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ICN on Selecting Safer Needle Devices

 

Introduction and background

Each year, two million injuries from needlesticks and other sharp objects occur to the world’s 35 million healthcare workers, according to the World Health Organization (WHO)  (WHO Aide Memoire 2003).  These tools for caring for patients put nurses at risk of exposure to and infection from bloodborne pathogens.

Nurses suffer the most needlestick injuries of all health care workers, on average 1-4 needlestick and other sharps injuries per year, exposing them to over 20 different bloodborne pathogens.  The most common and serious of the bloodborne pathogens are HIV/AIDS, Hepatitis B and Hepatitis C.  The risk of infection following a needlestick injury from a contaminated needle is:
HIV - O.3% (or a 1 in 300 chance of infection);
Hepatitis B (HBV) – from 2 to 40% risk; and
Hepatitis C (HCV) – from 2.7 to 10%. ¹ 

In November 2002, the World Health Report published data demonstrating that 4.4 % of HIV infections among health care workers and 40% of Hepatitis B & C infections are the result of occupational exposure. ²  

The Hepatitis B immunisation is safe and 95% effective to prevent HBV, but less than 20% of nurses in many parts of the world have received the immunisation.  There is no immunisation, however, for HIV or Hepatitis C, and no recommended post-exposure prophylaxis for Hepatitis C.  The only solution is to prevent infection by avoiding exposure.

Solutions

Methods to control occupational hazards have traditionally been discussed in terms of the Hierarchy of Controls.  These control measures include, in order of effectiveness:  elimination of the hazard; engineering controls; ,administrative and work practice controls; and personal protective equipment (PPE).  In addition to eliminating sharps and unnecessary injections, using safer needle devices (see table below) is one of the best ways to prevent injuries.  See also ICN on Preventing Needlestick Injuries at www.icn.ch/matters_needles.htm.

Method of Control	Efficacy of control measure
Engineering controls— controls that isolate or remove a hazard from a workplace.  Examples include sharps disposal containers (also know as safety boxes) and needles that retract, sheathe or blunt immediately after use (also known as safer needle devices or sharps with engineered injury prevention features).	Sharps containers reduced injuries by 2/3rds. A review of 7 studies of safer needle devices demonstrated a reduction in injuries from 23 – 100% with an average of 71%.

Standard Precautions (including the concept of Universal Precautions), an administrative control, is an important principle of infection prevention and control and recommended policy.

During the 1990s, engineering controls, also known as safer needle devices, became available.  These are now required in health care settings throughout the United States since the passage of the Needlestick Safety and Prevention Act of 2000 and, since 2004, have also been required in the province of Saskatchewan, Canada.  Safety devices are in wide use in Europe, especially in France, where they have proven effective in reducing up to 90% of sharps injuries.  In 2004, as a result of funded project on injection safety, five countries in Africa are using safer needle devices and products are being manufactured in Europe, Asia and North America.  

Evaluation and Selection of Safer Needle Devices
Selecting safer needle devices should be part of a comprehensive programme to prevent needlestick injuries using exposure surveillance data to target high risk procedures and devices for intervention.  The risk of transmission of HIV increases when the needlestick injury is caused by a blood-filled device, so targeting such devices, e.g. intravenous and phlebotomy devices, should be a priority. The process of product selection requires the involvement of frontline workers, infection control and purchasing staff in a multidisciplinary process.  This work is often conducted in a committee for the purpose of bloodborne pathogen exposure control and needlestick injury prevention.  Representatives of frontline workers from various clinical areas, including nurses and non-patient care staff such as housekeeping (to report the impact of sharps in bed-linens or otherwise misdisposed), are important participants on the committee.  

The selection process involves a two-step process – initial screening of devices and clinical pilot testing – for evaluation and selection of safer devices and recognises that a good plan must reflect each institution’s specific needs.  The first step is identification of all safety devices available for the purpose needed.  Product information can be requested from the manufacturer and is also found on-line.  The International Healthcare Worker Safety Center website maintains a comprehensive listing of safety devices (www.healthsystem.virginia.edu/internet/epinet/safetydevices.cfm).

 

What is a safer needle device?
A safer needle device is a sharp with a protective feature that blunts, retracts, sheaths or shields the sharp after use so that it is no longer sharp and therefore cannot cause an injury to the health care worker, cleaner, or the community.  

Desirable Characteristics of Safer Needle Devices The device is needleless. The safety feature is built into the device. The device works passively (i.e. requires no activation by the user). If user activation is necessary; the safety feature can be engaged with a single-handed technique, allowing the worker’s hands to remain behind the exposed sharp. The user can easily tell whether the safety feature has been activated.  Some safety features have a sound, such as a click, indicating that the feature has been activated. Others change colour when the feature is engaged. The safety feature cannot be deactivated and remains protective through disposal. If the device uses needles, it performs reliably with all needle sizes. The device is easy to use and practical. The device is safe and effective in patient care. (Does the use of the safety device impact the number of tries necessary to give the injection or start the IV? What is the impact on patient discomfort?)

 

EXAMPLES OF SAFETY DEVICES

 

Type of Device	Safety Features
Syringes and Injection Equipment	Needleless or jet injection – the medication/immunisation is injected under the skin without a needle, using the force of the liquid under pressure to pierce the skin. Retractable needle – the needle (usually fused to the syringe) is spring-loaded and retracts into the barrel of the syringe when the plunger is completely depressed after the injection is given. Protective sheath – after giving an injection, the worker slides a plastic barrel over the needle and locks it in place. Hinged re-cap – after the injection, the worker, using the index finger, flips a hinged protective cap over the needle, which locks into place. This safety feature may be fused to the syringe or come separate and detachable from the syringe.
Blood-Collection and Phlebotomy	Retractable needle – the spring-loaded needle is pulled into the vacuum tube holder after use. Shielded butterfly needle – a protective shield slides over the needle after use. Self-blunting needle – after use, the needle is blunted while still in the patient. Plastic blood collection tubes – used to replace glass tubes.
IV Access – Insertion Equipment	Retractable – the spring-loaded needle retracts into the needle holder upon pressing a button after use or the needle withdraws into the holder when withdrawn from the patient’s arm. Passive – a metal safety clip unfolds over the needle as it is withdrawn. Shielded IV catheters (midline and peripheral) – a protective shield slides over the exposed needle. Hemodialysis safety fistula sets (butterfly) – a protective shield slides over the needle as it is withdrawn.
Suture Needles	Blunt suture needles — used for sewing internal fascia.
Lancets	Retracting lancet – following skin puncture, the sharp automatically retracts back into the device.
Surgical Scalpels	Retracting scalpel – after use, the blade is withdrawn back into the body of the scalpel. Quick-release scalpel blade handles – a lever is activated that allows for a “touchless” attachment of the blade to the handle and releases it after use.

Note:  Auto-disable syringes (see www.icn.ch/matters/syringes.htm) recommended by ICN, WHO and UNICEF for immunisation campaigns are not considered safer needle devices but reuse-prevention devices.  The safety mechanism automatically locks the plunger so that the syringe cannot be reused but does not blunt or retract the sharp.

Initial Screening of Devices
The needlestick prevention committee should create or modify an existing safety feature evaluation form to incorporate the selection criteria important for the particular procedure and setting.  (see www.tdict.org for safety feature evaluation forms on-line).  The committee should then apply the criteria trying each device in all (needle and syringe) sizes on an orange, mannequin or other simulation.  The purpose of initial screening is to become familiar with all of the products available on the market and to eliminate less desirable devices prior to pilot testing in the clinical setting.

1. Try the product before reading the accompanying manufacturer’s instructions to see how intuitive the device is to figure out and use.
2. Review the evaluation criteria and brainstorm additional criteria that might be important for your institution, the particular procedure or clinical specialty.
3. Rank the priority selection criteria for your use.
4. Rate each device using the criteria and document the rating in writing.
5. Perform a failure analysis exercise with the acceptable devices by taking 100 of the devices out of the package and activating the safety feature. Record the number of devices with the safety feature adequately engaged.
6. Select up to four devices in each category for pilot testing in the clinical area. If all devices function equivalently during the screening process, you may choose to evaluate them all in a clinical simulation prior to pilot testing.  Tools for the creation of a clinical simulation can be accessed on the web at www.tdict.org.  

Important points to remember:

• Frontline worker involvement is essential.
• There is no one best device for all settings and uses.
• Passive devices are optimal.
• Training is necessary for the participants involved in product evaluation and for all users of new devices prior to their implementation.

 

References

American Nurses Association (2002).  ANA’s Needlestick Prevention Guide.  Available on www.nursingworld.org/needlestick/needleguide.pdf

Centers for Disease Control and Prevention (2004).  Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program.  Retrieved May 7, 2004 from http://www.cdc.gov/sharpssafety/pdf/WorkbookComplete.pdf

ECRI (2003). ECRI Sharps Safety and Needlestick Prevention: An ECRI Resource for Evaluating and Selecting Protective Devices. 2nd Edition (Plymouth Meeting, PA).

National Institute for Occupational Safety and Health (NIOSH) (1999).  NIOSH Alert:  Preventing Needlestick Injuries in Health Care Settings.  DHHS (NIOSH) Publication No. 2000-108.

Prüss-Üstün A, Rapiti E, Hutin Y (2003).  Sharps injuries:  Global burden of disease from sharps injuries to health-care workers.  Geneva, Switzerland: World Health Organization.  Available at http://www.who.int/peh/burden/9241562463/sharptoc.htm.

Royal College of Nursing (2001). Be Sharp - Be Safe: Avoiding the Risks of Sharps Injury.  London.

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1.	US Centers for Disease Control and Prevention (1998).  Guidelines for Infection Control in Health Care Personnel.  Infection Control and Hospital Epidemiology 19,6:445.
2.	World Health Organization (2002).  World Health Report.  Geneva, WHO.

 

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