Product Families

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Hi, we have recently had new standards and we have to put all of our trays into product families this has come from the ISO standards. I am wondering if there is anyone who can help me get my head around this?

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Posted by Jeannete Ryan (Australia) (Questions: 1, Answers: 2)
Asked on June 29, 2016 12:02 am
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Hi Jeannete,
I assume we are referring to Section 5.2 Product Families. We may need to form some sort of a table. Some of the factors that I would be considering are:

1) Critical item or a Non-critical item

2) Supplied as STERILE or HIGH LEVEL DISINFECTED. If HLD, Thermal HLD or Chemical HLD

3) Compatible with mild alkaline detergent with max pH 10.8 (Yes/No)

4) Mechanical wash/disinfection process allowed (Yes/No)

5) Additives like Rinse Aid/Lubricant can be added during disinfection process (Yes/No)

6) Are flushing ports required for cleaning (eg for lumens) (Yes/No)

7) Ultra Sonic required (Yes/No)

8) The medical device is Standard, Optics, Power tool, Lap, Implant, Electro-surgical etc

9) The material is Stainless Steel, Titanium, Anodised Aluminium, Polysulphones, PEEK, glass, insulation etc.

10) Endoscope – Rigid or Flexible

11) Endoscope processing chemical – Gluteraldehyde, OPA or Per Acetic Acid

12) Limited Re-use

13) Is Functionality check possible

14) Additional lubrication required while packing

15) Delicate item requires protection (tip protectors / sheaths / fixations)

16) Multi-part RMDs – To be packed assembled or disassembled

17) Is the tray made of stainless steel, anodised aluminium or Plastic

18) Does the tray have feet and sharp corners

19) Tray to wrapped in non-woven SMS or packed in Rigid Container

20) Sterilisation by Steam, Hydrogen Peroxide, ETO or sterilisation not required

21) Is the item Customer specific or is it general (eg. Budde Halo is specific to Neurosurgery, while a Mayo scissor is used by everyone)

There might be more factors that you may want to consider

I believe the idea is to have a system so that when a new medical device is introduced in the system, it will be easier to select the process

I believe this needs to be in place by Nov 2016. That gives us 4 months.

All the very best Jeannete
Kind Regards
Ravi Nayak

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Posted by Ravi Nayak (New Zealand) (Questions: 1, Answers: 15)
Answered on July 7, 2016 5:43 am
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Hi Ravi,
Thank you so much for your response to my question. I am not sure if you are aware or not but we now have until 2021 to comply with the ASNZ 4187 2014. I think we are going to need it.
I have done a lot of work on this product family and although I have worked out most of the product families for my RMD’s. I am finding the ISO standard that refers to this is contradictory. It doesn’t actually tell you how to find out the steam resistance number for RMD’s that don’t fit into their Product Family. If you look at some of their tables and try and match it up with their recommendations they don’t actually fit either.
I was kind of hoping that someone who has already been doing this for years would respond. It has been great to talk to someone else about it and I do appreciate your knowledge in this matter.

Kind Regards
Jeannete Ryan

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Posted by Jeannete Ryan (Australia) (Questions: 1, Answers: 2)
Answered on July 7, 2016 7:16 am
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