Moving and positioning of patient - Mechanical hazard

AbelVV

Starting to get Involved
#1
Good afternoon everybody,

I am currently trying to identify the hazards on a medical device. One of the inputs for that is the hazards identified in the applicable standards. Table 19 in chapter 9 of the general standard lists "Moving and positioning of PATIENT" as one of the hazards addressed by 9.2 Moving parts and 9.4 Unstability.

I think I have a good handle on all the other hazards in table 19, but I don't understand this one. English is not my native language so it could be part of the issue.

My intuition tells me that unexpected movement or position of the patient could cause hazards through interaction with other parts of the ME system or even external sources. Is that correct?

Really thankful about any help!
 
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Marcelo

Inactive Registered Visitor
#2
Good afternoon everybody,

I am currently trying to identify the hazards on a medical device. One of the inputs for that is the hazards identified in the applicable standards. Table 19 in chapter 9 of the general standard lists "Moving and positioning of PATIENT" as one of the hazards addressed by 9.2 Moving parts and 9.4 Unstability.

I think I have a good handle on all the other hazards in table 19, but I don't understand this one. English is not my native language so it could be part of the issue.

My intuition tells me that unexpected movement or position of the patient could cause hazards through interaction with other parts of the ME system or even external sources. Is that correct?

Really thankful about any help!
Yes, however, please note that the term "Moving and positioning of PATIENT" is not exactly a hazard in itself (as the source of the hazard is not the movement or positioning). The thing is, not all things labeled "hazards" in IEC 60601are exactly hazards, depending on the structure you define your hazards to be.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
"Moving and positioning of PATIENT" is not exactly a hazard in itself
???
The definition of HAZARD is "a potential source of HARM".
If an ME equipment or ME system moves or positions the patient (e.g. MRI machine) it is a potential (mechanical) source of harm - the patient might theoretically be pinched, scraped, crushed etc. So the fact that moving or positioning the patient is involved introduces a potential for patient harm.
 

Marcelo

Inactive Registered Visitor
#4
???
The definition of HAZARD is "a potential source of HARM".
If an ME equipment or ME system moves or positions the patient (e.g. MRI machine) it is a potential (mechanical) source of harm - the patient might theoretically be pinched, scraped, crushed etc. So the fact that moving or positioning the patient is involved introduces a potential for patient harm.
Unfortunately, the definition is so open that it's simply impossible to apply as it is. That's why you need to define a framework for hazard description and categorization. One common, historical framework used in several different fields is to categorize hazards based on the energy source that gives the harm - in this way, patient movement is not a hazard, but for example the impact was a result of patient movement is.

Unfortunately, ISO 14971 does not require a framework for hazard description and categorization, but you really need to do it, otherwise, you will create problems in the risk management process.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Unfortunately, the definition is so open that it's simply impossible to apply as it is. That's why you need to define a framework for hazard description and categorization. One common, historical framework used in several different fields is to categorize hazards based on the energy source that gives the harm - in this way, patient movement is not a hazard, but for example the impact was a result of patient movement is.

Unfortunately, ISO 14971 does not require a framework for hazard description and categorization, but you really need to do it, otherwise, you will create problems in the risk management process.
I don't see where the problem is.
To me, the purpose of identifying hazards is simply creating starting points / anchors from which scenarios or combinations of conditions that lead to hazardous situations can be laid out. IMO moving or positioning a patient is a very clear such starting point, at least in terms of harm that is brought about mechanically.
If an energy source categorisation is required, it should fall under kinetic energy or potential energy (e.g. lifting the patient to a position they might fall from).
 

Marcelo

Inactive Registered Visitor
#6
The purpose of identifying hazards is to create a starting point, but the hazardous situation is the exposure of the hazard. If the hazard does not match the hazardous situation, you can write anything you want, it just is not right. That's why you need to define a framework for that.

As I mentioned, a categorization is not required by the standard, but you can't apply the risk management process without it.
 

AbelVV

Starting to get Involved
#7
???
The definition of HAZARD is "a potential source of HARM".
If an ME equipment or ME system moves or positions the patient (e.g. MRI machine) it is a potential (mechanical) source of harm - the patient might theoretically be pinched, scraped, crushed etc. So the fact that moving or positioning the patient is involved introduces a potential for patient harm.
But acording to 60601 chapter 9, scrapping, crushing, et cetera are already hazards. Therefore "moving the patient" would be a hazardous situation (seeing that it leads to a hazard), not a hazard. I guess that's what I find confusing. I am inclined to listen to Marcelo and not read this table literally, seeing that it is not a requirement per se, only a list of things to keep in mind for the RMF.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Therefore "moving the patient" would be a hazardous situation (seeing that it leads to a hazard), not a hazard. I guess that's what I find confusing.
I get the impression that you got your definitions mixed.
You might be mixing harm with hazard.
A hazard is a characteristic of, or an aspect of the nature of the device, that allows some specific harm to even be relevant. The hazard is always there, or it always isn't there, depending on the very nature of the device. It isn't something that something else leads to under specific circumstances. What "leads to" a hazard is the definition of the device's intended use and its high-level design.
A hazardous situation is something that may or may not come about (it's probabilistic), under specific circumstances. It stems from a hazard; if no relevant hazard is there, the hazardous situation can't come about. For instance, if the device may, by nature, move the patient, and there's a pinch point that is accessible, then at some probability the patient's finger will be there. That's a hazardous situation.
Once a hazardous situation comes about, it may or may not lead to a specific harm. This is also probabilistic.

In the current specific context, the fact that a device involves moving or positioning a patient enables the discussion about some hazardous situations. If a device doesn't lift a patient or holds them at a significant height, there's no point discussing the possibility that the patient will fall. If the device is a blood pressure transducer, it can't endanger the patient through scraping or crushing. The probability of that is exactly 0. That device doesn't have hazards related to moving or positioning the patient.
 

AbelVV

Starting to get Involved
#9
I understand. Then Table 19 in Chapter 9 is not correct when listing "crushing hazard" and others, since the actual hazards are the subclauses associated with them like Trapping zone and overtravel, et cetera.
 

Marcelo

Inactive Registered Visitor
#10
For instance, if the device may, by nature, move the patient, and there's a pinch point that is accessible, then at some probability the patient's finger will be there. That's a hazardous situation.
In this particular example, the patient is exposed to being crushed, so the hazard is a crushing hazard, which is related to the possible harm. The fact that the patient moved or was moved is not related to the harm.
 
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