Every Medical Device that has been developed, whether its for our everyday consumption and benefit, or for surgical use, had to be FDA approved. FDA is known for performing numerous tests, and filing plenty of paperwork in order for a product to be marketed. However, some drugs and medical devices that were approved ended up on recall. Which medical products experienced recall, and why did it happen? Do you think that the FDA is responsible?
Very recently, Maquet IABPs were recalled from the market due to “false blood detection alarm and ingress of fluid in IABP” [1]. The recall, classified as Class 1, is very serious because IABPs are used as assistive-living devices and may result in serious harm or death. The device’s purpose is to help patients who are undergoing heart surgery and also as an assistive device for individuals with heart failure complications.
In this case, it can be said that both sides are at faults. It can be that Maquet did not perform proper testing and assembly that these products are experiencing some problems. It could also be possible that they hid important but detrimental information from the FDA which then resulted in the recall. On the other hand, the FDA investigators may not have done their job to the best of their ability which resulted in them overlooking important factors in the device.
[1] https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm574885.htm
The incident I would like to briefly talk about is the abnormal corrosion-wear of β-Ti alloy TMZF (Ti-12Mo-6Zr-2Fe) in one model of Stryker’s early hip implants that was recalled in 2011. In this case, Stryker used an innovative TMZF alloy in the stem segment of their implant instead of the Ti-6Al-4V (Ti64) alloy which was popular at the time. While all hip implants degrade over a period time due to metal on metal abrasion, it was found that the TMZF alloy was degrading twice as fast and creating excessive metal shavings localized around the implant. These shavings both caused irritation to the site and compromised the integrity of the implant compounding the issue. After research was done to investigate this issue, it was found that the TMZF and Ti64 both had similar wear in dry conditions, however, in simulated bodily fluid, hydroxyapatite particles greatly accelerated the wear on TMZF due to its intrinsically poor strain hardening capacity. This result meant that under abrasive conditions from the hydroxyapatite particles, the Ti64 would be able to withstand the abrasion more effectively than TMZF which would have microscopic pieces ‘chip off’ due to its brittle material property. In the end, Stryker took full responsibility for the defect and offered corrective surgery and financial compensation to all those affected over the past decade by the defective hip implant. In addition, I believe that the FDA’s job is to perform its due diligence by mandating clinical trials, however, they cannot be held responsible (like the manufactures should be) for any defective product if the defect was not initially visible in research/ report.
http://www.sciencedirect.com/science/article/pii/S1742706116303245
I recently worked on a product that was recalled voluntarily by our company. I want to make the distinction between a voluntary recall and an FDA mandated recall. A voluntary recall is when a company's post market surveillance of a product shows that there are recurring problems that they feel are a risk to the patient and therefore they voluntarily recall the product so it does not cause additional harm. An FDA mandated recall is usually more severe, because this means that the product issues have caught the attention of the FDA and that they have deemed it unsafe. dag556 made a very good point that the device manufacturer is ultimately responsible for the product, and the FDA approval is just a check to ensure that the manufacturer has gone through all necessary steps in the development of its product. However, no matter how robust a design is, there is always the potential for unforseeable risks that were not visible to the manufacturer or the FDA at the time of approval.
In 2015, Medline Industries, Inc. had a voluntary recall of one lot of acetaminophen tablets. The issue here was that the bottles were incorrectly labeled as showing 325mg instead of 500mg. The risk of this issue comes from possible maximum dosage intake that may lead to liver toxicity/failure. As a means to prevent and correct this error, a CAPA was issued. I believe since this is a voluntary recall by the company, FDA is not responsible for this recall. However, FDA would be if they found this issue.
https://www.fda.gov/Safety/Recalls/ArchiveRecalls/2015/ucm467049.htm
I agree with srg36 that there is always the potential for unforeseeable risks that were not visible to the manufacturer or the FDA at the time of approval. Last month medical device maker Abbott voluntarily recalled 465,000 pacemakers to install a firmware update to patch cybersecurity vulnerabilities in the devices. The vulnerabilities could allow an attacker to modify the devices's pacing commands or cause premature battery depletion. The updated firmware will limit the number of commands the devices can receive wirelessly and prevent transmission of unencrypted data. This is an example of a problem that was not an issue when the medical device was approved (nor FDA or manufacturer could have predicted it), although it became a problem due to evolving technology and treats that come with it. This is a wake up call to device manufacturers that they should be always reevaluating their devices for potential risks introduced by its design, manufacturing processes, use errors, and hackers!
Recently, in the April of 2017, Zimmer Biomet recalls Implantable Spinal Fusion Stimulators due to potential of harmful chemical which may be toxic to the tissues and organs. FDA has classified this recall as a Class I recall, most serious type of recall. Class I recall may lead serious injuries or death. The Spinal Fusion Stimulators are used during the spine surgery to permanently connect two or more bones together. As part of the routine monitoring, Zimmer Biomet has found in their procedure that higher levels of harmful chemical are allowed which may be toxic to the organs and tissue. This is clearly the company’s fault as not enough tests were done to assure the levels of chemicals present in the Stimulators. For example, cytotoxicity test, which can help identify the levels of chemical present in the medical device. During the approval from the FDA, they might have done testing, but may not be regularly monitoring or performing the tests on every lot manufactured.
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm561004.htm
Any medical device of any type can experience a recall for numerous different reasons. One prevailing issue that effects device such as sensor systems is the accuracy and precision of said medical device. Often times the FDA will shut down a company because their product is showing signs of lacking accuracy and precision in measurements. It only takes 24 hours for the FDA to shutdown a project, so its in a company's best interest to ensure their product lines up with FDA standards out of concern that the project will be taken down. The FDA is a big agency and as such many problems with products that get approved don't get into the limelight until its unfortunately too late, but this is why companies need to take stride in ensuring their product meets FDA standards. A recall can cost a company a lot more than simply continuing with R&D or even just abandoning the project.
You can view a list of recalled food, drugs, etc. directly on the FDA website with briefs descriptions on why they were recalled: https://www.fda.gov/safety/recalls/
Recently, Bella Pharma voluntarily recalled its unexpired sterile drug products like B-complex, Methylcobalamin, Mannitol etc. The lots from April to August 2017 wree recalled. This happened due to lack of sterility assurance. The sterile drug component which had to be sterile was not sterile and that would cause serious infections which was life threatening. This was unnoticed for sometime which later came to limelite. That is when the company recalled all the suspected lots. During the FDA approval, th drug product would have been sterile, but later during manufacturing of lots, it would have been unnoticed by manufacturer. Hence manufacturer should responsibly evaluate the safety of the drugs before releasing the lots into market.
Ref - https://www.fda.gov/Safety/Recalls/ucm572373.htm#recall-photos
I just became aware of all of the complications surrounding Johnson and Johnson’s vaginal mesh so I did some more reading. Transvaginal mesh products are sometimes used during hernia surgery or to repair pelvic organ prolapse or stress urinary incontinence. From what I havw read, the mesh has been risky from the start. The very first mesh in 1999 was recalled but the FDA continued to approve other products based on this design. The FDA has changed the device from Class II to Class III, some product have been recalled such as Boston Scientific’s ProteGen and some companies have discontinued certain product lines without taking the full responsibility of a recall. The FDA also issued numerous safety notices about the products, but the FDA says it hasn’t received enough data to warrant a full recall.
In this case, I believe the FDA is to blame. The issue seems systematic, with a propagating fundamental issue, and it doesn't isolated to one manufacturers. This just leads me to wonder, where does the FDA draw the line?
A recent prominent recall that happened was part of Johnson & Johnson's orthopedic subdivision Depuy Synthes. In this situation J&J was found negligent in properly informing consumers that their metal on metal hip implant (Pinnacle Hip implant) had a design flaw. The ASR hip implant was the first of the metal on metal hip implant's recalled by Depuy in 2010 due to wear debris and high failure modes, this voluntary recall was initiated after data was received from the National Joint Registry of England and Wales indicated that patients were undergoing secondary hip replacement surgery much quicker than usual. After this voluntary hip implant recall in 2010, recently in late 2016 a jury found J&J guilty of negligence with the Pinnacle hip implant line, which had a similar design defect as that of the ASR line that was voluntary recalled in 2010. The cost that J&J incurred from the ASR line is estimated to be 2.5 billion dollars in settled lawsuits (7,000) and in early 2017 a group of 6 plaintiffs won 500 million dollars as a result of the Pinnacle hip implant defects. The main cause behind these design flaws making it past the FDA is the loophole in the 510(k) process which allows companies to skip the rigorous testing process in the guise of predicate devices, resulting in many patients suffering.
Sources
http://www.asrhipinfo.com/content/asr-hip-0
http://www.reuters.com/article/us-johnson-johnson-verdict/judge-halves-1-billion-award-in-jj-hip-implants-case-idUSKBN14O0DF
The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.
When a company learns that there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place.
Correction - Addresses a problem with a medical device in the place where it is used or sold.
Removal - Addresses a problem with a medical device by removing it from where it is used or sold.
FDA uses the term “recall” when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, an artificial hip) is recalled, it does not always have to be explanted from patients. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.Examples of the types of actions that may be considered recalls: Inspecting the device for problems repairing the device, adjusting settings on the device,re-labeling the device, destroying device, notifying patients of a problem, monitoring patients for health issues.
I think there is some response of FDA. They maybe ignore some tiny problems, but when it comes to market, the problem will be enlarged. On the other hand, the company takes the major responses. After applying there are some mistakes that they made lead to the recall.
Researchers have examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives. Most of the devices - 71 percent - had been approved without undergoing testing in people, the researchers reported Monday in the Archives of Internal Medicine.
That's because under a process designed to get products on the market as soon as possible, they were deemed to be similar to another product already being sold. Only 19 percent underwent more stringent review.
Their findings revealed critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.
It is always the responsibility of a company to ensure the safety and efficiency of their product upon release. However, sometimes companies do not know the complete risk of a product until after it is distributed. For instance, Zimmer Biomet recalled their Comprehensive Reverse shoulder System because of its high fracture rate. The system was meant as a shoulder replacement implanted to repair arm movement. However, the product would fracture, which would then lead to surgery to correct the issue, which in turn may cause complete damage of shoulder function, infection, or even death. The distribution of the product was from 2008 to 2015. The FDA recalled the device and classified it as Class I.
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm541862.htm
A product that was recently recalled was the BD Intelliport Medication and Management System Sensor, which was officially recalled by the FDA on January 09, 2017. This product was recalled on its inability to assure sterility of the product, which poses an increased risk of infection to the end user.
For this type of recall (product sterility), I do not feel as though the FDA is responsible. It is the responsibility of the manufacture to demonstrate that the medical devices they are selling is in fact sterile. Although the manufacture needed to provide evidence of product sterility during the FDA 510(k) submission of the product, this sterility issue could be due to instances which were not considered by manufacture which lead to the possibility of having a non-sterile product.
