I believe in order to use an unapproved device, Physician's must understand their role and responsibilities. And also understand when an emergency is to use an unapproved device. For a situation to be an emergency, there must be a life-threatening disease or serious condition which is requiring immediate use. There is no generally accepted alternative available for treating the condition. Lastly, there is no time to use existing procedures to obtain FDA approval of an IDE. Before using, it is the Physician's role to assess the potential for benefits from the unapproved use and have substantial reason to believe that benefits will exist.
I don't agree in using unapproved devices because it is a Hail Mary attempt to treat someone. It could cure but there is a high chance that it could cause more pain. Physicians can enlist patients in clinical trials that are testing FDA unapproved medical device/drug. However, before being part of the trial the physician must information all warning and side affect that the patient will encounter during the trial. Physicians must also run pre-examination and background studies because there are specific requirements that patient must being to be consider in the study. So to summarize I don't agree on using unapproved medical device but they can be used by physicians if the patient is approved for the study.
I think in general, an unapproved medical device can be used on only human subjects when the device is under some clinical investigation and when it is used by some investigators participating in a clinical trial. (1) However, there may be circumstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to prevent something when the alternative is not available. I read something in the regulatory information document about that a physician can treat a patient using an unapproved medical device in an emergency situation is this patient concludes that: the patient has a life-threatening condition that needs immediate treatment, there is no generally acceptable alternative treatment for this specific condition, and making sure that there is no time to use existing procedures to get the FDA approval for the use. (1) If the patient’s circumstances meet the above criteria then the FDA expects the physician to make the decision to use an unapproved device.
(1) https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf
"While physicians may prescribe medical devices for unapproved uses, a manufacturer may not distribute medical devices in interstate commerce with the intent that those devices be used for unapproved purposes"
This sentence in an article on whistleblowerfirm website grabbed my attention. So it is possible for doctors to prescribe an FDA approved device to be used by the patient even in an unapproved way but not to use an unapproved device. So it is about selling the device in the market (There may be some rare exemptions for the 510(k) premarket approval). This could be useful in some cases for sure, as long as the device is initially safe to be used (not a Class III devices with a high-risk level) and not for invasive use such as electrical bone simulator.
I found as934 reply interesting as I never heard before about the Humanitarian Device Exemption (HDE) Program.
In case of an emergency, an unapproved medical device could be used if there is some enough that is has created positive results and has been tested in trials. As someone previously stated, there are about 4,000 patients each year that the FDA allows physicians to try unapproved devices or procedures. However, this is reserved for people who are terminal, meaning that they have no other option. Even though using an unapproved medical device could cause death in the patient, the reasoning is that either choice will mean death. The only difference is that using the unapproved medical device could perform a miracle and save the patient's life or help extend his/her life by some amount of time. I personally believe that there should not be a limitation on the number of terminally- ill people who are allowed to try an unapproved device. If the patient gives consent and decides to take the risk of dying from the medical device than the illness, then it shouldn't be an issue because if there is a small chance of working, meaning that symptoms have started to subside, then it would be better than nothing. Even if the medical device doesn't work and the worst scenario happens, then we would know that it's useless and that the device should be abandoned.
As well know, all medical devices require approval so that they can be used.
What do you think happens in the case of an emergency? Can a physician use an unapproved device, if it has the potential to cure a disease?
Before doing a research my immediate thought was absolutely not. The government will do everything in its power to avoid getting sued and using a device that has not been approved seems like the perfect situation for a person to develop a case. After looking up some information via fda.gov, I found that the FDA will allow physicians to treat patients with an unapproved medical device in an emergency situation under the following three conditions: the patient has a life-threatening condition that needs immediate treatment, no generally acceptable alternative treatment for the condition exists, and there is no time to use existing procedures to get FDA approval for the use of the device. Physicians also must receive informed consent from the patient or legal representative, clearance from the institution as specified by their policies, concurrence by the IRB chairperson, an assessment from a physician who is not participating in the study, and authorization from the IDE sponsor of an IDE exist for the device.
Good question.
When I think about the ideal of using unapproved medical devices that may cure the disease. I also think about the unapproved methods of healing the body such as an Herbalist. An herbalist is someone who use natural remedies to heal the body. In the early 2000s, there have been an increase of doctors who tried to speak out about the natural ways we can cure our bodies of diseases and their ideas was discredited by other doctors. Even though, their methods have proven to help the body get back to its natural state of homeostasis. With that being said, I think it is up to the individual. If the person, want to try it, then let them. This is how medical devices started before the FDA became an agency.
In case of an emergency certain medication and medical device for very rare disease can be used if they have not yet been approve but the patient must have exhausted all other forms of treatments. A physician and not used an unapproved medical device without the proper approval and in must cases a physician would not recommend something unapproved because of how hard it would be to obtain it and great risk associated with it.
In case of emergency, physicians can use medical devices if they haven't been approved by the FDA yet if it will help cure their patient. The physicians is given a go to use an unapproved device if:
1. The patient has a life-threatening condition that needs immediate treatment
2. No generally acceptable alternative treatment for the condition exists;
3. Because of the immediate need to use the device, there is no time to use existing procedures to get FDA approval for the use.
If the physicians concludes that this case follows these guidelines, then he/she is able to use the device on their patient. The use of the device should be reported to the FDA and IDE.
Reference:
According to the FDA, the medical device must fit specific emergency use authorization criteria such as, " Ventilators (and ventilator tubing connectors, and ventilator accessories), Personal Protective Equipment (personal respiratory protective devices), and In Vitro Diagnostics (COVID-19 diagnostic device)". Although the pathways to EUA differ among device types/ classes (class 1,2,3), the general pathway consist of, " Submit request to FDA via email with product information, FDA reviews request, if acceptable, FDA issues approval letter, manufacturer complies with conditions of approval (e.g., labeling as unapproved)". Therefore, physicians are able to use unapproved devices in an emergency. However, there still requirements.
This topic is a very interesting topic to discuss. This question can truly be traced back to the AIDS epidemic in the 1980s. During the early stages of the AIDS epidemic, very little knowledge was known about the deadly disease, therefore drugs to help combat the disease did not exist. People with HIV/ AIDs were dying daily with no chance at life due to the lack of medicine. As medicine started to develop, people were still unable to receive it as it had to pass through the many FDA regulations needed to be safely approved, yet many people with AIDs were begging for these drugs, that could potentially save/extend their lives, to be made available for them. This situation is the exact situation described as an emergency in the initial post and brought up the ethical issue of providing an unapproved drug to someone in dire need. The result of the early stages of the AIDs epidemic and many protests by activists forced the FDA to speed up the approval process in cases of emergencies, yet it does not permit physicians to prescribe unapproved drugs or medical devices. That is why this ethical issue still exists. I would agree with the many posts before mine with proper consent and sufficient information provided to the patient could potentially allow for unapproved drugs to be given and tested on human patients. The AIDs epidemic was the start of this ethical issue, which has not been totally resolved to present day.
According to the FDA, a physician can use an unapproved device in an emergency as long the patient has a life-threatening condition that needs immediate treatment, but he must get permission from the patient's relative. https://www.fda.gov/files/about%20fda/published/Frequently-Asked-Questions-About-Medical-Devices---Information-Sheet.pdf
I don't believe that an unapproved device will cure a disease, but rather treat it. In case of emergency, adrenaline is running in your bloodstream and all you care about is to help and assist someone who is about to die. Using an unapproved device is just an instinct based on the situation that is happening. So I think, the use of that unapproved device by the FDA should be considered and used as long as there is an emergency going on.
Testing and verification of some sort is necessary, no matter how much of an emergency it is. There might be cases where as much testing and validation tests may not be necessary — if there is a public health emergency — but it will still be required to some extent. FDA has the Emergency Use Authorizations (EUAs) for situations like these. This authorization allows FDA to authorize the use of unapproved medical devices or products to “diagnose, treat, or prevent serious or life threatening diseases or conditions caused by CBRN [chemical, biological, radiological and nuclear threats]...” [1]. The most relevant example of this is the recent COVID-19 pandemic. According to the FDA website, the HHS secretary determined that Corona-virus was a big enough threat to declare a public health emergency. Due to this, they issued a bunch of emergency authorizations for vaccines, blood purification devices, respiratory assisting devices, and other drugs. Even with such a big public emergency, the FDA stated that rigorous clinical testing was conducted, especially with the COVID-19 vaccines, to approve them. They needed this data to conclude that the vaccines would be safe and effective, and actually help people, and the benefits of the vaccine outweigh the risks. I assume this is the process in such emergency cases. In most cases, I think the FDA would see if the benefits of the unapproved device would outweigh the risks and then authorize it's use.
Source:
[1] https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
Hello,
As others have mentioned, the use of unapproved devices is permitted in emergency situations that may not allow for timely medical assistance. However, I believe it is unlikely for a physician to have unapproved devices on hand for use, unless the physician is in connect with a medical device company that have proposed a technology and have provided prototypes. Furthermore, the FDA has a program called Humanitarian Device Exemption in which a Humanitarian Use Device (HUD) can be used on 8000 patients or less per year for a rare disease. A rare disease for the FDA is considered to affect 200,000 people or less. The FDA does not allow a greater amount of treatments due to lack of proper safety and effectiveness testing of these devices. An example of an HUD is EPICEL, a cultured epithelial autograft produced by Genzyme Corp (citation). This device is intended for patients with deep dermal or full thickness burns that cover at least 30% of the total body surface, which is an emergency use scenario.
