Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are working on becoming a manufacturer for a sterile consumable to work with existing active device(s). It isn't a new or novel product, and could go through 510k or (unusually) equivalence for clinical evaluation in the EU. The consumable is not an active device in itself. Historically, we have made active devices, not consumables, and normally put storage conditions on our products, per IEC 60601-1.

I am astounded that most competitor consumables do not provide any environmental conditions on their packaging labels (box or sterile pack), those few which do state a range state about 0-30°C. These conditions during storage and shipping could easily be exceeded in some countries, breaking the sterile barrier and/or reducing shelf life. A retired business dev / salesman for one of the competitor products is helping us with the project (we're a small company, limited sales staff) and has said that they aren't aware of any environmental conditions being enforced during the distribution of such products in the past. Our sales staff, will rightly not want to state anything we don't have to, particularly if it will raise questions/doubt from potential clients.

Apart from raising this via risk management, I'm trying to come up with a sound justification to say we shouldn't just copy the competition, unless there's anything else I've missed? 

The only thing I can find is ICH guidelines for pharmaceutical stability studies, which breaks countries down into climatic zones. If this is the case, I will need to check our relative humidity tests. 

Thanks in advance.

Dear Anon,

I agree with your point and I personally would recommend similar indicators as mandated in the IEC 60601 series. Nevertheless, their is one detail >>  I always try to separate (in the risk management activities)  long term storage and short term transport.

One generic regulatory "anchor" is clause 14.2 (b) of the EU-MDR:
"14.2 Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:

(a) the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features;

(b) risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and acceleration or radio signal interferences;

(c) the risks associated with the use of the device when it comes into contact with materials, liquids, and substances, including gases, to which it is exposed during normal conditions of use;

(d) the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts;

(e) the risks of accidental ingress of substances into the device;

(f) the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given; and

(g) risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism."

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Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany
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Original Message:
Sent: 23-Feb-2021 07:42
From: Anonymous Member
Subject: Optional labelling of storage conditions, for sterile consumables ?!

This message was posted by a user wishing to remain anonymous

We are working on becoming a manufacturer for a sterile consumable to work with existing active device(s). It isn't a new or novel product, and could go through 510k or (unusually) equivalence for clinical evaluation in the EU. The consumable is not an active device in itself. Historically, we have made active devices, not consumables, and normally put storage conditions on our products, per IEC 60601-1.

I am astounded that most competitor consumables do not provide any environmental conditions on their packaging labels (box or sterile pack), those few which do state a range state about 0-30°C. These conditions during storage and shipping could easily be exceeded in some countries, breaking the sterile barrier and/or reducing shelf life. A retired business dev / salesman for one of the competitor products is helping us with the project (we're a small company, limited sales staff) and has said that they aren't aware of any environmental conditions being enforced during the distribution of such products in the past. Our sales staff, will rightly not want to state anything we don't have to, particularly if it will raise questions/doubt from potential clients.

Apart from raising this via risk management, I'm trying to come up with a sound justification to say we shouldn't just copy the competition, unless there's anything else I've missed? 

The only thing I can find is ICH guidelines for pharmaceutical stability studies, which breaks countries down into climatic zones. If this is the case, I will need to check our relative humidity tests.

Thanks in advance.

Good day Anon,

You will most likely not find anything specific in the medical device world about environmental conditions related to the finished device especially about shipping and transport.  There is no statement in a regulation saying: you must validate storage and temperature conditions of the finished device.  What you will find is regulations or requirements which speak to this which has evolved from a GMP perspective over the years.  Such as in 21 CFR 820 about storage and handling, ISO 13485:2016 same about product preservation.  In the EU MDR Annex I risks to packaging and thus the product including outside influences.  There are also standards like sterilisation and ASTM which also talk about packaging, storage, and transport.

What has evolved from a Good Manufacturing Practices (GMP), regulatory awareness, increased awareness in the industry, and increasing regulatory requirements - stemming from issues observed from the industry.  The expectation (and requirement) is devices, especially sterile devices have a storage condition identified on the packaging, e.g. 0-30degC. And yes this needs to be validated.  I have seen this as observations from Certification Bodies, Notified Bodies, and regulators from Japan, US and others.  In fact, not only in the temperature ranges specified, but the product can be "stressed" as well.  As example, if temperature low side is 0C ... what actually happens when frozen?  You are correct in being able to profile what the finished device goes through during distribution activities, this is quite expected now.  From my perspective, there is typical ranges for product which are generally accepted, so if your competitive devices are using a certain range this is probably industry expected.  However, yes part of risk management, but also do research to confirm those storage and handling conditions are appropriate for the device.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Feb-2021 07:42
From: Anonymous Member
Subject: Optional labelling of storage conditions, for sterile consumables ?!

This message was posted by a user wishing to remain anonymous

We are working on becoming a manufacturer for a sterile consumable to work with existing active device(s). It isn't a new or novel product, and could go through 510k or (unusually) equivalence for clinical evaluation in the EU. The consumable is not an active device in itself. Historically, we have made active devices, not consumables, and normally put storage conditions on our products, per IEC 60601-1.

I am astounded that most competitor consumables do not provide any environmental conditions on their packaging labels (box or sterile pack), those few which do state a range state about 0-30°C. These conditions during storage and shipping could easily be exceeded in some countries, breaking the sterile barrier and/or reducing shelf life. A retired business dev / salesman for one of the competitor products is helping us with the project (we're a small company, limited sales staff) and has said that they aren't aware of any environmental conditions being enforced during the distribution of such products in the past. Our sales staff, will rightly not want to state anything we don't have to, particularly if it will raise questions/doubt from potential clients.

Apart from raising this via risk management, I'm trying to come up with a sound justification to say we shouldn't just copy the competition, unless there's anything else I've missed? 

The only thing I can find is ICH guidelines for pharmaceutical stability studies, which breaks countries down into climatic zones. If this is the case, I will need to check our relative humidity tests.

Thanks in advance.