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					                             IMMUNIZE AND PROTECT YOUR FAMILY                                                                In   thIs Issue :

                                                                                                                        1	 Measles, Rubella & CRS Elimination
                                                                                                                        1 Revolving Fund Operating
                                                                                                                          Procedures
                           PAN AMERICAN HE            TION
                                          ALTH ORGANIZA                                                                 3 Regional Plan for Syringes
                                                                                                                        4 AD Syringes: Design and Use
                                                                                                                        6 Estimating Needs for Waste
                                                                                                                          Management
                                                                                                                        7 Management of Waste from
                                                                                                                          Injection Activities
                                                                                                                        8 Laboratory Containment of Wild
                                                                                                                          Poliovirus
                            Volume XXX, Number 3       June 2008


                                                                                                                        PAHO Revolving Fund:
Measles, Rubella, and CRS Elimination: Costa                                                                            Operating Procedures
Rica Makes History                                                                                                      for the Purchase of
                                                                                                                        Vaccines, Syringes,
                                                                                                                        and Related Supplies
On 14 May 2008, Costa Rica became the first country of the Region to create a national commission for docu-
menting the elimination of measles, rubella, and congenital rubella syndrome (CRS). The independent body                The primary purpose of the PAHO
will be comprised of national advisors and consultants who will collect and examine available country data as           Revolving Fund (RF) is to serve as a
a step towards declaring Costa Rica free from measles, rubella, and CRS. At the conclusion of this process, the         mechanism on behalf of countries
commission will submit its final report to the Minister of Health who will officially present it to an international    for the purchase of PAHO/WHO
Expert committee (see Immunization Newsletter, February 2008).                                                          prequalified vaccines and syringes.
From May 2007 to April 2008, Costa Rica also served as pilot country to test the regional protocol on elimina-          The RF provides participating Mem-
tion that PAHO developed to assist countries with data collection and analysis. In May 2008, national and               ber States with the assurances of a
international participants convened in San José to (1) discuss the regional protocol and incorporate recom-             constant flow of vaccines and related
mended modifications based on the lessons learned during the initial collection of evidence on measles,                 supplies for their immunization pro-
rubella and CRS elimination in Costa Rica, and (2) determine the next steps to implement to achieve the goal            grams. The RF offers two advantages
of elimination certification in Costa Rica. Meeting participants included representatives from Costa Rica’s             to participating Member States:
Ministry of Health, Social Security Fund, and Birth Defects Registry Center; country experts in the field of            1. Vaccine and syringe requirements
neonatology, ophthalmology, and cardiology; international experts from the World Health Organization, the                  from all participating Member
U.S. Centers for Disease Control and Prevention, PAHO, and the Oswaldo Cruz Foundation; and the former                     States are consolidated and an-
president of the American Academy of Pediatrics.                                                                           nual arrangements are estab-
A key recommendation for improving the regional protocol was to develop a document providing countries                     lished by the PAHO Procurement
with additional guidance on how to inter-relate all the pieces of evidence —including detailed information on              Services Area (PRO) with various
the national immunization program, epidemiological analysis of measles, rubella, and CRS, surveillance qual-               suppliers based on country re-
ity, molecular epidemiology, and population immunity— to support the argument of elimination.                              quirements; and
                                                                                                                        2. Bulk purchasing options offered
                                                                                                                           by suppliers result in the lowest
                                                                                                                           prices for vaccines, syringes, and
                                                                                                                           related supplies. This is especially
                                                                                                                           beneficial to smaller, less devel-
                                                                                            Dr. Oscar Árias Sánchez,
                                                                                                                           oped countries that otherwise
                                                                                            President of Costa Rica,
                                                                                                                           would have to pay higher prices
                                                                                            signing the executive
                                                                                                                           for small quantities.
                                                                                            decree creating the na-
                                                                                            tional commission on 14
                                                                                                                        Forecasting Vaccine and
                                                                                            May 2008. To his left is
                                                                                            Rodrigo Árias, Minister
                                                                                                                        Syringe Requirements
                                                                                            of the Presidency, and to   Member States and Institutions par-
                                                                                            his right Dr. María Luisa   ticipating in the RF prepare PAHO
                                                                                            Ávila Agüero, Minister of   Form 173-1 (Vaccines) and PAHO
                                                                                            Health.                     Form 173-2 (Syringe and Related
                                                                                                                        Supplies) to project their annual
                                                                                                                        vaccine and syringe requirements.


                                                                                                                                  See REVOLVING FUND	page 2
  2     IMMUNIZATION NEWSLETTER               Volume XXX, Number 3       June 2008                                         PAN AMERICAN HEALTH ORGANIZATION

REVOLVING FUND	from	page 1                                    the order, then the Member State requesting the      2. When goods arrive at destination with hidden
                                                              vaccine or syringe will be responsible for any          (not visible) damages, the consignee must
These forms are submitted to the Immunization                 charges up to the full value of the order.              complete customs clearances and immediate-
Unit (FCH/IM) no later than 15 July of the prior                                                                      ly upon arrival at their warehouse inspect the
year. Information provided must also include
updated delivery addresses and a schedule of
                                                              Vaccine, Syringe, and Related Sup-                      goods. The consignee should also inform the
                                                              plies Delivery                                          insurance company and PRO of its intention
national holidays for the coming year. To ensure                                                                      to file a formal claim and proceed with the
sustainability of supply, Member States prepare               PRO will make the necessary arrangements with           claim according to the instructions specified
a projection of vaccine and syringe requirements              the suppliers and their freight forwarders to ship      in the insurance certificate.
for one additional year through PAHO Forms                    and deliver, on a timely basis, all vaccine and
173-1 and 173-2.                                                                                                   In both instances, it is imperative to report the
                                                              syringe requests specified by Member States          damages immediately and send written notice to
Upon receipt of PAHO Forms 173-1 and 173-2                    on properly submitted PAHO Forms 173-1 and           the insurance company of the intent of filing a
from Member States, FCH/IM consolidates re-                   173-2.                                               formal claim. Most insurance policies establish
quirements by country (for vaccine type and vial              PAHO does not allow partial shipments from           very short periods of time for filing a formal
size, and for syringes) into a regional forecast.             suppliers unless prior authorization is obtained     claim. If the claim is not reported within the time
This information is forwarded in summary form                 from PRO. Depending on the circumstances,            limits set by the insurance company, the claim
to PRO to initiate the bid process in August.                 PAHO may request written authorization from          may be denied.
FCH/IM will ask the Member State to confirm                   the Member State or Institution to proceed with      The consignee should evaluate, based on the
quarterly requirements and/or changes five                    such a shipment.                                     total value of the goods damaged whether or
months in advance of the quarter in question.                 PRO will send copies of each vaccine, syringe        not filing a formal claim justifies the time and ef-
For example, faxes/e-mails confirming vaccine                 and/or related supplies’ purchase order to each      forts required to comply with the specifications
and syringe requirements for the third quarter                Member State concerned.                              set forth by the insurance company to accept a
(July-September) will be sent out on 15 Febru-
                                                              Depending on the product, the following docu-        claim. PAHO cannot file a claim on behalf of the
ary to be returned by the Member State no later
                                                              ments will be provided to the Member State or        consignee.
than 15 March. This will help to ensure a reliable
and sustainable procurement of vaccines and                   Institution, as Consignee, prior to shipment:        In the case of specific problems reported by the
syringes on a timely basis as suppliers require               • Air waybill or bill of lading, commercial in-      Member State or Institution (short expiration
a minimum lead time of three months to adjust                    voice and packing list;                           date, broken product, mislabeling, or instability)
their production plan.                                        • Insurance certificate;                             with the receipt of vaccine flasks or any related
                                                              • License from the National Regulatory Author-       supplies (needles, syringes, cold boxes and ther-
                                                                                                                   mos flasks) the PWR will contact PRO when it is
Vaccine and Syringe Procurement                                  ity (NRA) of the country of origin;
                                                              • Certificate of release per lot from the NRA;       informed of the problem by the Member State.
Once the bidding process has been completed,                  • Certificate of analysis per lot;                   PRO will in turn address the problem with the
PRO establishes annual arrangements with sup-                 • Free sale certificate; and                         supplier and proceed accordingly. The PWR
pliers for the forthcoming year. These arrange-               • Summary protocol of production and quality         should notify PRO within 3 working days after
ments will provide terms, conditions, and prices                 control based on WHO standards.                   receiving the formal acknowledgment of receipt
for the coming year and will guide placement of               Upon arrival of the vaccines, syringes or any re-    from the Member State. Upon receipt of the ac-
individual orders to meet the specific quarterly              lated supplies to the final destination, the Mem-    knowledgement, PRO authorizes payment to the
needs of each participating Member State.                     ber State or Institution is solely responsible for   supplier and closes the order. PRO must pay the
Vaccines will be supplied with an expiration                  completing customs clearance procedures.             supplier upon presentation of a commercial in-
date no less than 12 months unless otherwise                                                                       voice and a transport title as proof of shipment
specified by Member States on their PAHO form                 Acknowledgment of Receipt and                        within the time limit stated in the purchase or-
                                                                                                                   der.
173-1.1 If any shipment does not meet this expi-              Claim Process
ration date guideline, the Member State would
be asked to authorize the shipment, prior to the              The Member State or Institution should formally      Technical Clearance
order being placed.                                           notify acknowledgment of receipt of shipment to
                                                              the local PAHO/WHO Representative’s (PWR) of-        Final acceptance of vaccine shipments shall be
Participating Member States will be charged for                                                                    subject to technical clearance of production and
                                                              fice within 3 working days of arrival of the prod-
any vaccine or syringe orders placed by PAHO                                                                       control protocols by the receiving country’s NRA
                                                              uct:
on their behalf pursuant to PAHO Forms 173-1                                                                       and/or PAHO. Upon receipt of the product at
and 173-2. If a participating Member State de-                1. When goods arrive at destination with visible
                                                                                                                   destination, the Member State shall have ninety
cides to cancel or reduce a requirement after the                 damages, the consignee must complete cus-
                                                                                                                   (90) days to inspect and test products and to re-
orders have been placed with the supplier, it                     toms clearance, take possession of the cargo,
                                                                                                                   ject all products that do not conform to the speci-
must notify PRO 45 days before the vaccine or                     and report in writing the damages to the air-
                                                                                                                   fications, terms and conditions of the order.
syringe is scheduled to be shipped. If notification               line. The consignee should also inform the in-
                                                                  surance company and PRO of its intention to      PAHO will notify the supplier in case of discrep-
is not received on time by PRO to cancel/amend
                                                                  file a formal claim and proceed with the claim   ancies between laboratory results from the NRA
1 Seasonal influenza vaccines normally have a limited shelf       according to the instructions specified in the   and the supplier. Thereafter, for a prequalified
  life of 6 months.                                                                                                product, PAHO will request WHO to have the
                                                                  insurance certificate.
  PAN AMERICAN HEALTH ORGANIZATION                                                   IMMUNIZATION NEWSLETTER          Volume XXX, Number 3          June 2008              3

product re-tested in a WHO reference labora-                  tional samples to the reference laboratory for          Note: This article is adapted from PAHO’s document Op-
tory; the expenses will be covered by the WHO                 testing. The decision of the reference laboratory       erating Procedures for the Revolving Fund for Vaccine and
prequalification budget. For vaccines not includ-             will be considered final. Upon notice of rejection,     Syringe Procurement. The full document is available at the
ed in the WHO prequalification system, PAHO                   and destruction or return certificate, the supplier     following electronic address: www.paho.org/immunization.
will arrange to have the product re-tested in a               will either replace the shipment, or refund the
reference laboratory designated by PAHO; these                payment, as requested by PAHO and pay all
expenses will be covered by the supplier. PAHO                laboratory expenses.
may also request the supplier to furnish addi-



Regional Plan for Quality Control and Safety
                                                                                                                      with regulations, laboratory testing was conduct-
                                                                                                                      ed to verify the compliance of syringes submitted

of Syringes                                                                                                           to the 2007 Revolving Fund bid (Figure 1). The
                                                                                                                      evaluation showed several deviations from stan-
                                                                                                                      dards ISO 7886-1, ISO 7886-3, ISO 7864, and ISO
                                                                                                                      594/1. PAHO also conducted a follow-up on sy-
(This article is an update of the Plan following              shop on the evaluation of syringe quality (Octo-
                                                                                                                      ringes received by the countries, with a random
the article published in the Immunization News-               ber 2006), the protocols were reviewed and ap-
                                                                                                                      sampling to control quality and the conditions
letter of October 2005)                                       proved. They were then translated into Spanish
                                                                                                                      in which the syringes were received. PAHO will
In 2004, the Pan American Health Organization                 and sent to the countries to be used as reference
                                                                                                                      continue its follow-up activities to verify compli-
(PAHO) developed a plan to verify compliance                  documents.
                                                                                                                      ance with quality standards, in conjunction with
of disposable and autodisable (AD) syringes with              PAHO is organizing a Regional laboratory net-           the laboratory network.
ISO international quality and safety standards                work to verify the conformity of syringes and
(see box) and with World Health Organization                  needles with quality standards. Initially, six indi-    Safety
(WHO) guidelines. The plan was meant to en-                   viduals from NRAs in Argentina, Chile, Colombia,
sure the quality, efficiency, and safety of syringes          Jamaica, Mexico, and Nicaragua were trained in          Following the discovery of problems with the
and other products used by immunization pro-                  how to conduct tests, organize the laboratories,        syringes purchased through the Revolving Fund,
grams. Additionally it was meant to develop                   and certify them. The training program will be          PAHO implemented the Regional Incident Report
institutional capacity within National Regula-                extended to staff from six other countries. PAHO        System (RIRS), whose objective is to follow-up
tory Agencies (NRAs) to conduct tests and verify              provided the laboratories with the equipment,           and investigate incidents due to quality or any
product quality.                                              norms, and protocols required. The first six            problems related to syringes and needles. The
The plan includes all aspects of syringe procure-             laboratories are currently evaluating the testing       reporting system is internet-based and the portal
ment, from purchase until final disposal. Its ob-             protocols.                                              serves the following objectives:
jectives are as follows:                                      Each year, PAHO acquires syringes on behalf of          •	 Providing guidelines on quality and safety is-
• Ensuring syringe quality, efficiency, and safety;           the Region’s national immunization programs                sues;
• Developing and strengthening in-country                     through its Revolving Fund. For 2007, over 110          •	 Performing follow-up and investigation of re-
    laboratory capacity to verify quality and com-            million syringes were purchased at a cost of US            ported incidents;
    pliance with standards;                                   $4.56 million while, for the first half of 2008, over   •	 Circulating alerts based on investigation re-
• Promoting syringe standardization;                          41 millon syringes were purchased at a cost of             sults;
• Training on new technologies, such as AD sy-                US $1.75 million. For 2007 and the first half of        •	 Announcing investigation results;
    ringe use;1                                               2008, AD syringes account for 10.5% and 20.5%,          •	 Providing a forum for members to exchange
• Training on safe syringe use and disposal;2                 respectively, of the total of syringes purchased.          information;
• Promoting safe injection practices; and                     As part of the control for quality and compliance
• Strengthening mechanisms for syringe pur-
    chase, distribution, and storage.                         The International Organization for Standardization (ISO) is the world’s largest developer and
                                                              publisher of international standards. ISO standards are universally accepted and ensure desirable
Quality Control                                               characteristics of products and services. Among others, ISO develops international quality standards
                                                              to certify design, management, and manufacturing processes, thereby ensuring that all three pro-
PAHO has established a strategic alliance with                cesses are safe and efficient. ISO’s output ranges from standards for traditional activities, such as
the Emergency Care Research Institute (ECRI, see              agriculture and construction, to mechanical engineering, manufacturing and distribution, transport,
box) to verify quality. ECRI is a PAHO/WHO Col-               medical devices, and information and communication technologies. ISO also develops standards for
laborating Center and serves as reference labo-               good management practice and for services.
ratory. PAHO collaborated with ECRI to develop
the protocols and requirements for laboratory
                                                              ECRI Institute	is a nonprofit organization dedicated to draw on the discipline of applied scientific
design and equipment. During a training work-
                                                              research to determine the best medical procedures, devices, drugs, and processes, and improve
1. See article Design and Use of AD Syringes on page 4.       patient care. ECRI Institute is a center for health technologies engaged in the areas of consulting,
2. See article Estimating Needs for Injection Waste Manage-   research, analysis, and training. It serves as an information repository and a laboratory for the
    ment on page 6 and article Management of Waste from
    Injection Activities on page 7.
                                                              evaluation of medical devices.
      IMMUNIZATION NEWSLETTER           Volume XXX, Number 3                         June 2008                                                                PAN AMERICAN HEALTH ORGANIZATION

• Creating an information repository on prod-                                                  Figure 1. Number of Deviations, Quality Control Process,
   ucts, documents, and services, for use by im-                                                       2007 Bidding Procedure, Revolving Fund
   munization programs; and
•	 Circulating news and a calendar of events.                                         14
The RIRS was tested and implemented at Region-                                        12
al level. The next step involves testing at country




                                                               Number of Deviations
level before the official launch. PAHO provided                                       10
training on portal use to staff in countries at cen-
tral level and to PAHO focal points in the PAHO/                                       8
WHO Representations (PWRs). The portal is cur-
                                                                                       6
rently only available in Spanish, but an English
version will soon be added.                                                            4

Syringe Standardization                                                                2

PAHO has been disseminating information to                                             0
                                                                                           Labelling   Packaging     Cleanliness and       Scale         Accuracy    Dead Space   Dimensions   Leaks between
the countries regarding syringe standardization,                                                                        Lubricant
                                                                                                                         Syringe
                                                                                                                                          Syringe        Syringe      Syringe       Needle     Syringe/Needle

based on the WHO recommendations on syringe                   Providers (Samples Tested):                          1 (19)         2 (8)         3 (6)        4 (1)      5 (3)      6 (1)        7 (2)
type and needle caliber for each vaccine dose.
Through subregional meetings and information             Note: No deviation found for needle/cone assembly; needle defects, cleanliness, and lubricant; and needle bevel tip.
provided to the PWRs, PAHO has been educating            Source: PAHO Revolving Fund.
countries on the use of disposable (standard) sy-
ringes. The sizes of disposable syringes has been      Safety of Syringes, PAHO is expecting to make it                                             capacity to conduct quality testing of syringes
matched to those of AD syringes recommended            easier for countries to purchase high-quality and                                            and needles, along with training professionals
for use by WHO, in accordance with the vaccines        safe products. And, as standardization becomes                                               in good practices for the safe use and storing of
used. Changes are reflected in the PAHO Form           more universal, the shift to AD syringe use will                                             syringes and needles, should contribute to in-
173-2 for 2009 Revolving Fund requirements.            be facilitated.                                                                              creased injection safety.
Among the benefits of syringe standardization
                                                       A key component of the plan is the RIRS.                                                     References:
are improved volume control and delivery sys-
                                                       Strengthening this system and widening its use                                               1. Immunization Newsletter. Regional Plan for Quality Con-
tem management, economies of scale, and im-                                                                                                            trol and Safety of Syringes. Vol.XXVII, Num.5 (October
                                                       will benefit both regional immunization pro-
proved shipping, storage, product handling, and                                                                                                        2005).
                                                       grams and NRAs. Staff will benefit with training                                             2. Immunization Newsletter. Guidelines for Use of Auto-dis-
inventory capacity.
                                                       on procedures for product registration, follow-                                                 able (AD) Syringes. Vol.XXVII, Num.5 (October 2005).
                                                       up of product performance, post-marketing sur-                                               3. Immunization Newsletter. Design and Use of AD Syringes
Conclusion                                             veillance, and auditing.                                                                        Vol.XXX, Num.3 (June 2008).

With the Regional Plan for Quality Control and         Finally, organizing and supporting laboratory



Design and Use of AD Syringes
                                                                                                                                                    4. Syringes with a retractable needle prevent
                                                                                                                                                       reuse and eliminate accidents due to needle
                                                                                                                                                       sticks occurring when health workers recap
Managers of immunization programs have long            The AD syringes available on the market vary ac-
                                                                                                                                                       the needle after administering the vaccine, a
recognized the benefits of safe injection prac-        cording to their design (See Table 1).
                                                                                                                                                       practice that is unsafe but still in use.
tices, which have led to better infection control,     1. Some AD syringes have a fixed needle with
procurement of safe and quality products, and                                                                                                       Other technologies are available, such as intra-
                                                          a metallic clip that locks the plunger after a
appropriate waste disposal strategies. However,                                                                                                     dermal vaccination with a jet gun that does not
                                                          single use.
new technologies introduced without appropri-                                                                                                       require a needle. This technology is not yet com-
                                                       2. The K1 design features a security plunger
ate training have often been rejected by health                                                                                                     mercially available.
                                                          that blocks/breaks after one use. The incon-
workers, as is the case for autodisable (AD) sy-          venience associated with the K1 design is that                                            Each type of AD syringe requires that health
ringes. As a result, vaccine wastage and non-use          the plunger is not at the zero dosage marking.                                            workers carefully follow the manufacturer’s in-
of syringes have occurred.                                                                                                                          structions. Below is a description of the general
                                                          Since most health workers are not familiar
AD syringes are designed in such way that they            with this design, they push the plunger in too                                            steps to be taken for the safe and adequate use
can only be used once. After the administration           far, causing it to block itself and disable the                                           of AD syringes.
of a single vaccine dose, they become perma-              syringe prematurely.                                                                      1. Check the expiration date before opening the
nently deactivated (blocked) and any risk of           3. Some syringes are manufactured with a de-                                                    wrapper.
blood-borne infection is eliminated. For this             tachable needle that can only be used with                                                2. Check that the wrapper is in good condition.
reason, AD syringes are the preferred equipment           the AD syringe it comes with, thereby elimi-                                              3. Open the wrapper as indicated.
for administering vaccines, both in routine im-           nating the possibility of reusing a needle.                                               4. Remove the syringe from the wrapper.
munization and for mass campaigns.
  PAN AMERICAN HEALTH ORGANIZATION                                                      IMMUNIZATION NEWSLETTER             Volume XXX, Number 3          June 2008                

5. If the syringe has a detachable needle, attach
   it to the syringe and turn.
6. Remove the protective covers (caps) from the
                                                                   Calculating Needs for Vaccines and Syringes at Local Level
   plunger and needle, if applicable.                          1. Budget permitting, use one syringe per vaccine dose ordered and one reconstitution syringe per
7. Insert the needle in the vaccine vial all the                  vial to be reconstituted. This may lead to ordering more syringes than will be used with those
   way toward the bottom of the vial.                             vaccines.
8. Pull out the plunger to fill out the syringe.               2. The number of syringes can be calculated based on true vaccine and syringe wastage factors in
9. Maintain the end of the needle in the liquid                   each facility (Table 1).
   until the syringe is filled with the appropriate            3. A wastage factor of 1.11 (assuming a 10% syringe waste) can be used to order AD syringes.
   dose.
10.To remove the air, hold the syringe vertically
                                                                             Table 1. Calculating the Wastage Factor for Vaccines and Syringes
   and tap the barrel. With the needle still in the
   vial, pull the plunger to the appropriate dos-                                                                     Number of Syringes Used
   age marking.                                                        Syringe Wastage Factor      =
                                                                                                                   Number of Persons Vaccinated
11.Check that the dose is the appropriate dose.
12.Select the appropriate injection site.                                                                              Number of Doses Used
                                                                       Vaccine Wastage Factor      =
13.Insert the needle to the appropriate level beneath                                                              Number of Persons Vaccinated
   the epidermis.
14.Push the plunger forward and inject the vac-                                                            (Number of Syringes Used – Number of Persons Vaccinated)
   cine dose.                                                            Syringe Wastage Rate      =
                                                                                                                               Number of Syringes Use
15.After the injection, the plunger is automatical-
   ly blocked and the syringe cannot be reused.                                                             (Number of Doses Used – Number of Persons Vaccinated)
16.Do not recap the needle after use.                                    Vaccine Wastage Rate      =
                                                                                                                               Number of Doses Used
17.Immediately after the injection, dispose of the
   syringe and its needle in a safety box. If a                  Converting the Wastage Rate to the Wastage Factor:
   safety box is not available, use a leak-proof                                                                           1
   receptacle that can resist punctures from                                  Vaccine Wastage      =
   sharp objects.                                                                                                (1 – Wastage Rate)

Reference: Guidelines for Use of AD Syringes, Immuniza-
tion Newsletter, Vol XXVII, Num.5 (October 2005).               Adapted from Giving Safe Injections Training Manual Modules: Module 5 - Using Auto-Disable Syringes, PATH, 2000.




                                                                   Table 1. Autodisable Syringe Designs
                            Type                                        Packaging                      Requires Activation                             Disabled by

                                                                        Individual
                                                                                                                                                         Metal clip
                                                                      Paper package
                                                                                                                No
      Fixed                                                          Bulk-packed with
                                                                                                                                                   Ratchets on plunger
     Needle                                                            plunger caps


                                                                   Prefilled, single dose:                                                          Reservoir (bubble)
                                                                                                  Push port into needle shield
                                                                  individual foil package                                                           cannot be refilled


                                                                    Individual paper or           Remove tab or twist plunger                             Plunger
       K1
                                                                      plastic package                (depending on style)                                breaks off


   Detachable                                                           Individual
                                                                                                                No                                       Metal clip
    Needle                                                            paper package


   Retractable     Currently available on the market, this AD syringe is blocked when a mechanism cuts the needle after injection. The needle remains within the
     Needle        syringe and the plunger is blocked after use.

 Adapted from Giving Safe Injections: Using Auto-disable Syringes for Immunization, PATH, 2001.
         IMMUNIZATION NEWSLETTER            Volume XXX, Number 3         June 2008                                                  PAN AMERICAN HEALTH ORGANIZATION


                          Estimating Needs for Injection Waste Management
                                        Table 1. Calculating the Total Number of Safety Boxes to Be Used in a Month
                     Calculate the Number of Syringes to Be Used                                          Calculate the Number of Safety Boxes Necessary

                                                                 Total Number                   Capacity                                            +                Total Number of
                                              +                                                                              Theoretical
      Nb. of Injection Performed                                  of Syringes          /      (Sharps/Box)                                       Safety                Safety Boxes
                                       Safety Margin     =                                                          =           Nb.                            =
                                                                      [Sd]                         [C]                                           Margin                     [B]
                                          (10 %)
                                                                                                                                                 (10 %)


                                                Table 2. Calculating the Daily Production of Filled Safety Boxes

The disposal of the safety boxes on a daily basis must be ensured in each health care facility. The calculation of the daily production of safety boxes helps in
organizing the everyday logistics. It could be on weekly basis according to the number of injections performed.

Number of staff providing injections                                                                          S=
Average number of injections performed per staff per day                                                     Id =
Total number of syringes used daily                                                                          Sd =                                Sd = S * Id
Capacity of a safety box                                                                                      C=                                 100 or 400
Daily number of safety boxes to be disposed of at the focal centre                                           Bd =                                Bd = Sd / C (boxes/day)


                                                Table 3. Estimating the Costs for Waste Treatment and Disposal

 3.1. Sharp Collection Costs

                       Item                     Cost/Box              x               Nb. Boxes          =                Total
      Safety Boxes                                                                                                                                                 Total

 3.2. Waste Handling Costs

                       Item                    Cost / Unit            x               Nb. Units          =              Sub-Total
      Protective Clothes
      Plastic Bags
      Adhesive Tape
      etc…                                                                                                                                                         Total

 3.3. Minimum Investment Costs for Waste Treatment and Disposal Equipment

      Incinerator                                  (ratio plan 15 $ / 1000 syringes disposed of)                                       (Sd / 1000) * 15            Total
      Autoclave etc.

 3.4. Minimum Recurrent Costs

      Human Resources
                                                Daily Rate
               Nb. of workers                                                                     Nb. of Days                        Sub-Total
                                         x      ($ / day)                    x                                           =


      Combustible (wood, fuel, etc)

             Quantity Used / Day              Unit Price ($)                                      Nb. of Days            =           Sub-Total
                                         x                                   x
                                                                                                                                                                   Total

                                                                                                                                       Total Costs (3.1 to 3.4)

  Source: World Health Organization. Management of waste from injection activities at district level. Available at
          http://www.who.int/water_sanitation_health/medicalwaste/mwinjections/en/index.html.
   PAN AMERICAN HEALTH ORGANIZATION                                                                     IMMUNIZATION NEWSLETTER                     Volume XXX, Number 3                June 2008                  


                                 Management of Waste from Injection Activities
    1. Disposal of the Whole Syringe


                                                                                                                                                                           or




                                           or                                                                                           On-site protected
                                                                                                                                            burial pit                                On-site concrete pit




                                                                                                                                                                                      Autoclave

                                                                                                                                        Off-site treatment to
                                                                                                                                         centralized facility
                                                                                                                                                                                     Incineration



    2. Separation of Needles and Plastic Syringes
                                                                                                                            2a. Disposal of Needles




                            Luer-slip                                     Auto disable                                                     Encapsulation
                                                                                                                                                                                On-site protected burial pit
                            syringes                                       syringes
                                                                                                                                   or

                                                                                          *
                                or

                                                                                 or
                                                                                                                                             Sharp-pit


                                                                                                                    2b. Disposal of Plastic Syringes




                                                                                                                                               Shredding                        On-site protected burial pit



                                                                                                                                               or



                                                                                                                             0.5 % chlorine            Boiling water            Off-site disposal or recycling
                                                                                                                           solution for 30 min.          20 min.
* Several countries are currently managing needles and syringes according to this procedure. However, pilot projects are being carried out to allow a validation from WHO regarding the ease of use and safety of needles
  removers which may carry a risk of needle stick injuries.

Source: Water, Sanitation, Hygiene and Health, Department for Public Health and Environment, World Health Organization.
  8     IMMUNIZATION NEWSLETTER              Volume XXX, Number 3      June 2008                                         PAN AMERICAN HEALTH ORGANIZATION



Laboratory Containment of Wild Poliovirus:                                                                          30 September 2008, using the model format.
                                                                                                                 2. The final report should be signed by the Na-
Group B Countries Workshop                                                                                          tional Committee and sent by the national
                                                                                                                    authorities to PAHO/WHO, who acts as secre-
The American Regional Commission for Certi-                 towards completion of Phase I requirements.             tary of the AMR RCC. Final reports should be
fication of Poliovirus Laboratory Containment               Phase I, implemented under the guidance of Na-          submitted to PAHO by 31 December 2008.
and Verification of Polio-free Status (AMR RCC)             tional Certification Committees, includes drafting   3. Countries are requested to describe in detail
held a Workshop for Laboratory Containment of               a list of laboratories in the country, conducting       the process followed to prepare the list of
Wild Poliovirus in Panama City, Panama, from                a survey to find out whether laboratories are           laboratories in each country, as well as the
20-22 May 2008. The workshop was organized                  storing wild poliovirus or potentially infectious       process followed to classify them in groups
to comply with the commitments made during                  materials, and, based on the survey’s findings,         of high-, medium-, or low-risk. All (100%)
the second meeting of the AMR RCC, in February              establishing an inventory showing what types of         high- and medium-risk laboratories should
2008.1 The workshop specifically targeted Group             samples are stored in which laboratories.               be surveyed. Countries that chose to survey
B countries of the Region.                                  The conclusions of the workshop were as follows:        only a sample of low-risk laboratories should
                                                                                                                    explain whether the result of the survey in
During its February 2008 meeting, the AMR RCC               1. The AMR RCC recognizes the progress of               this sample confirms that the classification
concluded that countries could be divided into                  Group B countries and their enthusiasm to-          was adequate. If not confirmed, the sample
two general groups (A and B) based on assess-                   wards completing the task. They are request-        should be increased.
ment of available information and perceived                     ed to present a preliminary or final report by   4. Countries should include their laboratory da-
compliance with requirements of Phase I of the
                                                                                                                    tabase in this process (Phase I), in electronic
WHO Global Action Plan for laboratory contain-               The AMR RCC was established by the Direc-              format.
ment of wild polioviruses. Group B countries                 tor of PAHO/WHO in February 2004 in order           5. PAHO/WHO offers its support to countries to
(i.e., Argentina, Brazil, Colombia, Cuba, Ecuador,           to independently document that the require-            complete Phase I of the containment plan.
Guatemala, Panama, Paraguay, Peru, and Ven-                  ments for wild poliovirus laboratory contain-
ezuela) are those where much work remains                    ment have been fulfilled, and to verify that
1 Immunization Newsletter. Certification of Polio Labora-    the polio-free status of the Region remains
  tory Containment in the Americas. Vol.XXX, Num.2 (April    unchanged.
  2008).




The Immunization Newsletter is published every two months, in English, Spanish, and French by the
Immunization Unit of the Pan American Health Organization (PAHO), Regional Office for the Americas of the
World Health Organization (WHO). The purpose of the Immunization Newsletter is to facilitate the exchange
of ideas and information concerning immunization programs in the Region, in order to promote greater
knowledge of the problems faced and possible solutions to those problems.

References to commercial products and the publication of signed articles in this Newsletter do not constitute
endorsement by PAHO/WHO, nor do they necessarily represent the policy of the Organization.

ISSN 1814-6244

Volume XXX, Number 3 • June 2008

Editor: Jon Andrus
Associate Editors: Béatrice Carpano and Carolina Danovaro




Immunization Unit
525 Twenty-third Street, N.W.
Washington, D.C. 20037 U.S.A.
http://www.paho.org/immunization