February 2013 Medical Device "State-of-the-Art" updates

[Sam Lazzara]

A quick summary of some recent update activity I have noticed. Some of these have already been announced in other Cove threads.

Global
The Global Harmonization Task Force (GHTF) was replaced by the International Medical Device Regulators Forum (IMDRF). The IMDRF does not have industry representative like the GHTF did. It is comprised of regulatory authority representatives from the US, Canada, Australia, Brazil, Japan and Europe. GHTF guidance documents are now available on the IMDRF web site.

Europe

On 2013-01-24, updated harmonised standards listings were published on the Europa website. Nothing earth shattering here except EN 980 (Symbols) was removed and bizarrely EN ISO 15223-1:2012 was not added to replace it. Apparently, somebody in Europe has issues with it, so expect to see an update to the EN "informative" (aka annoying) annex before too long to enlighten us.

Europe Medical Devices Vigilance System Guidelines, MEDDEV 2.12/1 Rev 8 published January 2013 (replaces Rev 7); becomes effective July 2013.
In the attached document, I have highlighted the content that is new/revised, mostly related to In Vitro Diagnostics (IVD), In-Vitro Fertilisation (IVF) and Assisted Reproductive Technologies (ART).

Europe 2017(?) - Can you get ready by 2017 for the new European Community medical device legislation? If all proceeds as planned, the proposed medical device and IVD regulations are expected to be adopted during 2014 and would apply three and five years, respectively, after they enter into force.

EN ISO 14630:2012
Non-active surgical implants - Part 1: General requirements (ISO 14630:2012)

EN ISO 25539-2:2012
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)

ASTM Standards

ASTM F1140:2007(2012) Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
Reapproved without changes

ASTM F2063:2012 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

ASTM F640:2012 Standard Test Methods for Determining Radiopacity for Medical Use

ASTM F1929:2012 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

US Pharmacopeia

USP Bacterial Endotoxin Test monograph update
The chapter in the USP pertaining to the Bacterial Endotoxin Test (BET) using the LAL methodology, has undergone a minor update.

The changes are:
a) The referee test is now described as the “gel-clot limit test”, rather than simply the “gel-clot test”.
b) For sample solutions, the phrases “or diluted” has been added. So that “some substances or preparations may be more appropriately dissolves or diluted.”
c) Most importantly, a note about re-validation has been added, with the phrase: “the test for interfering factors must be repeated when any condition changes that is likely to influence the result of the test.”
d) Criteria for depyrogenation has been added, with reference to USP chapter 1211.
e) A reference has been added providing more detail about the entotoxin limit calculation for general pharmaceuticals; intarthecal drugs; and radiopharmaceuticals (each of which has a different value for ‘K’ [endotoxin limit per body weight]).
f) A number of references have been added.
This change applies to USP35-NF30 (2nd supplement, page 5625). The change will be published in full in the next edition of the USP: the 36th in 2013.

 

[Ajit Basrur]

Re: Feb 2013 "State-of-the-Art" updates

Thanks for the valuable post, Sam

 

[gramaley]

Re: Feb 2013 "State-of-the-Art" updates

Have you read this article on "State of the Art" that Quality Digest posted?

https://www.qualitydigest.com/inside/fda-compliance-article/your-medical-device-state-art.html

 

[Ronen E]

Re: Feb 2013 "State-of-the-Art" updates

Have you read this article on "State of the Art" that Quality Digest posted?

https://www.qualitydigest.com/inside/fda-compliance-article/your-medical-device-state-art.html

Thanks Grant. Now I have.

In general I agree, though I have 3 little comments:

1. I found it a bit disturbing that the author made numerous claims about the European Commission issuing various statements (to NB or otherwise), yet didn't provide any hyperlink or concrete reference to such statements (that are ought to be available to the public).

2. AFAIK the European Commission does not have direct jurisdiction over NBs. They are notified by their Member States, therefore they're accountable to the Member States and not to the EC. What the EC states is important but not as important as individual Member States attitudes and decisions. We already know that the latter are sometimes largely affected by politics and sometimes have to do little with direct benefit to patients (or medical devices manufacturers).

3. The author writes:

If you have treated 250,000 patients and have collected 25 customer complaints that have nothing to do with electrical safety, this provides evidence your device provides a high degree of electrical safety.

And I say: "... or your post marketing surveillance is S$#@&T." In fact, 25:250,000 is 0.01%. If this is the total complaint rate (complaints of any sort) then I would assume it is more probable that the communication channels are not too effective, rather than the device having impeccable quality. I once heard that in mass use a ratio of ~1:10 exists between complaint rate and actual incidence (of any sort). The real challenge is to lower this ratio as much as practicable. If you have treated 250,000 patients and have collected 250 customer complaints that have nothing to do with electrical safety, then you are on the right track to establishing such safety through use record.

Cheers,
Ronen.

 

[Marc]

@Ronen E and @Sam Lazzara - Thank you. Historical "Bump" - Is there an update to this?

 

[Sam Lazzara]

@Ronen E and @Sam Lazzara - Thank you. Historical "Bump" - Is there an update to this?

Hi Marc, there have been continual updates to medical device regulations, standards, and guidances since my posting. It is not practical for me to list those updates. At the time I made the posting above (6 years ago now) I just happened to have finished an annual report and had the info handy.

 

[Ronen E]

@Ronen E and @Sam Lazzara - Thank you. Historical "Bump" - Is there an update to this?

Heaps have happened since - quite impractical to try to provide an overview.