Perfect Selling Fully Functioning Class 1 Medical Device vs. Antique

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nick lekanides

#1
my company is in a bit of a quandary at the moment:
we are a long standing medical device manufacturer, and run somewhat old school. we are a small family owned business that has rather close ties to our customers. we are applying for iso 13485 certification, MDD and CE. here is the debate... since we have been doing business (approx 100 years) we have refurbished our older products with a lifetime guarantee, in order to please our customers. it seems as though the MDD and ISO regulations are against our company continuing to "update" or refurbish our products that are quite a few years old (to say the least; approx 10-30-50 yrs +). can someone please give me some advice as to what regulations say and where they would say it? i am currently trying to show the sr. managers what the ISO and MDD regs say regarding this issue, but they consistently "find that info hard to believe!". is is poss to refurbish the instrument under a "antique" or "for demonstration only" tag?

much appreciated.
 
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GStough

Staff member
Super Moderator
#2
my company is in a bit of a quandary at the moment:
we are a long standing medical device manufacturer, and run somewhat old school. we are a small family owned business that has rather close ties to our customers. we are applying for iso 13485 certification, MDD and CE. here is the debate... since we have been doing business (approx 100 years) we have refurbished our older products with a lifetime guarantee, in order to please our customers. it seems as though the MDD and ISO regulations are against our company continuing to "update" or refurbish our products that are quite a few years old (to say the least; approx 10-30-50 yrs +). can someone please give me some advice as to what regulations say and where they would say it? i am currently trying to show the sr. managers what the ISO and MDD regs say regarding this issue, but they consistently "find that info hard to believe!". is is poss to refurbish the instrument under a "antique" or "for demonstration only" tag?

much appreciated.

Welcome to the Cove, Nick! :bigwave:

Interesting question and situation your company is in currently. May I ask what kind of medical devices your company manufactures? What is the intended use? A few of this type details will help Covers understand and offer the most appropriate advice. :)

Looking forward to learning more...:agree1:
 
N

nick lekanides

#3
we are a medical device manufacturer specifically dealing with mercury and aneroid sphygmomanometers (blood pressure machines)- class 1 cuffs and latex/non-latexinflation systems. non invasive. used for the measurement of blood pressure.
 
A

Aaron Lupo

#4
my company is in a bit of a quandary at the moment:
we are a long standing medical device manufacturer, and run somewhat old school. we are a small family owned business that has rather close ties to our customers. we are applying for iso 13485 certification, MDD and CE. here is the debate... since we have been doing business (approx 100 years) we have refurbished our older products with a lifetime guarantee, in order to please our customers. it seems as though the MDD and ISO regulations are against our company continuing to "update" or refurbish our products that are quite a few years old (to say the least; approx 10-30-50 yrs +). can someone please give me some advice as to what regulations say and where they would say it? i am currently trying to show the sr. managers what the ISO and MDD regs say regarding this issue, but they consistently "find that info hard to believe!". is is poss to refurbish the instrument under a "antique" or "for demonstration only" tag?

much appreciated.

When they (the customer) send the bp units back what exactly do you do to them?
Are you saying that according to the MDD and ISO docs that you are not allowed "repair" the units for as long as you want??
 

Al Rosen

Staff member
Super Moderator
#5
my company is in a bit of a quandary at the moment:
we are a long standing medical device manufacturer, and run somewhat old school. we are a small family owned business that has rather close ties to our customers. we are applying for iso 13485 certification, MDD and CE. here is the debate... since we have been doing business (approx 100 years) we have refurbished our older products with a lifetime guarantee, in order to please our customers. it seems as though the MDD and ISO regulations are against our company continuing to "update" or refurbish our products that are quite a few years old (to say the least; approx 10-30-50 yrs +). can someone please give me some advice as to what regulations say and where they would say it? i am currently trying to show the sr. managers what the ISO and MDD regs say regarding this issue, but they consistently "find that info hard to believe!". is is poss to refurbish the instrument under a "antique" or "for demonstration only" tag?

much appreciated.
Where did you get this idea from? The only requirement is that you have to state what the expected lifetime of the device is?
 
R

Roland Cooke

#6
This all sounds a bit strange to me.

I'll throw my thoughts at the screen (and will probably refine them over time so bear with me :cool::D).

1. As these devices are measuring devices, Notified Body involvement is required. Talk to them about your options. If no joy, talk to your trade association. If you have a regulatory consultant, talk to him/her. Use Elsmar Cove...oh :tg:

2. You are placing medical devices on the European market, you need to meet the requirements of the Medical Device Directive. There is no exemption for antique devices, and quite right too:
"I will be putting you, the patient, at risk. However that is okay because this device has cultural and historical merit...."

3. In particular you need to meet Essential Requirement #1. Age of the DESIGN of the device is irrelevant. It is either safe and effective for its intended purpose, or it is not. Note however that the DESIGN of the device can become obsolete over time, gradually providing less and less clinical benefit (Edit: i.e. compared to more-recently developed devices that are then accepted as being the base standard for routine clinical use) against the identified risk.
In addition, risks posed by the device can change. You may find that justifying the use of mercury gets harder and harder on safety grounds, for example (assuming mercury doesn't get banned outright for environmental reasons first anyway).

3. Age of the DEVICE is irrelevant. It is either safe and effective for (immediate) use, or it's not. If products are sent back for repair or general maintenance, that's fine, they are the same product. Your quality system will be examined by the NB to ensure you are capable to perform this work. The repaired devices don't even need to go back to the same customer.

4. If the devices are updated (i.e. changed and presumably improved), they are likely to be considered a new product, and upfront approval from your Notified Body will be required for that significant change. That's not saying you need to physically overlabel a new CE mark onto the device, just that you can't blindly chop and change the product specifications. This is no big deal, by the way (after all medical device software companies develop upgrades all the time); the process just needs to be managed appropriately.

5. I'm not sure I understand your problem, nor why a "demonstration" tag would be of use - as I assume these refurbished devices are intended to be used in a clinical environment?
You CAN put samples out (e.g. prototypes at trade shows), but these should be marked "Not for human use" or somesuch.


Hope this helps.
 
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nick lekanides

#7
honestly, it is all a bit hazy on this front as well.
against their will, the company determined that the lifetime of the device is 5 years, due to the shelflife and wear and tear of the latex and the mercury. yet, they will say that the product does not need any routine maintenance, nor updates. when a design change takes place (not often, because they are reluctant to do so, even if risk management may call for it), they do not call for an update to the returned or repaired products. if the lifetime of the device seems to be an issue, it's simply disregarded.
basically, what i'm wondering is this:
when a 30 year old mercury device comes into our factory for a simple repair... when there was a design change 20 years ago...
1.) are we to simply do the repair?
2.) are we to update the device to the latest revision?
3.)are we allowed to handle the device at all? (considering that the lifetime is 5 yrs.)
the "antique" comes into play in this way: some of these models are of somewhat historical significance, and have been passed along in families for close to 90 years. for example, some people wish to have them refurbished for grandparents as some sort of present, or whatnot.
 

Wes Bucey

Quite Involved in Discussions
#8
honestly, it is all a bit hazy on this front as well.
against their will, the company determined that the lifetime of the device is 5 years, due to the shelflife and wear and tear of the latex and the mercury. yet, they will say that the product does not need any routine maintenance, nor updates. when a design change takes place (not often, because they are reluctant to do so, even if risk management may call for it), they do not call for an update to the returned or repaired products. if the lifetime of the device seems to be an issue, it's simply disregarded.
basically, what i'm wondering is this:
when a 30 year old mercury device comes into our factory for a simple repair... when there was a design change 20 years ago...
1.) are we to simply do the repair?
2.) are we to update the device to the latest revision?
3.)are we allowed to handle the device at all? (considering that the lifetime is 5 yrs.)
the "antique" comes into play in this way: some of these models are of somewhat historical significance, and have been passed along in families for close to 90 years. for example, some people wish to have them refurbished for grandparents as some sort of present, or whatnot.
The defnitive answer, of course, will have to come from the regulators in the jurisdictions where you hope to deliver these products.

As I see it, based on the information you have provided.
  1. repairing, refurbishing, or re-manufacturing a device (to original specifications) already owned by a private person shouldn't be affected by regulators at all. (Consider if you replaced a wheel on someone's wheelchair.)
  2. "updating" with compatible replacement parts (versus original specification) MAY depend on whether the update or upgrade constitutes a new device - definitely a question for a regulator.
  3. repairing, refurbishing, or re-manufacturing old dealer inventory for resale almost certainly would require regulator signoff.
  4. repairing, refurbishing, or re-manufacturing devices currently owned and used by health care providers MIGHT involve other regulators and definitely requires individual investigation.
Handling the device for repairs past the five-year life shouldn't matter as a stand-alone item except as noted in the four items above. (Consider - would a regulator keep a surgeon from reattaching a wire to a pacemaker dislodged in an accident to the patient merely because the device happened to be working past its original useful life (usually measured from when the battery is activated - about ten years.))

Out of idle curiosity, I looked up an old (9 year old study) paper about RE-USING pacemakers when the original implant patient had died. I have no idea if this is still current practice - something for the Google gurus to look up, I suppose. I offer it as proof "some" regulators allow (at least they allowed at some point in the past) regulated entities to offer practical proof of the efficacy of refurbishing and re-using otherwise "out of date" devices.
 

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nick lekanides

#9
thank you for all of your help.

another question i would like to clear up:
if the device is listed with a 5 year lifetime or warranty, and we continue to repair and refurbish devices well past this date, does this change the lifetime of the device?
what would the most appropriate definition for "lifetime of the medical device" be?
what is the best way of determining the lifetime of the device?
 
N

nick lekanides

#10
if the device is listed with a 5 year lifetime or warranty, and we continue to repair and refurbish devices well past this date, does this change the lifetime of the device?
what would the most appropriate definition for "lifetime of the medical device" be?
what is the best way of determining the lifetime of the device?
 
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