The FDA has a program called the Humanitarian Device Exemption (HDE) Program which allows for medical devices intended to benefit patients in treatment or diagnosis of a disease or condition that affects fewer than 8,000 individuals per year. Since conditions like this are hard to gather enough clinical evidence to meet FDA standards, this regulatory pathway creates an alternative route where the device is exempt from the effectiveness requirements of the FD&C Act. There are some additional restrictions including certain prohibitions on profit and a cap on annual distribution number.

Source: https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/humanitariandeviceexemption/default.htm

I don't think this situation will occur in any meaningful frequency. Most hospitals or physicians will only have FDA approved products on hand and those which do not are most likely not very reputable and will use any device they seem fit. As the previous post mentioned there are stipulations for extremely rare cases as well as for diseases or disorders which are deemed inoperable or terminal.

This is a very interesting topic that you have brought up ap962. The knowledge that as934 shared is very knew to me and is a very interesting concept to rad up on. It is good to see that there are steps in place to allow these smaller market shared health concerns still receive the treatment they need. It is alarming that these products do go through without a great deal of testing. It is concerning in that you cannot be fully confident that the product will work as intended if there is no proof that it will. Maybe more simulations or computer based testing could be used to help expedite and perfect these products.

To address this question, quite a few factors have to be considered and I believe the answer is not as simple as a yes or no. Among the factors to consider are the location and availability of supplies that can treat the illness that are approved. In the field, during natural disasters, or in the event proper medical care will not arrive in time, the use of unapproved medical devices are permitted for first aid treatment. Instances of this can be seen in medical emergencies in airplanes or in disaster zones with limited/lacking equipment. The tube portion of a pen has been used as a medical device during first aid treatment of patients with certain lung diseases when approved devices are not available and the patients life is in danger.
see the guidelines below:
https://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm

Currently, President Trump is trying to make unapproved treatments(from my understanding drugs mainly) available to patients with serious diseases who are left to either miraculously recover or live the remainder of their life waiting of a cure to be approved or dying. If that becomes law then we will see a new shift in the medical field. As to how that eventually impacts medical devices is yet to be known.
But with regards to the original question, within hospitals, it is highly unlikely for them to encounter a situation where unapproved devices can be used in emergency situations except in situations like in puerto rico.

Reading the question, my first instinct was to say no, I don't believe that devices/medicine not approved by the FDA should be used, regardless if they believe it works or not. But, after reading my classmates posts, I think that if the medical personal believes that the device/medicine has the potential to cure a disease and they have the patient's approval, then they should use the treatment they see fit.

FDA anticipates that the physician will make the assurance that the patient's conditions meet the criteria, for example, the patient has a life-threatening or serious disease, to evaluate the potential for advantage from the utilization of the unapproved device, and to have substantial reason to believe that benefits will exist. If a device is utilized as a part of condition meeting the criteria recorded over, the physician should follow as many patient protection procedures as possible.

I think this is a portraying an emergency situation which would require a quick Yes or No to use an unapproved medical device. I think as we learned with IRB, that it would also need IRB clearance. I can't think of many hospitals in the tri-state area that would allow one of their physicians to treat a patient with an unapproved device that wasn't IRB approved/FDA approved. From a legal perspective, that would really expose the hospital because if something happened, they would end up in NY Times and would incur a lot of legal expenses. Non-profits are risk averse and would not condone such use of unapproved devices. However, this almost then becomes an ethical dilemma for the physician in how to provide the best care. I think it is a very tough call, but I personally don’t’ think that this situation arises in hospitals a lot because there are so many formal procedures and approvals like IRB approval that this wouldn’t even be a consideration. I think as others have mentioned for HDE and other pathways to formalize pathways for compassionate use cases.

As @amin-sadig mentions Trump’s “Right to Try” agenda for terminally ill patients that “would allow patients to access experimental drug treatments that bypass the Food and Drug Administration's clinical trial process.” Article from CNBC in February:

cnbc/2018/02/21/president-trumps-support-for-risky-experimental-drugs-sidesteps-fda

I think it will be interesting to see if this Right to Try law passes and what the implications will be for this. Will it set the stage for changing some FDA approval timelines?

When a physician uses unapproved medical devices it risks the safety and health of patients. Such medical devices should not be available during regular clinical care. FDA recognizes the emergency use of a investigational devices in a immediate life threating situation when no standard treatments are available and there is no time available to obtain full IRB review. The physician first seek the permission of sponsor or IRB if they disagree physician cannot use the device. The sponsor needs to submit IDE supplement to FDA. If the FDA approved there should be an informed consent document from the patient. The physician would need to report the IRB after the use of device. The IRB will review the submission of any issues from the physician. If the device is used during clinical research the patient must not meet the inclusion criteria and the data obtained should not be included in research.

Most of the hospitals and doctors uses FDA approved devices. I don’t think such situation can happen. From the FDA perspective it approves the drug, products before it is used by doctors. If these devices are helping to cure any disease it should be properly tested and should be approved by the FDA before its use on the patients. But in case of the emergency the devices can be used as the first aid.

Have I read this post three years ago, my immediate answer would have been "no". My recent experience in the military, special with combat medic forces, has colored my perception. In a standard setting, where medical ressources are not scarce, FDA regulations should be implemented regarding the use of medical devices. However, as many pointed out above, certain regulations should be revised as to benefit patients who are terminally ill and left to die. Last semester, when doing some research into the evolution of BAK ( bioartificial Kidney) research, I came across some devices that didn't fully met the FDA regulations but succeeded in prolonging ( by a few months) the life of some ESRD ( end-stage renal disease ) patients. However, the device was removed from the market as it began to be wrongfully used on non-terminal patients.
The context in which I have seen the most non-approved devices used in patients will have to be in combat environment. Medical care in those environments isn't much concerned with FDA regulation, more than it is concerned with saving the life, leg, arm of the soldier at that very instant.

May 2018 saw the signing of the "right to try" bill into federal law. It allows terminally ill patients to try experimental drugs, biologics, and devices that have completed phase I testing but hasn't been FDA approved. Whether or not it is ethical is a different argument, but according to your question there are systems in place for "emergencies".

The use of unapproved devices during emergency is allowed but is conditional. The emergency situation is when there is a life threatening disease or condition that requires immediate use and no available alternative for life threatening condition. In such cases there is no time to obtain FDA approval. This condition is to be identified by the physician that is operating on the patient.

The conditions to use the unapproved devices are given as:
There is no IDE(Investigational Device Exemption.
Physician wants to use the device in a way not part of the IDE study.

The physician is allowed to use unapproved products but should also follow protection measures such as to use on single patient or small group only, takes sponsors authorization and sponsors IDE should be submitted.

Using an unapproved medical devices is allowed in a case where clinical trials are supposed to be submitted as claims for a pre-market approval (PMA) but with only a small group of people and with their approval. Apart from this if the physician knows that the device is capable of curing a life-threatening disease then it should be used with proper consent of the user and with proper safety tools. But as far as possible the use of FDA approved devices should be considered before reaching out to the unapproved medical devices.

Using an unapproved medical device seems to me like an ethical issue. If the device fails the patients health could be put at greater risk. If the device is not given a chance the subjects health might also deteriorate. Modern medicine can be seen as advanced, what I mean is that there are a plethora of different treatments available for physicians to use in order to treat a patient. Therefore, if a physician is even considering using an unapproved medical device it is most likely due to the fact that they have run out of options, and that in their expert opinion, believe that using this device will be the best course of treatment for a patient. I believe that with the correct supervision and very close monitoring a physician should be allowed to use an unapproved medical device. Additionally, I want to speak about consent. Of course, a physician has a very thorough understanding of the body's physiology and how a said medical device will affect the body. A patient will probably lack this knowledge and understanding. I believe that an ethical issue will arise when a physician explains to the patient all the positive outcome that an unapproved will have, and only brushes on the potential side effect. A person who is very ill or in pain will most likely accept any form of medicine that will make them feel better. Therefore, they will most likely accept being treated by a medical device that has not been approved. That is why a thorough explanation should be required to be given to the patient, or the patients family, by a physician when exploring the possibility of using an unapproved treatment.