INFECTION CONTROL
a small camera. The findings showed that although the tools appeared clean on the outside, the internal picture was much different, with human tissue and bone found in the devices.
In 2015, the FDA and the CDC issued a health advisory urging hospitals to assess their medical device reprocessing procedures due to concerns for patient safety. This followed a wave of lapses in cleaning standards resulting in patients who had undergone surgical procedures then facing tests for bloodborne pathogens, such as HIV. At the time, questions were raised about how effectively devices are disinfected and sterilised, and the need for standards and guidelines to be followed. Michael Denver added: “As a company, we want to raise the awareness of the dangers of dirty surgical instruments. It is important that cleaning is properly addressed and more attention is given to that fact that there are some instruments that are labelled as reusable which should never be reprocessed.” Investigations have revealed that suction tips – an instrument used in almost all types of surgery – are the most difficult to clean and in some cases may even be impossible. The research was conducted by risk management and reprocessing personnel in response to an FDA alert in 2009 about inadequate medical device reprocessing methods. Their objective was to identify
Investigations have revealed that suction tips – an instrument used in almost all types of surgery – are the most difficult to clean and in some cases may even be impossible.
Concerns raised over decontamination of robotic surgical instruments
It is virtually impossible to remove all contamination from robotic surgical instruments, even after multiple cleanings, according to a study published in Infection Control & Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America. The results show that complete removal of surface contaminants from these tools may be unattainable, even after following manufacturers' cleansing instructions, leaving patients at risk for surgical site infections.
"One of the top priorities for hospitals is to treat patients safely and with minimal risk of infection," said Yuhei Saito, RN, PHN, MS, lead author of the study and assistant professor at the University of Tokyo Hospital. "Our results show that surgical instruments could be placing patients at risk due to current cleaning procedures. One way to address this issue is to establish new standards for cleaning surgical instruments, including multipart robotic tools."
The study examined 132 robotic and
ordinary instruments over a 21-month period. Instruments were collected immediately after use to determine their level of contamination. The researchers
used in-house cleaning methods that included manual procedures with ultrasonication following the manufacturers' instructions. Measurements of protein concentration were collected from tools after three subsequent cleanings to determine changes in the total amount of residual protein.
Due to the complex structures of robotic instruments, these tools had a greater protein residue and lower cleaning efficacy compared to ordinary instruments. The cleanings were 97.6% effective for robotic instruments and 99.1% effective for ordinary instruments. As a result, researchers suggest that it might be necessary to establish new cleaning standards that use repeated measurements of residual protein, instead of only measuring contamination once after cleaning.
"These instruments are wonderful tools that allow surgeons to operate with care; but completely decontaminating them has been a challenge for hospitals," said Saito. "By implementing new cleaning procedures using repeated measurements of the level of contamination on an instrument more than once, we could potentially save many patients from future infections."
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a cleaning process that would result in a verifiably clean instrument. According to the team lead, to risk management consultant, Jahan Azizi, “Surgical instruments that cannot be thoroughly cleaned of debris cannot then be sterilised effectively for patient use.” Suction tips were chosen to test cleaning methods because they are used in most surgical procedures, are exposed to high levels of organic debris, and are difficult to clean. After using various processes and products to clean 350 different suction tips, test results revealed that the suctions “may be impossible to clean with current technology.” Even after the recommended decontamination process was repeated twice, “fewer than 5% of the suction tips were completely visibly cleaned at the end of the process.” So, why are reusable instruments so difficult to clean? Michael Denver believes that innovation has played a large part in this: “As technology has moved on, especially through the development of minimally invasive surgery, instruments have become smaller, more complex and contain moving parts. These intricate instruments are revolutionising surgery but the down side is they are difficult to clean and pose a risk to the patient.” Today, Surgical Use Surgical’s extensive range spans into many specialties including ENT, Head and Neck, Gynaecology, Laparoscopy, General and Vascular surgery. Unlike many other disposable instruments, the company manufactures its products with stainless steel tubes rather than aluminium. They have also worked hard to make sure their instruments capture the same look, feel and functionality as the reusable equivalent. Michael Denver added: “Many reprocessing and clinical staff have expressed concerns that suctions cannot be guaranteed clean but budget pressures and the challenge of linking surgical infections to contaminated instruments has meant that finding a solution hasn’t been a priority for many hospitals. “We are working hard to raise awareness and encourage those clinicians to consider single use as a viable alternative that protects patients against cross infection.”
References
1 Stephenson, K., ‘The Value of Lumen Inspection’, Vendor Vantage, 2015, P. 76-78
2 Azizi, J., et al., 2012. Uphill Grime: Process Improvement in Surgical Instrument Cleaning. AORN Journal, 96(2), 152-162.
3 Eaton, J., 2012. Filthy surgical instruments: The hidden threat in America’s operating rooms. Washington DC: The Center for Public Integrity. Available at: <
http://www.iwatchnews.org/ 2012/02/22/8207/filthy-surgical-instruments- hidden-threat-americas-operating-rooms>
4 Robert Lowes. 2015. Dirty Reusable Instruments Also Plague Outpatient Settings, CDC Warns. [ONLINE] Available at:
http://www.medscape.com/viewarticle/850894.
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