The second edition of the user manual for the revised WHO classification for the causality assessment of an adverse event following immunization (AEFI) was developed by the WHO with support from the Global Advisory Committee for Vaccine Safety (GACVS). This was based on the findings of a scientific study, “Indo- Zimbabwe inter-country study to assess the inter-rater reliability of the WHO AEFI causality assessment methodology and the utility of the new WHO AEFI causality assessment software” that was conducted in April 2017. The study determined that there was realistic agreement between assessors in their findings of assessment and identified areas of the methodology that could be made even more robust by the use of more accurate and clearer language, semantics and graphics. In addition recent surveillance systems and research studies have shed new evidence on areas such as, “substandard and falsified vaccines” and “immunization anxiety” that have been incorporated into this edition. The manual is now available: http://www.who.int/vaccine_safety/publications/gvs_aefi/en/

IAC recently updated its 3-page resource, Skills Checklist for Vaccine Administration, a tool to help assess staff members' and your own skills in administering vaccines. This resource, which is adapted from the California Department of Public Health's Immunization Branch, has been fully updated with many changes. Related Links IAC's Administering Vaccines Handouts web page The DVD, “Immunization Techniques: Best Practices with Infants, Children, and Adults” available for order at www.immunize.org/dvd CDC’s Vaccine Administration eLearn course, available at www.cdc.gov/vaccines/hcp/admin/resource-library.html

Hello all, Microarray patches (MAPs) are under development for delivering vaccine into the skin. The technology has exciting potential for application to immunization programs. PATH is looking for input from experts in low- and middle-income country immunization programs about the feasibility of MAPs to facilitate immunization, especially for novel delivery scenarios like self-administration of vaccine at home, as well as more traditional immunization settings in LMICs. We have created an online survey as a forum for collecting your feedback. We value your opinion on this topic. The survey will be open for one week and should take no more than 20 minutes: https://www.surveymonkey.com/r/vaccinepatch The results will inform dialogue with vaccine manufacturers and other stakeholders as we work to advance this exciting new method for vaccine delivery. I encourage you to share your opinion in the survey and to forward the link above to other colleagues, particularly those in LMIC immunization programs. I’m always happy to chat in person as well and have included my contact information below. I hope to hear from you. Best regards, Sarah     Sarah McGray Program Officer, Devices & Tools PATH Tel: 206.285.3500 Skype: smcgray Email: smcgray@path.org www.path.org

For realizing the above, identifying maximum causes of gap and operating good practices for mitigation is essential to meet the global vaccination targets by 2020.
We made video recording and still photos for presenting in the monthly Academic Society Meeting for teaching purpose, to prevent avoidable agony to the infants and to administer antigenic dose of intra-dermal vaccines: BCG/IPV. All professionals including pediatricians have expressed that administering intra-dermal BCG is a skilled process. The movements of the newborn/infants are unpredictable. The skilled de-professionals accomplish intra-dermal administration more satisfactorily. We took the opportunity of administering intra-dermal IPV for reorienting the service providers.

Breakthrough: The new smart syringes The surest way to protect against unsafe injections is to use injection devices that have been engineered so they cannot be re-used and don’t lead to accidental needle stick injuries among health workers. Re-use prevention features are essentially the same as the auto-disable features designed for immunization of a single child. The main difference is that syringes designed for delivering medicines allow the health worker to adjust the dose as needed and to move the plunger twice when it is necessary to mix two different medicines in one syringe or for the reconstitution of vaccines and medicines where appropriate. Some models include a weak spot in the plunger that causes it to break if the user attempts to pull back on the plunger after the injection. Others have a metal clip that blocks the plunger so it cannot be moved back while in others the needle retracts into the syringe barrel at the end of the injection. Syringes are also being engineered with features to protect health workers from “needle stick” injuries and resulting infections. A sheath or hood slides over the needle after the injection is completed to protect the user from being injured accidentally by the needle. These syringes also generally have a re-use prevention feature. WHO guideline on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in health-care settings http://www.who.int/injection_safety/global-campaign/injection-safety_guidline.pdf pdf, 620kb [32 pages] Stakeholder support: What needs to happen, who needs to do it The injection safety policy and global campaign is a three to five year initiative that engages many public and private sector stakeholders such as Ministries of Health, international donor programmes, industry players and umbrella organizations representing injection device manufacturers and health care workers. Some critical goals of the initiative include: Governments * By 2020 transition to the exclusive use, where appropriate, of safety- engineered injection devices with re-use prevention and sharps (needle) injury prevention. These devices should meet WHO quality standards. * Set health-system-wide policies and standards for procurement, use and safe disposal of disposable syringes in situations where they remain necessary, including in syringe programmes for people who inject drugs. * Develop an implementation strategy for safety syringes’ procurement, training and education of health workers and sound waste management. Establish a targeted communications programme and a framework for evaluating overall progress. Donors and development partners * Only fund procurement of safety-engineered injection devices in all projects that include administration of injectable medicines. *Provide funding for ancillary needs, including appropriate quantities of single-dose diluents and safety boxes, sharps waste management and health worker training. Manufacturers * Begin or expand production as soon as possible of safety-engineered injection devices while maintaining sufficient production of single-use disposable syringes. * Seek WHO Performance, Quality and Safety prequalification for their products. WHO is beginning to pilot test elements of the injection safety policy and global campaign throughout 2015 and will announce and integrate lessons learned.

WHO Injection safety policy and global campaign All of us, at some point in our lives, will have an injection to retain or restore good health. But sometimes injections that are intended to promote health do the opposite. This happens when they are given in an unsafe way - using the same needle or syringe to give injections to more than one person. Practices like this can lead to the transmission of life- threatening infections. According to a new study, unsafe injections are responsible for as many as 33 800 HIV infections, 1.7 million hepatitis B infections and 315 000 hepatitis C infections annually. Both patients and health workers are at risk through needle injury. Towards safe injections for all WHO and close partners – including the Safe Injection Global Network (SIGN), UNICEF and GAVI, the Vaccine Alliance – have been working actively together for more than a decade to promote safe injection practices. Educating policy makers and health workers on the critical importance of sterile equipment is key. The group’s initial push in 1999 focused strongly on spurring countries to use only auto-disable syringes for vaccinating children. Now the spotlight is on the risks associated with injections into muscle (intramuscular) or skin (subcutaneous or intradermal) to treat medical conditions; and how to make them safer through education on safe procedures, elimination of unnecessary injections and better design of equipment. Making all injections safe brochure http://www.who.int/injection_safety/global-campaign/injection-safety_brochure.pdf pdf, 554kb [6 pages]

New WHO Injection Safety Guidelines WHO is urging countries to transition, by 2020, to the exclusive use of the new “smart” syringes, except in a few circumstances in which a syringe that blocks after a single use would interfere with the procedure. The new guideline is "Who guideline on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in health care". It is available for free download or viewing at the link: http://www.who.int/injection_safety/global-campaign/injection-safety_guidline.pdf

Cross-posted from the SIGN newsletter with thanks! The Yves Chartier Award 2014 rewards an NGO, or an actor from civil society, from an African country, who will have elaborated a campaign or achieved an innovative project in the struggle against antimicrobial resistance and climate change, relative to one of three specific domains of intervention : Water – Sanitation & Toilets – Injection Safety. The French engineer Yves Chartier who died in a mountain accident January 8, 2012, was an international functionary in the World Health Organization (WHO) who had brought major contributions in these three domains of intervention. This initiative comes from civil society, in collaboration with the French Ministry of Health, contributing the sum of five thousand euros, to honor the memory of a man who devoted his life to «la santé publique à la française » (The French concept of public health). This follows the 2012 event to honor his memory at the World Health Assembly with an International Journal for People's Health, which includes the list of all the Yves Chartier contributions while at WHO: http://signpostonline.info/sign-links/peoples-health-movement-france. The official call for candidacies was announced by Garance F. Upham, President of Safe Observer International (SOI), at the WHO first world conference on "Health and Climate Change" on Wednesday August 27th during the plenary in the WHO headquarters. The call for candidacies will be ongoing for two months. The winner to be selected early November, the Award to be given end of November. The best five projects/campaigns to be reported on in a brochure and presented at a press event. Email nominations to Safe Observer CANDIDACY FORM: Name of the project or campaign: Summary: (300 words maximum) Description: (1500 words maximum) Name of the Association, NGO, Network or Institute: Country Project officer Name, First name Address Telephone E-mail Web Site Documentation about the project / the campaign Add, in electronic format, any document that supports the application: official documents, meeting reports, testimonies, press articles, references on the Web.

Around 12 million people in Pakistan are suffering from hepatitis B and C, with Balochistan topping the list followed by Punjab, Sindh and Khyber Pakhtunkhwa. Pakistan has the highest therapeutic use of injections worldwide and researchers in the country have found that the increasing incidence of hepatitis, especially hepatitis C, is directly related to the higher use of injections and reuse of syringes.

The research published two years ago was the first national population-based study on hepatitis.As per findings of the previous studies largely based on hospital and clinical data, 16 million people in the country were suffering from hepatitis B and C. Over 300 local and international papers have been published on the subject and most of them are based on hospital or clinical data. The hospital data usually shows a higher rate of disease prevalence. The study showed that 7.4 per cent (11.84 million) population in the country was suffering from hepatitis (hepatitis B 2.5pc) and (hepatitis C 4.9pc).The prevalence of hepatitis B was found to be: Balochistan (4.3pc), Sindh (2.5), Punjab (2.4pc) and Khyber Pakhtunkhwa (1.3pc).The prevalence of hepatitis C: Sindh (5pc), Punjab (6.7pc), Balochistan (1.5pc) and Khyber Pakhtunkhwa (1.1pc).

The high risk districts for hepatitis B: Musakhel (14.7pc), Khairpur (6.3pc), Ghotki (5.9pc), D.G. Khan (5.7pc), Islamabad (5.6pc) and Upper Dir (5pc).The high risk districts for hepatitis C: Vehari (13.1pc), Hafizabad (12.9pc), Ghotki (12.7pc), Hangu (6.4pc), Musakhel (5.3pc) and Jaffarabad (5.2pc).About 7,000 households were visited in the study and the average number of individuals found in each household was 6.7pc.

It wasn’t an easy task as to go to every district of the four provinces. People were tested on the spot and handed over the reports. The positive cases were referred to the nearest government health facility.The teams visited the areas faced no problems accessing people in militancy-hit areas, including that of Balochistan. “In fact, people were very supportive when they were informed about the survey’s objectives.

One major factor contributing to the spread of infectious diseases, especially hepatitis, was a high use of injections and reuse of syringes in Pakistan.The World Health Organisation allows 3.5 injections per person per year. However, the therapeutic use of injections in Pakistan is very high –13.6 injections per person per year.The higher use of injections makes a person vulnerable to infection. This vulnerability further increased with the reuse of syringes.

Other risk factors for hepatitis,included needles, drips,multi-dose injection vials, improperly sterilised invasive medical devices such as thermometers, tongue depressors and surgical and dental equipment, unscreened blood transfusions, communal shaving and unsafe sex.

Balochistan,had the highest (4.3pc) prevalence rate for hepatitis B which was almost double of the national figures (2.5pc). Though the incidence of hepatitis B was falling due to vaccination, hepatitis was still within the previous range. The breakdown of provinces showed higher incidence of hepatitis C in Sindh and Punjab.

More active vaccination against hepatitis B was required, especially in high prevalence districts of Balochistan.For that the government needs to take help from all organisations, all stake holders including security forces in campaigns advocating judicious use of injections should also be launched.

afzalmalik_awan@yahoo.com
Contact:00923002900688

Excerpts from a discussion on another forum about adverse events following immunization (AEFI) data collection. Dhruv wrote: A wise option. Why don't we develop a cellphone-based VAERS? Prabir wrote: See http://www.slideshare.net/prabirkc/sms-based-death-reporting which has to do with a similar system. You are quite right. An EPI Surveyor form would be easy or else something costlier -- but more user friendly like CG NetSwara (http://cgnetswara.org/)* I believe that a good VAERS or adverse event reporting system with compensation for likely cases and treatment and rehabilitation for all is a human right in a society that uses vaccines. Here I think both vaccine supporters and doubters will find common ground. Questions of compensating residual paralysis patients, rehabilitation and disability benefits are where physiotherapists, virologists, social workers and activists can agree. Deaths after HPV, after JE and the AFP who are weak need attention. Dr Sunil Kaul wrote: That is a good system you are suggesting. Only worry is who will judge whether the adverse event is attributable to the vaccination or not? But all the same, it may actually increase the adverse events directory and allow research in the long run. theant, Udangshri Dera Rowmari, P O Khagrabari, via Bongaigaon Dist Chirang (BTAD), Assam 783380 INDIA http://www.theant.org sunil@theant.org Ph: 094351 22042 (m) 03664 293803 (r) IDeA 03664 293801 the ant Office: 03664 293802 Padma Prakash wrote: There are a number of commercially available medical alert systems marketed abroad. They use a Global Positioning System (GPS), and are one-button instruments that also are cellphones. I've always wondered at why hospitals haven't thought of offering the service to vulnerable--- older people, or those with particular problems---in their areas. At one time these were thought to be too expensive. But it should not be so with the spread of cellphone services and if a service provider could be drawn into it. But there are some initiatives today ---and several successful ones in Kenya and Nigeria I think-- that are cheap; used if I remember, for pregnancy and delivery related events in far-flung but demographically small communities. There are of course any number of youth-led groups that are using the mobile phone services very effectively for community-related work of all kinds including alerts on help on sexual assaults, police assaults, violence, etc. I don't see why this cannot be developed for adverse drug reaction reporting. A simultaneous website like CG NetSwara would be easy enough. The critical issue is the content. Do you know if it isn't in fact being developed here? * Moderator's note: CGnet Swara is a platform to discuss issues related to Central Gondwana region in India. It is a voice-based portal, freely accessible via mobile phone, that allows anyone to report and listen to stories of local interest. Reported stories are moderated by journalists and become available for playback online as well as over the phone.

Many thanks to Diana Chang Blanc for sharing this information with the forum! Dear colleagues, ... Please find below the web link to the “first batch” of the WHO Information Sheets on Observed Rates of Vaccine Reactions. We would highly welcome if you could share these sheets with colleagues and relevant target groups. http://www.who.int/vaccine_safety/initiative/tools/vaccinfosheets/en/index.html At this link you will find the information sheets aiming to provide details on observed rates of vaccine reactions of selected vaccines. They can be used in the evaluation of Adverse Events Following Immunization (AEFI) reported during national immunization programs, but also in preparing communication materials about specific vaccines. Primarily, these sheets are designed for use by national public health officials and immunization programme managers but may appeal to others interested in such information. The information sheets have been developed and reviewed internally and externally in collaboration with the respective WHO Vaccine Focal Points and the Global Advisory Committee on Vaccine Safety (GACVS). We would like to particularly thank the Vaccine focal points from IVB, IVR (Ulrich Fruth) and FOS (Simone Magnino) for their great support in the development of the first available Information Sheets, and we thank the Global Advisory Committee that has helped in the further refinement of these information products. Attached is also flyer/poster to the information sheets that may be helpful for your further communication to colleagues and target groups. VaccRate-Infosheet-Poster.pdf We look forward to keep you posted on the next publication of the remaining sheets in the course of this year. Best regards Philipp Dr Philipp Lambach Global Vaccine Safety (GVS) Quality, Safety & Standards (QSS) Immunization, Vaccines and Biologicals (IVB) Tel. direct: +41 22 7911461 E-mail: lambachp@who.int

Cross-posted from the January 2012 issue of GIN with thanks.
31/01/2012 from Madhav Balakrishnan, WHO HQ

The Global Network for Post-marketing Surveillance (PMS) of Vaccines was established by WHO in early 2008 with a primary objective to monitor the safety of WHO prequalified vaccines supplied through UN agencies. By 2011, twelve countries, Albania, Brazil, China, India, Iran, Kazakhstan, Mexico, Senegal, Sri Lanka, Tunisia, Uganda and Vietnam have been included in the network. These countries were trained in Vaccine Pharmacovigilance, on the methods of causality assessment for vaccine Adverse Event Following Immunization (AEFI) classification and the use of Vigiflow© (a software platform to report and upload AEFI cases to the WHO Programme for International Drug Monitoring, which is maintained by the Uppsala Monitoring Centre (UMC) in Sweden).

As of 31 December 2011, eight of the twelve countries in the Global PMS network were uploading AEFI case reports to the Uppsala Monitoring Centre (UMC) in Sweden, using the Vigiflow system. Reports pertaining to 6,099 AEFI have been uploaded into the WHO UMC database. Of these, 2,770 involved multiple vaccines. DTP vaccines were associated to the largest number (3,745) of adverse events. Most events related to DTP were reported from Iran (3,516) and Sri Lanka (187) both of which have well established AEFI surveillance systems.

With one more year for the project, the PMS Network has improved the reporting of AEFI for vaccines in most participating countries. Systems are being established to ensure harmonization of the surveillance and reporting systems, including case report forms, software systems, and type of AEFI reported. The network countries have identified the need for a more simple data processing tool that could be more specific for vaccines and that could be operated off-line given the internet limitations in many countries. Currently the WHO and UMC are exploring the prospects of creating a simpler tool based on the experience gathered.

Cross-posted from the January 2012 GIN issue with thanks. 31/01/2012 from Philipp Lambach, WHO HQ An important part of post-licensure vaccine safety surveillance is to collect and analyse reports of Adverse Events Following Immunization (AEFI). Analysing multiple AEFI reports helps determine if the observed reaction rate to a specific vaccine ishigher than the expected vaccine reaction rate which is often determined from published studies or trials. If a vaccinated group and a placebo group have identical background rates of an event any differences between groups can be attributed to the vaccine, taking into account factors leading to variation of background, observed and vaccine reaction rates of events. To help strengthen the capacity to introduce vaccines in Member States, WHO will publish information sheets online shortly to provide details on selected vaccines that are relevant to the analysis of reported events. These information sheets include a short summary of the vaccine as well as details of mild and severe adverse reactions (local and systemic) following immunization. Where possible, the information presented includes the expected rates of vaccine reactions as published in the literature. The papers primarily target national public health officials and immunization programme managers but may appeal to others interested in such information. Data from these sheets can be used in the evaluation of AEFI reported during national immunization programmes, but also in preparing communication materials about specific vaccines. In total, information sheets of over 20 of the most important licensed vaccines will be developed and gradually posted on our website. If you and your colleagues would like to receive email notification when the first batch of the information sheets is available, you can subscribe by sending an email to: vaccsafety@who.int. Information sheet structure Designed for practical use in the field, the information sheets follow a simple, modular pattern, including information on vaccine specifics and adverse events. The section on Adverse Events usually includes passages in • mild adverse events; • serious adverse events; • other safety issues • summary table for quick overview To satisfy potential further research needs, all sheets include a detailed list of source material.

It all started with this letter to an e-group: Dear Friends, The need for screening before vaccination and the presence of a doctor during the procedure, as stated by Dr T Jacob John, cannot be overemphasized. I am happy that this much sense is now seeping back into mainstream thinking. Now what is needed is serious research into long term effects of multiple vaccines. Regards, Jagannath ANM cannot handle adverse reaction Shailvee Sharda, TNN Jul 26, 2011, 03.43am IST

On 11 May the Safe Injection Global Network published its 598th (yes, 598th) electronic newsletter that reaches some 800 subsribers worldwide. This week's email celebrates World Blood Donor Day but also has 24 other items about safe and appropriate use of injections throughout the world. Examples this week include: News of a webcast On Recognizing and Correcting Unsafe Injection Practices; An abstract on Staff nurses' sites of choice for administering intramuscular injections to adult patients in the acute care setting; and Fifteen news items on injection safety from around the world. Take a look at SIGNpost forum and SIGN up

Dear Moderator, Four more infants died due to measles vaccination in Kutch on March 16 and two more died on March 18. There are deaths being reported consistantly all over the country within few minutes of vaccination but none has been attributed to vacination by the investigating agencies. The investigating agencies are at fault in a way that the open vial from which the alleged vaccine was given is not taken as sample for testing for any contamination but the new samples of the same batch are taken, and so vaccine is declared as safe. http://www.dnaindia.com/india/report_four-infants-die-after-vaccination-in-gujarat-town_1520755 http://www.dnaindia.com/india/report_fo … wn_1520755 We need to get vaccine samples tested outside the country including the left out vaccine in the vial that caused deaths as local agencies fail to establish the cause of death. How long we keep on just reading the news without any sensitivities ! Thanks, Dr. Omesh Kumar Bharti M.B.B.S.,D.H.M.,M.A.E.(Epidemiology) OSD, Emergency Medical Response and Transport, Directorate of Health, Kasumpati, SHIMLA, Himachal Pradesh, India. +91-9418120302 bhartiomesh@yahoo.com; bhartiomesh@gmail.com

Have put together some slides on the issues involved. This is an educational power point- long, but of use to prepare classes for health workers or doctors- http://www.slideshare.net/prabirkc/toxic-shock-syndrome

Attached are some photos of Sun Frost's latest Tubular Sterilizer. Syringes are placed directly into the sterilizer, minimizing handling. When full the vacuum tube sterilizer is removed from its stand and placed in the sun. The collector is effective even in hazy conditions. Fifty syringes can be melted and sterilizer in less than two hours. The black plungers and needles are not melted are incased in a matrix of plastic. If you're interested in this device please contact Sun Frost. ##text## ##text## ##text## ##text##

Sun Frost recently developed a solar oven capable of air sterilizing medical equipment. For air sterilizing temperature of 190C must be achieved for 6 minutes. The heart of the sterilizer is an evacuated tube solar collector. The interior of the oven is cylindrical in shape and is 11.5cm in diameter and 91cm long. The tube is essentially a Thermos bottle. The interior can be 190C and the exterior will be at room temperature. Because heat losses are so small sterilizing temperatures can be achieved even in marginal solar conditions. The oven walls are glass. We are currently looking for applications for this technology. If you have suggestions please let us know.

Robert Chen sends in this request. For a study assessing injection site abscesses in a developing country, photos are needed for the training material. The challenge is that injection site abscesses are uncommon in developed world where cameras are common and more common in less developed settings where cameras have been less common. Please let me know if you have such photos you're willing to share. Robert T. Chen MD MA E-mail: [email=BChen@cdc.gov]BChen@cdc.gov[/email]

Rabies has been one of the most dreaded diseases, often leading to painful death in human beings. Globally, around 55,000 people die of Rabies and, of them, 20,000 die in India alone. The animal bite incidence rate is 17.4/1000 that is 17.4 million bites every year in India. The frequency of animal bite is 1 every 2 seconds and that of death is 1 case every 30 minutes. The annual medicinal cost (vaccines + other drugs) for treatment of animal bite in India is Rs. 2 billion and annual man days lost due to animal bite is 38 million. The discovery of nerve tissue vaccine (NTV) was a great savior for the animal bite victims and served the purpose for many years. Later, in 2004, the use of this vaccine, that was administered free of cost, was stopped by the supreme court in the country, citing some rare reactions but without bothering about the fate of the millions of poor people who were going to die for want of an affordable vaccine in the absence of a NTV. In my brief clinical career I myself saw such cases that, because of the cost, could not afford the vaccine and died due to Rabies; a recent case occurred just two months back in the Hamirpur district of Himachal Pradesh. With the supreme court banning the NTV, it was celebration time for many private antirabies vaccine manufacturers as there was acute shortage of the vaccine all over. The champions who helped these companies put up a strong case for stoppage of NTV did not bother either to look for an alternate that is affordable or ask these companies to allow intradermal use of the vaccine like they were doing in foreign countries. The cost of one complete course of antirabies vaccine (ARV), is around Rs.2220/- when given through an intramuscular route but the costs come down to Rs. 370/- when the antirabies vaccine is given intradermally. WHO recommended the use of cost effective intradermal regimen (IDRV) in 1992 and the same was introduced in Thiland, Phillippines and Srilanka subsequently by 1996. In India, many NGOs demanded that the IDRV be started in India as well but a powerful vaccine lobby along with the corrupt officials did not allow this to happen. When the pressure to start IDRV mounted, the lobby invented a noble way to prevent the introduction of a well-tested intradermal route saying that first the trials for efficacy and effectiveness of intradermal vaccine be undertaken in India before giving any approval. 10 years after the cheap intradermal route of antirabies vaccine was approved by WHO, the Indian government ordered the trials to be conducted by ICMR in the year 2003-2006. Now the efficacy was proved beyond doubt but the drug controller dragged his feet to block the implementation by putting an arbitrary ceiling of 50 patients. If someone wants to give intradermal antirabies vaccination in India and it was essential that the vaccine manufacturer mentions on the vaccine label that the vaccine is fit for intradrmal use and the label should mention 'for IM/ID use', which they were unwilling to do. No timeframe was set to ask manufactutrers to write on the label nor were the government vaccine manufacturers asked to expedite the amendment to the label of the vaccine to facilitate easy accessibility for the poor patients. Again the winners were the vaccine manufacturers and the lobby they were feeding to block the access to a cheaper vaccine. After many protests, the DCGI lowered the limit from 50 to 10 patients if someone wants to give IDRV, making it again difficult to gather these many patients to start IDRV. It was for the first time that DCGI was deciding the number of patients for use of a vaccine rather than the route and potency of a vaccine. The same DCGI office has allowed the marketing of highly costly like Hib, Pneumococcal and Monovalent polio vaccines based on the trials conducted outside the country and is still allowing such drugs and vaccines that have not been tested or undergone field trials on Indian populations. While the DCGI office was dragging its feet to give permission to use the intradermal antirabies vaccine, Dr. M.N.Siddiqui, a courageous man, along with the government of U.P. started the first antirbies intradermal clinic on 19 May 2006 in U.P., and then there was no looking back. Now already nine states have started IDRV and many are going to start it soon. The nine states to start IDRV are U.P., Orrissa, A.P., Karnataka, W.B., H.P., Kerala, T.N. and Uttrakhand alongwith a clinic each in J.J.Hospital Mumbay and at Ganiyari village clinic in Bilaspur district of Chattisgarh. The mechanism of action of intradermal vaccine is that it is directly presented to the immune system (axillary lymph nodes) and does not undergo dilution in the blood as is the case in intramuscular delivery; therefore a small amount of vaccine given intradermally is enough to produce the desired immunological response. Because the volume of the vaccine used for intradermal delivery is one-fifth of that of intramuscular delivery, the cost of IDRV also comes down to one-fifth of the cost for intramuscular vaccine. With more and more states opting for the intradermal route, pressure has been put on more and more companies to come forward to write 'IM/ID' on the label and two of the vaccine companies have made vials for ID use and more are assuring to do so soon. Unnecessary expenditure on the part of the poor patients and the government has been reduced since the IDRV started in India and more than a million doses have been given inradermally without a failure. Still a lot needs to be done, as the government and companies are still not serious to promote IDRV, e.g. the Delhi government can save more then 45 crores annually by shifting to IDRV from the IM route and money saved can be used to provide free rabies immunoglobulins to save lives; but there is laxity on this front and nobody is ready to take the responsibility. Similar is the case with other state governments that have not yet started IDRV. In Himachal, in a short period of eight months, we have vaccinated 2020 animal bite victims (8080 doses) and have saved more than 3 million rupees and hope to save millions when intradermal vaccination for rabies post-exposure prophylaxis becomes a routine in future. Also we are helping our neighboring states to start IDRV as early as possible to make the benefit of a life-saving vaccine reach the masses that is now available at an affordable cost; already they have been made to wait for more than 16 years and need not wait any more due to the apathy of decision makers! Thanks Dr. Omesh Kumar BhartiM.B.B.S.,D.H.M.,M.A.E.(Epidemiology)Directorate of Health Safety and Regulation, Himachal Pradesh+91-9418120302[email=bhartiomesh@yahoo.com]bhartiomesh@yahoo.com[/email]; [email]bhartiomesh@gmail.com[/email] The INTERNET now has a personality. YOURS! See your Yahoo! Homepage.

POST 01415E: INJECTION SAFETY SUPERVISION TOOL FOLLOW-UP ON POST 01412E 11 APRIL 2009 ****************************************** Thanks for the injection safety supervision tool posted on the TechNet21 (forum). I think it is a laudable effort to simplify existing tools - and thus making them more likely to be used at no extra cost - or very low cost. I think the division into 3 sections makes it easy to use: - Injection safety for the vaccinator/injection provider - Injection safety for the vaccinee/recipient - Injection safety for the community I am less sure about the need to have the 4th section (41, 42 and 43 could be lumped into injection safety for the recipient). A few suggestions: 1. Injection safety for the vaccinator: 1.1. Recapping: No suggestion 1.2. Use of safety box: change to "did the vaccinator dispose of all needles and syringes immediately in the safety box?" (the term "correctly" can be subject to interpretation) 1.3. Use of one syringe for each injection and for each reconstitution: split this question into 2 questions (one for reconstitution and one for injection) 2. Injection safety for the recipient 2.1. and 2.2 No suggestion 2.3. Avoid touching the injection site: suggest to get rid of this because it is trickier to observe than it appears—especially during busy sessions (the vaccinator HAS to hold some part of the injection "area" to perform the injection) 3. Injection safety for the community: looks good to me- No suggestion for change 4. Injection safety: Vaccine quality Could this section be lumped with section 2? Suggestion: delete section 4.3. because it cannot be assessed by observation (the supervisor would have to rely on hearsay by the injection provider, which is not verifiable). Dr. Jules Millogo ([email=jmillogo@VANISHPOINT.COM]jmillogo@VANISHPOINT.COM[/email]) Medical Director Retractable Technologies Inc. Washington DC Post generated using Mail2Forum (http://www.mail2forum.com)

POST 01364E: NEEDLESTICK PREVENTION DEVICES19 DECEMBER 2008 ****************************************** According to the World Health Report 2002, ‘there are 35 million health-care workers, of which 2 million experience percutaneous exposure to infectious diseases each year. The report also states that 40% of Hepatitis B, 40% of Hepatitis C and 2.5% of HIV/AIDS in Health-Care Workers around the world are due to needlestick injuries.’ A WHO injection safety assessment in 20 countries revealed that, on an average, health-care workers experienced 1-9 needlestick injuries every year. A similar assessment in the WHO Eastern Mediterranean Regional Office showed an average of 4 needlestick injuries per year per health-care worker. (Carsten Mantel, 2002) In developing countries, and especially in Africa, the health-care workforce is at high risk. In this context, the letter shared with us by Dr Jules Milligo is very heartening. Political and administrative support is crucial to greater injection safety A few reports and references relating to the same subject have also been cross-posted from SIGN. Many thanks to Allan. -------- Dear Terry, Attached please find a letter to "All development partners and friends of Nigeria" by the Director General of the Nigerian Agency for Food and Drug Administration and Control (NAFDAC), Professor Dora Akunyili. As you may recall, last year, Nigeria, under Prof Akunyili’s leadership, took the courageous decision to move toward adopting syringes with needlestick prevention features. In a country that is better known for its reputation of corruption, it is heart-warming to see someone that rises above the fray to do the right thing. Since taking office, despite death threats, she remained undeterred and fiercely committed to protecting Nigerian populations from fake drugs, fake medical devices and other products. She has always been a strong supporter of injection safety and more particularly of health workers' safety. It is a pleasant surprise to see that she is following suit with this letter to partners to support the implementation of this decision to protect health care workers from needle stick injuries and the risk of transmission of blood borne pathogens in health care settings. I hope you will be able to publish this in the next Technet. Thank you Jules Dr. Jules Millogo ([email=jmillogo@vanishpoint.com]jmillogo@vanishpoint.com[/email]) Medical Director
Retractable Technologies Inc.
 Washington DC ------- Safe needles save lives: Improving the knowledge and practice of injection safety amongst student nurses of the University of Benin Teaching Hospital (K.N. Stewart: University of Benin, Community Health, Benin, Nigeria) Background: The World Health Organization estimates that at least 50% of the developing world’s injections are unsafe and pose serious health risks to the recipient, health workers and the public. Nigeria has been identified as a country with poor injection practices among health care workers and patients. This study aimed at improving the knowledge and practice of injection safety amongst student nurses of the University of Benin Teaching Hospital, Edo State, Nigeria. Methodology: This quasi-experimental study was conducted between the 24th of January and the 8th of June, 2007 amongst 106 student nurses of the University of Benin Teaching Hospital using 115 students of the State School of Nursing as controls. A total population was used for the study. Every nursing student who had spent one year in the school was recruited for the study. Information was obtained from the respondents using a self-administered questionnaire and an observational checklist. The WHO/AFRO/JSI Inc. Facilitators Guide for Injection Safety was used as the manual for training intervention. Results: There was a marked increase in the overall knowledge of injection safety amongst subjects from a baseline knowledge of 42% to 82% following intervention and this difference was found to be statistically significant (p =0.0000). There was a slight increase in knowledge of injection safety amongst controls from a baseline of 45% to 47% but this increase was not statistically significant. Conclusion: The poor knowledge and practice of injection safety implies a need for its inclusion in the curriculum of Nursing Schools in Nigeria. -------The status of occupational safety among health service providers in hospitals in Tanzania (Manyele SV, Ngonyani HA, Eliakimu E. Tanzan J Health Res 2008; 10(3): 159-65). Unsafe injection practices in Gujarat, India [Pandit NB, Choudhary SK: Singapore Med J. 2008 Nov; 49(11): 936-9]. Post generated using Mail2Forum (http://www.mail2forum.com) ##text##

POST 01317E: PQS E10 NEEDLE DISABLER DEVICES: ATTACHMENTS 4 SEPTEMBER 2008 ******************************************* Inadvertently, the relevant documents were not attached to the earlier post; the error is hereby rectified. Apologies. --------- Dear TechNet21 members, Please be informed that PQS E10 needle disabler devices performance specifications and verification protocol are released for comments. We would appreciate if you could send your comments not later than 20 September 2008 to the following recipients: address to: 
Joanie Robertson > [email=jrobertson@path.org]jrobertson@path.org[/email] ([email=jrobertson@path.org]jrobertson@path.org[/email]) 
Andrew Garnett > [email=andrew@agarnett.demon.co.uk]andrew@agarnett.demon.co.uk[/email] ([email=andrew@agarnett.demon.co.uk]andrew@agarnett.demon.co.uk[/email]) 
Umit Kartoglu > [email=kartogluu@who.int]kartogluu@who.int[/email] ([email=kartogluu@who.int]kartogluu@who.int[/email]) 
Alejo Bejemino > [email=bejeminoa@who.int]bejeminoa@who.int[/email] ([email=bejeminoa@who.int]bejeminoa@who.int[/email]) and copy to: 
pqsinfo@who.int ([email=pqsinfo@who.int]pqsinfo@who.int[/email]) Please feel free to further circulate the documents for interested parties for comments. If you do so, please copy us so we can keep track of the communications. Once we complete the review process for needle disablers, the issuance of PQS performance specifications and verification protocols for all categories will be completed. Thank you for your time and efforts in giving comments during the establishment of PQS initiative. Thank you and cheers, UMIT KARTOGLU ([email=kartogluu@who.int]kartogluu@who.int[/email]) PQS secretariat Post generated using Mail2Forum (http://www.mail2forum.com) ##text## ##text##

POST 01316E: COMMENTS INVITED ON PQS E10 NEEDLE DISABLER DEVICES 3 SEPTEMBER 2008 ******************************************* Dear TechNet21 members, Please be informed that PQS E10 needle disabler devices performance specifications and verification protocol are released for comments. We would appreciate if you could send your comments not later than 20 September 2008 to the following recipients: address to: 
Joanie Robertson > [email=jrobertson@path.org]jrobertson@path.org[/email] ([email=jrobertson@path.org]jrobertson@path.org[/email]) 
Andrew Garnett > [email=andrew@agarnett.demon.co.uk]andrew@agarnett.demon.co.uk[/email] ([email=andrew@agarnett.demon.co.uk]andrew@agarnett.demon.co.uk[/email]) 
Umit Kartoglu > [email=kartogluu@who.int]kartogluu@who.int[/email] ([email=kartogluu@who.int]kartogluu@who.int[/email]) 
Alejo Bejemino > [email=bejeminoa@who.int]bejeminoa@who.int[/email] ([email=bejeminoa@who.int]bejeminoa@who.int[/email]) and copy to: 
pqsinfo@who.int ([email=pqsinfo@who.int]pqsinfo@who.int[/email]) Please feel free to further circulate the documents for interested parties for comments. If you do so, please copy us so we can keep track of the communications. Once we complete the review process for needle disablers, the issuance of PQS performance specifications and verification protocols for all categories will be completed. Thank you for your time and efforts in giving comments during the establishment of PQS initiative. < > < > Thank you and cheers, UMIT KARTOGLU ([email=kartogluu@who.int]kartogluu@who.int[/email]) PQS secretariat Post generated using Mail2Forum (http://www.mail2forum.com)

POST 01313E: SAFE INJECTION: AVOIDING OVER PENETRATION FOLLOW-UP ON POSTS: 01308E, 01309E & 01310E 28 AUGUST 2008 ******************************************* Thickness of subcutaneous tissue can be judged by pinching. When needle pierces the muscle the same can also be felt so if health staff is trained and made aware not to insert too deep, the over penetration can be avoided (do surveys show any evidence of over penetration?) regards Dr Anil Varshney ([email=anilvarshney@YAHOO.COM]anilvarshney@YAHOO.COM[/email]) -------- [list=1] Prospective Assessment of the Effect of Needle Length and Injection Site on the Risk of Local Reactions to the Fifth Diphtheria-Tetanus-Acellular Pertussis Vaccination (Pediatrics, 3 March 2008) Needle-free delivery of macromolecules across the skin by nanoliter-volume pulsed microjets (Proc Natl Acad Sci U S A. 13 March 2007) Intramuscular injection angle: evidence for practice? (Nurs Prax N Z. July 2002) The importance of injecting vaccines into muscle: Different patients need different needle sizes (BMJ, 2000) Needle Length and Injection Technique for Efficient Intramuscular Vaccine Delivery in Infants and Children Evaluated Through an Ultrasonographic Determination of Subcutaneous and Muscle Layer Thickness (Pediatrics, 3 September 1997) [/ol] Post generated using Mail2Forum (http://www.mail2forum.com)

POST 01310E: KNOWLEDGE OF OPTIMAL NEEDLE LENGTH FOR INJECTION IMPORTANT 24 AUGUST 2008 ******************************************* Dear Forum, Injection Safety is definitely a Big problem in India. Health workers still administer injections in the gluteal region instead of thigh- as validated from surveys of parents (unpublished data). But considering the new facts of risk of overpenetration in US settings, the training curriculum could incorporate the need to insert needle to 7/8 inch in the thigh and not more in all settings (till local studies are done) as Trainings still need to be done at this stage. The WHO Child Growth standards http://www.who.int/childgrowth/en/ based on the WHO Multicentre Growth Reference Study (MGRS) shows that breastfed children should grow optimally in all settings. However for malnourished children, there will be less muscle mass and we need studies on optimal needle length for injection (Unless needle free devices development and use catches up for RI in such settings which ma make the injection issues less relevant). Dr RK Sood ([email=drrksood@gmail.com]drrksood@gmail.com[/email]) Post generated using Mail2Forum (http://www.mail2forum.com)

POST 01309E: SAFE INJECTION PRACTICES AND TRAINING MORE IMPORTANT FOLLOW-UP ON POST 01308E 22AUGUST 2008 ******************************************* Hello Group, My response to the questions raised by Dr. Sood are as follows:- [list=1] Are the results generalisable to children in developing countries with higher malnutrition rates and less subcutaneous fat? Will the needles in such settings be required to be shorter due to less subcutaneous fat? Can data from nutritional surveys give an answer or do we need more studies? [/ol] As mentioned in the paper, the objective of this study was to accurately determine the muscle layer depth beneath the skin surface of the thigh and the shoulder in a large sample of US children from birth to 18 years of age. There is no question of generalization since the source population is totally different from US to developing countries. Adjusting nutritional surveys, even done at best can only control for some of the crude measures such as mid-arm circumference or mid-thigh circumference. What we need to know is the general built of children physiologically. Also, the injection practices differ largely between US and developing practice. No adjustment can validly estimate whether CDC recommendations are applicable in developing country settings. Alternatively, a similar study can be replicated in developing countries at different locations (since there is so much of difference based on region, socio-economic status) and then we can look at different recommendations. [list=1] The current length of Kojak Selinge used in immunisation programme in India is 1.2/1.0 inches. How can the current recommendation be adapted in the current supplied syringes- for instance- insert 1¾ of the needle? [/ol] The major issue in India is safe injection practices. Safe practices are to be ensured before going further into changing the length of needle and other specifications. The intermittent supply of AD syringes, different sets of safe practices (across states in India) make it difficult for uniform recommendation of particular length. As of now, I feel that it would be more efficient to train the workers for proper administration of injections rather than coming up with new set of recommendations (before studies can actually prove their worth in India) Regards Dr.Giridhara R Babu ([email=giridharbabur@GMAIL.COM]giridharbabur@GMAIL.COM[/email]), MBBS, MBA, MPH Department of Epidemiology, University of California Los Angeles PhD Scholar, FFP, Public Health Foundation of India Post generated using Mail2Forum (http://www.mail2forum.com)

POST 01303E: NEEDLE REMOVER DEVICE: FIELD EXPERIENCE 12 AUGUST 2008 ******************************************* Dear Moderator, PATH would like to post the following message to follow up on needle remover experiences. Best wishes, Nancy -------- Safely managing infectious sharps waste is an important component of any injection safety strategy and a means by which needle stick injuries can be prevented among health workers and the community. Cardboard safety boxes are the most widely used approach to managing sharps waste but recently, manual needle removers have been incorporated as a key element of some nations' sharps waste management strategies, such as India. Multiple studies have shown wide acceptance of needle removers and a feeling of increased personal safety on the part of health workers and waste handlers. PATH has recently become aware of an injury that occurred when, during use of a needle remover, the upper section of a cut needle rebounded from the device and injured the user. PATH is aware of one other rebounding incident of a needle section in the past four years of monitoring needle remover use, though it did not result in a needlestick injury. Although these appear to be rare events, they are a concern that must be addressed. In both instances, the device was a "barrel" style, double cutting needle remover, though they were made by two different manufacturers. More information is being gathered on the circumstances of the injury and the device is being evaluated. We are exploring minor design changes which would mitigate the problem. The issue has also been reported to both of the device manufacturers for further investigation. PATH is committed to improving health worker safety through identifying and refining solutions for safe sharps waste management. As one way to achieve this, we are requesting information on field experience related to needle remover device performance, including both benefits and limitations. If you or others have experience using needle removers in health facilities or through programs in your country, we encourage you to please complete the attached brief set of questions by August 22, 2008. This information will inform optimal device designs, ultimately leading to safer, more appropriate systems for waste management for health workers, waste handlers, and the community. Please follow this link to fill out the questionnaire on needle remover experiences: In the meantime, it is important to reinforce universal precautions for injection safety and include monitoring of needle remover use in supervision visits, particularly proper cleaning and maintenance procedures. Job aids on the proper use and maintenance of barrel style needle removers and guidance documents on planning for and introducing needle removers into health facilities are included on the PATH needle remover resource page: Thank you for taking the time to complete this brief survey. Nancy Muller ([email=nmuller@PATH.ORG]nmuller@PATH.ORG[/email]) PATH Post generated using Mail2Forum (http://www.mail2forum.com)

POST 01300E: ALTERNATIVE USE OF PORTABLE STEAM STERILIZERS FOLLOW-UP ON POST01299E 7 AUGUST 2008 ******************************************* An addition to what Michel said. If steam sterilizers are used for sterilizing instruments, it is critical that the instruments are clean before being sterilized. I remember some years ago an ex-soviet country finding that a high proportion of surgical instruments were unsterile even after passing through an autoclave because dried blood had not been cleaned off before autoclaving. Best wishes Anthony Battersby ([email=FBA@COMPUSERVE.COM]FBA@COMPUSERVE.COM[/email]) FBA Health Systems Analysts Dear Karma Yes you can use the pressure cooker by placing a steel stand (usually used for keeping hot vessels on the dining table) in the pressure cooker and water level should be below its top ( the stand is usually more than 1 inch so water level should be 1/2 inch) and then follow Michel advise. Regards Dr Anil Varshney ([email=anilvarshney@YAHOO.COM]anilvarshney@YAHOO.COM[/email]) Post generated using Mail2Forum (http://www.mail2forum.com)