A Q&A on best-practices for multidose vials

By: August 5th, 2010 Email This Post Print This Post

There has been much more attention recently on multidose vials, particularly the expiration date of these vials, especially from regulatory organizations such as CMS and The Joint Commission.

The following is an email interview with Susan A. Dolan, RN, MS, CIC, from the Department of Epidemiology at Children’s Hospital in Aurora, CO, and lead author of “APIC position paper: Safe injection, infusion, and medication vial practices in health care.”

This Q&A accompanies an article published in the September issue of Briefings on Infection Control.

Q: Why have multi-dose vials been an issue in the past, and why do they continue to be problematic for some facilities?

A: Multi-dose vials have been and continue to be a confusion for healthcare personnel (HCP) because they either are not fully aware of or do not follow basic infection control practices as they pertain to vials. The term multidose seems to be confusing because it is seen by some HCP as being able to be used more than once. While this is true, there are basic infection control practices that are not followed and/or corners that are cut that put the vial at risk for viral or bacterial contamination.

Q: Where do facilities fall short with compliance when it comes to best-practices for multidose vials?

A: There are a few common themes.

  • The label that indicates that a vial is intended for single or multidose is very small print. It is not overtly obvious when a vial is single or multidose. One manufacturer may make a vial multidose when another does not and yet the vials look very similar in size and label color.
  • Vials are used in a variety of settings and it is difficult to find one solution to use that meets everyone’s need.
  • Multidose vials should not be kept in patient care areas where direct care is provided. This can lead to it being used for multiple patients. They should also never be put into staff pockets and carried around with them.
  • When using multidose vials, dedicate them to a single patient.

However, the basic principle of not entering a vial with a used needle should be mostly universal with very few exceptions such as in surgery/anesthesia but only for the same patient.

Q: How long should you keep multidose vials? How often does the 28-day rule apply? Is that commonplace for most vials at this point? The paper indicates it is an unresolved issue, why is that?

A: Most would agree that you should limit use of multidose vials whenever possible. There are varying recommendations on when the used multidose vials should be discarded which is why our position paper noted it as an unresolved issue. Everyone would agree that it should be discarded if the sterility of the vial is in question. Prior to discarding it though, contact your Iinfection Preventionist, as they may want the vial to culture it for microorganisms. It would be helpful to have one evidence-based recommendation for discarding used multi-dose vials that healthcare personnel and surveyors can both utilize.

Q: What will regulators or surveyors look for concerning expiration dates?

A: When we wrote our position paper, our communication indicated that staff were to follow their own hospital policy. However, that may not be the case today given conversations I had with colleagues at our recent APIC national conference. Therefore, we are currently having conversations with various organizations to help develop one consistent message for HCP. It appears that the 28 day recommendation will prevail along with assuring vials are accessed, stored and utilized properly. Some manufacturers may have expiration dates sooner than 28 days from the first access and that would take precedence over the 28 day recommendation

Q: What kind of education or intervention methods can IPs provide to ensure front-line staff are following best-practices regarding multi-dose vials?

A: Only use them when single dose vials are not an option. Use them for single patients whenever feasible. Keep them away from the immediate patient environment. Do not store them in your clothing/pockets. Never leave a needle cannula or spike device inserted in to a vial stopper. Always discard if the sterility of the vial is in question. Access the vial with a new needle and syringe each time.


By Kathy Potts,LPN on August 10th, 2010 at 9:07 am

Regarding a multidose vial-“Use them for single patients whenever feasible”-where i work in a family physicians clinic a great deal of vials are used and not for one patient. Cyanocobalamin is usually given monthly for several patients as well as DepoMedro,Depo Testosterone and in procedures Lidocaine for local anesthesia-these of course should be used only when a sterile needle and syringe is used each time of drawing up.Some come in
50ml vials.Is there a general rule then that these vials shouldn’t be kept past a 28 day rule?

By Evan Sweeney on August 10th, 2010 at 12:26 pm

Yes, the general rule is that multidose vials should not be used after 28 days, however the best approach is to ask the manufacturer for the specific expiration date, as some medications may have a shorter time frame.

By Pam Darnell on August 10th, 2010 at 3:17 pm

I have struggled in finding guidelines for prep solutions that come in containers that may be used for more than one patient (i.e., Povidine Iodine solutions). We have encouraged our clinicians to make these products single patient use or to at least discard at the end of the day.
Are there any guidelines you are aware of that relate to prepping solutions and multipatient use?

By Ann Purvis BS BSN on August 11th, 2010 at 8:02 am

Can the same syringe and needle be used on a single patient if you are drawing up a med and only giving a small amount of it at a time to the patient.

Multi-dose labeled vials were labeled as such for pharmacy preparations and not for clinical use. They are only truely multi-dose if accessed under sterile conditions under the hood; the only exceptions being vaccinations, ppd, and botox.

While clinics are especially prone to utilizing these vials as a cost saving measure, it is inappropriate use. They should be used for a single patient and discarded. There have been too many examples in recent history of abuse and mismanagement of multi-dose vials with subsequent mass transmission of Hep C/B that this can no longer be taken lightly. Plain and simple, you put your patients at risk if you utilize multi-dose vials for more than one patient.

WHen applying the 28 day standard, does this specifically include opthalmic drops?

By Riki Renfro, RN on January 24th, 2011 at 7:04 pm

Some clinics use a spike device in multi-use vials to provide a needle-less access. Can these spikes be left in place for the entire 28-day period for which the vial is used or do they need replacement more frequently?
Thank you.

By Claire Rausch on September 19th, 2011 at 6:07 pm

In the behavioral health clinics where I work patients often are prescribed injections of long acting medications like Prolixin Deconate 25mg/ml iml IM monthly (comes in a 5ml 25mg/ml vial), so this 5ml vial can last for up to 5 months. If we were to expire the vial after 28 days the waste and the expense would be great. Am I understanding the above information correctly that if using the 5ml vial for only one patient (with date and time of first puncture noted) with sterility maintained and the expiration date of the manufacturer current this is OK? Thanks for your recommendations/insights into this dilemma.

Our hospital iv room spike mdv in a hood under sterile conditions, eg folic acid, decadron and a few others. We put a 28 day exp date on these vials. I get the fact about the vial use on the floor, but under these circumstances is this the best practice, or should we be using needles each time we enter the vial as well? Which leads me to my next question…How many times should you enter a vial before discarding it with a 28 day exp?

By dorothy racht on December 9th, 2013 at 9:38 am

i have been administering b12 shots to my husband for over a year…i use sterile procedure at all times…what i want to know is: how long after the expiration date is the drug still effective.

By dorothy racht on December 9th, 2013 at 9:42 am

i have been administering b12 shots to my husband for over a year,,i noticed that the exp date is coming close .. should i be concerned with the efficacy of this drug? how long after exp. date can this be used?

thank you

In Canada, as of this writing (August 2016) the 28 day expiry after opening a multi-use vial is not generally known by physicians or even endocrinologists.

Canada’s largest pharmaceutical manufacturer recommends discarding their T enanthate product delasteryl two months after opening or after five extractions, whichever comes first, saying that their testing has only extended to these two points. However, it does not make this research data available.

I note also that this firm, and every other Testosterone injectible manufacturer I’ve found, stipulates that injection should only be to the gluteous muscle and performed only by a “health professional”. Yet Canadian endocrinologists have been recommending subcutaneous self-injection of T enanthate for many years.

I’m surprised the CDC have not pronounced on this departure from orthodoxy as well, and wonder why. Perhaps because there is no financial loss to big pharma involved?

In any case, I have been self injecting anywhere from 10 to 17 doses of T cypionate or T enanthate from a single bottle over a period of 10 to 17 weeks (ie. 2.5 to 4 times the CDC’s safe use period) since 2009), and have not noted any ill effects.

Of course, I use a new sterile needle and syringe each time I pierce the vial membrane, and wipe the membrane with an alcohol swab before and after each extraction.

However, I have no means of sterilizing the air I inject into the vial, and I do wonder how health professionals sterilize their air?

My suspicion is that this rule is intended primarily to sell more product, with greater revenues for manufacturers and pharmacies.

The obvious question that comes to mind is:

why haven’t the manufacturers or the CDC tested these products beyond the 28 day period after being opened (or in the case of Valeant Canada, beyond the two month/5 injections period)?

In fact, a very pertinent study at McGill University, in Montreal,using Delasteryl on 12 subjects self-injecting 25 to 50 mg SC for a year was reported in 2006 in the

Saudi Med J 2006; Vol. 27 (12): 1843-1846

Sadly, the report doesn’t state how many vials were used, nor how many times the membranes were pierced. And unfortunately, the study’s contact person,
Abdullah M. Al-Futaisi, MD, FRCPC,
does not respond to my e-mailed questions about the study.

A certified health professional might have better luck. Perhaps this study can provide some evidence of the stability of Delasteryl and/or the efficacy of its antibacterial component after up to 20 weeks (at 25mg/week)following the first breach of the membrane.

Alternatively, I have a partly used vial of T cypionate that was first punctured at least six months ago that I would happily donate to (medical) science, if a lab in my vicinity (Southern Quebec) would undertake to test and report the bacterial contamination and stability of the contents.


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