inSafe
Safety Syringe System

inSafe provides complete protection

from the beginning of the medical procedure, through to the disposal of the needle. The specially designed syringe protects the needle at ALL times and its partnering sharps container removes the contaminated needle in complete safety!

Watch the inSafe Video

Needle protected by a lockable sleeve

Works with all needle types

Easy to see aspiration

Anaesthetic cartridge changeable during procedure

Autoclavable syringe made from metal and plastic. Feels and weighs like a conventional syringe

One handed disposal of contaminated needle

Economical system with low costs per use

Fits 150 needles

Base can be secured to worktop (Cabinet and wall mounted brackets are also available)

Minimal disposable components

inSafe – Safety Syring System Demo Video

How to use inSafe

inSafe provides comprehensive protection from the beginning of the procedure to the disposal of the needle. The specially designed syringe protects the needle at all times and its partnering sharps container completely removes the needles safely without contact.

Legislation and good practise technique dictate that appropriate safety systems are used in dental practices. inSafe is the Best Practise option offering total protection from needlestick injury with full choice of needles and aspiration techniques.

Push on needle adaptor

Blue needle adaptor for metric threaded needles, yellow needle adaptor for imperial threaded needles.

Screw on needle

in same way as a standard syringe.

Load cartridge

and the syringe is ready for administration of anaesthetic.

Cover needle

with the lockable sleeve before use, between injections and after final use.

Remove needle safely

by inserting syringe with locked sleeve into sharps container.

Twist and

fully insert syringe into container.

Withdraw syringe

to remove and dispose of the contaminated needle without resheathing.

Directions for use

Syringe Guide

inSafe Syringe Guide

A syringe to suit the way you work

With two handle types, two cartridge types and sizes, and with a choice of five aspiration options, inSafe can be used with all types of needle, cartridge and every aspiration technique.

Need help finding the right configuration? Try our Order Assitant to find the product matching your needs.

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Container Mounting Options

inSafe Container Mounting Options

Reprocessing

General

Process equipment (e.g. Washer-disinfectors and Sterilisers) must be subjected to periodic testing and validation in accordance with a recognised standard/reference document e.g. ISO 15883, CFPP01-01.

Process equipment must be operated in accordance with the manufacturer’s instructions.

Ensure appropriate Personnel Protective Equipment (PPE) is worn at all times when carrying out decontamination activities.

Cleaning

The device can be cleaned either by using an automated process or manually cleaned by hand.

A validated automated washer-disinfector is preferable to manual cleaning as it provides thermal disinfection and a reproducible process that should give consistently reliable results. However, the instructions below provide details of how the device can be processed using either method.

Detergents should be CE marked and specifically intended for cleaning medical devices.

Automated cleaning

Ensure any movable parts of the device are opened where possible in order to facilitate the cleaning process. To do so, lock the InSafe syringe sleeve in the forward position. Unscrew the plunger retaining nut and separate the plunger assembly from the body of the device (as shown in image above). The plunger should remain detached from the body assembly during the cleaning process as this assists the cleaning process.
Both the handle and body assembly can be processed in an automated washer-disinfector.
Do not overload the washer disinfector as this may compromise the effectiveness of the process.
Process using a standard instrument cycle.
After processing, the device must be visually inspected to ensure it is clean and dry. If there is any evidence that the device is not clean it must be reprocessed.
These instructions have been validated using the following washer-disinfector programmes:

Programme 1
Cold pre-wash
Wash stage: 5 minutes using an alkaline detergent with a pH 13-14.
Rinse stage: 1 minute
Disinfection stage: 90°C for a minimum 1 minute / Ao Value 600
Drying
Programme 2
Cold pre-wash: 2 minutes
Wash stage: 2 minutes using a neutral detergent
Rinse stage: 2 minutes
Disinfection stage: 80°C for a minimum 10 minute / Ao Value 600
Drying: 90°C
Ultrasonic Bath
If a suitable automated washer-disinfector is not available the device can be cleaned in an ultrasonic bath, but it should be manually cleaned, in accordance with the instructions (right), prior to being placed in the bath. When removed from the bath the device must be rinsed thoroughly in clean (preferably purified) water.

Manual cleaning

Fully immerse the device in a solution of detergent and water. The ratio of detergent water should be consistent with that recommended by the detergent manufacturer*.
Fully immerse the device throughout the cleaning process to prevent splashing and the creation of aerosols.
Ensure the temperature of the water used for the initial immersion of the device does not exceed 45°C.
Using a low-linting disposable cloth wipe all the accessible surfaces of the device. If necessary, a soft nylon brush may also be used. Agitate and irrigate the device as appropriate to help dislodge any contamination.
Rinse in clean (preferably purified) water.
Dry the device using a lint free single-use cloth.
Visually inspect the device to ensure it is thoroughly clean. Repeat the cleaning process if necessary.
*This process was validated using an enzymatic detergent.

Sterilisation

Sterilise using moist heat (steam).
Ensure the InSafe Syringe sleeve is locked in the forward position and that the plunger assembly is detached from the body assembly during sterilization.
If the autoclave is a vacuum steriliser, the plunger and body assembly can be placed together in an autoclavable bag and sealed prior to processing. If the autoclave is a Type N benchtop (gravity displacement) steriliser the device must not be wrapped prior to the sterilization process as this will inhibit steam penetration.
These instructions have been validated using a porous load steam steriliser (Autoclave) operating on a 134°C to 137°C cycle for a minimum 3 minutes.

The Facts about needlestick Injuries: Did you know..?

“
Eye of the Needle: United Kingdom Surveillance of Significant Occupational Exposures to Bloodborne Viruses in Healthcare Workers.Dec 2014: Public Health England
“Of significant occupational exposures caused by sharps (2004-2013) 65% were from hollowbore needles.

Published risk of bloodborne virus transmission among healthcare workers following a percutaneous injury: Hepatitis B 1 in 3, Hepatitis C 1 in 30, HIV 1 in 300”

“
BADN - Initial Medical Needlestick Injury Survey2014 Report
“Survey by British Association of Dental Nurses/Initial Medical indicated over half of respondents (dental nurses in UK and ROI) had had a needlestick injury, with 11% having had one within the last year.

The majority of injuries occurred after use/before disposal.”

“
Needlestick Injuries Incidence and Cost in the United States, United Kingdom, Germany, France, Italy and Spain (M.Saia, F.Hofmann, J Sharman, D Abiteboul, M Campis, J Burkowitz, Y Choe, S Kavanagh)Biomedicine International (2010) 1:41-49
“Estimated annual incidence of needlestick injuries is 100,000 in UK”

“
Zakrzewska JM et al. 2001 Br Dent J. 2001 Jan27;190: 88–92
“One third of all reported sharps injuries in dental practice are due to the use of non-disposable syringes, most injuries occur during the removal and disposal of needles.”

“
Felix DH et al, 1994 www.ncbi.nlm.nih.hovBr Dent J. 1994 Mar 5;176(5):180–4
“Studies report that up to 56% of dental clinicians suffer at least one needlestick injury per year.”

“
NHS, Scotland2001
“The costs associated with each needlestick injury can vary considerably, but are significant.”

The EU Directive for the Prevention of Sharps Injuries in the Hospital and Healthcare Sector:

In June 2010, a new European Directive was published on sharps injuries with the aim of creating the safest possible working environment by preventing injuries to workers at risk. All EU Member states are required to bring into force national legislation or legally binding agreements to implement the Directive.

What does the Directive say?

Risk of needlestick injury must be controlled by measures including the following:

Safe Procedures – specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste. The practice of recapping shall be banned with immediate effect. These procedures shall be regularly reassessed and shall form an integral part of the measures for the information and training of workers
Engineering Controls – providing medical devices incorporating safety engineered protection mechanisms

There are a number of selection criteria to be considered when considering a safety – engineered medical device.

What does this mean for me?

The Directives state where risk cannot be eliminated the employer shall take appropriate measures to minimise the risks. Appropriate measures to minimise the risks would include the provision by employers of safer needle devices and sharps containers.

As a minimum requirement, the Directives state: “Where there is a risk of mechanical contact with moving parts of work equipment which could lead to accidents, those parts must be provided with guards or devices to prevent access to danger zones or to halt movement of dangerous parts before danger zones are reached”

How does inSafe measure up?

There are a number of factors to consider when choosing a safer sharp:

Factors of Consideration

inSafe – Safer Sharp System

The device must not compromise patient care

Facilitates controlled administration comparable to standard syringe

The device must perform reliably

We make functionality and precision a top design objective. Engineered and manufactured to an exacting standard allows inSafe to perform reliably.

The safety mechanism must be an integral part of the safety device, not a separate accessory

inSafe protective sleeve is integral

The device must be easy to use and require little change of technique on the part of the health professional

The method of loading and administration is the same as traditional syringes. The additional feature can be quickly and easily learned

The activation of the safety mechanism must be convenient and allow the care-giver to maintain appropriate control over the procedure

Easy to operate twist and lock mechanism does not compromise aspiration or administration of anaesthetic

The device must not create other safety hazards or sources of blood exposure

Needle is protected at all times from initial setup to disposal

A singel-handed or automatic activation is preferable

Single-handed disposal of the contaminated needle – safety sleeve requires two hands to manoeuvre, both hands are behind the needle at all times

The activation of the safety mechanism must manifest itself by means of an audible, tactile or visual sign to the health professional

Audible, and tactile click when safety sleeve in place correctly and arrows line up

The safety mechanism should not be easily reversible once activated

Requires positive action to reverse sleeve which allows second injection to be given to the patient if necessary

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inSafe Safety Syringe System

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