Safety Injection Devices

Introduction

Needlestick Injuries (NSIs) are defined as an accidental skin penetrating stab wound caused by hollow-bore needles such as hypodermic needles, blood-collection needles, and IV catheter stylets. The risk of NSI’s: occupational exposure to blood and body fluids (BBF), this can lead to the transmission of pathogens causing an infection and hazardous consequences for health.

The current regulatory context is inciting single use syringes manufacturers to develop safety-engineered injection devices at affordable costs.

Prevention of needle stick injuries consist of different measures:

  • Elimination of needles: using needleless systems, eliminate unnecessary injections
  • Technical measures: quantity & quality of sharps containers, safety injection devices
  • Administrative controls: sharps policy, consistent information and training, incident reporting, no-blame culture, staff vaccination.
  • Work practice control: no needle recapping, safe use and disposal of sharps boxes, use of gloves when needed.

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Identification of risk in MSF context

The hollow-bore needle (with blood-filled when used):

  • syringe with needle (attached or not), for drug injection and vaccination
  • blood collection systems
  • IV catheters

The MSF context: since risks are different in different contexts, it appeared difficult to propose only one type of safety injection devices for all MSF activities. Consequently, two contexts for the use of these devices have been defined:

  • Context of highly contagious diseases (hemorrhagic fevers) where absolute priority is given to HCW protection, with less considerations for cost and waste management, also assuming that staff is more extensively trained before being allowed to work in high risk area.
  • Context of non-highly contagious diseases where intuitivism, the use of similar technique as a conventional device/current standard and low cost were favored. For general use in health facilities, priority projects for introduction and criteria to be fulfilled have to be defined.

It is possible to use the devices of both levels, depending on activity and also considering the price.

Selection of safety engineered injection device

Common features required for all contexts:

  • Only integrated safety design (i.e. built in as an integral part of the device, as opposed to external devices to be fixed to the point of use)
  • Similar use technique as a conventional device as far as possible
  • Must not create new safety hazards or sources of blood exposure: it must be usable wearing gloves; it is not prone to be activated by improper handling technique.
  • Activation of the safety mechanism is:
    • Easy and intuitive
    • Permanent and irreversible
    • Visible or audible

Acceptance of safety features:

Studies have demonstrated that general acceptance by the staff of safety devices is influenced by:

  • Perceived risk of infection
  • Design of the device
  • Training in the use of the device
  • Length of time to become adept
  • Ease of use
  • Required changes in techniques
  • Previous experience with safety devices.

Without appropriate support and education, safety injection devices may not be used, or may be used incorrectly.

Use of safety engineered injection devices in MSF projects

The injection devices to be used in high risk content are standard articles: syringe with needle, IV catheter, tube holder for blood drawing. They are retractable devices. The order is to be justified. The contents of the different VHF kits and modules have been adapted accordingly.

For the non-highly contagious contexts (= regular use) we introduced in 2018 the safety IV catheter (except for the neonatal 26G) with a passive safety mechanism.

SIP & RUP

AD syringe = auto-disable syringe for fixed dose immunization. Most have non-removable needle and all have a feature that blocks the syringe from being used a second time. (ISO 7886 part3)

RUP syringe = sterile hypodermic syringe for single use with a re-use prevention feature. These syringes can measure flexible dosing amounts, have removable needles and a feature that blocks the syringe from being reused a second time. (ISO 7886 part4)

SIP syringe = sterile hypodermic syringe with a sharps injury protection feature. Some SIPs have also a built-in RUP feature. SIPs cover AD and RUP syringes that have an additional feature to prevent sharps injury. (ISO 23908)

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ISO 7000 symbol no 2655 : Re-use prevention

On packaging for medical devices (e.g. hypodermic syringes): to indicate that the device possesses a "re-use prevention" or "auto-disable" function (i.e., a feature that allows one use and prevents further uses).