the quality department is the final forefront of making sure a medical device is ready for the real world and most medical device recalls occur because something was overlooked. There can also be an error in the design verification & validation processes such as faulty testing due to miscommunication between an engineer and technician. This faulty testing can lead to a false positive success and in turn force the engineer and the quality department to believe that the medical device is successfully functional. I believe the quality department has a big play in the cause of a delay in recall or even the cause of recall of a released medical device.
There is a delay in recall as there are some unforeseen issues that arise after the product is in the market for some time, though enough clinical trials are performed before the device is brought in the market, the products are not quite tested for longevity and that's why we have recalled after 4 years,6years or so.
I have no idea as to how to solve this problem as every device is unique, more testing & precautions should be taken so that the recalls can be avoided.
I believe some recalls are as a result of a new technology brought up too quickly to realize its unfortunate side effects. For example, take lead paint or asbestos, materials that for a long time were accepted in mainstream use and approved by regulators. Once the side effects of these materials were discovered to be linked to developmental disorders and cancer, paints and building materials were immediately scrutinized. Every study benefits from a larger number of subjects, and sometimes it takes years to reach the right numbers. However, by the time we understand all the effects of these medical devices, sometimes it may already be on the market. I'm not sure what the cause of these delayed recalls may be, but I believe many of them could have been prevented with further research and regulation, especially with devices that may cause severe injury or death.
Recall can be delayed for a variety of reasons. One of the biggest reason, in my opinion, is that majority of the recalls of the medical devices are "In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). " (From the FDA website: https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall ). In terms of the company itself they have to formulate a plan and depending on the scale, they have to figure which method to use to recall. Depending on the company's size it can take some times to formulate and execute them. Also, since they are not a deadline required by the FDA they can in theory just say to the FDA they are in progress and take however long it takes for them to execute the process. In addition, it is all money which was not accounted for in the planning stage the company has to figure out where to get the money as well which is usually a hard task. I have a question for people who have actually gone through the process of recall? How did you guys find out and how did the company dealt with it?
This is a great topic of discussion. Recalls usually occur due to the product no longer adhering to the FDA laws. For instances where certain devices are recalled after 5-8 years, this happens because of a circumstance that occurred which was unforeseen when the screening was done by the FDA. I do think that the FDA cannot foresee every possible outcome or malfunction that may occur. Although Failure Mode Effect Analysis and Risk Management are somethings that are conducted, there are a few points that are possible to be overlooked may be because the device was not initially intended to be used in the situation in which the malfunction occurred.
As I saw in my country, The Saudi Food and Drug Authority (SFDA) recall list is mostly involved cosmetics due to unpredicted results or for lack of information in usage instruction, which may not emphasize ingredient that cause allergy for some people. Also, the drugs that have been recalled by U.S. Food and Drug Administration (FDA) is recalled by SFDA too.
Depending on how a device is approved by the FDA, there may actually be less testing involved to get a device approved. For example, 501 K's allow for devices similar enough to pre-existing devices to enter the market with minimal testing. (although I believe this is changing?). In terms of delays in recall, it might take several years for devices to even start showing issues (i.e a hip replacement starting to degrade and cause metal poisoning). In that, it might be years after the device is released that it is even noticeable that the design is defective, add in legislation and research into the defects and you end up seeing a device get recalled long after it was released into the public. Another issue is finding trends in the failure of the device. For example, while one or two patients may react poorly to an implant or medication, this is not indicative of the device overall being flawed. There needs to be statistical evidence that the device is dangerous and needs to be recalled.
It really depends on what the device is, how its implemented, the timeline in which it became clear that there might be a flaw in the device, and the ways in which the team that released the device tested it.
This is a good question. There are a few reasons why products take so long to be recalled. One is that the effects of the product may be working perfectly initially but over time it may go bad due to overuse or just time passing. This could be solved by longer observation times during testing the product initially. Another reason could be that when the product was originally released, there were no know problems with it or how it reacted with the body but over time we find out that it was actually harmful and not helpful in terms of the body. An example of this is the chromium-cobalt hip replacement. It seemed charming when looking at the metal properties but, unbeknownst to researchers, it was not a good biomaterial and would end up poisoning the user. One thing we must consider is that medicine always changing along with the information we attain.
I recently worked on a recall remediation project for a device that has been on the market for over 10 years. The recall was issued only one year ago, which means the product has been on the market for over 9 years. This particular recall was issued due to a hardware component failure on devices manufactured within a specific time frame. The manufacturer decided to reduce manufacturing costs by downgrading the material and therefore they downgraded the quality of the product. It took over 5 years for this failure to be discovered because the failure occurred after prolonged use of the product. I am not sure if the FDA could have prevented this issue, however I believe the manufacturer could have performed materials testing to ensure a high-quality material.
Recalls are made because a risk to patient safety was identified whether it be for the entire product line or with a certain lot of the product. I can try to give an example of when I think there would be a recall due to a situation you didn't expect. Let's say a company works with human grafts. One donor can provide say a Lot of 10 grafts. One of those grafts gets implanted into a patient needing breast reconstruction. This patient later sees redness and gets a negative reaction to this graft resulting in additional surgery. The surgeon can file a complaint which prompts the quality department and complaints department to determine what happened. The grafts go through a whole list of clearance steps before release to ensure patient safety. However say for some reason the test results for this graft were a false negative for a certain endotoxin count. The test results passed so you released all the grafts. With this complaint you conclude that the result was a false negative and there is a high risk all grafts from this donor Lot are affected and have high endotoxin counts which can result in an adverse patient reaction. As a result you would need to recall all these grafts from this donor lot. Now your question is why didn't we detect this sooner. Well in this case it could have been something that was not able to be predicted. Maybe the laboratory made an error, in which case there might be something wrong with their test method. There are some things that can be predicted to go wrong and so you put controls in place to mitigate the risk however sometimes there are situations you can't account for. This is where I believe D/PFMEAS are very important and when reviewing them to have a diverse multi-departmental team be part of the review to make sure you are capturing every possible risk. Regardless there will always be things you miss. This is why post-market surveillance is very important.
