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Question: does anyone know of a maker of FDA ProCode "MMP" equipment covers that includes on their labels or in their marketing information a claim of "barrier performance" or a specific statement of ISO PB70:2003 barrier performance class 1, 2, 3 or 4?
Background Information for Those Who Are Interested: the FDA designates ISO PB70:2003, "Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities", as a Recognized Consensus Standard for ProCode MMP "Cover, Barrier, Protective". Several types of single-use, sterile, non-patient-contact equipment covers are typically classified in MMP. Such covers commonly are used on imaging equipment that is positioned in proximity to the patient within the sterile field so as to protect that equipment from contamination, and to provide a sterile barrier in case that equipment is contacted by sterile-garbed clinical personnel.
PB70 provides five classifications for barrier performance. Four of these classifications indicate test-proved fluid hold-out performance, and the fifth is a catch-all classification of "non-protective". PB70 provides that any device for which a claim of barrier performance is made, on the label or in marketing, must be classified into one of the four specific barrier-performance classes, and the product must be accompanied by technical-explanatory and training information regarding hold-out performance. Production must also be batch-tested to assure a continuous specified AQL.
If a product does not make a claim of barrier performance, it in effect is exempted from all compliance actions. The "non-protective" classification is not required to be stated on the label or elsewhere.
The FDA does not require a specific degree of barrier performance anywhere that it recognizes PB70.
We've been selling such equipment covers for over 30 years without specific statements of barrier performance. In all that time, as best we can tell from Customer Service records, apparently we've had zero customer inquiries as to the barrier performance class of our MMP products. Neither have any of our OEM customers specified a particular degree of barrier performance. Of course, for some of that time PB70 didn't exist. Nonetheless, it appears that we have no marketing justification for changing our PB70 stance, even though it's obvious that we're waltzing through a massive loophole.
Of course, we wouldn't take this approach if we had an ethical conflict, but in practice we know that our products are safe and effective for their intended use...and we have multi-million units of product use experience to back up that conclusion. Our stance is based on our conclusion, so far anyway, that our customers get more utility from our minimizing our costs and thus our prices, than they would from an additional performance statement that they aren't asking us to make.
So far I can't find any competitors that take an approach different from ours. This post is in furtherance of that search.
Background Information for Those Who Are Interested: the FDA designates ISO PB70:2003, "Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities", as a Recognized Consensus Standard for ProCode MMP "Cover, Barrier, Protective". Several types of single-use, sterile, non-patient-contact equipment covers are typically classified in MMP. Such covers commonly are used on imaging equipment that is positioned in proximity to the patient within the sterile field so as to protect that equipment from contamination, and to provide a sterile barrier in case that equipment is contacted by sterile-garbed clinical personnel.
PB70 provides five classifications for barrier performance. Four of these classifications indicate test-proved fluid hold-out performance, and the fifth is a catch-all classification of "non-protective". PB70 provides that any device for which a claim of barrier performance is made, on the label or in marketing, must be classified into one of the four specific barrier-performance classes, and the product must be accompanied by technical-explanatory and training information regarding hold-out performance. Production must also be batch-tested to assure a continuous specified AQL.
If a product does not make a claim of barrier performance, it in effect is exempted from all compliance actions. The "non-protective" classification is not required to be stated on the label or elsewhere.
The FDA does not require a specific degree of barrier performance anywhere that it recognizes PB70.
We've been selling such equipment covers for over 30 years without specific statements of barrier performance. In all that time, as best we can tell from Customer Service records, apparently we've had zero customer inquiries as to the barrier performance class of our MMP products. Neither have any of our OEM customers specified a particular degree of barrier performance. Of course, for some of that time PB70 didn't exist. Nonetheless, it appears that we have no marketing justification for changing our PB70 stance, even though it's obvious that we're waltzing through a massive loophole.
Of course, we wouldn't take this approach if we had an ethical conflict, but in practice we know that our products are safe and effective for their intended use...and we have multi-million units of product use experience to back up that conclusion. Our stance is based on our conclusion, so far anyway, that our customers get more utility from our minimizing our costs and thus our prices, than they would from an additional performance statement that they aren't asking us to make.
So far I can't find any competitors that take an approach different from ours. This post is in furtherance of that search.
