LabVIEW patient "monitoring and control," and Linux.

[R. Joseph Lyons]

The following is an email I sent to LabVIEW.

Maybe someone here knows something about this...?

- RJL

****************************************************************************
*********

Hello.

I'm doing some advanced "technical scouting"
for a medical instrumentation company (MIC)
involved in medical patient monitoring and control.

Example problem: monitor a patient's heartbeat and expand a balloon pump
(which has been, rather intrusively, placed right next to the patient's
weak heart)
at just the right time relative to the heartbeat, to help it along. Called
Cardiac Assist.

As you can imagine, there could be some major legal ramifications
if the software "underperforms" and excites the ballo
on pump
at the wrong time!

Right now the MIC's software is primarily C code running under WinNT.

I used LabVIEW while I was a PhD candidate, to acquire and analyze data.

I think you've got a great product, but my higher-ups wonder:
Is LabVIEW robust enough to use not only for patient monitoring,
but also for "patient control" if you will?

Is anyone currently doing this? Who, and for what?
Does the FDA endorse LabVIEW? How about other governmental agencies?

I found some links from your site wherein some people
use LabVIEW to test their medical instruments, but not many (any?)
that use LabVIEW not only to monitor patients but also to "control" them.

In short, what can you tell me that I can pass on to my higher-ups
that'll make them feel that LabVIEW is a safe and sensible product
for medical patient monitoring and control?

Also, the MIC is considering switching from WinNT to Linux.
If you have any comments about how LabVIEW performs under Linux
(versus how it performs under W
inNT) I'd be very interested to hear.

Sincerely,

- Robert Lyons
CEO, Rojopoco LLC
(617) 905-4954
rojopoco@ibm.net

[Jean-Pierre Drolet]

That is clear enough...Citation from the G Programming Reference Manual:

"
WARNING REGARDING MEDICAL AND CLINICAL USE OF NATIONAL INSTRUMENTS PRODUCTS
National Instruments products are not designed with components and testing
intended to ensure a level of reliability
suitable for use in treatment and diagnosis of humans. Applications of
National Instruments products involving medical
or clinical treatment can create a potential for accidental injury caused by
product failure, or by errors on the part of the
user or application designer. Any use or application of National Instruments
products for or involving medical or clinical
treatment must be performed by properly trained and qualified medical
personnel, and all traditional medical safeguards,
equipment, and procedures that are appropriate in the particular situation
to prevent serious injury or death should always
continue to be used when National Instruments products are being used.
National Instruments products are NOT intended
to be a substitute for any form of established process, procedure, or
equipment used to monitor or safeguard human health
and safety in medical or clinical treatment.
"


---------------------------------------------
Jean-Pierre Drolet, Ph. D.
Project Director
Scientech R&D inc.
Trois-Rivieres-Ouest (Quebec)
CANADA G8Z 4H1
Internet sinterna@tr.cgocable.ca


R. Joseph Lyons a �crit dans le message :
01befefd$e3eb9240$bb1b6520@default...
>
> The following is an email I sent to LabVIEW.
>
> Maybe someone here knows something about this...?
>
> - RJL
>
>
****************************************************************************
> *********
>
> Hello.
>
> I'm doing some advanced "technical scouting"
> for a medical instrumentation company (MIC)
> involved in medical patient monitoring and control.
>
> Example problem: monitor a patient's heartbeat and expand a balloon pump
> (which has been, rather intrusively, placed right next to the patient's
> weak heart)
> at just the right time relative to the heartbeat, to help it along. Called
> Cardiac Assist.
>
> As you can imagine, there could be some major legal ramifications
> if the software "underperforms" and excites the balloon pump
> at the wrong time!
>
> Right now the MIC's software is primarily C code running under WinNT.
>
> I used LabVIEW while I was a PhD candidate, to acquire and analyze data.
>
> I think you've got a great product, but my higher-ups wonder:
> Is LabVIEW robust enough to use not only for patient monitoring,
> but also for "patient control" if you will?
>
> Is anyone currently doing this? Who, and for what?
> Does the FDA endorse LabVIEW? How about other governmental agencies?
>
> I found some links from your site wherein some people
> use LabVIEW to test their medical instruments, but not many (any?)
> that use LabVIEW not only to monitor patients but also to "control" them.
>
> In short, what can you tell me that I can pass on to my higher-ups
> that'll make them feel that LabVIEW is a safe and sensible product
> for medical patient monitoring and control?
>
> Also, the MIC is considering switching from WinNT to Linux.
> If you have any comments about how LabVIEW performs under Linux
> (versus how it performs under WinNT) I'd be very interested to hear.
>
> Sincerely,
>
> - Robert Lyons
> CEO, Rojopoco LLC
> (617) 905-4954
> rojopoco@ibm.net
>
>

[sam@vi-lab.com]

On Tue, 14 Sep 1999 20:01:10 GMT, "Jean-Pierre Drolet"
wrote:

I am interested in your comments re. the use of National Instruments
products in medical applications. Please comment on the BioBench
products offered by National for "Biomedical Data Acquisition and
Analysis" applications. I understand that this product was designed
using LabView and interfaces to medical instruments via National
Instruments hardware.

Sam Caldwell
ETI
>
>That is clear enough...Citation from the G Programming Reference Manual:
>
>"
>WARNING REGARDING MEDICAL AND CLINICAL USE OF NATIONAL INSTRUMENTS PRODUCTS
>National Instruments products are not designed with components and testing
>intended to ensure a level of reliability
>suitable for use in treatment and diagnosis of humans. Applications of
>National Instruments products involving medical
>or clinical treatment can create a potential for accidental injury caused by
>product failure, or by errors on the part of the
>user or application designer.
>
>R. Joseph Lyons a �crit dans le message :
>01befefd$e3eb9240$bb1b6520@default...
>>
>> The following is an email I sent to LabVIEW.
>>
>> Maybe someone here knows something about this...?
>>
>> - RJL
>>
>>
>****************************************************************************
>> *********
>>
>> Hello.
>>
>> I'm doing some advanced "technical scouting"
>> for a medical instrumentation company (MIC)
>> involved in medical patient monitoring and control.
>>
>> Example problem: monitor a patient's heartbeat and expand a balloon pump
>> (which has been, rather intrusively, placed right next to the patient's
>> weak heart)
>> at just the right time relative to the heartbeat, to help it along. Called
>> Cardiac Assist.
>>
>> As you can imagine, there could be some major legal ramifications
>> if the software "underperforms" and excites the balloon pump
>> at the wrong time!
>>
>> Right now the MIC's software is primarily C code running under WinNT.
>>
>> I used LabVIEW while I was a PhD candidate, to acquire and analyze data.
>>
>> I think you've got a great product, but my higher-ups wonder:
>> Is LabVIEW robust enough to use not only for patient monitoring,
>> but also for "patient control" if you will?
>>
>> Is anyone currently doing this? Who, and for what?
>> Does the FDA endorse LabVIEW? How about other governmental agencies?
>>
>> I found some links from your site wherein some people
>> use LabVIEW to test their medical instruments, but not many (any?)
>> that use LabVIEW not only to monitor patients but also to "control" them.
>>
>> In short, what can you tell me that I can pass on to my higher-ups
>> that'll make them feel that LabVIEW is a safe and sensible product
>> for medical patient monitoring and control?
>>
>> Also, the MIC is considering switching from WinNT to Linux.
>> If you have any comments about how LabVIEW performs under Linux
>> (versus how it performs under WinNT) I'd be very interested to hear.
>>
>> Sincerely,
>>
>> - Robert Lyons
>> CEO, Rojopoco LLC
>> (617) 905-4954
>> rojopoco@ibm.net
>>
>>
>
>

[Jean-Pierre Drolet]

The same warning appears in the Biobench User Manual. See

ftp://ftp.natinst.com/support/biobench/manual/321612A.pdf

Monitoring and analysing biomedical signals with NI software/hardware is OK
as long as the life of the patient does not depend of such monitoring. I
would not trust a PC based system even to beep the nurse if it detects
something going wrong... and the original post is about a critical cardiac
assistance.
PC/software/hardware are prone to too numerous kinds of system failure and
are not suitable for life critical applications.

Jean-Pierre Drolet
Scientech R&D inc.

a �crit dans le message :
37e25e06.1386511@netnews.worldnet.att.net...
> On Tue, 14 Sep 1999 20:01:10 GMT, "Jean-Pierre Drolet"
> wrote:
>
> I am interested in your comments re. the use of National Instruments
> products in medical applications. Please comment on the BioBench
> products offered by National for "Biomedical Data Acquisition and
> Analysis" applications. I understand that this product was designed
> using LabView and interfaces to medical instruments via National
> Instruments hardware.
>
> Sam Caldwell
> ETI
> >
> >That is clear enough...Citation from the G Programming Reference Manual:
> >
> >"
> >WARNING REGARDING MEDICAL AND CLINICAL USE OF NATIONAL INSTRUMENTS
PRODUCTS
> >National Instruments products are not designed with components and
testing
> >intended to ensure a level of reliability
> >suitable for use in treatment and diagnosis of humans. Applications of
> >National Instruments products involving medical
> >or clinical treatment can create a potential for accidental injury caused
by
> >product failure, or by errors on the part of the
> >user or application designer.
> >
> >R. Joseph Lyons a �crit dans le message :
> >01befefd$e3eb9240$bb1b6520@default...
> >>
> >> The following is an email I sent to LabVIEW.
> >>
> >> Maybe someone here knows something about this...?
> >>
> >> - RJL
> >>
> >>
>
>***************************************************************************
*
> >> *********
> >>
> >> Hello.
> >>
> >> I'm doing some advanced "technical scouting"
> >> for a medical instrumentation company (MIC)
> >> involved in medical patient monitoring and control.
> >>
> >> Example problem: monitor a patient's heartbeat and expand a balloon
pump
> >> (which has been, rather intrusively, placed right next to the patient's
> >> weak heart)
> >> at just the right time relative to the heartbeat, to help it along.
Called
> >> Cardiac Assist.
> >>
> >> As you can imagine, there could be some major legal ramifications
> >> if the software "underperforms" and excites the balloon pump
> >> at the wrong time!
> >>
> >> Right now the MIC's software is primarily C code running under WinNT.
> >>
> >> I used LabVIEW while I was a PhD candidate, to acquire and analyze
data.
> >>
> >> I think you've got a great product, but my higher-ups wonder:
> >> Is LabVIEW robust enough to use not only for patient monitoring,
> >> but also for "patient control" if you will?
> >>
> >> Is anyone currently doing this? Who, and for what?
> >> Does the FDA endorse LabVIEW? How about other governmental agencies?
> >>
> >> I found some links from your site wherein some people
> >> use LabVIEW to test their medical instruments, but not many (any?)
> >> that use LabVIEW not only to monitor patients but also to "control"
them.
> >>
> >> In short, what can you tell me that I can pass on to my higher-ups
> >> that'll make them feel that LabVIEW is a safe and sensible product
> >> for medical patient monitoring and control?
> >>
> >> Also, the MIC is considering switching from WinNT to Linux.
> >> If you have any comments about how LabVIEW performs under Linux
> >> (versus how it performs under WinNT) I'd be very interested to hear.
> >>
> >> Sincerely,
> >>
> >> - Robert Lyons
> >> CEO, Rojopoco LLC
> >> (617) 905-4954
> >> rojopoco@ibm.net
> >>
> >>
> >
> >
>

[sam@vi-lab.com]

On Fri, 17 Sep 1999 16:21:43 GMT, "Jean-Pierre Drolet"
wrote:

Thank you for your prompt response. I am familiar with disclaimers
that specifically exclude the use of products in medical devices that
are designed to be used in life support systems. The National
Instrument disclaimer quoted in your post is much broader ...
"Applications of National Instruments products involving medical or
clinical treatment can create a potential for accidental injury caused
by product failure, or by errors on the part of the user or
application designer."

All applications involving "medical or clinical treatment" as well as
"diagnosis of humans" are subject to the quoted National Instrument
disclaimer. Yet the BioBench product is advertised on the National
Instrument WEB as being suitable for "Biomedical Data Acquisition and
Analysis" applications. I believe that analysis of biomedical data
could easily fall in the realm of medical diagnosis.

It seems to me that National on one hand declares it's products
unsuitable for medical applications and on the other hand, markets a
biomedical monitoring product that can be used to analyze bioMEDICAL
data.

If you believe I'm nit picking, please review the state of affairs in
US medical product liability law suits.

Either National Instruments products are suitable for medical
monitoring and analysis applications or they are not. If National
Instruments wishes to distance it's products from medical products
liability, I would recommend that National Instruments drop the term
biomedical from BioBench labeling. The phrase physiological monitoring
may be more appropriate, given the breath of the National disclaimer.

Sam

>The same warning appears in the Biobench User Manual. See
>
>ftp://ftp.natinst.com/support/biobench/manual/321612A.pdf
>
>Monitoring and analysing biomedical signals with NI software/hardware is OK
>as long as the life of the patient does not depend of such monitoring. I
>would not trust a PC based system even to beep the nurse if it detects
>something going wrong... and the original post is about a critical cardiac
>assistance.
>PC/software/hardware are prone to too numerous kinds of system failure and
>are not suitable for life critical applications.
>
>Jean-Pierre Drolet
>Scientech R&D inc.

[B & C Duffey]

if I design a system to "monitor" a $500K dollar diesel engine and my system
fails to report a malfunction (because of poor programming) and the engine
goes up in smoke - I may be liable for the engine -

if on the other hand a bug in LabVIEW causes the malfunction which results
in the destruction of the engine I might (depends on local laws) be able to
share the liability with National Instruments (i.e drag them into a
lawsuit). (I would still bear liability since I chose to use LabVIEW in the
implementation). The NI license agreement also covers this under the
heading "NO LIABILITY FOR CONSEQUENTIAL DAMAGES" with some small print at
the bottom that says " Because some states/jurisdictions do not allow the
exclusion or limitation of liability for consequential or incidental
damages, the above limitation may not apply to you."

And here is one more which I will paraphrase:

ANY APPLICATION WHERE SYSTEM FAILURE COULD CAUSE DAMAGE TO PROPERTY OR
PERSONS ... SHOULD NOT BE RELIANT SOLEY UPON ELECTRONIC MONITORING...

The analogy holds true replacing the engine with a much more valuable human
life - except that National Instruments has in a small way mitigated their
liability by the license disclaimer.

In a nutshell you can use LabVIEW for whatever you want but its NOT bullet
proof and if you damage property or injure or kill someone NI has to try and
protect themselves - My experience with any non-embedded computer with a
complex operating system like Windows NT, Solaris, MacOS is that there are
too many unknowns to predict all the possible failure modes of Software,
hardware, OS etc. IMHO it is not sound ( or moral) engineering practice to
risk someones life on a system like this.

Analyzing BIO Medical data usually means that a human is there in the loop,
certainly there is risk here also of you give the operator bad information -
but at least the operator may be (should be) smart enough to recognize that
the data is bogus and investigate further - a BIO Medical control
application is entirely different - if you don't give a patient the right
dose of medicine or stimulate their heart wrong you could injure or kill
them !

Too risky for me, I lose enough sleep at night as it is....

Just a few thoughts.

Chris



sam@vi-lab.com wrote in message
<37e2a868.586024@netnews.worldnet.att.net>...

>It seems to me that National on one hand declares it's products
>unsuitable for medical applications and on the other hand, markets a
>biomedical monitoring product that can be used to analyze bioMEDICAL
>data.
>
>If you believe I'm nit picking, please review the state of affairs in
>US medical product liability law suits.
>
>Either National Instruments products are suitable for medical
>monitoring and analysis applications or they are not. If National
>Instruments wishes to distance it's products from medical products
>liability, I would recommend that National Instruments drop the term
>biomedical from BioBench labeling. The phrase physiological monitoring
>may be more appropriate, given the breath of the National disclaimer.
>
>Sam
>

[Kevin_work]

sam@vi-lab.com wrote:
I am interested in your comments re. the use of National Instruments

> products in medical applications. Please comment on the BioBench
> products offered by National for "Biomedical Data Acquisition and
> Analysis" applications. I understand that this product was designed
> using LabView and interfaces to medical instruments via National
> Instruments hardware.
>

I am assuming here but my guess would be that BioBench is used
in BioMed LABS. That is it is used to do testing on Bio samples
and not on the patient.

This would make the most sense,to me anyway.
Of course I could be wrong unless I am not.
Kevin Kent

[bubucis]

Hello!

Yeah, I would not want my heart being pumped by LabVIEW. No offense, but
that thing tends to crash now and then. Maybe LabviewRT, but then there is
that disclaimer.

[Helmut Hullen]

Hallo, R.,

Du meintest am 14.09.99 zum Thema LabVIEW patient "monitoring and control," and Linux.:

> I'm doing some advanced "technical scouting"
> for a medical instrumentation company (MIC)
> involved in medical patient monitoring and control.
>
> Example problem: monitor a patient's heartbeat and expand a balloon
> pump (which has been, rather intrusively, placed right next to the
> patient's weak heart)
> at just the right time relative to the heartbeat, to help it along.
> Called Cardiac Assist.

Maybe the "real time" hardware from National Instruments does fit. I don't
know the proper name, I've seen it working. It's a card which is set into
a PC. The PC is only needed for power supply and for booting. Then the
card (with an own microcontroller) takes o
ver and does fit to technical
"real time" definition (response within a defined time).

Linux and "real time" is another story. Some guys are working on a kind of
"embedded system". I don't believe that "LabView" does fit into that
environment.

Viele Gruesse!
Helmut