No entanglement hazard of applied parts cables?

Loekje

Starting to get Involved
#1
Dear all,

I'm a hardware development engineer for polygraphic signal acquisition devices. New to this forum, so apologies up front if I have missed a thread that covered this already.

Identifying hazards frequently feels like kicking in open doors, but nothing surprises me anymore as even microwave manufacturers have to state that their equipment is not to be used for drying ones wet dog or cat...

Sub clause 9.1 has table 19, this is the only place in IEC-60601-1 where Entanglement HAZARD is mentioned. Trying to be thorough and equipped with a wild imagination I can foresee situations where people have ExG leads connected, or other applied parts, which could be highly uncomfortable when wrapped around ones neck, reducing blood circulation in limbs can be hazard enough.

The chances of entanglement with leads are not that remote, consider moving infants in incubators or with sleep diagnosis. So I would expect some warnings in the accompanying documentation of every lead manufacturer. But to my surprise I could not find any warning against entanglement hazards within the documentation of all competitors/colleagues/suppliers.
Is it because entanglement is not considered a hazard? Someone offered an explanation by stating that ?every medical professional gets instruction during their education how to use band aid to fixate applied parts, just to prevent getting hooked by a loose cable and to prevent entanglement. So plainly nobody sees it as a hazard?.
(But then I would expect a clear statement that ExG leads are only to be applied by well instructed personnel, which isn?t always the case either)

So what is it?
? No, applied part leads do not pose this mechanical hazard
? Yes, we should address this hazard in the RMF, and maybe in the user documentation.

I?d very much welcome your expert opinion.
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Moderator
#2
It looks like there is a significant risk, but the question here is whether a label or a line in the instruction manual is an effective risk control.

It is reasonable raise the subject in the RMF, but it may be determined as having acceptable risk with no manufacturer action based on the use of qualified staff, with a note on the specific action that controls the risk (like taping the cords in place). Ideally a decision to take no action should be based on more than anecdotal evidence, instead relying on literature, review of incidents, or with formal input from identified qualified persons (e.g. a person who has worked at several hospitals over many years and can attest that the action is indeed well established). The fact that other manufacturers also have no action helps as support, but should never be the main argument for no action.

While these details should appear in the RMF (it might require a supplementary report if the space in the line item is not enough), there is no requirement to repeat the detail in the instruction manual. If the risk is already acceptable, no action by the manufacturer is OK.
 

Loekje

Starting to get Involved
#3
Thank you Peter Selvey for your swift reply.

According to Annex ZA of EN ISO 14971 :2012 point 5:
b) However, the second sentence of Section 2 of Annex I to Directive 93/42/EEC requests "to conform to safety principles, taking account of the generally acknowledged state of the art" and "to select the most appropriate solutions" by applying cumulatively what has been called "control options" or "control mechanisms" in the standard.
c) Accordingly, the manufacturer must apply all the "control options" and may not stop his endeavours if the first or the second control option has reduced the risk to an "acceptable level" (unless the additional control option(s) do(es) not improve the safety).
I know that 14971 and 93/42/EEC are more appropriate for other forums, but it is to show that considering the risk acceptable in the RMF does not dismiss a manufacturer of applying a warning of the residual risk in the manual, at least for CE labeling which most of the applied parts have.

Not seeing any warnings in current manuals makes me wonder whether other manufacturers consider it a risk at ll. I know now by experience that test houses and NB's are more focused on electrical safety and all other things they have nice applicable tests for. There is not an easy test for entanglement. So the chances of getting approved are quite high if one leaves the risk of entanglement by leads out of the RMF (or set it to "Not Applicable" like so many other items).

Of course there is the risk that adding too many warnings and exclusions make a manual into something unreadable that users want to throw away immediately. So one could make an argument in the RMF that adding a line in the manual would raise the risks of other more important points in the manual not being read. So it would be better to leave it out, hereby invoking the last part in parenthesis of the quote, point 5 c.
But I doubt that all these plain vanilla ECG lead manufacturers are even that philosophical.

Thank you for the tip regarding invoking the input of an identified qualified person. I expect to get some results by going our contacts in the local hospital, a box of chocolates in one hand and a bouquet in the other.:)
 

Pads38

Trusted Information Resource
#4
Could it be that in an entanglement event it is most likely that disconnection takes place, whether by the electrodes being pulled of, or connectors becoming separated?

This would reduce the hazard from possible strangulation to the nuisance of interrupted monitoring (and consequent alarm).

Perhaps in very small children / neonates the force they might generate would not be sufficient to disconnect. But, as far as I am aware, they are not usually sufficiently mobile to "roll over" so entanglement is less likely.

It would seem that direct medical professional advice might be helpful. Another source of information might be ECRI (a non-profit organisation - no connections) have just published their latest list of patient technology hazards -

https://www.ecri.org/Resources/Whitepapers_and_reports/Top_Ten_Technology_Hazards_2015.pdf

but there is no mention there of entanglement.
 
R

Rini_simon

#5
I would recommend that you check if there are any collateral or particulars that are applicable for your equipment. they might have specific risk analysis requirements. for example it is not mentioned in 60601-1 about strangulation due to cables but it is a requirement to perform Risk analysis on strangulation in IEC 66001-1-11 (home healthcare equipments).

Also IEC 66001-1 3.1 edition clause 4.2.3.2 specifies that hazards or hazardous situations that are identified for particular ME equipment or ME system but are not specifically addressed in 60601-1 or its collateral or particular standards the Mfr shall address those hazards in risk management process.

It is not necessary that you should only do risk analysis on hazards specified in 60601-1 but all the hazards related to specific device must be considered.

I hope this helps. :)
 
Thread starter Similar threads Forum Replies Date
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
M Informational Work in progress at the FDA for biological evaluation – Color Hazard and RISk calculator (CHRIS) Medical Device and FDA Regulations and Standards News 0
A Fire hazard classification - Clause in IEC 60601 about gauze and electricity ISO 14971 - Medical Device Risk Management 0
N Should it even be on the hazard analysis (software)? FMEA and Control Plans 2
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
A Moving and positioning of patient - Mechanical hazard IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
A Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs ISO 14971 - Medical Device Risk Management 18
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
D Biological and Chemical Risks to the user in the Hazard Analysis ISO 14971 - Medical Device Risk Management 1
E EN/UL/CSA 61010 -1 (ed3) Safety and use of Software to Prevent Electrical Hazard CE Marking (Conformité Européene) / CB Scheme 3
M Hazard Identification for Pest Control Activities Other ISO and International Standards and European Regulations 9
N Hazard Probability of Occurrence Definition ISO 14971 - Medical Device Risk Management 11
A ISO 14971 Figure E.1 that starts with Hazard and ends with Risk ISO 14971 - Medical Device Risk Management 3
R Risk Analysis and Hazard Identification concerning Clinical Decision Support Systems ISO 14971 - Medical Device Risk Management 1
M IVDD ER 8.3 Vs. Hazard Labelling Regulations - Which outranks? EU Medical Device Regulations 2
G Combining Aspect Impact and Hazard Risk Register Miscellaneous Environmental Standards and EMS Related Discussions 8
R Risks which must be Distinctly Identified - Harm, Hazard, Severity ISO 14971 - Medical Device Risk Management 7
S Hazard Identification and Risk Assessment - Can Risk Assessment be "Grandfathered"? Occupational Health & Safety Management Standards 4
2 Medical Device Hazard Risks - Normal Use Risks vs. Faulty Use Risks ISO 14971 - Medical Device Risk Management 4
K Regarding ISO 62304 Clause 7.3.3 - Hazard and Risk Controls IEC 62304 - Medical Device Software Life Cycle Processes 9
S PMA Submission Software Hazard Analysis Document vs. Product Hazard Analysis doc ISO 14971 - Medical Device Risk Management 5
V FMEA vs. Process Hazard Analysis (PHA) FMEA and Control Plans 2
S Aspect vs. Impact and Hazard vs. Risk - Short/clear explanation & example Miscellaneous Environmental Standards and EMS Related Discussions 11
K When, whom, how to conduct hazard analysis of PRP?s, OPRP?s and CCP?s? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
K Seeking guidance on Preliminary Steps to enable Hazard Analysis Food Safety - ISO 22000, HACCP (21 CFR 120) 1
K Differences between "Hazard" and "Risk" in ISO 22000 Food Safety - ISO 22000, HACCP (21 CFR 120) 4
K General HACCP (Hazard Analysis Critical Control Point) Questions Food Safety - ISO 22000, HACCP (21 CFR 120) 8
D Occupational Hazard....is it worth ? Imported Legacy Blogs 3
somashekar Lead acid Batteries inside DG set acoustic enclosure - What Hazard and Risk and how ? Occupational Health & Safety Management Standards 5
S Hazcom (Hazard Communication) Labels per GHS Requirements Miscellaneous Environmental Standards and EMS Related Discussions 6
S Applying HAZOP and FMEA methods for HSE Hazard Identification in Construction Occupational Health & Safety Management Standards 3
K Behaviour Assessment for Hazard Identification & Risk Assessment Occupational Health & Safety Management Standards 25
M Two situations where it is appropriate to add further Hazard Audits to Internal Audit Occupational Health & Safety Management Standards 8
S Why is the definition of Hazard (OHSAS) focused on Humans alone ? Occupational Health & Safety Management Standards 13
D HHE (Health Hazard Evaluations) vs. HRA (Health Risk Assessment) US Food and Drug Administration (FDA) 6
M Trace Hazard Mitigation Requirements to Code Qualification and Validation (including 21 CFR Part 11) 4
W PHA (Preliminary Hazard Analysis) and Safety Case per UK MOD requirements Occupational Health & Safety Management Standards 2
Howard Lee In South Carolina We Mean "Water Hazard" Coffee Break and Water Cooler Discussions 1
somashekar DEHP vs. DINP as Plasticizer in PVC (Emerging Health hazard) Other Medical Device and Orthopedic Related Topics 3
S Hazard Review Checklist for Biomass Power Generation Plant wanted Occupational Health & Safety Management Standards 19
S OHS (Occupational Health & Safety) hazard review checklist? Occupational Health & Safety Management Standards 5
S Criteria for Determination of Significant Aspect/Hazard in IMS Miscellaneous Environmental Standards and EMS Related Discussions 3
tsmith7858 How to treat something (biological hazard) you know is there... Food Safety - ISO 22000, HACCP (21 CFR 120) 7
W Medical Device FMEA vs. ISO 14971 to create our Hazard Analysis ISO 14971 - Medical Device Risk Management 2
C Health Hazard Evaluation (HHE) template needed US Food and Drug Administration (FDA) 6
A Correlating Hazard Analysis and DFMEA Risk Acceptability Criteria FMEA and Control Plans 8
G Medical Device Choke Hazard standard or guidance ISO 13485:2016 - Medical Device Quality Management Systems 2
W FMEA vs. Hazard Analysis per FDA interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10

Similar threads

Top Bottom