Progress on Injection Safety in National Immunization Programs in the Americas
Nora Lucia Rodriguez, Regional Advisor, WHO/AMRO, Washington DC USA
PAHO’s immunization safety initiative is one of the fundamental components of the injection safety program and requires the use of safe and quality syringes. To implement the initiative, PAHO developed a regional plan for accomplishing the objectives of the plan.
Since 2004, the Unit of Immunization and the Unit of Essential Medicines, Vaccines, and Health Technology have developed a Regional Plan to verify the quality and safety of syringes. The plan was originally based on compliance with international ISO regulations (specific to AD and disposable syringes and needles). This program was extended to include the whole shelf life cycle of the product, from its procurement, including storage, distribution, and safe use, to its final disposal. The objectives of the plan includes: injection safety, the development of capacity at national level, the organization and establishment of laboratory capacity to verify quality of syringes, and strengthen national immunization programs and the transferring of the accumulated knowledge, infrastructure and expertise on syringe management to countries and strength National Regulatory Authorities.
In 2007 40 samples provided to PAHO’s by manufacturers were evaluated by PAHO’s reference laboratory (WHO/PAHO collaborating center) . The testing revealed that 5 manufacturers had syringes with deviations and nonconformities with reference to ISO standards related to proper labeling. In addition, three manufacturers had syringes that did not meet the standards for ‘accuracy’ and three manufacturers had syringes with nonconformity in relation to dead space.
In order to improve the capacity for verification of the conformity of syringes efforts are under way with the national regulatory authorities to establish quality control laboratories in six countries. In November 2009 a Workshop on GLP on syringe assays and preparation on ISO/IEC 17025 for accreditation was carried out in Nicaragua, November, 2009.
A notification system and database have been set up to register and monitor incidents reported by countries in relation to quality and safety of syringes. Documentations of such problems allow for follow up, research activities and posting of alerts based on the results.
Injection Safety workshops were held in Nicaragua and Honduras in July 2008 and November 2008 respectively. Funds for workshops were provided by GAV and technical collaboration for the workshops was provided by: WHO, the US Centers for Disease Control (CDC) and NIOSH.
During the 2009 Regional Immunization Week (April) many countries targeted health care workers for protecting them from vaccine preventable diseases, nearly 27,675 health workers were vaccinated against measles and rubella, and hepatitis B and yellow fever in Bolivia, El Salvador, Dominican Republic and Suriname. Dominica complemented their vaccination week campaigns by training health care workers on occupational health and infection control measures.
Taking advantage of the introduction of the H1N1 influenza pandemic vaccine in the Region, training activities made special efforts to update remind participants to follow safe injection practices as part of preparedness planning for vaccinating the targeted populations.
Sustaining investments in the areas of supervision and training underpin the Regional plan to protect the health care worker from occupational health risks. Likewise improving the safe collection, transport and final waste disposal used injection equipment as well as ensuring the availability of safe technology and personal protection equipment (PPE) will require continuous investments by the governments
Each country should develop regulations and codes to govern management of health care waste and support best practices for Injection Safety. Investments will be required to support: establishment of the required infrastructure (logistics, land fills, incineration equipment & human resources); develop and maintain the required processes to support the infrastructure, and train and update health care workers. Evaluation and monitoring activities will be critical for measuring compliance and for documenting the impact, as well as, indispensable for achieving and protecting the gains.