SBS - The Best Value in QMS software

Medical Device Hazard Risks - Normal Use Risks vs. Faulty Use Risks

2

20130523

#1
Hi All-
Can anyone think of a good explanation as to why Hazards were at one time categorized into Normal Use Risks and Faulty Use Risks, and what the benefit was of that breakout? Are there certain elements or info that could be missing by identifying the individual Hazard as the starting point? I see that most assesments now look at probability and danger to assess risk, and this makes sense. But when I look at older analysis tools I have saved on file, there are many that look at Fault and Normal, about 2002 and earlier.

Also, if anyone would like to share what they use, particularly for a class I disposable risk assessment, that would be great! I have several copies, but not any close to my industry.
Thanks!
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hi All-
Can anyone think of a good explanation as to why Hazards were at one time categorized into Normal Use Risks and Faulty Use Risks, and what the benefit was of that breakout? Are there certain elements or info that could be missing by identifying the individual Hazard as the starting point? I see that most assessments now look at probability and danger to assess risk, and this makes sense. But when I look at older analysis tools I have saved on file, there are many that look at Fault and Normal, about 2002 and earlier.

Also, if anyone would like to share what they use, particularly for a class I disposable risk assessment, that would be great! I have several copies, but not any close to my industry.
Thanks!
Can someone help with this one?

Thank you!

Stijloor.
 
M

Mr. Petey

#4
Specialized ignition sources such as lasers are utilized in oxygen-rich atmospheres, such as hospital operating rooms. Oxygen increases the threat of fire, but this is a Normal Risk.

A patient that smokes while using oxygen in a nursing home or in an apartment is a an example of a Faulty Use Risk.
 

yodon

Staff member
Super Moderator
#5
Not sure what you mean by categorized at one time into normal / faulty use risks. I think that's still the case and the FDA is continuing to push for more consideration of such risks.

You do need to consider likely misuse cases. Mr. Petey cites excellent examples of each and you should consider both in terms of eliminating / reducing risk. Using the example above, you probably can only put something in the User's Manual or accompanying literature that says "Don't smoke or operate around open flame." But you HAVE considered and addressed it.
 
Thread starter Similar threads Forum Replies Date
S The Severity of a Medical Device Hazard - Risk Analysis Clarification ISO 14971 - Medical Device Risk Management 6
D Hazard analysis for our medical device - Hazards seem to overlap 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
W Medical Device FMEA vs. ISO 14971 to create our Hazard Analysis ISO 14971 - Medical Device Risk Management 2
G Medical Device Choke Hazard standard or guidance ISO 13485:2016 - Medical Device Quality Management Systems 2
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 1
DanBOS Cloud Connected Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 0
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 3
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4
J Calling a medical device a medical device (when it might not be one..) UK Medical Device Regulations 29
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
N Medical device name in different countries EU Medical Device Regulations 4
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
H Tukery Medical Device Regulstion Other Medical Device Regulations World-Wide 0
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 3
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom