Insights from Field Introduction of “Smart” Syringes for Enhanced Safety in Voluntary Medical Male Circumcision Programs
The World Health Organization (WHO) has launched an initiative to transition public health programs to the use of safety-engineered syringes with re-use prevention (RUP) and sharps injury prevention (SIP) features – also referred to as “smart” or “safety-engineered” syringes – by 2020. The initiative calls upon donors to fund only smart syringes in all projects that involve administration of injectable medicines,, such as the local anesthetic used for most voluntary medical male circumcision (VMMC) methods.
Both sets of features are intended to protect people from exposure to bloodborne infections. SIP features do this by protecting providers and clients from accidental injuries from used needles, while RUP features protect clients from deliberate re-use of syringes and/or needles, and from prior “double dipping” into their medication vials (entry with a needle and/or syringe already used to inject a previous client, potentially contaminating the vial with any bloodborne infection he carried).
Project IQ “smart syringe” pilots
To help VMMC programs introduce smart syringes, Project IQ is working with service providers in selected countries to pilot multiple models of smart syringes that meet WHO quality standards and specifications for use in routine VMMC service delivery. This preliminary report summarizes provider and program manager feedback from an initial “proof-of-concept” exercise using smart syringes with RUP features in Zambia. Additional pilots of syringes with both RUP and SIP features are in process in other VMMC focus countries. This report will be updated as provider and program feedback is received from those activities. The feedback in this document is intended to orient VMMC programs to smart syringes and help them begin formulating an approach to a smart syringe introduction suited to local context.
Smart syringes 101
The International Organization for Standardization (ISO) uses three independent characteristics to categorize smart syringes, which are summarized below along with their relevant application to VMMC procedures:
- Needle attachment (fixed or detachable): fixed needles are most commonly used for fixed-dose immunizations with small-body syringes ranging from .1 – 1.0 ml in capacity (ISO 7886-3). In contrast, detachable needles are more commonly used with large-body/ISO 7886-4 syringes used for injecting medicines, including the local anesthetic used for most VMMC methods. (However, some large-body syringes up to 10.0 ml in capacity are also equipped with fixed needles.)
- Re-use prevention (RUP) – an RUP mechanism prevents or significantly discourages re-use of the syringe and/or needle. Designs for this feature vary in their disabling mechanism and activation timing. The disabling mechanism may require deliberate activation by the provider, for example by pushing a separate button; or may activate automatically, for example once the plunger is fully depressed. It also ranges from mechanically locking the plunger to physically breaking part of the syringe. For mechanisms that activate automatically, the activation timing may occur after a single aspiration, activating as the plunger is depressed so that it cannot be drawn back up; or it may allow for multiple aspirations, only occurring once the plunger is fully The latter design is intended for uses where the syringe will be used to reconstitute the contents or to mix multiple drugs before administration. By allowing multiple aspirations, this type of RUP mechanism cannot completely prevent “double dipping” or re-use, but it is an accepted means for reducing those risks while preserving the necessary clinical function of the syringe.
- Sharps injury prevention (SIP) – this feature adds protection for the provider by automatically or easily blocking the sharp end after an injection is complete, for example by covering it with a sheath or hood, or by withdrawing the needle into the body of the syringe.
Note: While some available syringe models feature both RUP and SIP, others, including those summarized in this preliminary report, feature only one protection mechanism. Syringes in the currently active second stage pilot feature both RUP and SIP.
- WHO guideline on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in health care settings (Appendix 2, accessible here: http://apps.who.int/iris/bitstream/10665/250144/1/9789241549820-eng.pdf) offers detailed information about smart syringes. See pages 20-23 for tables describing different types of safety-engineered syringes available, their advantages, disadvantages and cost profile, as well as description and sample images of safety features.
- WHO Department of Essential Medicines and Health Products Prequalification Team performance, quality, and safety catalog (http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/index.aspx) provides specifications for smart syringe models prequalified for use in public health programs.
Note: Project IQ found manufacturers had additional sizes and needle fixations (fixed vs. detached) of prequalified syringes available beyond what is listed online.
WHO-prequalified RUP syringe models piloted in Zambia VMMC services
Project IQ VMMC providers in Zambia piloted use of the below models in order to develop and document experience with their suitability for use in VMMC programs.
Model 1: Becton Dickinson (BD) Emerald Pro
Model 2: Helm Medical Helmject
Model 3: Hindustan Syringes and Medical Devices (HMD) Kojack
These models were selected to give providers a variety of clearly distinct RUP syringe types that met the criteria for VMMC service delivery, but did not contain an SIP mechanism. See the WHO Department of Essential Medicines and Health Products Prequalification Team performance, quality, and safety catalog for specifications of the above models. Note the BD Emerald Pro used in Zambia had a fixed needle, whereas the specifications indicate the needle is detachable.
The majority of feedback on all models was positive, but some providers highlighted isolated quality and usability issues, summarized here. Some issues can be addressed through training; others may lead programs to prefer an alternative syringe manufacturer or model. Overall, all RUP models were felt to be acceptable for integration within VMMC programs once providers grew familiar and comfortable using them.
- Unintentionally activating RUP mechanism: The most common initial usability challenge, noted with all models, is unintentional activation of the syringe safety mechanism(s). This was addressed by giving providers adequate training to grow comfortable with the safety features of the given syringe model so that they could adjust their grip to maintain efficient injection technique and minimize discomfort for the client.
- Needle fixation and gauge considerations: As described in the “Smart syringes 101” section, syringes with fixed needles are difficult to use in VMMC programs. The needle’s gauge can affect the provider’s experience, as that needle must be used for both drawing up and injecting anesthetic. The larger the gauge, particularly if larger than 23, the more bleeding and client discomfort was observed. The smaller the gauge, the more time and force are needed to withdraw anesthetic from the vial. Bupivacaine is more viscous than lidocaine, so programs using lidocaine with bupivacaine may see this as a crucial consideration and find detachable needles particularly important. Project IQ found both needle fixation options were available in several models.
|Model||RUP mechanism||Positive feedback||Negative feedback||Manufacturer price quote|
|Becton Dickinson (BD) Emerald Pro (fixed needle – 21 gauge; also available with detachable needle)||Locking gasket upon completion of injection||Generally found to be high quality.||Plunger was difficult for some providers to depress.||Unit cost: $0.76
Minimum order: 1,000
|Helm Medical Helmject (fixed needle – 21 gauge; also available with detachable needle)||Locking plunger upon completion of injection||Most providers able to use syringe comfortably after gaining experience.||Mixed feedback on overall syringe quality – providers reported it was more time-consuming to use than a conventional syringe, and that it was difficult to be precise depressing the plunger while wearing gloves.||Unit cost: $0.06
Minimum order: 800
|HMD Kojack (detachable 23 and 21 gauge needles)||Locked/broken plunger upon completion of injection||Generally found to be high quality.||Some found RUP only activates when the plunger has been fully withdrawn prior to injection (so would not activate if less than 10cc originally drawn up), but not found to be a universal problem.||Unit cost: $0.078
Minimum order: 100,000
* NOTE: All model-specific comments represent the viewpoints of the individual providers and do not represent the opinion of Jhpiego Corporation or the U.S. Centers for Disease Control and Prevention.
Program management feedback
Smart syringes can be integrated into programs with minimal disruption, but the following considerations will ease the transition:
- Procurement: If not participating in pooled procurement/supply chain, prior to selecting a syringe model for introduction in a given program, ensure the manufacturer can comply with your organization’s procurement policies and regulations. Project IQ encountered challenges with select vendors due to payment terms that conflicted with organizational policies (vendor requesting full prepayment) and manufacturing/shipping timelines and locations which were slow or inconvenient for implementers in sub-Saharan Africa. Manufacturers with nearby regional distribution centers can help expedite shipment, reducing the risk of stock outs due to delivery delays. Inexpensive, high-quality products with high minimum orders may be optimal for large programs or those using pooled procurement mechanisms. Smaller programs procuring separately may prefer products with smaller minimum orders.
- Orientation/training: Smart syringes are designed for use with little or no instruction. However, in a high through-put, high efficiency program like VMMC, there may be a need to manage providers’ and supervisors’ expectations so they understand smart syringe injections can require several additional minutes until providers grow accustomed to the change in technique. The Zambia field pilot revealed providers were accustomed to working with such efficiency that smart syringe acceptability was only assured with dedicated orientation and training time to allow providers to confidently maintain their previous speed of service. For this reason, supervisors may wish to first accustom themselves and/or a small group of senior providers/trainers to using the syringes so they can mentor others; summarize the manufacturer instructions for use (IFU), introduce a job aid if the manufacturer’s is insufficient or nonexistent, and oversee practical use without time pressure in five clients per provider, or until providers are confident.
Appendix 1: Provider feedback summary
Appendix 2: Feedback form template from field introduction
 WHO. WHO guideline on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in health care settings. Geneva, Switzerland; WHO: 2016. Available: http://apps.who.int/iris/bitstream/10665/250144/1/9789241549820-eng.pdf
 WHO. Making all injections safe. Geneva, Switzerland; WHO: 2015: Available: http://www.who.int/injection_safety/global-campaign/injection-safety_brochure.pdf