The SafeScope^TM  provides a simple and workable solution to eliminate the risk of patient-to-patient cross-contamination.  The internationally patented design provides a sealed transparent Coupling Device which separates the shaft and disposable bellows from the non-disposable light source, and protects the patient from exposure to cross-contamination from previous patients.

THE PROBLEM OF CROSS-CONTAMINATION

Rigid sigmoidoscopy is an important tool in the investigation of patients with anorectal symptoms. It is used by many surgeons and gastroenterologists as the initial outpatient assessment of patients with rectal bleeding, providing there is no painful and tender anal lesion. It is also used to monitor the progress of chronic conditions such as proctitis or distal colitis. It is useful to examine a palpable or suspected lesion in the rectum, particularly if there may be a delay before colonoscopy.  It can be helpful in identifying rectal prolapse in the patient who has not been aware of external prolapse, by observing the rectum while asking the patient to strain down. If the rectal mucosa is obscured by the presence of stool in the rectum then an enema may be administered and the procedure repeated. In some outpatient clinics, patients routinely receive an enema prior to the initial examination. A small amount of solid stool generally will not preclude a satisfactory examination.

In most centres, non-disposable metal sigmoidoscopes have been replaced by disposable instruments since the cost of having several metal instruments is high, as is the labour cost of cleaning and sterilizing re-usable instruments. It has traditionally been accepted that rigid sigmoidoscopy using a disposable sigmoidoscope is a sterile and safe procedure. However, removal of the obturator may contaminate the proximal end of the shaft, which in turn may contaminate the light source head. Furthermore, reflux of liquid stool or even gas may contaminate the re-usable insufflation bellows and the light source, which may then potentially cause cross-contamination when used with successive patients. 

One study from Sydney has found that enteric bacteria can be cultured after a single use from the inside of the bellows and the fibreoptic light source head that had been sterilized.¹ Intuitively, one might expect even more significant contamination after multiple uses; the only way to overcome this problem has been to sterilize the light source head and bellows after each use.

It has been proposed that a disposable filter be interposed between the light head and the bellows to prevent reflux of micro-organisms into the bellows. Although a filter may prevent passage of bacterial and viral particles, any fluid or liquid droplets refluxing onto the filter will render it ineffective. Additionally, a filter does not prevent contamination of the inside of the light source head.

In the modern era of endoscopy, careful and monitored sterilising of flexible fibreoptic instruments is considered mandatory in order to prevent transmission of viral and bacterial particles. Most endoscopy units use automated sterilising equipment. It is surprising that the same standards have not been applied to rigid sigmoidoscopy.

GUIDELINES

The Australian Therapeutics Goods Administration (TGA) has raised concerns about the possibility of cross-infection and recommended sterilisation of re-usable parts of the rigid sigmoidoscope including the bellows by autoclave, ethylene oxide, or glutaraldehyde. ²

The TGA has further noted that decontamination processes will only be effective when preceded by prior mechanical cleaning as per the guidelines of Standards Australia (Australian / New Zealand Standard 4187:2003 ³), which may not be effective on the inside of the bellows.⁴  

The Gastroenterological Nurses Society of Australia has also raised concerns about the risk of cross-contamination, and has emphasized the difficulties of using glutaraldehyde to disinfect the inside of the bellows and tubing, as well as the potential risks to the patient of retained glutaraldehyde in the bellows.⁴

Filters are a single use item and should be discarded after each use as per Australian/New Zealand Standard 4187. ³

1  Lubowski DZ, Newstead GL. Rigid sigmoidoscopy: a potential hazard for cross-contamination.  

    Surgical Endoscopy 2006; 20:812-815 Cross-contamination with Sigmoidoscopy.pdf

2  Therapeutics Goods Administration.  Australian Therapeutics Device Bulletin,

    No.28 October 1995- Page 9: - www.tga.gov.au/docs/pdf/tdbultn/atdb28.pdf

3   Standards Australia; Standards New Zealand. Aust/New Zealand Standard  4187:2003  Cleaning, disinfecting

     and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated

     environments in health care facilities; www.saiglobal.com/PDFTemp/Previews/OSH/as/as4000/4100/4187.pdf

4   Therapeutics Goods Administration.  Australian Therapeutics Device Bulletin ( No.29 April 1996),

     cited TGA April 2006 - Page 11:

     www.tga.gov.au/docs/pdf/tdbultn/atdb29.pdf

DEVELOPMENT OF THE SAFESCOPE

The SafeScope^TM has taken several years to develop, and was supported by Australian Commonwealth BIF grants and NSW start-up grants.

Simple in design, yet highly effective in preventing cross-contamination, it is a cost-effective way to avoid the need to sterilise the light head and bellows of the rigid sigmoidoscope between patients.

The SafeScope was developed for Daltray Pty Ltd by A/Professor David Lubowski in Sydney. It has patents issued in the Australia, New Zealand, USA, Taiwan, Argentina, Malaysia, and all countries in Europe.

Daltray Pty Ltd is a company committed to the development of technologies which improve the prevention of infection Med-Chem Surgical Pty Ltd has the exclusive distribution rights for the SafeScope in Australia and New Zealand.