Applicability of ISO 13485:2016 Clause 7.5.2(d) for Non-Sterile, Reusable Class IIa Devices

[Regulity]

As part of our review of Clause 7.5.2 – Cleanliness of Product under ISO 13485:2016, I would like to seek clarification on the applicability of subclause (d) for a specific type of device.

The manufacturer in question produces a Class IIa, non-sterile reusable medical device (ex: blood pressure cuff). The device does not require any special cleaning or decontamination procedure; rather, it is cleaned between uses with a simple 70% alcohol-based wipe (e.g., Sani-cloth).

Upon review:

• Subclauses (a) through (c) have been assessed and deemed not applicable based on the nature of the product.
• The question is whether Clause 7.5.2(d) is applicable in this case, given that the product is non-sterile, does not require controlled environmental conditions, and only requires minimal surface cleaning.

Could you please provide your interpretation on whether 7.5.2(d) should still be applied for such a product? If so, what level of control or documentation would be expected in the QMS?

 

[Silly Stallion]

This is my interpretation:

- Cleanliness is important for clinical safety (i.e., not transferring contamination to patients)
- Although sterility isn't required (as not being used internally), the item still needs to be clean (e.g., no bioburden, skin flakes, residues, factory dust, or foreign objects)
- Even though the user performs cleaning, the manufacturer still has a responsibility to avoid introducing contamination during manufacturing and packaging (hence the clauses about cleanliness of the production areas)

Also has manufacturer tested that the cleaning processes don't cause deterioration in the product, and potentially affect the readings? I know it's unlikely for blood pressure cuffs, but if it's novel technology it will still need assessing.

Edit

I'd include the following in the quality manual/statement of applicability

"Cleanliness of the product is of particular importance to ensure patient safety and prevent cross-contamination in clinical environments. Although the device is non-sterile and cleaned by the user between uses, it is essential that no contamination is introduced during manufacturing or packaging. XYZ has documented cleanliness requirements and environmental controls during final assembly and packaging to ensure the product is visibly clean and free of foreign matter at the time of release. These requirements are implemented through work instructions, in-process checks, and final inspection."

 

[Regulity]

@Silly Stallion
Thank you for the detailed explanation, I really appreciate your response. Regarding the point on contamination control during manufacturing or packaging, I believe that aspect is already addressed under Section 6.4, which covers the work environment and contamination control. It outlines the necessary controls and considerations from a production standpoint.

That’s why we were considering marking Section 7.5.2 as not applicable for our case, since the device is low-risk and doesn’t involve direct contact with blood or internal body parts. Specifically, 7.5.2(d) refers to cases where "cleanliness is of significance in use."

In the context of something like a blood pressure cuff, would its cleanliness truly be considered significant in terms of impacting its safety or performance? If not, then it seems reasonable to conclude that 7.5.2(d) may not apply. I'd appreciate your thoughts on how "significance" is typically interpreted in this context.

 

[v9991]

The manufacturer in question produces a Class IIa, non-sterile reusable medical device (ex: blood pressure cuff). The device does not require any special cleaning or decontamination procedure; rather, it is cleaned between uses with a simple 70% alcohol-based wipe (e.g., Sani-cloth).

d) product is supplied to be used non-sterile, and its cleanliness is of significance in use;

• Subclauses (a) through (c) have been assessed and deemed not applicable based on the nature of the product.
• The question is whether Clause 7.5.2(d) is applicable in this case, given that the product is non-sterile, does not require controlled environmental conditions, and only requires minimal surface cleaning.

from compliance stand point , this stands relevant as the "prescribed/recommended cleaning step is defined".

Further the term "Significance in use" is the one which determines the extent ; points to consider range from the the durability/longivity of the cuff upon being subjected to the repeated cleaning/decontamination, and to the patient effects., suitability of cleaning agetns.

 

[EmiliaBedelia]

In the context of something like a blood pressure cuff, would its cleanliness truly be considered significant in terms of impacting its safety or performance? If not, then it seems reasonable to conclude that 7.5.2(d) may not apply. I'd appreciate your thoughts on how "significance" is typically interpreted in this context.

Are you directing users to clean the device prior to first use? Or only between uses? The cleaning process between uses is irrelevant if you're not telling users to clean the device before they use it.

No one can answer whether cleanliness is significant for your specific intended purpose. As the manufacturer you are free to identify the device aspects that are important. The pFMEA is a perfect place to put this rationale/evaluation. You probably already have some kind of thought process on cleanliness (considering you have cleaning instructions) so start there and think about what would happen to the user if the device were not clean.

Also, check out AAMI TIR30 or AAMI ST98. These might have some more helpful information to understand what you need to consider for your device. These are not going to tell you the answer to your question but it could help you justify what is "significant".

 

[v9991]

Are you directing users to clean the device prior to first use? Or only between uses? The cleaning process between uses is irrelevant if you're not telling users to clean the device before they use it.

irrespective of the first-use or between uses, determining the suitable and relevant solvent falls under the ambit of the manufacturer. that will be by virtue of either design or by requirements specified by the client; ( in this example , cuff in itself is not end product, it is part of the final product assembed by the client )

No one can answer whether cleanliness is significant for your specific intended purpose. As the manufacturer you are free to identify the device aspects that are important. The pFMEA is a perfect place to put this rationale/evaluation. You probably already have some kind of thought process on cleanliness (considering you have cleaning instructions) so start there and think about what would happen to the user if the device were not clean.

another point to consider is that., if /when it is specified by the client, it will becom epart of your DI; or when you are designing/defining it based on your product and process, then its part of our DO; Either case, it finds place in dFMEA isn;t it?

Also, check out AAMI TIR30 or AAMI ST98. These might have some more helpful information to understand what you need to consider for your device. These are not going to tell you the answer to your question but it could help you justify what is "significant".

 

[EmiliaBedelia]

irrespective of the first-use or between uses, determining the suitable and relevant solvent falls under the ambit of the manufacturer. that will be by virtue of either design or by requirements specified by the client; ( in this example , cuff in itself is not end product, it is part of the final product assembed by the client )

100% true. Cleanliness requirements must be defined for the product and the manufacturer must ensure that the recommended cleaning process is appropriate for the device. But this is tangential to clause 7.5.2(d). This clause is from the product realization/production controls section. It is talking about cleanliness coming out of the manufacturing process, not cleanliness after it has been put into use.

The potential contaminants/residues resulting from the manufacturing process are completely different from the bodily fluids or whatever else that might get on the product while it's being used. Thus you need to consider those 2 sources (and the potential hazards) differently. "Visually clean and free from biological contamination" is a reasonable cleanliness endpoint for a non critical device. If this is the case and if the manufacturer doesn't use any process agents/glues/lubricants/coatings in the production process, it's very reasonable that there are no extra controls implemented in the manufacturing process to achieve the required cleanliness level.

I believe we agree on the fundamental responsibility of the mfg (define the cleanliness required) but I think it is confusing to the original question to bring up the point of use cleaning validation.

Anyway, I would mark the clause as required, define the cleanliness level at whatever low level is appropriate for the device, and justify through the pFMEA/work instructions that the manufacturing process meets that level. You would likely have to do the same amount of work to justify why cleanliness is NOT significant, so it's likely just easier to justify that you do meet the requirements of the clause and move on.