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MIREGMGR
This post pertains to the subject-company of [DEAD LINK REMOVED] who have been (but no longer will be, starting yesterday) one of our suppliers.
It's about the worst medical-device-company Warning Letter I've ever seen...even exceeding the Triad situation in a number of respects, especially finding #10.
The subject-company is a maker of ultrasound probe coupling gel, among other products. Such coupling gel is commonly provided to end users in various forms, including pre-sterilized, single-use 20ml foil packettes for ultrasound imaging in medical contexts where materials contacting the patient must be sterile.
As reported in the Warning Letter, an end-user hospital had multiple babies in a neonatal intensive care unit develop infections with pseudomonas aeruginosa. Pseudomonas infection can be lethal, especially to immuno-weak persons such as already-sick/premature infants. An investigation by the hospital revealed that their supplies of subject-company-made ultrasound probe gel in two different package sizes were contaminated with pseudomonas. The hospital filed a mandatory Medical Device Report with FDA, which apparently led to a for-cause inspection of the subject-company.
As the Warning Letter notes, apparently the subject-company hasn't been calibrating or maintaining its in-house sterilizers, hasn't been using validated processes, hasn't been doing sterilization verification-testing (!), hasn't been maintaining a DMR/DHF, hasn't been maintaining a DHR with sterilization batch information, and openly destroyed legally required production records rather than let them be FDA-reviewed.
So, what's my point?
It turns out upon our initial internal review that our Quality and Purchasing folks hadn't physically visited this company to audit them. Instead we trusted their ISO13485 certification, and continued a prior relationship with them that was established by another company we bought some time ago.
In theory, we should be able to do that, right? What does ISO13485 certification mean, if the certificate doesn't indicate that the subject company actually operates according to the standard, and the company has been certified for a number of years so that many audits have (supposedly) taken place?
Bad mistake on our part.
At this point, I'm perfectly willing to change our internal procedures to completely disregard ISO13485 certification as a supplier qualification. If we can't trust any certificate without more knowledge of the issuer's and the individual auditors' track records than anyone will provide to us, it's meaningless.
We need a meaningful, rigorous certification system for medical device companies. ISO13485 doesn't cut it.
It's about the worst medical-device-company Warning Letter I've ever seen...even exceeding the Triad situation in a number of respects, especially finding #10.
The subject-company is a maker of ultrasound probe coupling gel, among other products. Such coupling gel is commonly provided to end users in various forms, including pre-sterilized, single-use 20ml foil packettes for ultrasound imaging in medical contexts where materials contacting the patient must be sterile.
As reported in the Warning Letter, an end-user hospital had multiple babies in a neonatal intensive care unit develop infections with pseudomonas aeruginosa. Pseudomonas infection can be lethal, especially to immuno-weak persons such as already-sick/premature infants. An investigation by the hospital revealed that their supplies of subject-company-made ultrasound probe gel in two different package sizes were contaminated with pseudomonas. The hospital filed a mandatory Medical Device Report with FDA, which apparently led to a for-cause inspection of the subject-company.
As the Warning Letter notes, apparently the subject-company hasn't been calibrating or maintaining its in-house sterilizers, hasn't been using validated processes, hasn't been doing sterilization verification-testing (!), hasn't been maintaining a DMR/DHF, hasn't been maintaining a DHR with sterilization batch information, and openly destroyed legally required production records rather than let them be FDA-reviewed.
So, what's my point?
It turns out upon our initial internal review that our Quality and Purchasing folks hadn't physically visited this company to audit them. Instead we trusted their ISO13485 certification, and continued a prior relationship with them that was established by another company we bought some time ago.
In theory, we should be able to do that, right? What does ISO13485 certification mean, if the certificate doesn't indicate that the subject company actually operates according to the standard, and the company has been certified for a number of years so that many audits have (supposedly) taken place?
Bad mistake on our part.
At this point, I'm perfectly willing to change our internal procedures to completely disregard ISO13485 certification as a supplier qualification. If we can't trust any certificate without more knowledge of the issuer's and the individual auditors' track records than anyone will provide to us, it's meaningless.
We need a meaningful, rigorous certification system for medical device companies. ISO13485 doesn't cut it.
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