Tuesday, 09 January 2001
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Post00310 A-D RECONSTITUTION SYRINGES 9 January 2001 CONTENTS 1. PROVISION OF A-D RECONSTITUTION SYRINGES: DESIGN & AVAILABILITY In Technet Post00302, 30 November 2000, John Lloyd, PATH/CVP, wrote "One technical issue which emerged from the last Fund review is that the Fund should, in addition to providing AD syringes, also provide reconstitution syringes for freeze dried vaccines at the rate of one per vial of vaccine, including reserve stock (buffer)." "But the review group recommended auto-disable reconstitution syringes which cannot be used for human injections. This would remain consistent with the policy behind the provision of a-d syringes for injections." * "We are urgently seeking sources for these products and will send you what we have found as soon as we can." In the same Technet Forum post, Robert Steinglass, BASICS II, suggested that the AD Reconstitution Syringe should incorporate a fixed non-removable needle to prevent needle reuse. Change is complex! The discussion follows this introduction. CAN YOU ENLIGHTEN ME? In todays posting, Rebecca Fields, AED, and Robert Stienglass, BASICS, discuss how an AD syringe may or may not be used along with the consequence of not having a mixing syringe for reconstituting vaccines. * The key question raised is: How would an AD reconstitution syringe work in practice? SOME THOUGHTS Anthony Battersby, FBA, raises a series of points leading to recommending a focus on training staff in correct behaviour and practice, and not burdening health systems with ever more specialised types of syringe. FIXED OR REMOVABLE? Serge Ganivet, WHO, returns to the question of fixed or removable needles on the potential AD reconstitution syringe and opts for a fixed needle. John Lloyd, PATH/CVP agrees and raises the question of syringe size - 5ml preferred but complicated by the need for reconstituting 20 dose Yellow Fever vaccine along with 10 dose presentations of other vaccines. Julie Milstien, WHO/ATT, suggests the need for a trade-off of Yellow Fever vaccine for a less than ideal [universal] AD reconstitution syringe. AVAILABILITY AND COST! Michael Free, PATH, informs us that Star Syringe's "licensee in PRC is already making 1,5 and 10 ml AD syringes for curative use" and that samples will be seen soon. REALITIES... TRAINING AND EXPENSE Dianne Phillips, SA/DOH, reminds us that nursing injection practices are very difficult to change and that as government procurement is on the basis of price - AD syringes are not likely to be routinely bought with national funding. Opinion, comments and additions please: [[email protected]][email protected][/email] or use your reply button ___________________________________________________________________________ AD is Auto-Disable, for a one use, self disabling injection device ___________________________________________________________________________ From: "Rebecca Fields" To: Subject: Re: Fwd: Post00302 AD SYRINGES FOR VAX RECONSTITUTION 11/30 4:06 PM Can you enlighten me? How can you use an AD for reconstitution? Doesn't the process of reconstitution require pushing in and withdrawing the plunger at least 2-3 times? --- Date: Thu, 30 Nov 2000 From: "Robert Steinglass" To: [[email protected]][email protected][/email] Cc: [[email protected]][email protected][/email], [[email protected]][email protected][/email], [[email protected]][email protected][/email] Subject: Re: Fwd: Post00302 AD SYRINGES FOR VAX RECONSTITUTION Good point. We actually discussed that, John and I, and I believe that he was going to check whether a single injection of fluid would be enough to do the reconstitution, together with whatever handshaking might be needed (although maybe that makes the solution too frothy). I am going to forward your query to TECHNET and to John. I hope you don't mind! * Maybe someone out there has actually handled the reconstituted Hib vaccine and can enlighten all of us. Robert Robert Steinglass Immunization Team Leader BASICS 1600 Wilson Blvd., Suite 300 Arlington, VA. 22209 USA voice: 1-703-312-6800 fax: 1-703-312-6900 e-mail: [[email protected]][email protected][/email] --- From: "Rebecca Fields" To: Subject: Re: Fwd: Post00302 AD SYRINGES FOR VAX RECONSTITUTION I wonder if there have been any "natural experiments" with measles vaccine. I remember that during Haiti's measles campaign about 5 years ago, they had received only ADs and had forgotten to obtain mixing syringes. I'd heard that things came to a halt until they found some mixing syringes, but maybe not. regards, Rebecca --- Date: Thu, 30 Nov 2000 From: Anthony Battersby Subject: Post00302 AD SYRINGES FOR VAX RECONSTITUTION To: Technet Moderator Dear Allan, Some thoughts: Why is consideration being given to only half the reconstituted vaccines in the schedule, why ignore BCG and measles? How many doses of penta-valent vaccine are expected to be sold over the next 5 years? Why is it offered in a two dose presentation? All pentavalent I have seen is in single dose prefilled which would solve the problem. The price should come down if sold in large quantities and it would reduce the logistics burden, but possibly not the cold chain burden. Have any tests been done to see if the AD can reconstitute a singe dose? If it can then use a single dose presentation. What about the option where Hib is reconstituted with DPT? We have lived with 10 dose measles being reconstituted with a conventional 5ml syringe and BCG being reconstituted with 2ml for years. Where is the evidence that these reconstitution syringes are being abused? If they were being abused what would be the market for a 5ml and 1ml reconstitution syringe? Is it the best solution to ask the manufacturers to make two special syringes for Subject: Re: Post00302 AD SYRINGES FOR VAX RECONSTITUTION John, Maybe I miss a part of your discussion but: why either an AD syringe plus removable needle or disposable syringe with fixed needle? For me both are a risk, I would suggest an AD syringe plus fixed large needle .... Regards, serge --- From: "John Lloyd" To: "Serge Ganivet" Cc: "Michael Free" , , Subject: RE: Post00302 AD SYRINGES FOR VAX RECONSTITUTION Date: Fri, 1 Dec 2000 Dear Serge, I would agree with you and so does Debbie Kristensen who was here yesterday. We should go for a-d syringes with fixed needles not suitable for human injection. So - we need 1ml capacity for 2-dose pentavalent and 5ml for 10 dose yellow fever. but the problem is that the current UNICEF tender proposes 20 dose yellow fever...which would require a 10ml recon syringe. Instead of seeking a 10ml a-d syringe, I think it would be better to try to get 10 dose yellow fever...considering the wastage already experienced with 10 dose measles. What do you think? All the best, John --- From: [[email protected]][email protected][/email] Date: Fri, 1 Dec 2000 Subject: Re[2]: Post00302 AD SYRINGES FOR VAX RECONSTITUTION To: "Serge Ganivet" , "John Lloyd" Cc: "Michael Free" , [[email protected]][email protected][/email] Given a global shortage of YF vaccine, going down to 10 dose vials will not help it. Better to have some vaccine and not the ideal reconstitution syringe than none at all?! --- Date: Fri, 01 Dec 2000 To: "John Lloyd" From: Serge Ganivet Subject: RE: Post00302 AD SYRINGES FOR VAX RECONSTITUTION Cc: "Michael Free" , [[email protected]][email protected][/email], Absolutly, Seek 10 dose yellow fever and an AD syringe 5 ml with fixed large needle. --- From: "Free, Michael" To: Technet Moderator Subject: RE: Re[2]: Post00302 AD SYRINGES FOR VAX RECONSTITUTION Date: Fri, 1 Dec 2000 Greetings all We met with Star Syringe yesterday. Their licensee in PRC is already making 1,5 and 10 ml AD syringes for curative use. We are getting samples shortly. They anticipate no problems in supplying sufficient of any of these sizes. They are the only AD design that is being made in all these sizes as far as we can determine. They indicate that they can supply with just a couple of months notice if necessary, and would respond to a tender on this at any time. The familiar fixed cannulae AD is an inherently more expensive product that cannot be made on standard syringe lines. However, a hub-type cannula can be factory welded on to the syringe quite easily. The dead space is a tiny bit more but that should not be a problem for reconstitution. If there are any issues with this, they will need to be cleared up early on or they will affect the required lead time. Cheers Michael --- Date: Mon, 18 Dec 2000 From: "Dianne Phillips" To: Subject: Re: Post00302 AD SYRINGES FOR VAX RECONSTITUTION Robert Steinglass asks the question whether the reconstitution needle should be fixed or removable. Our experience with separate needles is that the health workers like to leave the needle sticking through the septum, and refill the next syringe using that needle. We use 2ml disposable syringes with separate needles and the nurses all tend to use two needles, one for drawing up and one for the injection. They claim that the needle is blunt after plunging through the septum and it then hurts the children. One would think we are a country with unlimited funds, but this is the method taught in our nursing schools and it is very difficult to change practices. The only injection using one needle is the BCG, because we only have syringes with fixed needles. I would dearly love to change to AD syringes, but until I have evidence that they are more cost effective, I will have no chance of getting the AD syringes through the tender system - the lowest prices rule the day. Dianne Phillips National Cold Chain Manager Department of Health Private Bag X828 PRETORIA South Africa 0001 Tel: +2712 3120329 Mobile: +2782 8069253 Fax: +2712 3244525
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