Recalls are an effective method for removing or correcting marketed products, their labeling and promotional literature that violate the laws administered by Food and Drug Administration (FDA). Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or judicial actions, especially when the product has been widely distributed. FDA regulated firms may initiate a recall at any time to fulfill their responsibility to protect the public heath from products that present a risk of injury or gross deception, or are otherwise defective.
Recently some capsules sold by Sandoz Inc. got recalled by the FDA. Apparently it had excessive amounts of some ingredient for the drug. When it comes to a recall like this, I think the FDA is in fact more at fault than the company itself. Sure the company is supposed to make a product that complies with FDA regulations, but this is the kind of thing that the FDA should find when conducting their tests! It seems to me that there are a lot of mishaps with the FDA's testing and it seems like 50% of the time even if your product isn't within regulations it will get approved anyways just because the testing is so faulty. Below is the link I used to find the FDA recalls. One of the recalls there is for some kind of cookie dough because it doesn't disclose that there are peanuts and walnuts. Seriously, how does the FDA let a product get on the market without disclosing that?
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts?fragment25_NextRow=211
Many medical devices and medical products get recalled every year. This could be due to a variety of different issues with the item, mostly revolving around a possible harm to the consumer. For example, a company called DePuy Synthes had to recall battery adapters already on the market due to a discovered risk for possible explosion. In these situations, I believe that the FDA is definitely at fault, because after all, the main purpose of the FDA is to ensure safety of these products for the consumers prior to market release. However, it is true, that mistakes will always be made, and although the FDA will make some of these mistakes in letting a potentially harmful product to market, by recalling the product and fixing the problem or malfunction, the product can hopefully safely make it back to market. Post-market management is responsible for finding these products in need of a recall.
While the FDA cannot predict every outcome from approving a certain medical device, it should definitely be held accountable in cases where the recall was issued due to gross negligence in their screening process. In September 2018, Alcon's CyPass Micro-Stent was recalled due to significant endothelial cell loss. The stent was implanted and meant to drain fluid responsible for "high eye pressure and vision loss in people with glaucoma." In the randomized controlled clinical study, several individuals implanted with the stent during cataract surgery. During the 2 year follow up after implantation, no significant loss in corneal cells were exhibited. In this case, the FDA did predict potential adverse problems after the two year period, and instructed Alcon to conduct a post-approval study. In this post study, significant endothelial cell loss was shown in the patients from the initial 2 year study. This is a major issue since the damaged cells can never recover and this loss can be associated with damage to the cornea. However, since the FDA showed proper precaution even after the 2 year study by issuing a post-approval study, I believe the FDA should not be held fully accountable for the recall. In this case, the FDA exercised due diligence and properly approved the device to the best of its ability.
So there is actually a long list of medical device recall that have occured this year alone.
What is very interesting is I did not realize there was a public listing available of all such devices accessible from the FDA website.
Since I work in the diagnostic industry I chose to give my response related to the following recall described in the link below.
Which, why and who is responsible?
The product that was recalled is a blood analyzer manufactured by Beckman Coulter.
It was recalled because it gave blood analyses. That is the medical device sporadically gave elevated reading for platelet counts. Such errors could result in adverse health decision being made for a patient exposing them to medical treatment unnecessarily or withholding medical treatment unnecessarily.
Whos is responsible: I dont think the FDA is responsible because its not clear how frequently and under what level of usage is required for the error to occur. There article says the root cause of the error may be due to a clogged aperture. So again such an error may not have occured while the FDA ran its tests.
Clogging could occur after a large amount of test, maybe a lack of cleaning agent is applied to the aperture. I think if you start by assuming the FDA is conducting due dilligence, but also realizing that not every scenario can be accounted for otherwise innovation stifling would be claimed due to even longer testing cycle. I think that that instead after market reporting should continue to be done to flag errors in the field.
And medical devie companies need to be prepared to accept responsibilty for such errors
FDA recalls of medical devices are uncommon and always cause for concern. When a product on the market starts receiving complaints or is discovered in postmarket surveillance to have issues, the company can either remove the product themselves or wait until the Food and Drug Administration steps in on their behalf.
One example of a recent FDA recall is for the Ovation iX system that is used for treatment of aortic disorders. This product was recalled due to a material weakness adjacent to the polymer fill channel that can cause polymer leaks. This was classified as a Class I recall which does not require physical product removal. However, two patient deaths were reported due to polymer leak complications. To correct this issue, the company, Endologix, has committed to replacing Ovation iX with a new FDA-approved ALTO graft by the end of October this year. In this case, I do not believe that the FDA is responsible for the cause of the recall since the recall was related to the product's function.
I recently worked on a project remediating a recall on Alaris Medley 8100 Infusion Pumps. The recall was issued due to a hardware component failure after the component material was downgraded to reduce costs. The failure consists of cracks and damages to the internal frame assembly which essentially holds everything together. I do not believe the FDA could have foreseen this issue since it occurred years after manufacture, however if the downgraded material was low quality, maybe the FDA could have prevented the use of it.
What process does a Medical Device Company have to follow if they would like to update or change a component within their already approved device? What ways can this process be abused?
I think the FDA is responsible in the unlikely event. The FDA is the institution responsible not only for the tests/experiments before production but also for the follow-up of any drug/product after it enters the market. Therefore, the FDA has to take responsibility and recall the drug/product for any error. Otherwise, this situation can create serious problems in terms of both human and environmental health. In addition, the side effects of some drugs may occur after many years. It should be collected after these effects are seen.\
Thanks!
One product that I found is the Neuro Omega System from Alpha Omega Engineering. The purpose of the device is to assist neurosurgeons in identifying brain structures during functional neurosurgery and to aid in the placement of depth electrodes for seizure monitoring. The device was recalled due to a design flaw that connected two separate electrode stimulation channels into one which caused higher than expected electrical stimulation. This results in significant harm to a patient’s brain tissue. In this case, I do not believe the FDA is responsible. I think Alpha Omega should take the blame; however, no one was harmed by the design flaw and the company made the necessary updates and changes to relabel the devices to inform users about the circumstances that cause the malfunctions and the risks that occur when stimulation electrodes are incorrectly connected to the device.
https://www.fda.gov/medical-devices/medical-device-recalls/alpha-omega-engineering-recalls-neuro-omega-system-due-design-flaw-which-may-cause-significan t"> https://wayback.archive-it.org/7993/20201222124329/https://www.fda.gov/medical-devices/medical-device-recalls/alpha-omega-engineering-recalls-neuro-omega-system-due-design-flaw-which-may-cause-significant
Each year there are about 4,500 drugs and devices taken down from U.S. shelves due to recalls. A recall that I have looked into is Baxter Healthcare Corporation's recall of Clearlink Basic Solution Set with Duovent due to risk of leaks that may expose providers and patients to hazardous/toxic substances. This recall was considered a Class I recall by the FDA which is the most serious type of recall. This medical device is used for the delivery of hazardous drugs (chemotherapy). Any leakage could expose healthcare personnel, patients, and others to potentially hazardous drugs that may lead to serious injury or death. In this case I do not believe it was the FDA fault for this recall. Out of the 511,728 Clearlink Basic Solution Sets with Duovent distributed in the United States, there have been 83 complaints with no injuries or deaths related to this issue. This is equivalent to the FDA finding this issue in one out of every 10,000 ff these devices, which could go easily unidentified. Although the likelihood of failure is a small percentage, the risk from this failure has major consequences. Therefore, it was right by the FDA to recall this medical device and have the company attempt to mitigate this issue before entering back into the market.
A recent, infamous example of a recall is Abbott's recall of their baby formula products which occurred February 17th, 2022. The recall was initiated voluntarily by Abbott as a response to an FDA investigation into their powdered baby formula. Certain lots of the formula were suspected to contain Cronobacter bacteria, which resulted in 4 infant hospitalizations, 2 of which resulted in death. Because of this, Abbott ended up shutting down manufacturing of baby formula at one of their major production facilities for a few months.
Baby formula is considered a food product, so it is regulated by the FDA's Center for Food Safety and Applied Nutrition. Though formula is not considered part of the drug, medical device, or biologic classifications discussed in this week's lecture, the impact to public health this recall caused cannot be understated. Unlike foods and beverages consumed by adults, many infants depend on formula as their sole nutritional source. Plus, this recall caused a widespread shortage of baby formula in the United States, since baby formula production is limited to a very few number of companies in this country. What this incident shows is that there are fundamental issues in the supply chain that need to be resolved in order for such a crisis not to occur again.
A medical device that was recently recalled, in January of this year was an insulin pumps created by Medtronic with the purpose of automatically dispensing insulin dosages to its patients. Over 100,00 devices were recalled due a software issue present in the pump, which resulted in an under-dosage of insulin delivered to patients. The recall did not require device retrieval, but representatives from the company had to travel all across the nation to update software and pump functionality. The device labeling did not properly notify users of the complications that could arise with the device's software. I do not think this recall was the FDA's fault. The company should have been more thorough with their product testing. Any medical device that requires heavy software should be heavily monitored and tested due to the fact faults in the medical device are more likely.
Very recently, LivaNova recalled the LifeSPARC System, which is a device used to pump blood for periods lasting less than 6 hours for surgical procedures. The system consists of the pump and a controller which provides the interface between the pump and the user as well as power to the pump. The controller component of the system was recalled due to software malfunction. The malfunction may lead to serious injury or death of the patient. In this case, I do not blame the FDA as it's possible that during the testing period, the software malfunction may not have occurred and was therefore not documented. I think there should have been more software troubleshoot testing to better prepare for the possible malfunctions and plan recovery.
Most recently, there was a recall on Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). It was originally disturbed in January 2022, and at least 56,300 devices were recalled. The Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) uses the patients’ samples to detect antigens found in the SARS-CoV-2 virus, by a nasal swab. Skippack Medical Lab COVID-19 Direct Antigen Quick Tests (Colloidal Gold) are being recalled by Universal Meditech Inc. because they were sold to Americans without the FDA's permission, clearance, or approval. The FDA has not received sufficient information from Universal Meditech Inc. or SML Distribution LLC to demonstrate the accuracy of the test's performance. This indicates that there is a chance of false negative, false positive, or incorrect findings interpretation. I do not believe the FDA was at fault, it was the companies’ fault for not supplying sufficient information.
