I am currently writing a procedure to define the design control requirements for sterile medical devices. Can anyone suggest a reference for the initial design choice: "does this device need to be sterile".

Usually this is an intuitive decision, but for a high level procedure I want to be able to offer a process for making the decision, and all of the standards I can find appear to assume that you have already made the choice before they become applicable.

Can anyone help me?

Yours, in hope!

JtB

Look at 820.30 (c)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

and

ISO 13485, section 7.3.2

I think that may be why...

:bigwave:

Hi

How about because either a) the device is going to be used in a sterile part of the body. b) is going to contain substances which are subsequently to be used in a sterile part of the body, or c) is going to contact another sterile device; and there is a risk of infection if a non-sterile device was used.

Look at 820.30 (c)

and

ISO 13485, section 7.3.2

I think that may be why...

:bigwave:

Thanks Gert, I have a nasty feeling you may be right. Probably too hard to regulate so best to give responsibility to the customer and manufacturer.

I'll probably have to bite the bullet and try to define something for the design controls process.

JtB

Hi

How about because either a) the device is going to be used in a sterile part of the body. b) is going to contain substances which are subsequently to be used in a sterile part of the body, or c) is going to contact another sterile device; and there is a risk of infection if a non-sterile device was used.

Thanks Chris, that is a good starting point. Where I run into trouble is when certain standards (e.g. ANSI/AAMI ST67) include mucosal contact devices (tongue depressors) and topical devices (ECG electrodes) that go beyond conventional sterility assessments. I imagine that there is some basis of litigation avoidance in the choice to sterilize these devices. For example a patient with severe burns could possibly catch an infection from an ECG electrode, although if their tissue is that compromised a Staph infection is the least of their worries. It is so hard to put your finger on a cut-off point between the need for sterility and the routine acceptance of non-sterility. I know that an MRI scanner is not supplied sterile and I know that a tracheotomy tube is supplied sterile - I just can quite define why?

:frust:

... It is so hard to put your finger on a cut-off point between the need for sterility and the routine acceptance of non-sterility. I know that an MRI scanner is not supplied sterile and I know that a tracheotomy tube is supplied sterile - I just can quite define why?

:frust:
The cut-off point is the risk acceptability within the framework of your risk management, as it was mentioned in the previous responses.

1. Write up the intended use for your device
2. Identify contamination/cross-contamination /infection hazards
3. Evaluate probability and severity
4. Decide, based on your established risk acceptability policy, whether the risk of using non-sterile device is acceptable or not. If not acceptable then supply sterile.

Hope this helps,
I.

Hi Jimmy

I agree, there is no technical reason for some devices to be sterile. However another driver for the design inputs could be "Custoomer Expectation - all competitors are sterile and there would be potential loss of business if the device is non-sterile".

Great responses so far.

Jimmy - another link could be one from TGA on Medical Device standards order No. 3 - Medical device standards for medical devices required to be sterile (http://www.tga.gov.au/devices/mdso3.htm#sch2)

I would add that there are (at least) two further options.

The device could be offered in both sterile and non-sterile configurations.

Alternatively your device could be offered non-sterile for subsequent decontamination/sterilization by the end-user (perhaps repeatedly so).

(In addition, some sterile products are often subsequently placed into kits, which are then themselves sterilized. Thus designing/proving your device to be able to withstand a second sterilization process might also be a requirement.)

Along the lines of Roland's comment above, my employer makes hundreds of products that almost always are sterile when used, but that we sell in both sterile (individually pouched) and non-sterile (usually bulk packed) form. We also have a few products that are usually used sterile, but that for some reason a particular customer wants to buy non-sterile in pouched form, appropriately labeled of course.

Our take on "need for sterility" as "what the responsible physician, or persons acting under his or her authority, wants or expects to buy".

Because of that, we don't distinguish in our design control procedures as to what products must be sterile when sold. We do, on the other hand, determine as an element of design control whether a product must be able to be sterilized.

Hypothetically I could imagine a scenario in which we might make a product that by its nature could not be effectively sterilized after manufacturing, and for which we had a high level of confidence that our clinical knowledge was adequate for us to determine that it could never be used safely in non-sterile form. In that case, we might provide high-level pushback if someone tried to obtain that product from us in non-sterile form.

Other than that, we supply what the clinical-user customer wants.

We do, on the other hand, determine as an element of design control whether a product must be able to be sterilized.
I think this is a very pragmatic response and one that I will certainly consider. Whilst reusable devices present all sorts of challenges for the supplier (you have to be able to demonstrate that a specific cleaning regime is effective at removing a replica test soil, and then that the device can survive a specific number of cleaning/sterilization cycles)

However for a single use device that the customer may want to buy in bulk, non sterile (maybe in order to include in a theatre pack /ER pack of their own design before sterilization, as Roland suggests), ensuring that the device can be sterilized and stipulating the method, provides additional value to the customer, without adding cost that offers them no value, and may even increase their costs (if they have to repackage).

Thanks for the concept,

Jimmy