Needlestick and sharps

injuries in diabetes:
R U FIT4Safety?
Debra Adams, Debbie Hicks,
Su Down
Article points
In 2010, the European Union adopted the “Council Directive 1. Needlestick injuries
2010/32/EU Implementing the Framework Agreement on are common among
Prevention from Sharps Injuries in the Hospital and Healthcare healthcare workers within
both the hospital and
Sector”. Member states of the EU have until 11 May 2013 to community environment.
implement the directive into national legislation. This article 2. The authors examine the
examines the issues concerning needlestick injuries and the recent recent recommendations
publication of “Safety of sharps in diabetes recommendations”. regarding the safety of
sharps in diabetes and
the issues concerning

N
eedlestick injuries (NSIs) are infections were transmitted from subcutaneous needlestick injuries.
common among healthcare workers NSIs (Lot et al, 2001). 3. It is concluded
(HCWs) within both the hospital In October 2011, 57 leaders in the field of that the continued
and community environment. In a survey of injection technique and sharp safety from implementation of safe
working practices is vital,
over 600 nurses, it was identified that 32% had 14 different countries gathered in Brussels to for which healthcare
received an NSI whilst giving an injection to a attend the Workshop on Injection Safety in workers have a
patient with diabetes (Costigliola et al, 2012). Endocrinology (WISE). The delegates from pivotal role.
Needlestick injuries may occur for a number of the UK later formed “FIT4Safety in UK and Key words
reasons including a lack of training on the safe Ireland” and, in May, published the “Safety - FIT4Safety
use and disposal of needles and sharps, and a of sharps in diabetes recommendations” - Needlestick injuries
lack of knowledge of the consequences of such (Forum for Injection Technique, 2012). These - Sharps
injuries, as well as the types of devices used and recommendations provide contemporaneous
Debra Adams is
procedures undertaken. evidence-based best practice information Independent Consultant
NSIs can transmit disease and therefore are to assist individuals and organisations in Advisor and Programme
a significant occupational hazard for HCWs. identifying the risks associated with sharps and Specialist – Healthcare
Between 1997 and 2009, there were 17 recorded accidental blood or body fluid exposure. Associated Infection, NHS
cases of HCWs sero-converting to hepatitis C in Midlands and East;
Safety of sharps in diabetes Debbie Hicks is Nurse
England following percutaneous exposure to a Consultant – Diabetes,
virus-infected patient (NHS Employers, 2011). recommendations 2012 Enfield Community
Five cases of HIV sero-conversions resulting The recommendations are divided into seven Services, Barnet, Enfield
from percutaneous exposure were reported in categories: risk; European legislation; device & Haringey Mental
HCWs in the UK up until 2007; however, there implications; injection technique implications; Health Trust, Enfield;
Su Down is Nurse
have been no new cases reported since 1999 education and training; value; and awareness Consultant – Diabetes,
(Health Protection Agency, 2008). In France, and responsibility. The discussion below provides Somerset Partnership NHS
three occupationally acquired hepatitis C more insight into these recommendations. Foundation Trust, Somerset.

Journal of Diabetes Nursing Vol 16 No 10 2012 391

Needlestick and sharp injuries in diabetes: R U FIT4Safety?

Risk
Box 1. Hierarchy of controls for reducing the risk
Risk of transmission following an NSI
of exposure to blood-borne pathogens.
Cardo et al (1997) identified that the risk of
transmission following NSIs or sharps injuries
Elimination of hazard (most effective)
may be affected by:
l Substitute injections by administering medications through another
l The depth of injury sustained.
route.
l The type of needle or sharp used.
l Remove sharps and needlesticks, and eliminate all unnecessary
l The amount of blood or bodily fluid
injections.
inoculated at the time of injury.
Engineering controls l Whether the device was previously in the
l Employ safety devices. patient’s vein or artery.
Administrative controls l How infectious the patient is at the time of
l Develop policies aimed to limit exposure to the hazard. the injury.
l Incorporate a needlestick prevention committee. In cases where an injury results from a
l Implement an exposure control plan. hollow-bore needle that has been used to
l Remove all unsafe devices. access directly into a vein or artery, the risk
l Ensure consistent training on the use of safe devices. of transmission is higher because it contains
more blood and therefore carries a greater risk
Work practice controls
than that of a solid needle or blade.
Safe handling and disposal of sharps.
l

Personal protective equipment (least effective) Which healthcare workers are at risk?
l Place barriers and filters between the healthcare professional and the
The HCWs at increased risk of acquiring
hazard, for example: eye goggles; face shields; gloves; masks; and sharps injuries or NSIs include doctors, nurses,
gowns. phlebotomists, and domestic service staff, such
as cleaners, porters and waste removal teams.
Data from the UK and US indicate that
nurses account for 45–63% of reported NSIs
RISK by Critical Intravenous Blood
amount of catheter collection and sharps injuries among HCWs, and that
blood
Serious Intramuscular Lancet medical staff account for 9–17% of all such
pressure
injection injuries (Mercier, 1994; Cone, 2000; NHS
per device
Medium Acupuncture (Blood Surgical Scotland, 2001). In the UK, almost 40% of
splashes) devices* NSIs and sharps injuries were experienced
Low No patient Heparin Insulin by someone other than the original user of
injection injection the device, known as downstream workers
(May and Churchill, 2001).
Frequently
Sometimes
Seldom

Often

Risk assessment
Foley and Leyden (2002) identified a
FREQUENCY of needlestick injuries in healthcare settings
hierarchy of controls to reduce the risk
Use of safety devices essential, vaccination against hepatitis B and proper
of exposure to blood-borne pathogens
information and training for staff obligatory. (see Box 1).
Use of safety devices required, vaccination against hepatitis B and proper The priority is to eliminate and reduce
information and training for staff obligatory. the use of needles and other sharps where
Training for staff obligatory to achieve the highest possible safety level. possible. Furthermore, Wittmann (2011)
Eliminate the use of sharps if alternative available. developed a standardised risk-assessment
*Where safety devices do not exist, the use of double gloving, vaccination against matrix for medical sharps which identifies
hepatitis B and proper information and training for the staff is recommended.
the potential risks associated with devices
Figure 1. Risk assessment matrix and analysis (reproduced with permission or procedures, and the appropriate level of
from Wittmann, 2011). sharps safety required (see Figure 1).

392  Journal of Diabetes Nursing Vol 16 No 10 2012

Needlestick and sharps injuries in diabetes: R U FIT4Safety?

European legislation staffing levels, and ensure personal protective

Many sharps injuries or NSIs are preventable equipment and appropriate sharps disposal
and employers have a duty to ensure the safety systems (SDSs) are available at the point of
of their employees. The key legislation in the use. Ensure the organisation has developed
UK, addressing the issues of protecting HCWs an overall occupational exposure policy.
from obtaining a sharps injury or NSI, is l Training on the use, safe handling and
identified in Box 2. Further to this legislation, disposal of sharps procedures.
member states of the European Union have l Promoting occupational exposure awareness,
until 11 May 2013 to implement the Council such as that of the risks associated
Directive 2010/32/EU framework agreement with exposure to blood and body fluid,
on the prevention from sharps injuries in the hepatitis B virus immunisation and
hospital and healthcare sector. The main aims occupational exposure reporting.
of the directive include: l Information regarding sharps injuries or
l To achieve the safest possible working NSIs should be reported promptly and
environment for employees and patients. appropriately, and the risks identified
l To prevent injuries to HCWs as a result of following a root-cause analysis into each case.
sharps or needlesticks. l Awareness raising and monitoring.
l To set up an integrated approach, Employers are responsible for ensuring all
establishing policies in risk assessment, risk staff are aware of the risks associated with
prevention, training, information, awareness occupational exposure from sharps/NSI. In
raising and monitoring, including the addition, health monitoring and vaccination
provision of medical devices incorporating should be provided where available.
safety-engineered protection mechanisms. The directive requires that healthcare
The key requirements that need to be providers undertake all that is reasonably
implemented include: practical to prevent HCWs and other staff from
l Risk assessment – quantifying the risk of harm. Failure to implement the directive will
exposure to a blood-borne pathogen from be seen as a criminal offence. Strauss (2012)
NSIs and sharps. identified the elements in the EU directive,
l Risk elimination and prevention, and review which together create a “wall of safety” (see
practice. Where possible, eliminate the Figure 2).
unnecessary use of sharps, use safety devices,
improve education and awareness, review Device implications types of devices
Passive versus active
Box 2. UK legislation protecting healthcare There are two main types of features used in
workers from needlestick or sharp injury. the design of safety-engineered needle devices
(SENDs). These include the passive SEND,
l The Occupiers Liability Act, 1957. in which no additional actions are required by
l The Health and Safety at Work Act, 1974. the user to activate the safety feature, and the
l The Reporting of Injuries, Diseases and Dangerous Occurrences active SEND, in which the user is required to
Regulations, 1995 (RIDDOR). activate the safety feature (Centers for Disease
l Council Directive, 89/391/EEC. Control and Prevention, 2008). Strauss and
l European Directive, 89/655/EEC. WISE Consensus Group (2012) identified the
l The Management of Health and Safety at Work Regulations, 1999. main features of a SEND (see Box 3).
l EC Directive, 2000/54/EC.

l Control of Substances Hazardous to Health Regulations, 2002. Evaluating safety-engineered needle devices
l Health and Social Care Act, 2008 When evaluating a SEND, four key factors
l Code of Practice on the prevention and control of infections and should be examined, including safety, usability,
related guidance, 2010. compatibility with need and ensuring the device
does not cause other concerns, such as splashing

394 Journal of Diabetes Nursing Vol 16 No 10 2012

Needlestick and sharps injuries in diabetes: R U FIT4Safety?

“It has been reported

that, following the
introduction of three
safety-engineered
needle devices, a
significant reduction
in the number of
reported needlestick
injuries was achieved.”

Figure 2. Elements in the EU directive which

together create a “wall of safety” (reproduced
Box 3. Features of safety devices. with permission from Andreas Wittmann;
also published in Strauss, 2012).
During use:
l Can be activated using a one-handed technique or routine use of the on activation (Adams and Elliott 2003;
device causes the safety mechanism to deploy automatically (passively) 2006a; Roff, 2011). To assess product safety, a
immediately after the sharp has been used. systematic evaluation should be undertaken by
l Does not obstruct vision of the tip of the sharp. the users of the device in the clinical setting
l Offers a good view of any aspirated fluid. (Adams and Elliott, 2003). Examples of safety
l Does not require more time to use than a non-safety device. device evaluation tools have been devised by
l Works appropriately with a wide variety of hand sizes. the Training for Development of Innovative
l Easy to handle while wearing gloves. Control Technologies (2012; see Figure 3).
l Works with all required syringe and needle sizes. Adams and Elliott (2006a) reported that,
l Provides a better alternative to traditional recapping. following the introduction of three SENDs,
After use: including safety insulin syringes, safety needles
and safety blunt needles, a significant reduction
l Clear and unmistakable change (audible and/or visible) occurs when
in the number of reported NSIs (70%) was
the safety feature is activated.
achieved.
l Operates reliably.
Injection pens are auto-delivery devices
l Exposed sharp is permanently blunted or covered after use and
designed for the self-administration of
remains so until and after disposal.
medicine via the subcutaneous route. Pellissier
l No more difficult to dispose of after use than non-safety devices.
et al (2006) identified in a study undertaken
These criteria represent optimal target features, which may not be in France that the NSI rate associated with
achievable in every device; they do not represent an exhaustive list injection pens (IPs), of which 60% was
and may evolve over time (Strauss and WISE Consensus Group, related to disassembly and re-capping, was
2012). six times that of the NSI rate associated
with disposable syringes. It is recognised

396 Journal of Diabetes Nursing Vol 16 No 10 2012

Needlestick and sharps injuries in diabetes: R U FIT4Safety?

Page points Injection technique implications

1. A variety of SAFETY FEATURE EVALUATION FORM
Correct injection technique is important to
safety-engineered SAFETY SYRINGES TDICT ensure the optimum benefit is gained from
needle devices (SENDs) Date: Department: Occupation:
the injected drug, such as insulin. Needle
have become available, Product: Number of times used:
length is also important to ensure the insulin
designed to minimise the Please circle the most appropriate answer for each question. Not applicable (N/A) may be used if the ques-
tion does not apply to this particular product.
is delivered into the subcutaneous layer.
risk of needlestick injuries DURING USE: agree............disagree

(NSIs).
1. The safety feature can be activated using a one-handed technique........................... 1 2 3 4 5 N/A
2. The safety feature does not obstruct vision of the tip of the sharp............................. 1 2 3 4 5 N/A
Unfortunately, there are only 8 mm and
3. Use of this product requires you to use the safety feature.......................................... 1 2 3 4 5 N/A
4. This product does not require more time to use than a non-safety device................. 1 2 3 4 5 N/A
12.7 mm needles available on disposable
2. It has been demonstrated 5. The safety feature works well with a wide variety of hand sizes................................. 1 2 3 4 5 N/A
6. The device is easy to handle while wearing gloves.................................................... 1 2 3 4 5 N/A insulin syringes; 12.7 mm needles should
that the increased cost 7. This device does not interfere with uses that do not require a needle....................... 1 2 3 4 5 N/A

of SENDs is offset
8. This device offers a good view of any aspirated fluid.................................................. 1 2 3 4 5 N/A
9. This device will work with all required syringe and needle sizes................................ 1 2 3 4 5 N/A
not be used as there is a real danger of
by the reduction of
10. This device provides a better alternative to traditional recapping............................... 1 2 3 4 5 N/A
AFTER USE:
administering the insulin intramuscularly,
costs associated with 11. There is a clear and unmistakeable change (audible or visible) that occurs
when the safety feature is activated...................................................................... 1 2 3 4 5 N/A which can cause major hypoglycaemia (Karges
the investigation and 12.The safety feature operates reliably........................................................................... 1 2 3 4 5 N/A
13. The exposed sharp is permanently blunted or covered after use and prior to dis- et al, 2005), and 8 mm needles may not be
treatment of potential posal........................................................................................................................... 1 2 3 4 5 N/A
14. This device is no more difficult to process after use than non-safety devices........... 1 2 3 4 5 N/A
suitable for all patients, especially thin adults
NSIs. TRAINING:
15. The user does not need extensive training for correct operation.............................. 1 2 3 4 5 N/A
16. The design of the device suggests proper use........................................................... 1 2 3 4 5 N/A
or children. Where only an 8 mm needle
3. Correct injection 17. It is not easy to skip a crucial step in proper use of the device.................................. 1 2 3 4 5 N/A
is available, then a lifted skin-fold will be
technique and needle Of the above questions, which three are the most important to your safety when using this product?

length is important to Are there other questions which you feel should be asked regarding the safety/ utility of this product?

ensure optimum benefit Box 4. Examples of safety-engineered

from insulin injections. © June1993. revised August 1998
needle devices.
Training for Development of Innovative Control Technology Project

Figure 3. Example of a safety feature AutoShield™

evaluation form (Training for Development of Duo Safety
Innovative Control Technologies, 2012). Pen Needle

that IPs have been shown to improve the

patient experience and should be offered to
patients routinely (Da Costa et al, 2002).
Furthermore, nurses agreed that IPs were Monoject™
more convenient, simple and easy to use, and Insulin Safety
noted an overall improvement compared with Syringe
conventional vials and syringes (Davis et al,
2009). Therefore, there is a need to improve
the HCW safety associated with these devices.
There are a variety of IP-SENDs available,
which have been designed to minimise the risk Terumo
of NSIs (see Box 4). SurGuard™

Costs and benefits

Financial considerations are of paramount
importance when initiating any change of
clinical practice. Glenngård and Persson
(2009) completed a study to evaluate the Clickfine®
costs associated with the implementation AutoProtect™
of SENDs to reduce the risk of NSIs in 18 Safety Pen
hospitals in Sweden. The study demonstrated Needle
that the increased cost of SENDs was offset
by the reduction of costs associated with the
investigation and treatment of potential NSIs.

398 Journal of Diabetes Nursing Vol 16 No 10 2012

necessary to ensure that the insulin is still First-aid action “All healthcare workers
delivered into the subcutaneous layer. This The Department of Health (2008) advises should be trained and
could cause a potential problem as the hand that the initial action in the event of either an assessed in the correct use
holding the lifted skin-fold is at risk from an NSI or sharps injury should be to encourage and disposal of sharps
NSI. Thus, IP-SENDs and insulin syringes the wound to bleed. Sucking of the wound and safety-engineered
should always be used when insulin is being by mouth is not recommended. Healthcare needle devices.”
administered by an HCW. workers should then immediately follow local
policy and protocol regarding receiving further
Education and training expert advice in order to reduce their risks
Safe handling and disposal of sharps associated with potential viral transmission
All HCWs should be trained and assessed following the sharps injury or NSI.
in the correct use and disposal of sharps and
SENDs. The principles concerning the safe Value and costs related to
use and disposal of sharps and IPs have been needlestick and sharps injuries
identified by the Royal College of Nursing Treatment costs and loss of productivity
(2012), Centers for Disease Control and as a result of NSIs and sharps injuries may
Prevention (2012) and NICE (2012); see Box 5 place additional financial strain on the NHS.
for an overview of these principles. Financial costs associated with the initial
treatment of a staff nurse following exposure
Vaccination to a patient with hepatitis B, hepatitis C or
Pre-exposure vaccinations to hepatitis B HIV have been calculated (Adams and Elliott,
should be considered for all HCWs who are 2006b).
at risk of exposure to the virus from contact The costs were estimated to be £1540,
with blood, blood-stained body fluid or tissue £235 and £938 for exposure to patients with
(Department of Health, 2006). hepatitis B, hepatitis C and HIV respectively.

Journal of Diabetes Nursing Vol 16 No 10 2012 399

Needlestick and sharps injuries in diabetes: R U FIT4Safety?

In addition to the financial costs, there are the responses: depression; crying spells; tension in
psychological traumas that the injured HCW the family; relationship issues; panic attacks;
may experience whilst waiting for the results of excessive worry; and the inability to work.
blood tests confirming whether there has been
transmission of a life-threatening infection Awareness and responsibility
following a sharps injury or NSI. Costigliola Waste disposal varies amongst councils
et al (2012) identified the following emotional throughout the UK. The “gold standard”
option is a system providing the sharps user
with an SDS to dispose of sharps after every
Box 5. Principles of safe handling and disposal
use. When the SDS is two-thirds full, it
of sharps and injection pens.
would be collected free of charge by the waste
department of the local council and replaced
l Handling of sharps should be kept to a minimum.
with an empty SDS for future use.
l Syringes or needles are not dismantled by hand and are disposed
If people with diabetes do not have access
of as a single unit straight into a sharps container for disposal.
to an SDS, then this may result in the syringe
l Sharps are not passed directly hand to hand.
or IP being discharged into the household
l Sharps containers are readily available as close as possible to the
refuse, leading to an increase the risk of NSIs
point of use (sharps trays with integral sharps boxes are a useful
by downstream workers, exemplified by an
resource).
incident in West Sussex where two waste
l Needles are never re-sheathed or re-capped.
disposal men accidently incurred NSIs from
l Needles are not broken or bent before use or disposal.
waste (BBC News, 2012).
l Arrangements should be in place to ensure the safe disposal and

transport of sharps used in a community setting, such as the Conclusion

patients’ homes.
All HCWs are at risk from NSIs and sharps
l All sharps containers should conform to UN standard 3291 and
injuries. Continuing implementation of safe
British Standard 7320.
working practices is vital, as is risk assessment,
l Sharps containers are not filled to more than two-thirds.
risk elimination, training in the use of
l Sharps containers are signed on assembly and disposal.
devices and awareness of the consequences
l Sharps containers should be temporarily closed when not in use.
such injuries. HCWs have a pivotal role in
l Sharps containers are stored safely away from the public and out
assessing risks and evaluating any new SEND
of reach of children.
introduced in their clinical areas.
l Sharps containers should be disposed of every 3 months even if
It is anticipated that the “Safety of sharps
not full.
in diabetes recommendations” (Forum for
l Staff should report sharps injuries in line with local reporting
Injection Technique, 2012) will support
procedures and policies.
individuals and organisations to apply the new
l Staff should attend training on the safe use of sharps and
EU directive to clinical practice in their field
safety-engineered devices.
of care. n
l Insulin pens containing multiple doses of insulin are meant for

use on a single person only, and should never be used for more
than one person, even when the needle is changed.
l Insulin pens should be clearly labelled with the patient’s name

or other identifying information to ensure that the correct pen is Adams D, Elliott TS (2003) A comparative user
used only on the correct individual. evaluation of three needle-protective devices. Br J Nurs
12: 470–4
l Hospitals and other facilities should review their policies and

educate their staff regarding the safe use of insulin pens and Adams D, Elliott TS (2006a) Impact of safety needle
similar devices. devices on occupationally acquired needlestick injuries:
a four-year prospective study. J Hosp Infect 64: 50–5
l If re-use is identified, exposed patients should be promptly

notified and offered appropriate follow-up including blood-borne Adams D, Elliott TS (2006b) Financial costs associated
pathogen testing. with a contaminated needlestick injury. J Hosp Infect
64: S31

400 Journal of Diabetes Nursing Vol 16 No 10 2012

Needlestick and sharps injuries in diabetes: R U FIT4Safety?

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402 Journal of Diabetes Nursing Vol 16 No 10 2012