31 replies to this topic

[protoject]

I am wondering what are members' opinions on the filtering of supplements that are contained in glass ampoules that are cut open with an ampoule cutter? It appears some individuals aren't concerned. I remember one member saying he was using ampoules for 20 years or something along those lines [maybe less years, a bit of broken telephone but close enough] , NEVER filtered, and never had a problem with glass particles being injected. Yet there were also some studies some members posted about risks with glass particles and it seems like a really bad thing and that everyone should use filtering.

My question is does anyone have experience or an opinion on this they'd like to share? Is filtering worth the time? Also does filtering effect what components are being drawn up into the syringe, i.e. could the space in the filter be small enough to filter out components of the actual medicine?

[Hebbeh]

Amps have been used for a very long time and from what I've seen, it's practically unheard of to filter. Any possible shards are going to sink to the bottom of the amp and unlikely to be sucked up...and along with using a small gauge pin (ie 25), the chances of sucking anything up would seem slim. If worried, you could use an insulin pin (ie 29) to fill and then switch to a 25 but I don't feel it's necessary. If it was an issue, you would a) have heard about problems long before now (and you don't) and b) manufacturers would of switched to small rubber stopped multi dose vials...but for whatever reason, that hasn't happened on a large scale in some markets. Of the thousands of PED users over the years, I have never heard of any filtering or of any having suspected of injecting glass particles.

[protoject]

Amps have been used for a very long time and from what I've seen, it's practically unheard of to filter. Any possible shards are going to sink to the bottom of the amp and unlikely to be sucked up...and along with using a small gauge pin (ie 25), the chances of sucking anything up would seem slim. If worried, you could use an insulin pin (ie 29) to fill and then switch to a 25 but I don't feel it's necessary. If it was an issue, you would a) have heard about problems long before now (and you don't) and b) manufacturers would of switched to small rubber stopped multi dose vials...but for whatever reason, that hasn't happened on a large scale in some markets. Of the thousands of PED users over the years, I have never heard of any filtering or of any having suspected of injecting glass particles.

Ah, very good point! Of course the glass might sink to the bottom considering its weight... thanks for the tip.

[CIMN]

i wasn't really aware of this issue, but it makes sense if you have nanoparticulates damaging cells/etc in the body..

[Bigbrains]

Well this is soem of the information I got from the web below.To each their own,if people don't want to use filtered needles fine by me,but I thought I would point out the possible risks. What really scared me was reading a reply by a user on Allnurses.com that said this:

Yes it is a real risk esp if the particles accumulate ...all of those particles usually end up in your lungs. On Autopsy if they go looking they can be found in the lungs esp if the patient has had prolonged hosptialization. The size of allowable particles in IVF is also regulated and there is a cuttoff by mircon size of the particles you can have in IVFs. One function of a filter is also to catch paticulate matter and in the case of a microaggregate filter..it prevents micoraggregates from entering the vascular system.

That reminded me of a worker at my work who was a painter at out company for 6 years back in the late eighties. He is 48 and when he went to get his physical he failed the breath test portion and found out he had chronic obstructive pulmonary disease. Our company is very safery conscious,but it was unknown that certain particulates such as silicas could pass through the type of filters he was wearing. Now they have high efficiency particulate filters.Sucks for him though because he might end up on an oxygen machine in 10 years.

Read also this from the American Association of Critical Care Nurses website.

Q. Are special filter needles required when drawing up medication from a glass ampule? Are there hidden risks to patients, ie, sharp glass particles, if a filter needle is not used?

A. Fred L Meister, PharmD, replies:
Bacterial contamination has always been the major concern associated with the intravenous administration of medications and is a well-known cause of morbidity and mortality. Additional risk factors, however, have been identified and must also be considered.

The potential risks associated with administration of medications supplied in glass ampules is much greater than realized by most practitioners. Opening a glass ampule produces a shower of glass particles, many of which enter the ampule and contaminate the contents. Some of the particles have been shown to carry bacteria, though the significance of this has not been determined.

The number of glass particles found in opened ampules varies, but most reports indicate approximately 100 particles, ranging in size from 10 to 1,000 µm, per 10-mL ampule. The particle count increases as the size of the ampule increases (ie, a 20-mL ampule will contain more glass particles than a 10-mL ampule). When the content of a 10-mL ampule is aspirated through an 18-gauge, 1.5-inch needle, the particle count is reduced by approximately one third (ie, approximately 65 particles remain in the aspirate), and the maximum particle size is reduced to less than 400 µm.

The potential risks associated with intravenous administration of glass particles are based on animal studies, though similar risks would apply equally to humans. It has been shown that glass particles cause inflammatory reactions (eg, phlebitis) and granuloma formation in pulmonary, hepatic, splenic, renal, and intestinal tissue. This represents a significant risk of an adverse patient outcome.

The effective removal of glass particles from an opened ampule can be accomplished by aspirating through a 19-gauge, 5-µm filter needle. Using this method decreases the average total number of particles in the aspirate to approximately ±1, and the particle size to less than 200 µm. Using a 0.22-µm in-line filter offers little or no additional benefit, and is more costly and labor intensive—once the ampule content is aspirated into a syringe, the filter needle must be replaced with a standard needle prior to transferring or administering the medication.

Based on the available information, a filter needle is recommended when aspirating a medication from a glass ampule.

References

• Turco S, Davis NM. Glass particles in intravenous injections. N Engl J Med. 1972;287:1204-1205.
• Carbone-Traber KB, Shanks CA. Glass particle contamination in single-dose ampules. Anesth Analg. 1986;65:1361-1363.
• Waller DG, George CF. Ampules, infusions and filters. Br Med J. 1986;292:714-715.
• Kempen PM, Sulkowski E, Sawyer RA. Glass ampules and associated hazards. Crit Care Med. 1989;17(8):812-813.
• Sabon RL, Cheng EY, Stommel KA, Hennen CR. Glass particle contamination: influence of aspiration methods and ampule types. Anesthesiology. 1989;70(5):59-62.
• Falchuk KH, Peterson L, McNeil BJ. Microparticulate-induced phlebitis: its prevention by in-line filtration. N Engl J Med. 1985;312:78-82.

Also from the American Association of Critical Nurses Website:

Research Corner: Myth Versus Reality: Do We Need to Filter Medication Ampules?

By Paula Lusardi, RN, PhD, CCNS, CCRN
Chair, Research Work Group

�Withdrawing medication from ampules through a filter straw or filter needle takes time, especially during a code,� lamented Alice. �Do we really need to filter ampules? I find it hard to believe that there would be any glass particles in these ampules that would hurt patients.�

Is Alice correct in assuming that there is little need to filter medication from ampules?

Myth: There is no need to filter ampules when withdrawing medication for patient injection.

Reality: Glass ampules contain macroscopic glass particles that, if broken, may be harmful to patients.

Is there particulate matter in ampules?
Particulate contamination of small-volume parenteral products has been considered since single-dose ampules were developed nearly 30 years ago for ease of administration and accuracy.1 In 1972, Turco and Davis first noted that glass fragments greater than 5�m could be aspirated from open ampules of furosemide.4 Today, the fact that snap-opening of ampules leads to contamination of contents with glass fragments is well known.1-4 Numerous studies confirm particulate contamination of ampules upon opening, implicate a variety of side-effects from injecting nonfiltered ampule medication into patients3-7 and offer suggestions for changes in practice.

What is the fate of injected particles?
The fate of infused particles has been studied in both animals and humans. Systemic side effects of infused particles, though not clearly understood, exist.2 Phlebitis is the most common side effect of infused particulate matter in humans.8,9

What does filtering do?
Several studies have investigated particulate contamination from ampules and a variety of aspiration techniques.1,3,4,7,8 Both needle and straw filters reduce the number of particles and the potential side effects of infused particulate matter. However, forced aspiration of ampule contents, even with a filter, does not protect patients from particulate matter infusion.1

Practice Implications and Suggestions

Some of the common medications packaged in ampules are adrenaline (epinephrine), Cordorone (amiodorone), Furosemide (lasix), Inapsine (droperidol), Lanoxin (digoxin), Levophed (norepinephrine), Lopressor (metoprolol), Naloxone (narcan), Sublimaze (fentanyl).

All hazards related to microparticles should be eliminated for high-risk patients, such as neonates and those who are immunosuppressed, critically ill or who require long-term infusion therapy.3

Use filter straws or needles when aspirating fluid from glass ampules.2

Do not force aspirate when withdrawing medication from glass ampules.1

Filtration is a simple and relatively inexpensive way to prevent phlebitis.3,8

References
1. Waller D, George C. Ampoules, infusions, and filters. British Medical J. 1986;292:714-715.
2. Shaw N, Lyall E. Hazards of glass ampoules. British Medical J. 1985;291:1390.
3. Carbone-Traber K, Shanks C. Glass particle contamination in single-dose ampules. Anesth Analg. 1986;65:1361-1363.
4. Turco S, Davis N, Glass particles in intravenous injection. New Eng J Med. 1972:287:1204-1205.
5. Falchuk K, Peterson L, McNeil B. Microparticulate-induced phlebitis Its prevention by inline filtration. New Eng J Med. 1985;312:78-82.
6. Furgang F. Glass particles in ampules. Anesthesiology. 1973;41:525-526.
7. Gillies I, Thiel W, Oppenheim R. Particulate contamination of Australian ampoules. J Pharm. Pharmacol. 1986;38:87-92.
8. Sabon R, Cheng E, Stommel K, Hennen C. Glass particle contamination: Influence of aspiration methods and ampules types. Anesthesiology. 1989;70:859-862.
9. Turco S. Infusion phlebitis. Hosp Pharm. 1974;9:422-426.

source:http://www.aacn.org/...s?menu=practice

Seems to mw that filtered needles are only not effective when forced aspiration occurs

Here form Eschelman School of Pharmacy:

A 5 micron filter needle should be used when drawing the contents of an ampule into a syringe since glass particles may have fallen inside the ampule when the top was snapped off

http://pharmlabs.unc...nterals/svp.htm

Nursing Fundamentals: Caring and Clinical Decision Making by RIck Daniels (RN.)

Rationale for filtered needles when using glass ampoules:

Filtered needle entrap any glass fragments

http://books.google....nursing&f=false

Any solution taken from an ampoule must be filtered with a 5-micron filter,because glass particles can fall into the ampoule when it breaks open.Most often a filter needle is used.The filter needle may be used for withdrawing the solution from the ampoule.THis filteres the solution as it enters the syringe. A regular needle must then be put on the syringe before the solution can be injected into the IV bag

source: Pharmacy Practice for Technicians by Jane M Durgin,Zachary I,Hanan

http://books.google....s glass&f=false


Also an abstract form the American Journal of Nursing recommends it.You can check out the link below since when I paste the information in here it comes out all strange
http://www.nursingce...ticle_ID=481847

I found one nursing training manual online that said nurses should look for glass shards when breaking the ampule and if they see any to use a filtered ampule. Can't prove link,hiwever as I forgot what I typed in google to fing the manual.


Quite a few nurses on the allnurses forums use filtered needles when opening glass ampoules,even one saying her school would fail her if she didn't use one on her nursing test if a glass ampule was used.There are, however, those who have never heard of them and think that proper techinique is the trick.They probaly are right The problem here is most of us on this forum aren't nurses and aren't properly trained how to draw from a vial or ampule so it would seem prudent especially with the sources I gave to do so.

Note: If you're using a very small needle such as a 23 guage to withdraw and inject you're probably fine as I read in one study results were equal for needles 23 guage or smaller. It also doesn't seem to be that serious when giving an intramuscular injection,unless you accidentally hit a vein.

Edited by Bigbrains, 29 September 2012 - 03:06 AM.

[Luminosity]

What are you injecting?

[evo]

OK to add a contrasting perspective to this discussion;

1) Bacterial contamination from opening an ampoule is a very real risk, which is why you should ALWAYS swab the neck prior to breaking in line with the scored edge. Bigbrains was right to point this out as a risk.

2) I'm not sure if you read the study quoting efficacy of filters, but you realize the standard deviation there is 1. I would hardly call that significant...

3) The only other factor that has any effect on the # of particulates is the diameter of the ampoule.

4) Sources for those so inclined:

Data' class='bbc_url' title='External link' rel='nofollow external'>http://www.anesthesia-analgesia.org/content/65/12/1361.full.pdf']Data are summarized in Table 2. The mean number of glass particles filtered when aspirated through a 3-mm internal diameter bore tubing was 12, through an 18-gauge needle 12 k 6, through a 25- gauge needle 14 + 6 and through a 5-micron filter needle 13 7. No differences in sizes were noted. There was no significant difference in the number of particles aspirated by any given technique.

→ source (external link)

This' class='bbc_url' title='External link' rel='nofollow external'>http://ge.tt/9N0OlZO/v/0?c']This report on the effects of glass particles when injected into animals‘ indicates that massive doses are required to produce damage to the organs examined during the study.

→ source (external link)

[Edit] Summary for those who don't want to read all of the above... Basically animals who received 1.3 - 2% glass for a period of a year showed slight accumulation in the lungs. The body dissolved the basic ion, and the slight tissue damage was caused by the remaining salicic acid. In the mice injected for less than a year, no such accumulation or tissue damage was found. In those receiving these injections for over a year, they were unable to produce a fatal embolism. The damage is primarily done from microparticles <1 micron, and the other study shows us that most particles are between 10 & 200 micron. A 5micron filter would not remove the most harmful particulates, but as we see their effects are negligible anyway.

Bottom line, if it makes you feel better go for it... but I think the evidence is pretty clear.

Edited by lmlj, 29 September 2012 - 04:20 AM.

[protoject]

OK to add a contrasting perspective to this discussion;

1) Bacterial contamination from opening an ampoule is a very real risk, which is why you should ALWAYS swab the neck prior to breaking in line with the scored edge. Bigbrains was right to point this out as a risk.

2) I'm not sure if you read the study quoting efficacy of filters, but you realize the standard deviation there is 1. I would hardly call that significant...

3) The only other factor that has any effect on the # of particulates is the diameter of the ampoule.

4) Sources for those so inclined:

Data' class='bbc_url' title='External link' rel='nofollow external'>http://www.anesthesia-analgesia.org/content/65/12/1361.full.pdf']Data are summarized in Table 2. The mean number of glass particles filtered when aspirated through a 3-mm internal diameter bore tubing was 12, through an 18-gauge needle 12 k 6, through a 25- gauge needle 14 + 6 and through a 5-micron filter needle 13 7. No differences in sizes were noted. There was no significant difference in the number of particles aspirated by any given technique.

→ source (external link)

This' class='bbc_url' title='External link' rel='nofollow external'>http://ge.tt/9N0OlZO/v/0?c']This report on the effects of glass particles when injected into animals‘ indicates that massive doses are required to produce damage to the organs examined during the study.

→ source (external link)

[Edit] Summary for those who don't want to read all of the above... Basically animals who received 1.3 - 2% glass for a period of a year showed slight accumulation in the lungs. The body dissolved the basic ion, and the slight tissue damage was caused by the remaining salicic acid. In the mice injected for less than a year, no such accumulation or tissue damage was found. In those receiving these injections for over a year, they were unable to produce a fatal embolism. The damage is primarily done from microparticles <1 micron, and the other study shows us that most particles are between 10 & 200 micron. A 5micron filter would not remove the most harmful particulates, but as we see their effects are negligible anyway.

Bottom line, if it makes you feel better go for it... but I think the evidence is pretty clear.

Thanks for the info, I just thought I'd mention that I can't actually read anything on the second link as it is asking me to buy it...

[Bigbrains]

Hmm, I'm seeing different studies that give different results concerning the effects of glass ampoules on animals.It must be do to the quality of the studies. Seems like every time I look for a study on the net,I find another one with a different conclusion,

Here's a study below that appears to say the opposite according to what IMLJ posted.Notice the bold in the article.Summary: Study says large particles over 20 micron were found in lung,while particles 5 micron to 10 micron were found in liver,spleen and occasionally the kidney .Study also says that a large quantity of particles less than 5 microns were not found in all the organs investigated,but were most likely spread throughout the body at a low density. I don't know how long the study was performed,however,as I don't have access to the full article. Small particles in the body, could take years to cause noticeable damage in the organs,so a study saying no tissue damage was found before a duration of a year could be relevant.

Edit: My understanding is: Study primarily focuses on larger glass particles being dangerous and presumes smaller particles (less than 5 microns) to be unimportant since they were not found in all of the organs investigated.

Glass particles derived from the cutting of glass ampoules and suspended in parenteral solutions were introduced into mouse organs by intravenous injections in the tail vein. Organs were removed, thin sectioned, and plasma ashed on glass slides by means of glow-discharged oxygen to remove organic matrices which interfered with microscopic observation of glass particles. The ashed specimens were subsequently coated with a thin film of plasma-polymerized tetrafluoroethylene which suppressed the hygroscopicity of the specimens so that they became hydrophobic and at the same time permanently preserved the microstructures of the ashed specimens. Microscopic investigation of the glass particles retained in the ashed specimens supported size-dependent localization of the glass particles in different organs; i.e., large particles over 20 μm in diameter were mostly retained in the lung, while smaller particles around 5–10 μm in diameter were found in the liver and spleen, and occasionally in the kidney. A mesh-screen effect was therefore supposed along the route of blood circulation. No glass particle was found in the brain. Large numbers of extremely small glass particles less than 5 μm in diameter were not accounted for in all the organs investigated, but a wide diffusion in the whole body at very low density was presumed.

source:http://www.sciencedi...026265X83900541

I think the saying is though,always err on the side of caution.Maybe there is maybe there isn't a real risk,but whats a couple of bucks extra for a little piece of mind. Coworker at work is suffering from lung damage to the lung from silicates after he was exposed over 20 years ago.He had taken many breath tests and past them before. He's only smoked two years in his life and he became a meter reader and driver after leaving his paint job. He looks the picture of health at 48 and I though he was lying about his age and in his mid thirties because he is constantly in the gym and just eats Subway and other healthy food. All of this because the filters he was using were for larger particles other than silicates.It was thought at the time a standard filter was fine for all contaminants,but numerous medical complaints,some happening years after the fact changed that theory.

Edited by Bigbrains, 29 September 2012 - 07:50 PM.

[evo]

I think the saying is though,always err on the side of caution.Maybe there is maybe there isn't a real risk,but whats a couple of bucks extra for a little piece of mind. Coworker at work is suffering from lung damage to the lung from silicates after he was exposed over 20 years ago.He had taken many breath tests and past them before. He's only smoked two years in his life and he became a meter reader and driver after leaving his paint job. He looks the picture of health at 48 and I though he was lying about his age and in his mid thirties because he is constantly in the gym and just eats Subway and other healthy food. All of this because the filters he was using were for larger particles other than silicates.It was thought at the time a standard filter was fine for all contaminants,but numerous medical complaints,some happening years after the fact changed that theory.

Honestly I'm torn because you seem to be interested in conducting good research, and then you go and post something like this ^ which is not only unrelated, but completely anecdotal and a bit ridiculous.

From your previous post I've gathered that your friend is a painter. You realize that the inhaled particulates he would have been exposed to are ENTIRELY different in size, density, chemical composition, and dissemination. Apples and oranges my friend.

More importantly perhaps; on what planet is Subway considered healthy?

You're looking for studies to corroborate your belief that the more precautions you take, the safer things will be (consistently). Sadly, things don't always work that way. If you want to buy the fulltext I would love to see both the duration of administration and concentration of the injected particulates in that study you referenced.

Until then however you justify your choices is none of my business, just try not to mislead others before you turn 'glass ampoule contamination' into the next fluoride.

Edited by lmlj, 29 September 2012 - 08:21 PM.

[NG_F]

I agree with BigBrains, that the potential for damage from particulates is very real.The long term sequelae has not been studied well enough or long term down the road.
Seeing that this is a great Nootropic, it's a shame that Ebewe has not yet incorporated the use of muti-dose vials for their solution. I intend on using this nootropic for long periods of time, and I certainly dont need any more complications with my health!
We should all email/contact Ebewe regarding this issue, as should many from all over the world who are aware of this potential risk. They should reduce risk to users to a minimum to ensure compliance, satisfaction and increased sales. it would certainly be an investment for them.
I have used 75 ml's so far with out a filter or even swabbing the bottle neck. I hope I have not subjected myself to any serious damage, but only time will tell. I am definitely taking all necessary precautions from now on. BigBrains and other similar methodologies are on the ball with the common sense approach that whats a few dollars for greater safety and piece of mind!

One will never be able to eliminate all particulates; glass, bacteria or other with any type of filtration method but using what is available still provides a lot more safety.

Different studies I've read show different results but its standard practice for nurses who work with aneasthetic preperations that filtration from glass ampoules is mandatory!
Some facilities dont carry any such filters. I'm sure just to save on cost.

Although Imlj has mentioned a good point as far as IM injections having much less potential for damage as opposed to injection via IV, the risks are still there! So we're here to help improve our health not to tempt bad luck on causing organ damage, emboli or a thrombus.


http://www.safeinfusiontherapy.com/documents/Products/Particulate_Contamination_M.pdf

http://www.baxa.com/syringefilters/downloads/syringefilterdiagram.pdf

http://allnurses.com/nursing-patient-medications/what-do-you-693504.html

http://www.dtic.mil/dtic/tr/fulltext/u2/a284401.pdf

The last study/link is very controversial and does not explore the many missing variables. Weighing instead of counting for particulate might present with more accurate data and a more credible conclusion.

[evo]

One will never be able to eliminate all particulates; glass, bacteria or other with any type of filtration method but using what is available still provides a lot more safety.


http://www.dtic.mil/dtic/tr/fulltext/u2/a284401.pdf

The last study/link is very controversial and does not explore the many missing variables. Weighing instead of counting for particulate might present with more accurate data and a more credible conclusion.

You did read the last study you posted right? Also given other studies' mention of average particulate size, most are 10-200 micron in size. They used a 5 micron filter in this study and noticed no significant difference. I'd say that's quite clear.

Although results demonstrated that use of the 19-gauge filtered needle had the lowest number of glass particle contaminants (mean number of particles - 267.793), followed by the 20-gauge non-filtered (mean - 270.542), 18-gauge non-filtered (mean - 271.238), and 25-gauge non-filtered (mean - 279.769); analysis of variance (ANOVA) indicated no significant difference existed between the four groups. Thus, no significant difference existed in the number of glass particles counted following aspiration of medications from glass ampules uring filtered needles compared to non-filtered needles, or when comparing non-filtered needles of varying sizes.

One group of animals received 32 days of injections with a total of 0.416 grams of glass per animal. Based on body weight, this is about 14 grams in a human in one
i month, or about 0.5 grams per day. Other animals were injected with lighter suspensions over longer time periods. 5 When 1 ml of a 1.3% suspension of glass was injected for 32 days, no pneumonia or inflammation was noted. Venules were 12 dilated to capacity. Capillaries were moderately engorged. 5 Grossly the animals appeared well. Macroscopically the organs appeared normal and the lungs had no gross pathology

but using what is available still provides a lot more safety.

Do whatever makes you feel better just don't mislead people by stating you have evidence showing it's dangerous, when the evidence you posted clearly states otherwise.


[edit] On a side note, I am in no way saying conclusively that glass particulates in ampoules are NOT a problem, just that no current, legitimate study has found any significant connection, either on their potential for damage at low concentrations, OR the effectiveness of filters. While filter efficacy seems very concrete and easily observed, the extent and severity of glass particulate damage is still open to debate. If anyone has any contradicting studies on this (NOT HEARSAY) it would be very much appreciated.

That said, if glass particulates do pose any health complications, it still doesn't make sense to use a filter because they HAVE NO EFFECT on reducing particulates. If you wish to take more precautions, the smart thing to do would be to only use 1ml ampoules, swab the neck prior to opening, and make sure they are kept at consistent temperature and humidity to avoid creation of extra microparticles.

Edited by lmlj, 29 September 2012 - 10:32 PM.

[NG_F]

Yes I did read the study completely but did you read this part ??

Previous studies indicated that use of either
3 filters, filtered needles, or smaller gauge needles were
significantly effective in reducing the number of glass
particles obtained. This study failed to concur with these
3 findings. The method of counting glass particles proved to be
inaccurate and imprecise. No significant difference in the
3 mean number of glass particles counted following aspiration
through 18-gauge, non-filtered; 19-gauge, filtered; 20-gauge.
U non-filtered; and 25-gauge, non-filtered needles was noted.
3 However, each needle type/size had a wide variation in the
number of glass particles counted to obtain the mean. Each
3 standard deviation was almost equal to the mean for that
specific needle. Thus, the results obtained were neither
I accurate nor reliable using this method of determining the
3 amount of glass particle contamination and, therefore, is not
an accurate comparison to results obtained in other studies.

In other words, it's a flawed study with too many uncertainties from inconsistencies.

I agree with you using smaller ampoule sizes but so far I only trust one source and thats IAS. Unfortunately they only carry 5 ml amps. If anyone has had good results, with no concerns about bunk or unsafe products or chinese knock-off's, with the 1 ml size, please post your source. I'd greatly appreciate this.
Much thanks in advance

Edited by NG_F, 29 September 2012 - 11:38 PM.

[evo]

However, each needle type/size had a wide variation in the
number of glass particles counted to obtain the mean.

Yes; there was another study I read a long time ago (don't have time to locate at the moment) which said glass contamination was only present in ~69% of test cases in their experiment. Another study also mentioned that filters are entirely ineffective when contents are aspirated forcefully. Thus my hypothesis is that the variance has more to do with how the ampoule opens (ie, clean break or otherwise) and force of the suction from aspiration--differences in breakage and draw-in would account for the wide variance across tests.

Nevertheless this variance aside, all the means are SO close together that if they performed any reasonable number of trials, it seems improbable to draw any conclusion other than filters are irrelevant, and larger needle diameter has a slight negative correlation. This study alone would be insufficient to conclude such, but looking at all the evidence together it seems to be a rather common consensus.

Also in support of this theory, you notice that the 25 gauge needle showed a higher mean than those lower (thinner needle = more contamination). My guess is that more particles were drawn in due to the suction from aspiration being higher (smaller diameter needle).

Edited by lmlj, 30 September 2012 - 01:41 AM.

[Bigbrains]

I'm not going to spend pointless hours debating on a forum about the need for filtered needles,I was just pointing and referencing studies which come to the conclusion that filtered needles are necessary. I do find it silly that two people neg repped me for simply posting valid sources to support my view. I try to my best to debate honorably and will not stoop to low to be unethical or lie to prove a point at all costs

. It seems that the internet does have a conflicting view on whether filtered needles are useful,but overall it seems to me from spending more time researching that there is a far greater support for their use than not. Sure,I found a partial Jstor article that negated their usefulness,but also one that praised their usefulness when withdrawing from glass ampoules. Maybe I confused people with with my honest admission of conflicting data found on the net.I,however, today made a more thorough search on the net as time allowed. What i found was an overwhelming(by far) support among the medical community for filtered needles

.I'm also too nice,unless provoked to be a great debater,and should have looked through IMLJ sources which are obviously flawed and dated,but I guess I naively expected him to read them more thoroughly.

Thanks NGF for you last post.I didn't even notice it,until the middle of this reply,but it cleared some thing up in regarding accuracy.

Until then however you justify your choices is none of my business, just try not to mislead others before you turn 'glass ampoule contamination' into the next fluoride

. I doubt an article that you presented dated October1947 vs the one from Japan which directly refutes yours ( mine,1983) is going to mislead anyone..Technology as well as medicine from 1947 to 1983 has increased leaps and bounds. Heck back then the Electron microscope was a fairly new invention far from being refined and computers used to analyze data were next to useless.You might as well have quotes a study from the 1800s as far as medicinal technology is concerned. I hate to go there,but if you're trying to prove a point please post more current data,at the very minimum late 60's. How do I, or anyone else know whether they were reliably able to discern microscopic tissue damage with such archaic technology.Heck,even the definition of damage to the tissue considered to be dangerous might have been different then.Talk about flouride, this is the era when lobotomies were going full circle. I mean tell me where in modern journals do you find references dated from the 40's? Rare to never. Edit: Your the one misleading others because you don't completely read the sources you post and wrongly state inconclusive results as fact Something NG_F noted:

Fluoride contamination of course is not written about in medical journals or textbooks as anything to take seriously where as filtered needles and the dangers of glass shards are. I highly doubt that filtered needles would be written about in current medical and nursing textbooks had there not been a belief in their efficacy.

Here,please read this below:. No,I'm not going to pay the money for the full article because I'm cheap,but there's enough here to prove a point regardless about them being taken seriously by current professionals

Glass ampules and filter needles: an example of implementing the sixth 'R' in medication administration.(Best Practice)(American Society of Health System Pharmacists)



The use of filter needles is not often considered when discussing medication preparation from glass ampules. Fundamentals of nursing references prior to 1999 typically do not acknowledge this as an important component of safe medication administration. Safe medication administration traditionally has been regarded as adhering to five rights (5Rs): right medication, dose, patient, route, and time. Adding a sixth right may be appropriate--the right technique in medication preparation.
The use of filter needles in aspirating parenteral medications from glass ampules was first recommended by Katz, Borden, and Hirscher (1973). This recommendation came from their observations during their anesthesia clinical practice that intravenous medications packaged in glass ampules often became contaminated with glass particles when opened. The American Society of Health System Pharmacists (ASHP) and the Infusion Nurses Society (INS) also offer current recommendations regarding the use of filter needles to remove tiny glass particles that result when glass ampules are opened (ASHP, 2000; INS, 2002). Glass particulate and bacterial contamination have long been recognized as hazards associated with ampules (Stehbens & Florey, 1960). IV administration of glass particles may lead to complications, including pulmonary thrombi and microemboli, infusion phlebitis, end-organ granuloma formation, and inflammation (Furgang, 1974; Garvin & Gunner, 1964; Rodger & King, 2000; Shaw & Lyall, 1985; Waller & George, 1986; Zacher, Zornow, & Evans, 1991).
The hazards of glass particulate contamination associated with glass ampules and the effectiveness of filter needles in decreasing such contamination are discussed. Strategies for compliance with filter needle use are highlighted.
Parenteral Medication Administration
The fundamentals. The knowledge and skills needed to prepare medication from glass ampules are taught early in nursing curricula. A review of several nursing fundamentals and basic skills textbooks revealed different perspectives regarding the use of filter needles to withdraw medications from glass ampules. Textbooks written from 1992 to 1998 (Baer & Williams, 1992; Craven & Hirnle, 1996; Elkin, Perry, & Potter, 1996; Kozier, Erb, Blais, Wilkinson, & Van Leuven, 1998; Perry & Potter, 1998; Taylor, Lillis, & LeMone, 1993) indicated that use of filter needles was optional. Books written from 1999 to 2005 (DeLaune & Ladner, 2002; Perry & Potter, 2002; Potter & Perry, 1999, 2003, 2005) recommended filter needle use when aspirating medication from glass ampules. This change may not have been communicated clearly to practicing nurses, who may consider use of a filter needle to be discretionary.
Even nurse educators and leaders do not seem to perceive the importance of filter needle use. During hospital orientation, the use of filter needles is not validated as a core competency, perhaps because of the assumption that students have already mastered this skill (Hadawa

Source:http://www.highbeam....-154069203.html

Yes; there was another study I read a long time ago (don't have time to locate at the moment) which said glass contamination was only present in ~69% of test cases in their experiment

I think you read that study recently and it was from one I just sourced yesterday,except it was 65% and not 69%

Seven hundred and ninety eight ampoules were inspected. Glass particles were detected in 65% of ampoules (95% CI 61.6-68.3)

another study also mentioned that filters are entirely ineffective when contents are aspirated forcefully

Again, your using information from a another study I posted yesterday. Forced is the key word,and it would make perfect sense as forcing something almost always has the desired opposite effect.

Also in support of this theory, you notice that the 25 gauge needle showed a higher mean than those lower (thinner needle = more contamination). My guess is that more particles were drawn in due to the suction from aspiration being higher (smaller diameter needle).

Where are you reading that smaller needles =More contamination. You do realize that the study I posted that you're using to get that information stated that 23 gauge needles and smaller had results equal to filtered needles which was 0 glass particles. A 25 gauge would be smaller not larger than a 23 gauge.


Comparing my coworker silicates contamination and glass contamination as apples to oranges is not a a good analogy on your part, because I provided a relevant point.Size does matter in relation to filtration of both glass from ampoules and silicates. My point was not to compare the difference between glass shards and ampules.Habing a filter that was only good for larger contaminants,was as good as having no filter at all when it came to silicates, There was no OSHA standards for silicates which are water glass or liquid glass or the use of appropriate filters. at that time since their dangers were considered negligible.Modern science didn't even convince the Epa until the mid 80's that asbestos was harmful. That reminds me, that also gives relevance to my point about your outdated article with inconclusive results.

I think I proved enough of a point here. Research and knowledge is the key to prevention of hazards,and obviously its safer to err on the side of caution,especially when the dollar expense is negligible.

IMLJ I also refuse to debate further with you or others here on this topic. Its not really that important to me as I feel I've given more than enough sources for my point of view, plus I feel I'm doing the right thing by using filtered needles,and don't need to spend countless hours trying to convince someone else. If they care about their health they can either pay heed to the sources I gave or do their own research.

Lastly,I have in the past spent countless hours debating with someone on another forum about a topic,ended up using 10 articles to his 2 to support my viewpoint,and even purchased current books to source from.What ended up happening was I was spending 90% of the time in the debate,only to find the other poster was constantly using either old, proven unreliable sources, or extremely biased primary sources, since this was a history forum. He was convinced about his point regardless of whether most of the forum was in agreement with me, or whether the sources I provided were far superior than his.When I tried to quit the debate he tried to get me to agree that I conceded my defeat in the debate because I refused to spend my entire life debating with him. Only to find out later he was using information directly from my sources and trying to debate others on different topics!Funny my current sources written by military historians (Colonels with masters and P.H.D.'s )were flawed in relation to his WIki articles when they didn't support his view at the time -LOL. So never again! Sorry for the rant at the end all,I just hate spending my time to no avail.

Edited by Bigbrains, 30 September 2012 - 07:30 AM.

[protoject]

Please ignore my last post LMLJ i didn't realize you updated the link.

Everyone, How about the topic of IV injected glass particles vs IM injection, anything I missed here? Also would the weight of even the smallest glass particles allow the glass to sink to the bottom? I'd assume that any movement could kick even the smallest glass particles up, and perhaps they would diffuse, Perhaps refrigerating the ampouled product would lessen diffusion, though I am not sure if this is really relevant at all.. PS Bigbrains calm down just continue the debate as per usual, we need all the evidence we can get

[Luminosity]

Are there healthy things people are injecting into themselves outside of medical supervision?

[Bigbrains]

PS Bigbrains calm down just continue the debate as per usual, we need all the evidence we can get

There must be standards for evidence.PM. Sent

[protoject]

Another thing I wanted to mention here. I've been opening my glass ampoules without a cutter, just using a brand new dish cloth and my "manly" grip so that I don't cut myself. But when I open the ampoules, the are not standing up but instead are at an almost 90 degree angle horizontally. I try to break "away" from the ampoule, hoping that the glass particles fall "away" from the ampoule. Of course, i do this all without spilling, or maybe spilling a minimal, unsignificant amount of liquid.

[chrono]

It should be totally possible to have this discussion without this level of exasperation.....it's not really an emotionally charged issue, lol. We're here to further our understanding, not necessarily to change people's minds...good arguments speak for themselves, and people who are too stubborn to engage effectively are fairly apparent, so always remember that the audience isn't necessarily the person you're arguing with.

And don't use the negative vote to disagree with someone, that's very inconsiderate...please use your votes to encourage good posters, it feels good ^^. Thanks for all the cites, there's a lot of data to look through.

However, for me, it's all fairly academic. We frequently say that the decisions we make here need to be based on a risk/benefit analysis. As far as I can tell, there are zero possible benefits to injecting unfiltered solutions which may contain glass fragments, and several potential risks. And while glass fragments may sink to the bottom, I have no clue how convection will affect this when the liquid is drawn up, and there's also expensive peptides down there that we want! If we're talking about cerebrolysin, the filters that work with larger peptides are somewhat pricey IIRC, but if you're spending $10-20 per amp anyway, you may as well treat yourself right. ^^

Incidentally, GPZ has a cheap amp breaker, recommended by dudes on bodybuilding sites. AO and SnapIt also look good, but they're pricey and/or hard to get in the US. Proper technique is to make the break "away" point at the dot on the ampuole neck, if there is one.

Edited by chrono, 05 November 2012 - 01:14 PM.

[gamesguru]

GPZ's amp opener doesn't really work. Half of the time the glass ends up snapping in the middle of the amp, nowhere near the neck. Even if it makes a clean snap along the perforation, I've still noticed glass particles if I mix w/ bacterostatic water & let it set for a few minutes, then swirl it like...to see glass particulates swirl around like white glitter in a Christmas globe. I know it wasn't the powder because it dissolves instantly. This disgusted me, and owing the price of filters, I've never again returned to ampoules. This may interest you: http://www.anesthesi.../1361.full.pdf. Most people don't use filters btw. If you're not going to, I recommend you at least let the glass particles settle for 10 minutes before you draw up the medicine (and be sure to leave a little at the bottom...because that's where most of the glass will be). I don't think it's a good idea to be injecting glass particles into your fat, muscle or blood, but it's not our decision to make. It reminds me of a marauder on 1000 Ways to Die who, to celebrate his gang's successful raid of a local diamond store, decided to snort some lines of brown-brown (cocaine+gunpowder) off of a desk, which was used, unbeknownst to him, by workers to grind diamonds. Needless to say, insufflated microscopic flecks of diamonds caused massive damage to blood vessels and arteries in the linings of his nose and lungs, which resulted in internal bleeding and his death minutes later. While using amps w/o filters hasn't been enough to (as far as I know) kill or even cause major injury to anyone, I'd certainly avoid it if I were you.

[chrono]

Thanks for the heads up...will maybe try a little harder to find a Snapit vendor that doesn't cost $40 just in shipping. The AO is also nice, but no way is that little piece of plastic worth $39 :O plus they're only available up to 5mL, while the Snapit accommodates a decent range of sizes.

Millipore's sub-micron PVDF filters seem to cost a good $4-5 each unless you're willing to get a $150-200 bulk order :/ that's like 1/4 the cost of each CRB vial. Pretty discouraging, but I don't think I'd feel comfortable if I didn't use one.

Edited by chrono, 05 November 2012 - 09:25 PM.

[gamesguru]

Maybe I wasn't doing it correctly, but sometimes the filters would jam, and it could cost $10-$20 for a single dose of medicine. -.-

Plus if we're discussing cerebrolysin, you'll need to use 5 micron, not 0.2 micron filters. People here are even concerned the 5 micron filter is removing some peptides (hopefully they don't use the 10 micron filters). But the 5 micron filter won't even catch 95% of the glass! That's a little alarming.

To me it's just not worth it. I have to get a few vaccines every couple years from the doctors which they carelessly load from ampoules (including tetanus & others). I think that's enough glass for one body to process. Unless these injectables are working miracles, I'll pass. Plus there's always the question of how reliable the source is.

Edited by dasheenster, 06 November 2012 - 02:16 AM.

[Mr Matsubayashi]

Creativity...

I have tried to melt a hole in an ampoule but the propane torch without oxygen isn't hot enough. A dual fed propane/oxygen torch is a serious piece of equipment and outside the scope of the problem, the same goes for ampule sealing machines which require dual fuel.

Would the application of suction from something akin to a vacuum cleaner at the ampules neck help while it breaks? The edge that breaks first would be closest to the suction.

Is there a device that could spin the ampoule on its vertical axis and break the neck? Some particles with less velocity from the break could be removed this way. May be of little benefit as I'd imagine most particles have velocities higher than could be overcome by spinning the ampule without losing solution at the break point. Perhaps losing some solution at the break point would remove further particles?



Using the GPZ amp opener that can score the rim, would additional scoring on the ebewe ampules reduce glass in solution?

There is the chance for reduced glass in solution by letting it settle. The smaller the particulates the more time required. Aspiration technique will greatly affect any benefit here. This sounds more like an art, not a reliable solution.

Things I think we all agree on:

• Glass in solution is less dangerous for IM injections
• There is a correlation between increased ampoule size and increased glass in solution, however any benefits from using smaller ampoules is removed by opening more ampules for the same dose.
• Filtering is expensive, size required is 5um
• Needle size used to aspirate does not affect the outcome
• Forced aspiration with a filter needle reduces its functionality (how does one not force aspirate??)

This is a hard one...

edit: Can't spell ampoule

Edited by Mr Matsubayashi, 02 December 2012 - 09:10 AM.

[Mr Matsubayashi]

Talking about the dark arts of aspiration without drawing in particles:
Be sure to watch the video.
http://pharmlabs.unc...rals/ampule.htm

My opinion is to use a filter straw or needle, if only to catch the larger particles. The value of money diminishes when it comes to my own safety.

[avelez]

It doesn't happen often, but the few times it does makes it not worth it to get a product in a glass ampoule. Due to the risk, a lot of companies are switching over to plastic ampoules.. I suggest going in that direction altogether..

Edited by avelez, 05 December 2012 - 03:26 AM.

[Atropy]

Is a size 23 needle OK when not using a filter,will it protect against glass shards?

[Flex]

This is what I´ve posted in the Cerebrolysine thread:

http://www.longecity...-50#entry582989

So due to the micro-meter size of the glass shades, a Needle could never filter them.

 

There is a chance that those particles are perhaps harmful, but some Hospitals do use filter and some have it but dont use it and some just dont have it.

( dont ask me why, maybe because of the costs ?)

 

My refference to this is a german nurse forum, You can use the google translator for reading it.

http://www.krankensc...-deckels-2.html

 

Or look at this:

Even though our method of visual eyeballing for glass particles may not be very sensitive as some fragments may only be visible under light microscopy, those visible to the naked eye are probably over 75 µm in diameter [4] and would have lodged in the pulmonary capillaries if administered. Pulmonary capillaries have an average diameter of 10–12 µm.

http://onlinelibrary...3.296812.x/full

 

Btw:

I´m using Sterifix filter straw (10cm) with a filter size of 5 μm meters

But it costs me 0.70 Euro per piece

http://www.bbraun.co...id=PRID00003096

Edited by Flex, 13 August 2014 - 09:03 PM.

[Ben]

Btw:

I´m using Sterifix filter straw (10cm) with a filter size of 5 μm meters

But it costs me 0.70 Euro per piece

http://www.bbraun.co...id=PRID00003096

 

Don't you worry about this binding protein?

[Flex]

 

Btw:

I´m using Sterifix filter straw (10cm) with a filter size of 5 μm meters

But it costs me 0.70 Euro per piece

http://www.bbraun.co...id=PRID00003096

 

Don't you worry about this binding protein?

 

 

Which binding protein ?