The O’Neil Sterile Field Intermittent Urinary Catheter (ONS) is a single use disposable device used to catheterize the patient without the need for an extensive sterile field.  The catheter has been designed with an introducer tip, which is able to bypass the majority of organisms that exist at the opening of the urethra and therefore greatly reduce the risk of urinary tract infections (UTI) due to catheterization. 

The ONS has a silicon tip which is inserted into the urethra. The pre-lubricated nelaton catheter is then able to pass through the tip, thus bypassing the organisms that exist at the opening of the urethra. The nelaton catheter is sealed in a polyethylene drainage bag to collect the urine thus providing a closed collection system.  Volume markings exist on the drainage bag as a guide to the amount of urine collected. The entire device is packaged individually and sold as a sterile single use device. The device is intended to be used in the hospital or home environment by either medical staff or self administration.

The principles of using intermittent catheterization are based on regular and complete emptying of the bladder to maintain a low bladder pressure and minimal residual urine volumes, consequently securing bladder and renal health. Correctly performed intermittent catheterization is a safe method suitable for long-term use, minimizing the risk of urological complications (e.g. those relating to bladder and kidney dysfunction, UTI, urethral strictures and male infertility) and improving a person’s quality of life.

Intermittent catheterization is the preferred method of catheterization in patients who have bladder dysfunction, specifically neurogenic neurogenic (spinal cord injury, spina bifida and multiple sclerosis) and non-neurogenic bladder disorders (infravesical obstruction due to prostate enlargement, urethral strictures and post-operative urinary retention). Lower urinary tract symptoms of neurogenic bladder include either urinary incontinence or incomplete bladder emptying and urinary retention caused by outlet obstruction, poor detrusor contraction, or compliance.

Product History

The device is designed following a study on the distribution of organisms in the female urethra published by Dr O’Neil in 1981.  The silicon tip is essentially the same design as the elastomeric cover used in the original study.  Similar studies demonstrate the presence of organisms in the distal part of the male urethra.  A series of studies published mainly from the USA demonstrate a statistically significant decrease in infection rates when this catheter is used.

The catheter is enclosed inside a bag which also acts as a urinary container so that when patients are catherterised the urine is collected in the bag.  The use of the catheter commenced in the spinal injuries unit in Perth in 1981 and the use of the catheter to decrease the cost of catheterisation then was popularised in Melbourne, Sydney and Brisbane spinal units.  The bags surrounding the catheter allowed less gowns, gloves and drapes to be used.  Following the studies from the states in the late 80’s and early 90’s that indicated a decrease in urinary tract infections, the catheter became widely used in spinal injury units in the USA and Europe.

Indications

Patient who have bladder dysfunction, specifically neurogenic neurogenic (spinal cord injury, spina bifida and multiple sclerosis) and non-neurogenic bladder disorders (infravesical obstruction due to prostate enlargement, urethral strictures and post-operative urinary retention).

Safety and Performance Claims Made for Device

• Introducer tip provides a sterile field for the pre-lubricated catheter to bypass the uretha, thereby reducing the risk UTI.
• Pre-lubricated Nelaton catheter is easier to use.

Device Variants

O’Neil Sterile Field Intermittent Urinary Catheter

* Size of catheter may appear as FG, F, FR, Fr.

Catheter Kits

The Catheter Kits contain a standard ONS packaged with a pair of Vinyl Gloves, 3 Povidone iodine swabsticks, a white swab cloth and a Blue underpad. Currently the Catheter Kits are only supplied to North America.

* Size of catheter may appear as FG, F, FR, Fr

# S denotes spanish labeling

Reference Material

The following papers report on the safely and clinical effectiveness of the Go Medical ONS catheter.

1. Bennet C, Young M, Razi S et al. (1997) The effects of urethral introducer tip catheters on the incidence of urinary tract infection outcomes in spinal cord injured patients. The journal of urology 1997:158:519-521 http://www.jurology.com/article/S0022-5347(01)64523-3/abstract
2. Bennett C, Young M and Darrington H. (1995) Differences in urinary tract infections in male and female spinal cord injury patients on intermittent catheterization. Paraplegia, 1995, Vol.33(2), pp.69-72 http://www.nature.com/sc/journal/v33/n2/abs/sc199517a.html
3. Charbonneau-Smith, R. (1993) No-touch catheterization and infection rates in a select spinal cord injured population. Rehabilitation Nursing, 18(5), 296–299. http://onlinelibrary.wiley.com/doi/10.1002/j.2048-7940.1993.tb00774.x/abstract
4. Day RA, Moore KN, Alberts MK. (2003) A pilot study comparing two methods of intermittent catheterization: Limitations and challenges. Urologic Nursing 2003;23(2):143–7,158. http://www.ncbi.nlm.nih.gov/pubmed/12778828
5. O'Neil, AG, Jenkins, DT & Wells, JI. (1982) A new catheter for the female patient. The Australian & New Zealand journal of obstetrics & gynaecology, 1982, Vol.22(3), pp.151-2. http://onlinelibrary.wiley.com/doi/10.1111/j.1479-828X.1982.tb01429.x/abstract