Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Per 60601-1, Can I say that a single-use device has no expected service life? Or would you use the max medical procedure time to determine the service life? 

Is it wrong to state Shelf life == Service life? 

Many thanks,

Hi Anon, 

As per 60601-1, stating that a single-use device has no expected service life is acceptable, but typically its a good practice to determine service life based on the maximum medical procedure time. 

I might have to say shelf life and service life are 2 different things, shelf life typically refers to the period during which a product remains suitable for use when stored under specified conditions, while service life is more related to the duration a device is expected to function safely and effectively in actual use.

I hope this makes sense!

------------------------------
Rupali Natekar
Regulatory Affairs Specialist
Medtronic Diabetes
Northridge CA
United States
------------------------------

Original Message:
Sent: 02-Jan-2024 13:30
From: Anonymous Member
Subject: Expected Service Life for a single use device.

This message was posted by a user wishing to remain anonymous

Per 60601-1, Can I say that a single-use device has no expected service life? Or would you use the max medical procedure time to determine the service life? 

Is it wrong to state Shelf life == Service life? 

Many thanks,

Hi Anon,

I would also look at the Annex A Guidance and Rationale for sub-clause 4.4 which is for Expected Service Life.  Here is the parts of the Annex A sub-clause 4.4 that I think is important aspects to be aware of with respect to the definition of Expected Service Life and other important info to be aware that many manufacturers miss out knowing about that is important to be aware of. Of the below quoted text, the first and last paragraphs have an impact on the definition of Expected Service Life.

"The EXPECTED SERVICE LIFE is the time period during which the ME EQUIPMENT or ME SYSTEM is expected to remain suitable for its INTENDED USE. It is also the period when all RISK CONTROL measures need to remain effective to ensure that RISKS remain acceptable.

...

"In the ACCOMPANYING DOCUMENTS, the MANUFACTURER should provide information to allow the RESPONSIBLE ORGANIZATION to assess when the ME EQUIPMENT is approaching the end of its life. Such information should include the EXPECTED SERVICE LIFE as determined by the MANUFACTURER (e.g. in terms of years of service or number of uses) but could also include tests to be performed as part of preventive maintenance, or other criteria to allow the RESPONSIBLE ORGANIZATION to make an appropriate determination. The need for such information and the appropriate way to present it should be addressed as part of the RISK MANAGEMENT PROCESS.

In defining the EXPECTED SERVICE LIFE, the MANUFACTURER should assume that the RESPONSIBLE ORGANIZATION will follow the MANUFACTURER'S instructions for routine maintenance. See 7.9.2.13."

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 02-Jan-2024 18:30
From: Rupali Natekar
Subject: Expected Service Life for a single use device.

Hi Anon, 

As per 60601-1, stating that a single-use device has no expected service life is acceptable, but typically its a good practice to determine service life based on the maximum medical procedure time. 

I might have to say shelf life and service life are 2 different things, shelf life typically refers to the period during which a product remains suitable for use when stored under specified conditions, while service life is more related to the duration a device is expected to function safely and effectively in actual use.

I hope this makes sense!

------------------------------
Rupali Natekar
Regulatory Affairs Specialist
Medtronic Diabetes
Northridge CA
United States

Original Message:
Sent: 02-Jan-2024 13:30
From: Anonymous Member
Subject: Expected Service Life for a single use device.

This message was posted by a user wishing to remain anonymous

Per 60601-1, Can I say that a single-use device has no expected service life? Or would you use the max medical procedure time to determine the service life? 

Is it wrong to state Shelf life == Service life? 

Many thanks,

This message was posted by a user wishing to remain anonymous

Thank you very much.

After reading more, do you think service life is more appropriate for a medical device that would likely require servicing, while single-use devices (which are not reprocessed, for example not intended for resterilization ) do not have service life but have a device lifetime? 

Original Message:
Sent: 02-Jan-2024 18:30
From: Rupali Natekar
Subject: Expected Service Life for a single use device.

Hi Anon, 

As per 60601-1, stating that a single-use device has no expected service life is acceptable, but typically its a good practice to determine service life based on the maximum medical procedure time. 

I might have to say shelf life and service life are 2 different things, shelf life typically refers to the period during which a product remains suitable for use when stored under specified conditions, while service life is more related to the duration a device is expected to function safely and effectively in actual use.

I hope this makes sense!

------------------------------
Rupali Natekar
Regulatory Affairs Specialist
Medtronic Diabetes
Northridge CA
United States

Original Message:
Sent: 02-Jan-2024 13:30
From: Anonymous Member
Subject: Expected Service Life for a single use device.

This message was posted by a user wishing to remain anonymous

Per 60601-1, Can I say that a single-use device has no expected service life? Or would you use the max medical procedure time to determine the service life? 

Is it wrong to state Shelf life == Service life? 

Many thanks,

Like other cases where the legal text does not provide definitions, it is up to the manufacturer to create them. This is done with a purpose. The intended purpose and mode of action should be taken into consideration when discussing the service life of device. For example, I have seen a single use device that had a warning on the label: 'Do not use for more than 60 seconds' and a catheter may stay in the body for weeks. 

As a manufacturer, you have this freedom. Use it wisely!

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands
------------------------------

Original Message:
Sent: 02-Jan-2024 13:30
From: Anonymous Member
Subject: Expected Service Life for a single use device.

This message was posted by a user wishing to remain anonymous

Per 60601-1, Can I say that a single-use device has no expected service life? Or would you use the max medical procedure time to determine the service life? 

Is it wrong to state Shelf life == Service life? 

Many thanks,

Hello Anon,

As Rupali indicated Shelf Life and Service Life can be two different activities depending on the type of device.  The shelf life is typically associated with sterilised product which is "sitting on the shelf" or other products which sit on a shelf for some period of time.  Service life can be more complicated because it can indicate use of a device, use between maintenance schedules, or overall life of the device from re-processing cycles (though this is sometimes called Usable Life).  Leo provided the definition, for a single-use device the Service Life may be that period of time the device is used according to its intended use.  As an example, single-user disposable infusion pumps are small units with a battery unit intended for providing medication delivery over a period of time.  Typically this period of time would be a few days where the battery will eventually not provide power or functionality to the device - this could be considered the Service Life.  From the point the infusion pump is provided for the initial infusion to the patient over the management of the medication delivery for the next few days.  This would be a single-use device with a Service Life of a few days - this of course can be applied to whatever device you are addressing.  (Incidentally, the infusion pump could also have a shelf life before it is initially used.)

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
------------------------------

Original Message:
Sent: 03-Jan-2024 03:19
From: Ronald Boumans
Subject: Expected Service Life for a single use device.

Like other cases where the legal text does not provide definitions, it is up to the manufacturer to create them. This is done with a purpose. The intended purpose and mode of action should be taken into consideration when discussing the service life of device. For example, I have seen a single use device that had a warning on the label: 'Do not use for more than 60 seconds' and a catheter may stay in the body for weeks. 

As a manufacturer, you have this freedom. Use it wisely!

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 02-Jan-2024 13:30
From: Anonymous Member
Subject: Expected Service Life for a single use device.

This message was posted by a user wishing to remain anonymous

Per 60601-1, Can I say that a single-use device has no expected service life? Or would you use the max medical procedure time to determine the service life? 

Is it wrong to state Shelf life == Service life? 

Many thanks,

Adding to the informative answers already provided, here are a few other points:

• there are multiple terms used that cover the same topic (from different regulations, standards and guidance documents), with slight variations in meaning: expected service life, expected lifetime, device lifetime, functional life, effective life, service life, lifetime, lifespan.
• your risk analysis should flush out the factors that could affect the overall lifetime (whether that be in storage, or in use) and thus require controls and evidence of effectiveness.
• and following on from one of Ronalds points, the MHRA's draft legislation for PMS in the UK introduces lifespan and lifetime as two different concepts, which are key for both implantable devices and durable/reusable equipment (such as the MEE/MES covered by IEC 60601-1). One is governed by the manufacturer's claims/statements and the other is the risk-based....what is the likely and foreseeable time for this to be used (which may just require supporting safety data, but for some devices may also require performance data too). It is likely that other regulators will start to talk about this distinction too, and Team-NB have recently released a position paper on Lifetime.

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom
------------------------------

Original Message:
Sent: 02-Jan-2024 13:30
From: Anonymous Member
Subject: Expected Service Life for a single use device.

This message was posted by a user wishing to remain anonymous

Per 60601-1, Can I say that a single-use device has no expected service life? Or would you use the max medical procedure time to determine the service life? 

Is it wrong to state Shelf life == Service life? 

Many thanks,

In response to Ed's last point Team, NB released a position paper on Medical Device Lifetime on 15 Dec 2023.  In the introduction, it states that the MDR 2017/745 doesn't define medical device lifetime but there are requirements in the GSPRs that are related to lifetime. So, the paper's focus is to create consistency in approach and point to guidance and standards to identify expectations and illustrate different device types and how they relate to lifetime.

So, this would be an ideal document to review.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 04-Jan-2024 06:28
From: Edward Ball
Subject: Expected Service Life for a single use device.

Adding to the informative answers already provided, here are a few other points:

• there are multiple terms used that cover the same topic (from different regulations, standards and guidance documents), with slight variations in meaning: expected service life, expected lifetime, device lifetime, functional life, effective life, service life, lifetime, lifespan.
• your risk analysis should flush out the factors that could affect the overall lifetime (whether that be in storage, or in use) and thus require controls and evidence of effectiveness.
• and following on from one of Ronalds points, the MHRA's draft legislation for PMS in the UK introduces lifespan and lifetime as two different concepts, which are key for both implantable devices and durable/reusable equipment (such as the MEE/MES covered by IEC 60601-1). One is governed by the manufacturer's claims/statements and the other is the risk-based....what is the likely and foreseeable time for this to be used (which may just require supporting safety data, but for some devices may also require performance data too). It is likely that other regulators will start to talk about this distinction too, and Team-NB have recently released a position paper on Lifetime.

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 02-Jan-2024 13:30
From: Anonymous Member
Subject: Expected Service Life for a single use device.

This message was posted by a user wishing to remain anonymous

Per 60601-1, Can I say that a single-use device has no expected service life? Or would you use the max medical procedure time to determine the service life? 

Is it wrong to state Shelf life == Service life? 

Many thanks,