Hello All,

While searching for the accuracy and precision over the internet, I came across a very interesting blog :

Check the following link where people discuss about accuracy, reliability safety and regulations from other countries.They have explained multiple examples of medical devices and their drawbacks as well.

https://www.researchgate.net/post/How_do_you_know_that_medical_devices_are_reliable_accurate_and_safe2

Phil Petursson
Phil Petursson
How do you know that medical devices are reliable, accurate, and safe?

How do you know that medical devices are reliable, accurate, and safe?
I would like to evaluate several medical devices (for example: therapeutic ultrasound unit, interferential unit, cardiac defibrillator, laser therapy unit, etc.). The evaluation would include the reliability, accuracy, and safety of the medical devices. This would be important contributing to best practice procedures.
For example, I looked at AED (Automated Electronic Defibrillator) info by checking the FDA site: http://www.fda.gov/default.htm
There are numerous defibrillators that are not approved/registered by the FDA. And several approved/registered units, have been recalled by the FDA, due to serious problems. Therefore, I thought the FDA is a very credible site to obtain an independent evaluation of medical devices.
I believe that approval ratings that include: ‘CE’, ‘UL’, and ‘GS’ are only electrical safety ratings, and do not evaluate the reliability and validity (accuracy) of a medical device. I believe that ISO certification generally refers that a manufacturer “has introduced and applies a Quality Management System”; “demonstrated compliance of the Quality Management System” related to a particular area/code/regulation/policy. This information does not readily show reliability, accuracy, safety of a product. And, any claims by the manufacturer could be prone to internal bias. This is where independent evaluations by the FDA provides strong, credible evidence. And, I noticed that several medical devices state that they are FDA approved/registered. However, medical devices are regularly sold without FDA approval/ registration.
Please let me know if I am mistaken with any information, and provide further advice.
Why would a manufacturer of a medical device not obtain FDA approval/registration? I believe that FDA approval would be an exceptional selling feature.
Is it best to choose a medical advice on the basis of FDA approval and registration?
Or are there other regulatory bodies that provide a recognised standard of approval?
I hope that this information would be helpful to share with all health/medical practitioners.
Cheers, Phil
Topics

Medicine
May 16, 2012
Recommend5 Recommendations
Popular Answers
Rahul Dimber
Rahul Dimber · Frimley Park Hospital NHS Foundation Trust
There is the fundamental problem in classification of medical device.Current classification is risk based-which is more of an engineering concept applied to medical field.This makes the device assessment more confusing.There are more than 100,000 medical devices on market compared to around 10,000 medicinal product.The current regulatory system is not is a position to assess each and every medical device placed on the market.There is a need for development of regulatory system which can evaluate medical device for its efficiancy and effectiveness.
Jun 1, 2012 · Recommend8 Recommendations
Steven Bellistri
Steven Bellistri · Mercy Health System
My advise is to first look to FDA approved devices and those with the CE for European devices. Those are more then electrical. Then I look to those that meet my budget, are easy to use, and have support from the manufacture. Then do a side-by-side comparison to make your choice.
May 6, 2013 · Recommend5 Recommendations
All Answers (90)
Phil Petursson
Phil Petursson ·
Thank you for the info. http://www.hc-sc.gc.ca/index-eng.php is an excellent site, and I found that the site is strongly correlated with the FDA. I have contacted Health Canada regarding: How to confirm if medical devices are reliable, accurate, and safe? The situation is that I find several medical companies are promoting medical devices without an established standard of valid and reliable evidence. Best evidence would be with independent testing/ approvals from appropriate medical organisations or regulatory bodies. I believe this is an important topic. I’ll post my updates as I receive info.
Regards,
Phil (New Zealand)
May 16, 2012 · Recommend1 Recommendation
Lava Kafle
Lava Kafle · Kathmandu University
Great for healthcare entrepreneurs researchers like me thanks
May 16, 2012 · Recommend1 Recommendation
Arnaldo Guimarães Batista
Arnaldo Guimarães Batista · New University of Lisbon
And as far as I know non-CE marked device is not marketable in the European Union, right?
May 16, 2012 · Recommend1 Recommendation
Conrad Wall
Conrad Wall · Massachusetts Eye and Ear Infirmary
Potential investors might be put off unless your device did have some kind of certification. This is true in the US in my experience.
May 16, 2012 · Recommend1 Recommendation
H.-J. Cappius
H.-J. Cappius · W.O.M. World of Medicine GmbH
In Europe the CE mark is needed for marketing a (medical) product, as it signifies the conformation with the EC-wide harmonized standards.
But also researchers need a simplified EC conformation just to use a medical device in clinical research settings..
May 16, 2012 · Recommend1 Recommendation
Arnaldo Guimarães Batista
Arnaldo Guimarães Batista · New University of Lisbon
That explains the labelling “for research purposes only” . No clinical treatment based upon on the device outputs
May 16, 2012 · Recommend1 Recommendation
Patrice Forget
Patrice Forget · University Hospital Brussels
I agree that the CE mark is needed for safety issues. But it does not imply that the device is reliable/accurate and certainly not that it makes sense from a clinical point of view. The only way is to critically analyse the published litterature.
May 16, 2012 · Recommend1 Recommendation
Arnaldo Guimarães Batista
Arnaldo Guimarães Batista · New University of Lisbon
defibrillator history confirms that: certified devices going wrong…

I find that, many times, there is a gap between state-of-the-art research and the certified corresponding systems. At least in my research area (biomedical signal processing). By the time the systems hit the hospital, the algorithms might be just not up-to-date…
May 16, 2012 · Recommend1 Recommendation
Sabine Sabouraud
Sabine Sabouraud · Centre Hospitalier Universitaire de Lyon
In France, the manufacturer himself has responsibility for putting on the market a medical device. First, the CE mark must be given, before putting on the market, that is evidence of its agreement with health and safety European requirements. The French health Authorities, called Afssaps, becoming ANSM at present (www.ansm.sante.fr), intervenes after, doing the surveillance (safety).
I personally fit the Lyon city out with AED, and the duration of guaranty is 7 years now, instead of 5 years. The problem is maintenance, servicing.
Best regards
Sabine
May 17, 2012 ·