Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

The FDA Gives Us Recalls and Label Changes for EMS Week

Image credit.

The FDA (Food and Drug Administration) has been busy with recalls and label changes this past week for EMS week.

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015.[1]


This is worse than the usual particulate matter. Since this is often used to lower the blood pressure of patients with bad things happening in the brain or the heart, a bit of particulate matter could be the coup de grâce.

The embedded particulate was identified as stainless steel and the floating particulate as iron oxide. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has attributed the embedded particulate to a supplier’s glass defect.[1]


Image at DailyMed.

Dobutamine is another medication with a recall that is given to some of our less stable patients.

In general, injected particulate matter may result acutely in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Small capillaries may become obstructed.[2]


Dobutamine is supposed to improve circulation through small capillaries. 😳


Suppose you would like to ventilate a patient with a BVM (Bag Valve Mask) resuscitator (with the mask or connected to an endotracheal tube, a tracheostomy tube, and LMA, a King airway, . . . ). Some of them might not work properly.

voluntary medical device removal of a limited number of Ventlab™ Resuscitator Bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. The valves may stick due to incomplete curing during the manufacturing process. Resuscitation bags affected may not function properly and may result in a delay of treatment and life threatening health consequences that include hypoxia and hypoventilation.[3]


A sticking duckbill valve?

At 25 seconds of this video, there is a good view of the duckbill valve from the patient end.


There has been one report of injury requiring medical intervention due to the lack of a functional resuscitation bag and 31 reports of a delay in oxygenation due to the requirement to utilize a 2nd or 3rd device. The FDA has been notified of this voluntary action by Ventlab, LLC.[3]


If you are using injectable risperidone (Risperdal), watch out for anaphylaxis. It is rare, but it can make a bad situation worse and you probably were not injecting risperidone because the patient is being helpful.

6.8 Postmarketing Experience [for Risperdal Consta ]

  • added: Very rarely, cases of anaphylactic reaction after injection with RISPERDAL CONSTA have been reported during postmarketing experience in patients who have previously tolerated oral risperidone.[4]

    One of the new anticoagulants does not appear to increase the rate of stroke or heart attack (compared to warfarin [Coumadin]). Yay!

    But it does appear to increase the rate of GI bleed (GastroIntestinal bleed) (compared to warfarin [Coumadin]). Remember to pay attention to any signs of changes in bowel habits of signs of anemia in patients taking the newer anticoagulants.

    The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.[5]


    NTG (NiTroGlycerin – GTN GlycerylTriNitrate in Commonwealth countries) no longer has the following precaution –

    Drug Interactions

    deleted: “Patients receiving antihypertensive…..concomitantly”


    That was the good news.

    NTG is still discouraged if a patient is taking a PDE-5 (PhosphoDiEsterase-5) inhibitor.


    [1] Hospira Announces Voluntary Nationwide Recall Of One Lot Of Labetalol Hydrochloride Injection, USP, 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial, Due To Visible Particulates
    May 16, 2014
    Recalls, Market Withdrawals, & Safety Alerts

    [2] Hospira Announces Voluntary Nationwide Recall Of One Lot Of Dobutamine Injection, USP, 250 MG, 20 ML, Single-Dose Fliptop Vial, Due To Visible Particulates
    May 16, 2014
    Recalls, Market Withdrawals, & Safety Alerts

    [3] Ventlab, LLC. Issues a Nationwide Recall of Ventlab Resuscitator Bags Due to Possible Health Risk
    May 16, 2014
    Recalls, Market Withdrawals, & Safety Alerts

    [4] Risperdal (risperidone) tablets, oral solution, Risperdal M-Tab (risperidone) orally disintegrating tablets, and Risperdal Consta (risperidone) long-acting injection.
    Page Last Updated: 05/16/2014
    Safety information
    Label change

    [5] Pradaxa (dabigatran): Drug Safety Communication – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin
    [Posted 05/13/2014]
    Safety information
    Label change

    [6] Nitrostat (nitroglycerin, USP) Sublingual Tablets
    Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

    Page Last Updated: 05/16/2014
    Safety information
    Label change


    EMS Week 2012 at EMS Office Hours

    This week on EMS Office Hours, Jim Hoffman, Josh Knapp, Bob Sullivan, and I discuss the images we use for EMS Week and what they say about us.

    EMS Week 2012 Episode

    Click on the images to make them larger.

    The image of EMS Week 2012 as seen by FDNY –

    Image credit.

    Is that the way we see ourselves?

    Image credit.

    Are we the faceless dark misunderstood outlaw character of this poster?

    We certainly do not have Bruce Wayne money.

    Does the motto for EMS Week 2012 go with the image?

    Image credit.

    Does listening to voices lead to a slightly different calling?

    Is it crazy to try to do a good job of caring for patients, when few understand what we do, but many want to tell us how to do it, and few want to pay us well to do it?

    Is it even crazier to pretend that we can provide excellent care without continually maintaining and improving our understanding?

    Image credit.

    Maybe we should reconsider EMS recruitment.

    Image credit.

    Somebody’s missing out on all the fun.

    Is EMS a lifestyle of being accountable for understanding patient care, or some sort of a different lifestyle?

    Go listen to the podcast as you bask in the glory of EMS Week.

    For a less dark view of EMS Week, read Kelly Grayson’s end of the world version.

    Top 10 ways to celebrate the last EMS Week ever

    People engage in risky behavior when they believe world is ending, such as telling their supervisors what they really think of them.


    Beyond EMS Week

    EMS Week is over.

    Now what?

    According to Kelly Grayson, 51 more weeks of the same thing, just without the fame and fortune we were showered with last week. SSDW (S S Different Week).

    But we didn’t really do anything when EMS Week was official!

    What can we do?

    Here are some of Kelly’s suggestions.

    Condemn misconduct or incompetence in our midst, and do it publicly. One of the hallmarks of a true profession is the willingness to police its own ranks. But also be careful not to rush to judgment, and close ranks around our colleagues when they are scapegoats for the failures of others.[1]

    Just because something sounds bad/looks bad, does not mean that there was any misbehavior.

    Conversely, just because we have been getting away with certain misbehaviors for a while, does not mean that it is OK.

    Educate our colleagues about the capabilities of EMS, and the best way to do that is by being, well… capable. Don’t demand respect, earn it. If you’ve done that, and they still insist on calling you an ambulance driver, be the bigger man (or woman) and let it pass without comment. Arguing with jerks only gives them the power to make us look like jerks ourselves.[1]

    If we want to intubate, we need to be prepared to demonstrate to anyone that we are not just capable of intubating, but excellent at intubation.

    Our patients should not be harmed by a medic, who is too lazy to regularly practice all aspects of airway management. If I am not up to intubating, for whatever reason, then is much better for me to place an extraglottic airway, than for me to harm the patient just to be able to show that I can intubate.

    If I am excellent at airway management, I will not feel the need to demonstrate that I can intubate. I will do what is best for the patient.


    [1] Beyond EMS Week: Advocating your profession all year.
    by Kelly Grayson


    HIPAA Education for EMS Week

    Writing about the EMS Office Hours podcast, A Lighter Note On EMS Week, I mentioned that we might be better off spending our time on HIPAA Education. Let me explain.

    HIPAA Education –

    HIPAA (Health Insurance Portability and Accountability Act of 1996) is generally misunderstood. We should have a week just to educate hospital, nursing home, and doctors’ office staff about their obligation to share information with us.

    If I am transferring care to someone else and I do not provide a report, including available information about medications, allergies, medical history, and current medical condition, I am abandoning that patient and my license may be restricted/suspended/revoked for that.

    This is also true of a nurse or doctor telling me to just transport a patient because they have transferred care to the hospital.

    If the patient has already been transferred to the hospital, then the patient must be already at the hospital and not on their property, so I am cancelled – Right?

    Maybe that is not the best way to explain things. I could point out that not providing a report as part of pretending to be transferring care to me is something that the state nursing/medical board might take very seriously. The patient is in room X, is not transfer of care. A sealed envelope is not transfer of care.

    If anything bad happens – this is EMS, so nothing bad ever happens – and I am not aware of allergies, medications, history, recent changes in treatment, or something else that might affect the patient’s response to my treatment, that is not going to look good.

    I asked for report, but the nurse/doctor refused to provide information. At this point, something bad has happened, so I can point out that it would not have been good to delay on scene attempting to find out what is going on with the patient.

    Fortunately, it has been a long time since I have dealt with a real refusal to provide information, but I do get some people telling me, The patient is in room X. I respond with, What’s going on. If they say, The patient needs to go to the hospital, I just start asking the questions that should get me the answers that would be a part of a real transfer of care.

    I am polite, but I don’t start moving to the patient’s room, unless accompanied by someone giving me report. If they want the patient transported, and I am not even going into the patient’s room, they need to figure out a way to get me to transport their patient – and as long as the patient is in their facility, the patient is their patient. Most of the time, this is not an issue. Frequently, people seem to be surprised that I am asking questions – as if EMS does not usually do that. Maybe some of us do not, but is that any different from not giving report?

    Then there is the other side of HIPAA Education –

    We can educate people at the hospital about who is permitted access to information about patients we transported. Yes, we are included in that.

    I know. There is no we in team, but who pays any attention to a cliché?

    It may be necessary for your organization to make arrangements with a contact person to have a formal process to provide information, so that they know they are not providing the information to the wrong people. We are not the wrong people. We are entitled to that information.

    One of the big problems with EMS is that too many of us work at getting the vital signs to look good at the time of transfer, even though we had to do things that will decrease the likelihood that the patient will have a good outcome.

    Delayed on scene intubating to arrive with a tube that looks good.

    Caused hypoxia while intubating to arrive with a tube that looks good.

    Flushed out blood and clotting factor with a lot of fluids to arrive with a blood pressure that looks good.

    Et cetera.

    If we follow the outcomes of our patients (they are our patients, too) and read the research on the treatments we provide, we may not be so aggressive with harmful treatments. We may be more aware of what is best for our patients.

    It is a mistake to claim that, We got the patient to the hospital alive, but they killed him.

    If we follow up on what happens with the patient in the hospital, and why the patient receives the treatments provided, maybe we will understand more about patient care.

    EMS is not about coming up with vital signs that look good for the QA/QI/CYA bureaucrats.


    A Lighter Note On EMS Week

    On EMS Office Hours Wednesday night the discussion with Jim Hoffman and Josh Knapp was about EMS Week and how it is frequently perceived by those of us being honored as a form of backhanded compliment.

    There is a post by Too Old To Work, Too Young To Retire that expresses this without attempts at being politically correct –

    Take This Week And Shove It

    Some of the things we could do for EMS Week.

    Have the medical director meet the medics working with the authorization of the medical director. Some medical directors do know their medics very well, while others may never have met them.

    If you are a medical director and you do not know the people giving poisons to your patients (Yes, they are your patients, too) and inserting things in various parts of your patients’ bodies, then maybe this is a good time to get to know them.

    Likewise, if you are a paramedic and you do not know your medical director, this may be a good excuse to introduce yourself.

    HIPAA Education!

    HIPAA (Health Insurance Portability and Accountability Act of 1996) is generally misunderstood. We should have a week just to educate hospital, nursing home, and doctors’ office staff about their obligation to share information with us. Whether we are receiving the patient or we have transferred the patient to the hospital.

    If we follow the outcomes of our patients (they are our patients, too) and read the research on the treatments we provide, we may not be so aggressive with harmful treatments. We may be more aware of what is best for our patients.

    Money for EMS!

    We need money for education. Better trained EMS means better care for our patients.

    We need money for training equipment.

    We need money for medical directors. Too many places rely on volunteer medical directors. Others pay medical directors so little, compared to what they would make working in the hospital, that it feels like they are volunteering. Or they pay medical directors a competitive wage, but only expect a few hours a month from the medical director. Why should a good doctor give away time that could be spent with family or working at paying down medical school loans?

    Some other posts on EMS Week 2011 –

    Everyday EMS Tips – EMS Week posts.

    Muddy Angels Memorial Bike Ride.

    DavesEMS.com – EMS Week Page.

    Advocating for EMS all year long – EMSWeekIdeas.com.

    EMS Week Comments at The Social Medic.

    EMS Week 2011.

    Beyond EMS Week: Advocating your profession all year.

    And there are links to EMS Week contests at the page for this podcast –

    A Lighter Note On EMS Week


    How to Handle EMS Week at EMS Office Hours


    Jim Hoffman has an excellent discussion with Josh K. from Wantynu.com and with Army Medic SSG Broyles.

    EMS Week – Take That Spoon Away, I’m Fed Up

    We do focus on all of the wrong things during EMS Week.

    If we are going to educate people about EMS, maybe we should spend EMS Week educating hospital personnel about what HIPAA (Health Insurance Portability and Accountability Act of 1996) really means.

    HIPAA means EMS is authorized to have the same information the hospital is authorized to have.

    EMS is an important part of the care of patients. EMS is not an obstacle to the care of patients.

    Patient care is improved by improving communication, not by discouraging communication.

    Go listen to the podcast.

    Listen live to tonight’s podcast. Call in and participate.