The maker of eye drops linked to a deadly outbreak of extensively drug-resistant infections in the US had a slew of manufacturing violations—from brown slime on filling equipment to a lack of basic measures and systems to ensure sterility—according to an inspection report released by the Food and Drug Administration (PDF).
In February, the regulator warned consumers to immediately stop using eye drops and eye ointment made by Global Pharma, whose products were sold in the US under brand names EzriCare and Delsam Pharma and were available through Amazon, Walmart, eBay, and other retailers. Global Pharma later issued voluntary recalls of the products.
Health investigators had linked the drops to cases of an extensively drug-resistant Pseudomonas aeruginosa strain that had never been seen before in the US. The strain is identified as VIM-GES-CRPA, which stands for a carbapenem-resistant P. aeruginosa (CRPA) with Verona integron-mediated metallo-β-lactamase (VIM) and Guiana extended-spectrum-β-lactamase (GES). Although affected people reported using multiple brands of eye drops, EzriCare was the most common. Additionally, testing by the Centers for Disease Control and Prevention and independent researchers have identified the outbreak strain in opened bottles of EzriCare artificial tears.
As of March 14, 68 people in 16 states have been infected with the strain, the Centers for Disease Control and Prevention reports. Three people have died from the infection, eight have lost vision, and four have had their eyeballs surgically removed.
(Score: 2, Interesting) by Anonymous Coward on Thursday April 06, @06:16PM (5 children)
> ... in opened bottles of EzriCare artificial tears.
My aging mother had "dry eye" and was prescribed a product like this. The eye doc was very specific about using individual dose packaging - little plastic bubbles, cut off the end to open and toss any unused product. The comment was that in a bottle this product is easily contaminated.
While the problems described in tfa were in manufacturing (bad plant management?), it seems like similar problems could happen with the product in a multi-use bottle?
In a nursing home setting, where giving eye drops is common, I've seen the nurses use a bottle...which seemed pretty sketchy to me.
(Score: 4, Insightful) by mhajicek on Thursday April 06, @07:15PM
Makes sense, but I think it depends on how long it takes to go through a bottle, and if you touch the tip to anything in use.
The spacelike surfaces of time foliations can have a cusp at the surface of discontinuity. - P. Hajicek
(Score: 2, Interesting) by Anonymous Coward on Thursday April 06, @07:59PM
I don't think it's even a remotely similar problem.
If the product was not contaminated when you opened it at home then any later contamination came from your home. Probably from your own body when you touch the bottle. So assuming your home environment does not normally give people deadly eye infections, the main concern of multiple-use bottles is probably cross contamination (like spreading an infection from one eye to the other, or from one person in your household to another, or maybe even re-infection when you use it again later).
It seems extraordinarily unlikely that you will pick up an "extremely drug-resistant ... strain that had never been seen before in [your country]" this way.
In a nursing home setting the danger of mishandling is more significant than in a private household. In this case, since we are talking about trained professionals, I would hope/assume that they have appropriate training and procedures in place to reduce known risks to a reasonable level.
(Score: 1, Interesting) by Anonymous Coward on Thursday April 06, @09:03PM
A quick look at wikipedia [wikipedia.org] suggests that there are two main types of artificial tears: those with preservatives that prevent bacteria growth, and those without such preservatives. The preservatives apparently can cause eye irritation which limits how frequently this type can be administered. I imagine that for the most part, multi-use bottles have preservatives and single-use vials don't.
Presumably the "extensively drug-resistant" bacteria in this incident is also resistant to the preservatives used.
(Score: 0) by Anonymous Coward on Friday April 07, @01:41AM (1 child)
Is she incapable of producing tears or does she forget to blink?
Maybe she needs to remember/relearn to blink regularly: https://skyvisioncenters.com/blog/dry-eye-sufferers-try-blinking-exercises-app/ [skyvisioncenters.com]
Many people stare at screens/books/etc for hours and forget to blink.
(Score: 0) by Anonymous Coward on Friday April 07, @01:20PM
> does she forget to blink?
That too. As you say, it's a common problem.
(Score: 5, Insightful) by DannyB on Thursday April 06, @08:11PM (10 children)
Can corporations police themselves? Probably not in all cases.
Regulations are often the result of bad corporate behavior that made the regulation necessary. Because greed knows no bounds. None at all. Greed has no sense of decency. No concern for others.
It's not that we are unable to feed the hungry, it's that we can't satisfy the rich.
How often should I have my memory checked? I used to know but...
(Score: 5, Informative) by JoeMerchant on Thursday April 06, @09:07PM (7 children)
It's fairly shocking how thinly spread FDA inspectors are. I worked at a company making medical devices that went over 9 years between visits from the FDA. Advice from ex-FDA employees advising companies in the private sector sometimes includes statements to the effect of: "well, you _should_ do X, Y and Z, but... the odds of an inspector getting here in the next two years are quite low, so if you just outline some plans about how you're going to do X, Y and Z - that should get you off the hook in the unlikely event they show up, and you can do other things more directly important to your business in the meantime."
Then you get to the bigger companies, I've been at one of those for 10 years now, and while we've had two or three FDA inspectors on-site during those years, I'd estimate they only interact with a tiny slice of our site when they are there. Being big, with a lot to lose, we run a low-risk operation: doing everything we say we are going to do, documenting it all, keeping up with the new regulations as they are announced in Draft even, but... in reality, if we didn't, it might take decades before it was noticed outside the company. And, there's the thing about regulation: you don't notice that the railroads are running dangerously right away, it takes years before a derailment finally blots out three Ohio counties with a massive toxic cloud. Similarly, without pro-active regulation and auditing, medical manufacturer problems really don't show up until people start getting sick or dying in connection with the product.
Україна досі не є частиною Росії Слава Україні🌻 https://news.stanford.edu/2023/02/17/will-russia-ukraine-war-end
(Score: 3, Interesting) by RS3 on Thursday April 06, @09:35PM (4 children)
Hopefully this story will raise some spirits. I recently worked in a food and beverage processing factory where everything was USDA organic. Not only was _everyone_ very careful, maybe over the top careful (the place had many incredibly brilliant people), but the company had to pay the govt. for a full-time FDA inspector on site 40 hours a week. Nobody _ever_ suggested nor accepted anything that could compromise product quality or safety.
It was all high-end (expensive) stuff, and I found it personally inspiring that everyone who had anything to do with ingredient and product handling cared so much.
That said, everything was Pasteurized after sealed in packaging, unless it was a hot product sealed in hot jars and capped with steamed lids (Pasteurized by definition). Pasteurization does often reduce the taste, but there's no choice without preservatives.
We had in-house testing for all kinds of chemical and pH balancing. pH had something to do with long-term safety- I didn't get involved too much but I knew a lot of what happened. Samples were regularly sent to biological labs for full testing.
My hunch is the eye drops had no preservatives. Many people have had problems with preservatives in various eye drops, contact lens cleaners and solutions, and medications. I would hope the eye drops were Pasteurized after being sealed, but I don't know- maybe not...
(Score: 1, Informative) by Anonymous Coward on Friday April 07, @12:48AM (3 children)
> all kinds of chemical and pH balancing.
Some veges including string/green beans are "low acid"...and if not properly canned may be infected with botulism, https://nchfp.uga.edu/publications/nchfp/factsheets/greenbeans.html [uga.edu]
A family friend (and organic farmer) told a story of one of his friends that canned some string beans...and died in minutes from botulism after eating some that had been stored for some months.
(Score: 2) by crm114 on Friday April 07, @01:26AM
And now I finally understand why my mom canned our string beans in vinegar!
Thanks!
(Score: 2) by RS3 on Friday April 07, @04:08PM (1 child)
Wow, I'm sad to hear the person died trying to do a good thing. I'm not a chef by any means, but my mom used to "can" (jars). She had a BS in bio/chem and had learned much from the ancients who learned the hard ways.
I don't know much about botulism, but I've always assumed you could tell- pressure in the can/jar means BAD! Can you smell it, does it stink?
Do you know if the person cooked the beans and capped (lidded) them while still very hot?
You may notice "Mason" and other brands of "canning" jars have a lid with a rubber gasket, and a separate threaded locking ring. Mom would place the lids on the jars, not the tightening the ring yet, in a big pot of water on the stove that will heat up to boiling. As the food heated up it would release steam. The steam pretty much displaces the air and oxygen.
Oxygen in stored food is very bad, btw. It's one of the reasons sodas are carbonated. It wasn't the original intent, but ends up being a great preservative. If not carbonated, N2 (nitrogen) is used, but oxygen must be completely purged. And then it's Pasteurized too.
Anyway, as the canning jars cool, the lids are sucked down and you tighten the ring. Any that didn't seal, you'll know because the lid will be flat, not concave (dished inwards). So use those right away and refrigerate (or freeze) in sealed tight lids and watch for any bulging of the lid, and maybe don't trust them at all.
One of the main food products at the aforementioned food factory is a spaghetti sauce and they would control the pH very carefully, always on the acid side. I forget the numbers- 4.3 - 4.9 IIRC. Each product had a different pH number, and they'd control within pH 0.1, and visually inspect that all lids are concave, and reject a lot of product if there were any doubts.
(Score: 0) by Anonymous Coward on Friday April 07, @08:54PM
Botulism doesn't care about the things you remember from your mother...
1. From the link I posted earlier, https://nchfp.uga.edu/publications/nchfp/factsheets/greenbeans.html [uga.edu]
2. From this link, https://www.cdc.gov/botulism/general.html [cdc.gov]
3. More from the CDC at, https://www.cdc.gov/botulism/consumer.html [cdc.gov]
(Score: 0) by Anonymous Coward on Friday April 07, @01:35AM (1 child)
There are a lot of companies and plenty of people don't want to pay more taxes or even consider taxes theft.
So there'll be gaps even if everything was 100% efficient.
(Score: 2) by JoeMerchant on Sunday April 09, @01:42AM
While people may consider taxes to be theft, they should also consider how they would be living without them: in small bands throwing spears or shooting arrows at each other - that's about as far as human society ever progressed without taxes.
Back in this reality, the theory of regulation is to keep products safe without having to use people dying as a clue that there is a problem. That requires some amount of pro-active inspection to keep the greed drivers from optimizing profits so far that people's lives are at unreasonable risk.
Україна досі не є частиною Росії Слава Україні🌻 https://news.stanford.edu/2023/02/17/will-russia-ukraine-war-end
(Score: 2, Touché) by Anonymous Coward on Friday April 07, @01:56AM
Don't forget some corporations are struggling to make a profit and don't have huge funds behind them. Lots of people start companies and go bankrupt, burning most of their savings. Some of them would still follow the rules all the way to bankruptcy, but plenty won't.
And in many cases the stuff they do is unlikely to kill people even if it's less unhygienic than "best practice" e.g. defeathering chickens in a back alley. Also this might actually be a bit more hygienic than the factory way where even larger numbers of chickens are scalded using the same water and thus increasing the risk of contamination.
(Score: 4, Interesting) by Immerman on Friday April 07, @05:00PM
Can they? Sure - and they'll happily prove it to you until you stop looking over their shoulder.
If we want it to have any chance of working we really need a system where they can police *each other*.
Make it an adversarial system, where Company A polices their competitor, Company B, and can easily get them fined/shut down upon providing documented evidence of wrongdoing, thus bolstering their own bottom line.
Of course corporations are no strangers to collusion and conspiracy, so probably best to declare it open season for *everyone*. Heck - let's recruit the people with the best opportunity to detect and document wrongdoing - the company's own employees.
To heck with lackadaisical "whistleblower protection" laws, lets get some "malfeasance bounty" laws on the books - you blow the whistle, you get a fat cash bounty in thanks for the service you've done for society.
(Score: 2) by sjames on Thursday April 06, @08:17PM (4 children)
Why in the world are the bottles not run through a sterilizer after they have been sealed?
(Score: 2) by Tork on Friday April 07, @01:06AM (1 child)
Profit!
Slashdolt Logic: "25 year old jokes about sharks and lasers are +5, Funny." 💩
(Score: 2) by driverless on Friday April 07, @09:51AM
And at what stage do the underpants come into it?
(Score: 2) by Immerman on Friday April 07, @05:04PM (1 child)
I don't know abut this case in particular - but as a rule high temperatures break down/denature complex chemicals like medicine. (Hence "store in a cool, dry place" instructions on most medicine bottles)
I mean, that's basically how heat kills microbes, animals, etc. - breaking down the complex chemistry of their bodies until they can no longer survive. It's not really surprising that it does the exact same thing to the similarly complex bio-active molecules in medication.
(Score: 2) by sjames on Friday April 07, @06:04PM
Heat isn't the only option. There's gamma and e-beams as well. Those can also have effects on chemical compounds, but not as much for smaller molecules as larger ones like DNA or RNA strands.
As I understand it, the product in this case was artificial tears, so probably not a lot of large molecules.