If you are looking for practical tips and insights about medical device risk management, you have come to the right place!
My name is Naveen Agarwal. My mission is to elevate our collective capability in risk management across the global medical device industry so we can significantly improve patient safety, accelerate innovation and reduce cost.
Let us face it - risk management is now much harder than before in the rapidly changing global regulatory environment. Medical device regulation in the EU, for example, includes references to risk management more than 250 times! The US FDA is also working on harmonizing the Quality System Regulation (QSR) with ISO 13485:2016, which has a much higher emphasis on risk management.
In practice, risk management is difficult. That is why I am creating these videos with practical tips and insights. You can also subscribe to my free newsletter at naveenagarwalphd.substack.com/ for additional resources.
Hi Naveen, I always love to watch you ❤. This video specially sparked me to look at 05 year back. When I have started to manage PMS activities. Thank You
5:24 "(...)Certain sequence of events may not have a very high exposure for the patient and as a result the harm may be of low severity(...)" I don't agree with this statement. I think you meant "risk" instead of "severity". The severity is not affected by the sequence of events and hazardous situation, however risk is.
Really like the presentation and efforts to team and share us knowledge, benchmarking benefits analysis and linkage with risk level can be studied like we can apply that mechanism to all devices if possible
If only people with symptoms test themselves, the true positive rate is probably better than if a group of asymptomatic people are screened, prior to flying for example.
I'm sorry, someone here has no idea what open source means. It does NOT mean that anyone can access your data. Open Source means, making the source code available, not personal data. The questions were not about open source, they were about granting access to 1. your QMS (which if it's just SOPs etc. should not have patient data) 2. complaints 3. to do some risk assessment: 1. not a problem if your qms doesn't contain personal data or PHI, 2. I would not do it as complaints might be hard to clean from personal data automatically, and 3. was too unspecific and also unrealistic. AI is not magic. Risk assessment is highly subjective even when incorporating plenty of pms data. I assume he meant going through PMS information automatically. And again, if you have audited the open source AI you want to use for that (assuming that's what "open source" here hinted at), and that AI does not transmit anything anywhere out of your control, then I don't see a problem. Algorithms != Data. This kind of risk assessment really should be done with subject matter experts. The auditors also have a team with technical experience, that will go through your technical file way before the actual audit happens.
Hi Naveen, amazing lecture once again. Shree Koushik mentioned something about P1 and P2 and said that the annex H actually talks about how P2 may not be necessarily required for IVD. Is that really the case? My first look into annex H did not tap this information.
Hello Yusuf - please see Figure H.1 in Annex H for an illustration of how you could use a P1, P2 approach for IVDs. Note that it is not required to use this approach. You can estimate the probability of harm using another, more direct method. I talk about it in this webinar naveenagarwalphd.substack.com/p/webinar-estimating-probability-of-harm
Hello, a common practice in the medical device industry is to use a 1-5 scale to assign a specific level of severity to each individual harm. It is not a quantitative scale. In case of financial risk, you could use a more quantitative scale in terms of money or other metric.
So, that means FDA would allow us to take the risk of killling 1 in 1000 if others lose significant weights ? Actually, who and when will decide that numbers? Is it kind of estimation before market, and live data at post-market? If more people get injured or damaged, then we should reconsider the risk analysis again. By the way, thank you so much for all of your videos :)
You are correct that benefit-risk is evaluated given the available information at the time of pre-market approval. You can refer to the FDA guidance referenced in this video. You are also correct that FDA's assessment may change in the post-market phase if the actual real-world safety performance is worse than the pre-market assessment.
In case anyone needs to use this test in the future, be aware that it is single use only. And if for some wile reason the app crashes or the result is "Invalid", try tearing the cartridge down. The kit is way too expensive to trash it and try again. Use a flat head screwdriver to split it open and look at the test strip inside to see if there is a line in the test area and that the control line has worked. Twice ive had this test brand give me invalid results. No other interruptions occured, or time problems. When taken apart, test strip appears to be fine and in working order. Therefore, if you have these test kits for some reason and theyre being ridiculous on the app, tear them down and take a look at the test strip yourself. I received multiple boxes of these from the USPS, for visually impaired. I do not know how these could be beneficial to visially impaired since there are more steps in this method than others, and requires reading on a cell phone. There is a brand of strep tests that I recall using many years ago that has large plus signs that pop up, lateral flow kits, and I would assume the same could be made for covid using similar kits. Would be much better than this kit for visually impaired.
as per ISO 24971 if probability of hazardous situation leading to harm is very low or high it can be taken as 1 but is this approach is correct it is question for you sir Thank you very much My name is Chinmay Sapre I work as a quality engineer
Hello Chinmay - yes you can assume P2 as 1. This is the most conservative approach. However, make sure to use probability values and not probability levels. For example, if P1=0.01 and P2=1; then POH will be 0.01*1 = 0.01.
Hello Sir Thank you for reply While calculating P1 Should i directly use Complaints/ devices sold as P1 or any further calculation is needed can i add number of complaints and no of defective devices and divide sum by devices sold would that be a accurate prediction of P1 one more approach i am thinking is if i divide defective devices due to hazard over total sales please let me know which approach is the best
@@chinmaysapre6956 check out this article to learn more about how you can estimate P1, P2 using complaints data naveenagarwalphd.substack.com/p/using-pms-data-to-determine-changes-in-risk
Hello doctor, How is it possible that a testing machine at work tells a person that they tested positive but the same person, on the same day takes home Antigen tests five times in a row and from five different brands and has a result of NEGATIVE and then also goes to take a PCR test and test result is also NEGATIVE too. What can cause a work place machine to give someone a FALSE POSITIVE test result.?
Hi Dr Agarwal. I have a cough/sore throat. I tested positive with a very faint line on one antigen test, but negative on two others. The next day I tested negative on two additional tests. Should I consider the one positve test as being accurate?
Hello Naveen thank you for Video on Risk Analysis and question is any case study or information on risk analysis, how to identify the risk associated to Medical device...some glance on it..
no reason i need a fucking bluetooth device and an app for a home test. just crack the device and take the stick out and rub it on there for anyone wondering how to do this test
I agree with your examples. However ISO 14971:2019 Table C.3 provides examples of Hazardous Situations that encroach into the Harms territory. Their example of a Biological Hazard: Sequence of events: 1) Inadequate decontamination of anaesthesia tubing, 2) Contaminated tubing used during anaesthesia Hazardous situation: Bacteria released into airway of patient during anaesthesia Harm: bacterial infection If I understand your examples, it would be written as: Sequence of events: Inadequate decontamination of anaesthesia tubing, Hazardous situation: Contaminated tubing used during anaesthesia Harm: Bacteria released into airway of patient during anaesthesia leading to bacterial infection I would argue that the Hazardous Situation exists as soon as the contaminated tubing is available for use, without even coming into contact with a patient. Same logic for an exposed live wire or a wet floor. Thoughts?
I am trying to understand the standard after 4 years of it's revision. The insights in the video are very much helpful. I have watched other videos on let's talk risk and I find them interesting because of the practical approaches you use to explain the concepts. Please keep posting such useful information. Looking forward to much more concepts in medical device industry. Thank you for sharing your knowledge.
I do not know if the following comment was submitted. Will try again. On April, 2021 I had my second Pfizer covid shot. I was age 89. The next day I went into heart failure with no apparent hope of recovery. It took many weeks to recover to a point where my health was better thanks to great care from doctors. On June 12th 2023, I had what seemed to be Covid. The test kits provided by the government tested negative. I was sick with the usual runny nose, continuous cough, weakness, etc lasting 5 weeks which did seem to be Covid despite the negative test result. We recently learned a daughter did have Covid during a visit in May/June although she had no indications. Surprisingly, an antibody high positive test result for her did show a definite recent case of Covid in the prior 4 to 6 weeks. To possibly confirm my case, I had an antibody test done. It is a positive 800. It was performed using DiaSorin Liaison (R) Sars-Cov-2 Trimeric S lgG assay. Can you please tell if this indicates my recent sickness was Covid, perhaps a variant? To my knowledge I have not had any illness between my last vaccine in 2021 and this recent illness in June. Please advise and thanks.
i wonder during the analyzing time, if the phone turns black, what would happen. usually by default the phone is set to turn black in 30 sec or 1 min if no activity....
Hi! I have a question. what happened if the fluid dropped on my phone, then my mom touched my phone, and she didn’t washed her hands after she touched my phone, then she touch all over the house, will this be danger? I heared the chemicals in the fluid is not safe, I am so anxious right now.
