Suturing Device to Reduce Needlestick Injuries in the Operating Room

The SuturTek 360° Fascia Closure Device™ is designed to reduce needlestick injuries during suturing procedures in the operating room (OR). The needle is contained within a cartridge, thus avoiding exposed “sharps” that may injure the surgeon, other OR staff, or the patient.

The SuturTek 360° Fascia Closure Device with disposable needle-protected suture cartridge.

Photo courtesy of SuturTek Inc.

Most needlestick injuries in the OR occur during fascia closure.[1] The fascia is the tough band of fibrous connective tissue between the skin and underlying muscles and organs that must be closed at the end of most major surgical procedures.

How it Works

The SuturTek 360° Fascia Closure Device is a reusable unit that encloses a pre-loaded, single-use suture cartridge and curved fascia closure needle. When the suturing is complete, the cartridge and needle are disposed of in standard hospital sharps containers.

Prevalence of Needlestick Injuries

Needlestick injuries are a major occupational health concern for hospital staff as these “sharps” injuries can spread infectious diseases, particularly blood-borne viruses, such as hepatitis B, hepatitis C and HIV.

The Canadian Institute for Health Information estimates that approximately 180 Canadian health care workers experience needlestick injuries each day, or about 66,000 per year.[2] According to the Canadian Needle Stick Surveillance Network, five categories of devices are responsible for 62% of sharps injuries. Of these, 12% are caused by suture needles.[3]

Regulatory Status

The SuturTek 360° Fascia Closure Device was developed by SuturTek Inc. (North Chelmsford, MA). SuturTek was commercially launched in the US at the end of 2005, following US Food and Drug Administration (FDA) approval. The SuturTek device is not yet licensed by Health Canada.

Cost

According to the manufacturer, the SuturTek 360° Fascia Closure Device is often supplied at no charge to hospitals that purchase the disposable suture cartridges. The cartridges cost approximately US$300 per box of 12.

Evidence

Many sharps injury prevention programs recommend the introduction of safety engineered devices that are evaluated by the health care workers who use them.[4,5]

SuturTek Inc. provided the FDA with simulated use testing data, demonstrating zero needlestick injuries with the device. Further clinical studies of the device are underway, though published results are not yet available.

[1] American College of Surgeons. Statement on blunt suture needles [ST-52]. Chicago: The College; 2005 Nov. Available: http://www.facs.org/fellows_info/statements/st-52.html.

[2] Moser MA. Safe Angle 2004;5-7. Available: http://www.hchsa.on.ca/misc_pdf/NeedStikArt.pdf.

[3] Needlestick injuries [OSH answers]. Hamilton (ON): Canadian Centre for Occupational Health and Safety; 2005. Available: http://www.ccohs.ca/oshanswers/diseases/needlestick_injuries.html.

[4] Sharps safety. A practical guide for establishing and evaluating a sharps injury prevention program. Health Devices 2002;31(3):81-94.

[5] Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention. Workbook for designing, implementing and evaluating a sharps injury prevention program. Atlanta: The Division; 2004. Available: http://www.cdc.gov/sharpssafety/index.html.