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Ethics and Regulation of Medical Device Development and Manufacturing in Times of Crisis

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(@mduru)
Posts: 24
Eminent Member
Topic starter
 

During the COVID19 pandemic we've seen significant shift of resources in many industries. The medical device industry was one of the industries that felt this shift the strongest. Some approvals were fast tracked by regulators while some others put on the back-burner. Some new medical device manufacturers quickly became FDA registered or ISO certified while some others were delayed. While those directly involved in combating COVID19 were prioritized, others were pushed lower on the list. Do you think this was just/fair and ethical?

What are some examples of medical devices you've seen being approved by regulators quicker than the norm or some devices you've seen put on the back-burner? Do you think it was the right thing to do?

 
Posted : 07/09/2020 8:54 pm
(@jal58)
Posts: 60
Trusted Member
 

Speeding up the approval of medical devices certainly has its benefits. The COVID-19 pandemic has created a dire need for devices such as vaccines and respirators. The dilemma of COVID-19 devices taking precedent over other "direly needed" devices is quite arbitrary without knowing which devices are put on the back-burner. The development of a vaccine affects the global population which leads me to believe the decision was ethical.

I think the rushed development of such devices is a real ethical dilemma. The FDA provides a "Breakthrough Device Program" which speeds up the development of necessary devices while maintaining review and approval standards. The rushed development of COVID related devices can be done in an ethical, and proper manner.

 
Posted : 11/09/2020 1:50 pm
(@pjf22)
Posts: 40
Eminent Member
 

This is a very interesting and controversial point. I think that the need for COVID-19 alleviating devices justified the need to postpone other pending devices or drugs approvals and patents. This pandemic reached a critical level that hospitals and clinics needed all the help they can get. The FDA actually posted a letter indicating that they will use of emergency authorities (EUA's) that will allow medical devices used for COVID-19 to bypass approval in order to help patients in need. Aside of all of the regular 3D printed material like masks and face shields, there are other important medical devices like respirators, blood purification devices, infusion pumps, and others that were included in this EUA's release. While looking further into some of the devices included on the document, there was definitely a reviewing process to check the actual validity of the device and clinical relevance that the devices worked. 

Regarding the ethical aspect of this topic, due to the virus being a global pandemic I do not believe there is anything unethical about the choice the FDA made. Regardless as a whole, the entire system stopped and they should be condoned for working and doing this expedited approvals. 

Please see the link posted below that will bring you to the document mentioned in this post. 

 

1. FDA Combating COVID-19 WITH Medical Devices. Federal U.S. Food & Drug Administration. 2020. Accessed Online 13, September 2020.

https://www.fda.gov/media/136702/download

 
Posted : 13/09/2020 3:31 pm
(@ssbufford)
Posts: 50
Trusted Member
 

The medical device industry most certainly felt the shift from the covid 19 pandemic.  Medical devices are an industry that needs resources to thrive. It simply cannot be a successful industry without the materials needed to be innovative. If you were watching the news at any time during the first year and a half during covid then it is a strong possibility that you are aware that priorities shifted from the governments and dictatorships around the world to accommodate finding a vaccination for covid. As a result of this, many of the medical device manufacturers were delayed while others depending on the urgency of the development were quickly registered by the FDA and/or certified by ISO. This was directly lead by the direct relation to finding a vaccine for covid.  Normally I do not believe in shifting projects and allowing one to take precedence over another but in the case of the worldwide covid outbreak, I absolutely believe that this was the fair and safest route. The FDA granted emergency use of authorization for the investigational monoclonal antibody bamlanivimba for the mild treatment of COVID-19. Yes, I think this was ethical and fair because the world was trying to contain a new worldwide threat. 

 
Posted : 06/05/2021 2:05 am
llefevre
(@llefevre)
Posts: 49
Eminent Member
 

Extraordinary measures have been put into place to develop the core of coronavirus vaccines that we’ve seen on the market that have received emergency use authorization by the FDA. But these processes were not developed overnight or in a matter of a few months as may have been mentioned in the media; this has been a 17 year process with the early onset of SARS and MERS from years past. In order to address this topic I believe one of the more recent discussions has been on the possibility of tech transfers within the industry given the height of an emergency situation. There is now ongoing discussion by the Biden administration to lift patent restrictions on COVID-19 therapeutic treatments and devices. Drugmakers around the world may have the uncanny opportunity to look at the trade secrets of how the viable COVID-19 vaccines have been manufactured and developed which has received some push back by the protections of copyrights on these proprietary formulas. It speaks directly to not only devices but patents being approved and waived quicker than others which speaks directly to the conversation around Emergency maneuvers and mutual benefit of populations of risk. From a device manufacturers perspective, years of development and Hardwork are now subject to the distribution without compensation which ultimately affects the profit margin of those companies. On the other hand getting beyond the special interest and addressing the core concern of COVID-19 and it’s devastating effects on society may mitigate the need for profits during a pandemic so it plays to both ethical and business concerns and needs to be weighed closely. It’s an ethical quagmire but I encourage the conversation because it plays at the fundamentals of our civilization as well as free market enterprise. 

 
Posted : 06/05/2021 5:35 pm
(@armoneee)
Posts: 48
Eminent Member
 

Since the Covid 19 pandemic, the progress of certain medical devices have thrived in certain areas while others have not been able to see fast progress. This pandemic has put the focus on devices that will directly aid in the stop of the spread of Covid 19. It is important to keep the medical devices that help stop the spread of Covid 19 heavily available. Other medical devices should not be completely pushed to the side if the proper FDA regulations are being followed by the company. It would be fair to allow every device the same approval process if it follows FDA regulations. Molecular testing to diagnose Covid 19 is a medical device that was prioritized during the pandemic. It is also known as a viral test or nucleic acid amplification test, which utilizes nasal swabs. It is essential that this medical device was a priority during the pandemic. This will allow for continuous testing on multiple patients multiple times as needed currently. It may not be fair, but it is necessary in combating Covid 19 at such a crucial time compared to other medical devices.

 
Posted : 09/05/2021 10:11 pm
(@armoneee)
Posts: 48
Eminent Member
 

@ssbufford

This is a unique and crucial time for medical devices. I understand your reasoning for wanting to prioritize the medical devices that directly impact Covid 19. It may not seem fair, but it is safe and necessary. If these testing resources were not available, then the pandemic would rage on without the proper controls. Other medical devices can help other areas, but may not directly assist in this pandemic. A unique situation requires almost all of the attention. It is important that these resources are available to all patients so that companies do not run out. 

 
Posted : 09/05/2021 10:17 pm
(@eowinomsm-edu)
Posts: 40
Eminent Member
 

Concerning devices, controlled studies of devices can be difficult since outcomes can depend on how they will be used, for example, in surgical procedures, which may vary. The device risks may also be long-term, but many studies do not report long-term outcomes because doing so so would require long delays for approval. So I don't think the proper measures are taking regarding regulations, and the ethics behind these decisions can be questionable.

 
Posted : 10/05/2021 12:00 am
(@ssbufford)
Posts: 50
Trusted Member
 

@armoneee 

great point! Thank you for sharing your thoughts. Have a great week. 

 
Posted : 10/05/2021 1:17 am
(@arianaburch)
Posts: 45
Eminent Member
 
Posted by: @mduru

During the COVID19 pandemic we've seen significant shift of resources in many industries. The medical device industry was one of the industries that felt this shift the strongest. Some approvals were fast tracked by regulators while some others put on the back-burner. Some new medical device manufacturers quickly became FDA registered or ISO certified while some others were delayed. While those directly involved in combating COVID19 were prioritized, others were pushed lower on the list. Do you think this was just/fair and ethical?

What are some examples of medical devices you've seen being approved by regulators quicker than the norm or some devices you've seen put on the back-burner? Do you think it was the right thing to do?

This is a very great question being that COVID-19 has affected lives in so many ways. I believe that the FDA is trying to combat COVID-19 and prioritize anything that will ultimately save lives. So I can understand that anything that is not necessary helping to combat this pandemic is then placed back and is not a focus as of now. I cannot state that this is not ethical as so many are dying daily so the FDA has to do its job to process and get what is needed to the people first. Though to many who are registered a device with the FDA this can seem very unfair as they worked very hard on there idea to have it move to the bottom of the list. I guess the ultimate question is are the devices that are being approved are they safe and have all the steps been taken to assure this?

 
Posted : 27/08/2021 6:16 pm
(@adumas)
Posts: 9
Active Member
 

I have seen a huge influx of PCR tests and antibody serum tests.  I worked and have been working in healthcare during the pandemic and in fact, some of the clinics have run out of specific tubes, such as CBCs and EDTA tubes.  While all of the products aren't directly related to the medical device field, shipment of specific medical devices have definitely surged.

 
Posted : 28/08/2021 11:27 pm
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