A recalled item was Boston Scientific Corporation’s Chariot Guiding Sheath. Almost 6000 of these devices were recalled. The Guiding Sheath is used to help guide placement of interventional devices into peripheral vasculature. The reason for the recall was that fourteen complaints were filed where the shaft of the device separated from the guide. This can result in small pieces becoming dislodged and enter the patient’s bloodstream. This will result in serious organ damage and potentially death. The FDA is partially responsible for this issue. The FDA already has strict rules in place for medical devices but sometimes certain issues or problems are not faced during the clinical studies. Again, the percentage of defects was low compared to 6000 devices sold but human lives were still at risk. Therefore, the FDA does deserve some blame. However, majority of it falls on the Company itself because it is their product and they are thus responsible.
One product that was on recall by the FDA was the Insulin Corporation Omnipod Insulin Management System. This product is basically a small pod that you fill with insulin, attach to any part of the body that will receive the injection, and press start for it to be delivered. However, there was a huge recall on the product because the needle may fail to deliver the insulin, the main point of the product. The product is also small and portable, which makes it easy for diabetics to use, since they may forget to take their shots at the right time. Since the pod is connected wirelessly to another device, you can input the right time the shots can be injected. Thus, if the needle does not inject the insulin, it can lead to hyperglycemia (high blood sugar) and cause life-threatening issues and even death. In this particular case, there have been 10 cases where the pod showed not to be working. It might not have been an FDA issue than it was a manufacturing issue. All pods should be guaranteed to work and last, and they should come with instructions on how to make sure they are working properly.
Srg36 I agree with your statement "However, no matter how robust a design is, there is always the potential for unforeseeable risks that were not visible to the manufacturer or the FDA at the time of approval." Granted its the job of the FDA and the company to extensively test these products but there are also technological limitations to testing. For example, in vivo implants see a lot of recall, this can be due to the fact that mimicking the body's condition is very difficult. Unless the technology allows for prolonged in vivo performance, there can be a slight certainty on how an implant might behave years form implantation due to varying activities of the body. Medical devices and the technology needed to extensively test them I can say go hand in hand. Even though you can say it is the fault of the FDA and the company for having a defect/recall, testing and research can have its limitations when it comes to new innovative products and the uncertainty of its performance.
The Tylenol Recall in 1982 was what started the idea of recalling products off shelves. Johnson and Johnson had to deal with this issue and James Burke, the CEO at the time, was commended for the way he handled the entire issue. The issue arose when several people died due to cyanide-laced Tylenol capsules. As a result, he recalled all the products on the shelves and they re-configured the packaging of the Tylenol. It ended up being a really quick turnaround and Johnson and Johnson was able to recover the market share that they had lost due to the incident.
Was the FDA responsible for this? No. However, this did contribute to more stringent rules an regulations toward packaging of products and product labeling.
Also in 2016 the FDA recalled Dexcom G4 Platinum and G5 Mobile continuous glucose monitoring system receivers, due to complaints that the audible alarm may not activate the receiver when patients experience low or high glucose levels. This is an essential feature of the device that protects persons with type 1 and type 2 diabetes from experiencing hypoglycemia or hyperglycemia. Without the alarm sounding, persons with diabetes may not know they have low or high blood sugar, and thus could experience an episode of hypoglycemia or hyperglycemia that could end with hospitalization or, in more serious circumstances, death.
Also, the FDA recalled DePuy ASR XL, The FDA cleared this device without clinical testing based on “substantial equivalence” to earlier devices, though such metal-on-metal hips had long been on the agency’s high-priority list for requiring advance clinical trials. The device cause increase in the chromium and cobalt levels in his blood as some people described it as “profound poisoning”, and in an article in the British Medical Journal called it “one of the biggest disasters in orthopaedic history.”
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=96142
https://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index.htm
I have seen very few products that are being recalled very early. I think the products that are recalled very early shows how much company are concerned regarding the safety. One I would like to discuss is ATAR Reusable and Disposable Extension Cable(s) by OSCAR.
Reason for recall was risk of the extension cables separating from the connectors during use. Which could lead to failure of cardiac pacing therapy for the patient. As the failure occurs without warning, it is possible that pacing-dependent patients may suddenly be left unpaced without adequate warning to their caregivers to quickly exchange the defective cable. Sudden pacing delay and/or failure may result in immediate and serious condition.
Comapany sold 13000+ cables and only 66 of them were reported for the recall. I think this recall was way to early. But I would like to know how to decide and probably what time to decide that product was eligible for a recall?
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm568011.htm
Even Though it's FDA’s responsibility to test and certify a product safe for clinical use, they are not held responsible for the mistake. The manufacturer are responsible to produce a safe and a reliable product. However, with every recalls, the FDA’s credibility is at stake. Also, with particular recalls, identifying such loopholes pave ways to modify or add new rules and guidelines that will ensure recalls on similar lines are not repeated again.
AS Myton expressed in the previous post, Maquet/Datascope IABPs were recently recalled for the "False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump" [1]. However, this recall only resulted in the recall of the pump mechanism itself, the models CS100i, CS100, and CS300 [2] The intra-aortic balloon itself was not at fault. This recall was justified by the FDA in order to protect potential users. However, by the company separating the manufacturing of the product into two parts, the balloon catheter itself and the pump separately, a recall would not be totally detrimental.
[1] https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm574885.htm
[2] https://www.maquet.com/uk/products/cs100/
Hi Everyone,
The response to the question has been answered by many participants in this group. Most of them agree that FDA has initiated a recall for safety regulations.
While researching over the internet, I found that US, UK and EU has very different way of recalling procedure. See below
Blog: How do medical device recalls differ between the US, the UK and the EU?
By Patricia Anderson
A medical device recall is action taken to remove or correct a problem with a device on the market because it contains some defect, poses some risk to users, or otherwise violates regulatory law. Naturally, manufacturers go to great lengths to prevent recalls from happening with all the research conducted before a device ever comes to market. However, you may wonder exactly how recalls work – both in the US and outside the US. While countries handle recalls differently, this article contains an overview of three examples of how countries handle recalls: recalls in the UK, the EU and the US.
In the UK:
Recalls in the UK are conducted and regulated by The Medicines and Healthcare products Regulatory Agency (MHRA), which is a government organization that was established in 2003. Prior to this, the MHRA existed as aspects of two separate organizations, Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The role of the MHRA in medical device recalls includes withdrawing a product from the market, issuing alerts when a recall occurs, suspending production, prosecuting a manufacturer or distributor, regular inspections, annual routine sampling of around 3,000 marketed medicines, reports and review of new evidence, commissioning research, assessing labeling for misleading information, and looking for illegally manufactured medicines and devices.
The MHRA works closely with the European regulator, the European Medicines Agency (EMA) and collaborates with other international regulators such as the FDA, the National Patient Safety Agency (NPSA) in the UK and the National Institute for Health and Clinical Excellence (NICE) in the UK.
From a patient perspective, a product containing a new medicine, vaccine, or a new indication for an existing medication will have a black triangle on the label for up to 2 years after it comes to market. This black triangle is designed to encourage healthcare professionals to report any side effects. If the MHRA issues a recall, an alert is issued which can be found publicly and is sent to pharmacies as well as the manufacturer or distributor so that the recalled device will be removed from pharmacy shelves.
In the EU:
The European Medicines Agency (EMA), established in 1995, is a decentralized agency of the European Union (EU). The EMA operates in 28 EU Member States, which is an estimated market of over 500 million people. In the EU, the EMA is a main governing body that handles recalls of medicinal products.
The EMA follows a process for analyzing reports of product defects that may result in the decision to recall the product. When a product defect is reported, the EMA strives to determine the root cause(s) of the quality defect to ensure it is not user error and to consider the risks to the public. Before issuing a recall, they also consider how widely the product was distributed, what the risk to users/patients is, the impact to the market if the product was recalled, and whether or not there are other options on the market or if there will be a shortage situation. Finally, if a recall is deemed appropriate, it must fall into one of three categories: Class I recall (potentially life threatening), Class II recall (could cause illness or mistreatment) and Class III recall (no significant hazard). Class I recall typically occurs at the patient level and is the most urgent type of recall, and Class II and Class III recalls are typically recalled at the distributor or pharmacy level.
Once a product is recalled, the products are stored separately until a formal decision is made about what to do with them. At that point the EMA begins to monitor the effectiveness and progress of the recall to make sure rules are being followed and everyone is safe.
Authorities from the country initiating the recall may send an urgent alert to other authorities in other countries. This alert is called a “rapid alert,” and is typically only used for very serious/urgent alerts.
In the US:
Recalls in the US can be either “firm initiated” or “FDA requested/mandated.” In the US manufacturers and/or distributors may initiate a recall on their own. These recalls are called “firm initiated” or “voluntary.” Manufacturers and/or distributors may also initiate a recall following notification of a problem by the FDA, in response to a formal request by FDA, or as ordered by FDA. These recalls are called “FDA requested” or “FDA mandated.”
The FDA as an organization has a number of responsibilities regarding recalls. The FDA can:
1 Initiate recall – Voluntary, FDA requested, and FDA mandated.
2 Determine an action is a recall
3 Notification and public warning
4 Monitoring and auditing the recall
5 Terminate a recall
6 Take regulatory action if or when a firm fails to recall
Similar to recalls in the UK, once a recall is issued, patients can find that information publicly, and the combination product will disappear from pharmacy shelves. The general public can access a database created and maintained by the FDA, in which they can look up specific information about recalls for medical devices that have occurred since 2002. Information available includes the reason for the recall and the number of commercial units affected.
Resources:
The Medicines and Healthcare products Regulatory Agency. 2008, 2012. “Medicines & Medical Devices Regulation: What you need to know.” Retrieved from: http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf
The Food and Drug Administration. 2013. “Regulatory Procedures Manual.” Chapter 7 Recall Procedures. Retrieved from: https://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074312.pdf
Brendan Cuddy. 2012. “Dealing with reports of suspected defective medicinal products.” Retrieved from: http://www.ema.europa.eu/docs/en_GB/document_library/Standard_Operating_Procedure_-_SOP/2009/09/WC500003189.pdf
European commission: Health and consumers directorate-general. 2014. “The rules governing medicinal products in the European Union.” Volume 4 EU guidelines for good manufacturing practice for medicinal products for human and veterinary use. Chapter 8: Complaints, quality defects and product recalls. Retrieved from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2014-08_gmp_chap8.pdf
https://www.fda.gov/safety/recalls/ and https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm These website link provides a list of all FDA recalls, market withdrawals, and safety alerts and why the item was recalled.
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm561004.htm Zimmer biomet recalled implantable spinal fusion stimulators due to potential of harmful chemicals which may be toxic to tissues and organs. If a cytotoxitity test comes out positive it can indicate that the device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient. I believe that recalls on devices/medical products is the FDAs responsibility. Yes, the company may have played a role in why the device needed to be recalled but it is the FDAs responsibility to ensure that the device is safe. This means confirming that all documentation, testing, and research on the device is done accurately and is truthful.
As stated before there are many reasons for a recall to occur. From personal experience I do not think it is the FDAs fault most of the time. The only reason it would be is a lack of auditing a certain company. Every couple years or so the FDA usually performs audits of medical device manufacturers and ensures they are following all the important regulations and engaging in Good Practices. Sometimes companies are left alone for maybe a decade though and may not be following procedures accurately which could result in product failures. It would be a major issue to perform manufacturing steps which have not been validated properly and deviate from what the FDA approved initially as suitable for consumers. If the manufacturer does this either on purpose or unknowingly, it still seems like it is negligence on the companies side, not the FDA. The FDA cannot vouch for processes that are not disclosed to them. Another example of a recall being the manufacturers fault is not assuring the quality of incoming parts from vendors. I know of a time when a supplier switched up the material on a certain tubing component and did not tell the manufacturer about it. This change in material resulted in tiny holes forming in the tubing later in the assembly process, causing failure of products. The medical device manufacturer needs to be very thorough since it is ultimately them who will be sued by adversely affected customers, not the supplier of the faulty part.
There is a list of drugs on FDA website that have been recalled to protect public health from defective or potential harmful product. Some on the products included on the list are: Nasal Products, Baby oral gels, Homeopathic medicines, hydrochlorothiazide tablets, ibuprofen, sinus relief, compounded drugs and piperacillin and tazobactam injections. If you go through the list you realize that whenever a drug is found to be potentially harmful or defective, it is removed from the market. FDA continuously monitors drugs even when they are in the market for unexpected problems. Some health risks are not recognized during research and clinical trials and they appear after the product is in the market. FDA recalls the drugs when number of reports are seen related to the product from pubic. FDA can’t be held responsible for the health hazard caused by the drug.
The DORO Lucent Headrest System has been recalled. It is supposed to support the head and neck during brain or spinal surgeries while the patient being still. However, DORO® LUCENT Base Unit, Locking Transitional Member, and Transitional Member were fitting properly which could cause harm and even death because during surgery one slip cut in the brain or spinal cord due to the inaccuracy of the system can paralysis or kill the patient. Pro-Med Instrument has recalled the system, but the FDA has classified it as a Class 1 recall. The reason it is class 1 because it can kill patients. I don’t think FDA is responsible because they didn’t initiate recall.
Back on September 9, 2018 the FDA recalled a lot of Montelukast Sodium 10 mg tablets, the generic for Singulair 10mg. The reason behind this recall was a product/label mix-up which may result in some tablets of Losartan Potassium, or Cozaar, to be mixed into the bunch. This is a huge issue because Losartan is a medication that is used to treat high blood pressure in while Montelukast is a medication used to help with allergies and asthma. If someone who takes Montelukast accidentally took Losartan, they could have experienced symptoms like dizziness. A more serious risk that could occur from this mix-up would be fetal toxicity, which could result in death if taken by a pregnant woman. While it is a good thing that the FDA issued this voluntary recall, Camber Pharmaceuticals are to blame for not taking more care in making sure the medication they were distributing was not prepared correctly.
Many people may have heard of the recent recall on Sonic-Fusion's flossing toothbrush. Just recently, this toothbrush was recalled due to "localized melting and sparking of the charging base." There was an increasing amount of consumers reports of this malfunction, totaling to 3,800 units within a year. Many of the consumer's had stopped using them and returned them to Water Pik inc. This overheating issue could have been avoided if there had were more testing on the battery during clinical trials, rather than the effect of the flossing toothbrush. There should have been more research done on the battery life as well and it's effects after prolonged use. This recall was announced by the company, not the FDA, therefore the company is to blame for this incident.
