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Canadian News article on impact of MDSAP

Edward Reesor

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#1
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Mark Meer

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#2
Confirms a lot of our predictions...

Most interesting quote:
"[The survey] said about 1,750 of the 5,943 facilities where the products are manufactured have had audits registered with MDSAP as of last week. That’s up from about 1,500 a week earlier, which Health Canada says suggests momentum for the program is picking up as it offers more help with the transition."

1. So with just over half the year left to the deadline, not even 30% of facilities are compliant?
2. 1500 facilities registered in one week? Either their numbers/sampling is off, or CBs sure had a busy week!
 

Edward Reesor

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#3
They have recently changed the requirements noting that the auditing organizations (ao's) don't have the staffing to get all of these completed in time. To my best of knowledge, there are only 4 ao's in Canada that can perform MDSAP audits.

The most recent Health Canada notification stated that they are willing to accept small companies that are in good standing, do not require a re-certification audit (i.e. just need a surveillance audit) and have it booked by January 2019. Suddenly the numbers shot up.
 

Mark Meer

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#4
They have recently changed the requirements noting that the auditing organizations (ao's) don't have the staffing to get all of these completed in time. To my best of knowledge, there are only 4 ao's in Canada that can perform MDSAP audits.
Geez, if that's the case, there's no question it's a debaucle!

- 4,193 unregistered facilities (by the article's estimate)
- Only 4 accredited AOs
- ~7 day initial certification audit required per facility
- Only 237 days left in the year

The numbers don't look good for either CBs or companies still intending to meet the deadline.

I'm happy that Health Canada is considering concessions, but I'm annoyed that they didn't foresee this sooner. To issue concessions at this point (be it with audit-time reductions, or deadline extensions) is to punish those companies that got on board MDSAP early to meet the deadline.
 
S

snoopy2017

#5
Mostly small companies without adequate resources to meet the MDSAP deadline. I don't think they are punishing companies which are either already compliant or will be able to meet the deadline.
 

Edward Reesor

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#6
Its not punishment as much as it was (originally) a ten-fold increase in fees that made selling their products in Canada a bad business decision. Now that they have stated that the fees will be reduced for some companies, the question is whether those who have chosen to leave the market will again calculate whether its worth their time and efforts or just walk away.

Evidence is indicating that they are walking away.
 

Mark Meer

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#7
Mostly small companies without adequate resources to meet the MDSAP deadline. I don't think they are punishing companies which are either already compliant or will be able to meet the deadline.
That's not quite what I meant. I think we can all agree that anything that increases operational costs by mandate will disproportionally affect smaller organizations.

Here's what I mean by "punish" by way of example:
- Consider a company (large or small) that diligently follows regulations, and hence got on the MDSAP program as soon as possible to avoid missing the deadline. They pay for it at the original cost and incur a 30k-40k cost of certification for the year (where normally it would be a fraction of this).
- THEN, in response to surveys, CB scarcity, etc. Health Canada announces they are reducing costs, or extending the deadline.
- Now, the company has incurred an unnecessarily inflated cost. Their competitors - those who were not diligent enough to adopt MDSAP early - gain an artificial advantage, as they will pay less.
 
A

Access2hc

#8
in any implementation of regulations anywhere in the world such situations are bound to happen.
just hope those ones that went first to be compliant would have 'first mover advantage' and are also the first wave to help HC gain the momentum they have now.

Cheers,
Ee Bin
Access2hc
 

Edward Reesor

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#9
I am hard pressed to see the "first mover advantage" when HC mandates an auditing system that results in hundreds if not thousands of medical device companies withdrawing from the market. Many foreign companies offer their products to North American distributors in which Canada is 1/10 of the market (USA being the other 90%). When these distributors decide to withdraw from Canada, their bottom line is affected minimally but the population of Canada no longer has access to these medical devices.
While the goal of this program is to improve medical device safety, I fail to see how it will improve over the existing 13495, 14971 and the previous CMDCAS system (all audited by third parties), especially when you compare it to the root causes of medical errors in general.
 

Mark Meer

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#10
...While the goal of this program is to improve medical device safety...
Is that the goal?
From their original announcement:
...Employing a single audit program allows regulatory agencies to efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements, among other benefits...
- "...allows regulatory agencies to efficiently leverage resources..."
Perhaps Health Canada may save some money, but I'd like to see the estimates. How is surveying MDSAP compliance cheaper than CMDCAS?

- "...reduce regulatory burden on industry..."
Riiight... So a more than doubling of audit time each year, and tripling of cost is "reducing regulatory burden"?

- "...without compromising public health..."
As Edward Reesor points out, the outcome appears to be the opposite. Either costs will increase (as companies increase their prices to offset this added cost), or access is reduced (as some companies simply opt to leave the Canadian market altogether).

- "...more aligned and consistent technical requirements..."
What was wrong with ISO 13485/CMDCAS in this respect? I don't believe that system had any inconsistencies that MDSAP remedies.

...I fail to see how it will improve over the existing 13495, 14971 and the previous CMDCAS system (all audited by third parties), especially when you compare it to the root causes of medical errors in general.
Exactly. :agree1:

:topic:
Slightly off-topic: but I'd love to see some hard data here with respect to the effects of increased regulation on public safety. Specifically: Can it be demonstrated that the rate of adverse incidents declines
(a) Above any historical trend prior to implementation of the regulations
(b) When adjusted for any increased sales & use of devices
(c) Taking into account root-causes the regulations are intended to address

My gut tells me we are at the point of diminishing returns...
 
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