Leff Hand side:
Single-handed scalpel blade removers: Non  sterile and sterile

Right hand side:
Safety scalples- sheath type and retracting type

BACKGROUND

Operating theatres are the second most common site for Sharps injuries[1] and the second most common injury reported in this environment are scalpel cuts, accounting for 7% of the total number of reported injuries [2]. The risks to the surgical staff and downstream workers are well documented and can be grouped under the following headings:

Infection – HIV / AIDS, Hepatitis B, Hepatitis C etc

Physical Trauma – in particular to a digital artery or nerve or a tendon (of either a hand or a foot)

Psychological trauma

Cost – 15 years ago, the cost of an uncomplicated injury was estimated to range from US$500 [3] to US$2,000 and US$50,000 to US$100,000 for an injury requiring microsurgery and up to 3 months of rehabilitation (This is probably a gross underestimate when loss of salary for a private surgeon is considered.) To date the highest reported litigation is US$12.2 million[4], paid to a doctor who contracted HIV from a sharps injury.

Syringes are the most common type of injury, however, the incidence of scalpel injuries is much higher [5].

 

A NEW WAY OF THINKING

Issues

1.Surgeons are continuing to refuse to use safety scalpels - citing patient safety as their reason - lack of correct balance and feel, obstructed vision, limited range of choice

oStaff continuing to be at risk of potentially preventable injuries.

oNursing staff and OSHA compliance staff are left with the impossible job of trying to make hospitals comply with safety regulations [6]

2.Safety scalpels are unproven. There is no evidence that they prevent injuries.

oA huge systematic literature review conducted by the Australian College of Surgeons found absolutely no evidence that safety scalpels prevented injuries [7]

3.Safety scalpels may be more dangerous than traditional reusable metal handles.

oThe original data used to support safety scalpels was mis-interpreted. On review it actually shows the injury incidence was two to four times higher for safety scalpels than the incidence for the standard metal handle [8]

oIn a recent publication pushing for greater uptake of safety scalpels it was noted that the number of injures was the same for both safety scalpels and traditional scalpels - again the incidence of injury with a safety scalpel must be much higher because traditional reusable metal handles are still the most common in use in US operating theatres. [9]

4.Single-handed scalpel blade removers and traditional handles remain the safer alternative in many situations.

oThey are OSHA compliant

oCDC studies shows that up to 87% of active medical devices are not activated. Safety scalpels are active devices and therefore the risk of not activating is still significant. [10]

oBased on the above CDC research, Fuentes et al. shows that combining a single-handed scalpel blade remover and a hands-free-technique (such as a passing tray or neutral zone) is up to five times safer than a safety scalpel. (This is best explained by knowledge of "active" vs. "passive" safety devices.) [11]

oUse of a single-handed scalpel blade remover & a hands-free-technique will ensure optimal staff safety AND optimal patient safety.

RELEVANT ARTICLES

Click here for the list of articles.

Surgeons are continuing to refuse to use safety scalpels

 

Outpatient Surgery Instapoll: Safety Scalpel Face Uphill Struggle.
http://www.outpatientsurgery.net/newsletter/eweekly/2008/08/19.php#4

Abstract: Out of 57 responses, nearly three-fourths reported futility in trying to convert their surgeons to safety scalpels: 25 percent can't even get surgeons to trial them and another 44 percent say their surgeons tried, but didn't like, them. (August 2008)

 

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Stoker, R. (2008). "Making Your Scalpels Safer." Outpatient Surgery. May issue.

Abstract: If your surgeons are still using conventional blades rather than switching to safety scalpels, there's still much you can do to prevent sharps injuries and bloodborne pathogen exposure in your ORs. Your next line of defense consists of scalpel blade removers, neutral zones and passing trays.

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Stoker, R. (2008). "Scalpel Safety - Protecting patients and clinicians". Managing Infection Control. May issue.

Abstract: Scalpel blade injuries are among the most frequent sharps injuries, second only to the ubiquitous needlestick. Scalpel injuries make up 7 percent to 8 percent of all sharps injuries. A study indicates that there were actually four times more injuries with safety scalpels than reusable scalpels. When taking into account activation rates, the combination of a single-handed scalpel blade remover with a passing tray or a neutral was as safe and up to FIVE times safer than a safety scalpel.

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Safety Scalpels are unproven

(2007). Scalpel safety in the operative setting. ASERNIP-S Report no. 59. Royal Australasian College of Surgeons.

Abstract: There are few studies published that systematically assess the effectiveness of safety devices in reducing percutaneous injuries, despite the proliferation of such devices. As noted in this review, available reports show substantial variation in study methodology and measurement of outcomes. The concept of 'scalpel safety' must be reinforced through practice and education in order to achieve lowered rates of scalpel injury in the operative setting in the long-term.

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Safety Scalpels are more dangerous

Sinnott, M. and Wall, D. (2007) “’SCALPEL SAFETY’: How safe (or dangerous) are safety scalpels?” International Journal of Surgery 6(2):176-177, doi:10.1016/j.ijsu.2007.01.010

Abstract: "Scalpel Safety" is a new term coined to inform users that there are two choices currently available to them to ensure their protection from this common sharps injury - (1) a combination of a single-handed scalpel blade remover and a passing tray or (2) a safety saclpel. Although safety scalpels have been promoted as the safer method, the medicatl literature contradicts this assumption.

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Watt, A. M., Patkin, M., e.t al. (2008). "Scalpel injuries in the operating theatre". BMJ. 336: 1031.

Abstract: International evidence based guidelines are needed to standardise approaches to reducing risk. Scalpel injuries represent a multi-faceted risk as they cause mechanical injury and expose both the injured worker and the patient to the risk of contracting blood borne infection. The sequelae of scalpel injuries are time consuming, emotionally fraught, and potentially expensive for the people and institutions involved. A large part of preventing injuries from scalpels involves creating a culture of safety within an institution and its operative personnel.

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Jagger J., et al. (1998) “A Study of patterns and prevention of blood exposure in OR personnel - operating room.” AORN Journal.

Abstract: The authors conducted a surveillance study of occupational blood exposures in the ORs at six hospitals to identify risk patterns and prevention strategies. For 15 months, trained circulating nurses recorded OR staff members' exposures during all surgical procedures using a modified version of the Exposure Prevention Information Network surveillance system. It was discovered that a high proportion of percutaneous injuries were potentially preventable if safer devices had been used, and the authors estimate that use of blunt suture needles alone could reduce injuries by 30%. Increased use of barrier precautions is indicated to prevent mucocutaneous blood exposures. Health care workers' eyes were identified in the study as being the most vulnerable location for serious blood exposures.

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Single handed scalpel blade removal

Alvarado-Ramy, F., et al. (2003). “A comprehensive approach to percutaneous injury prevention during phlebotomy: results of a multicentre study, 1993-1995.” Infection Control and Hospital Epidemiology 24(2):97-104.

Objective: To examine a comprehensive approach for preventing percutaneous injuries associated with phlebotomy procedures. Results: The three selected phlebotomy devices with safety features reduced percutaneous injury rates compared with conventional devices. Activation rates varied according to ease of use, healthcare worker preference for ESIPDs, perceived "patient adverse events," and device-specific training. CONCLUSIONS: Device-specific features and healthcare worker training and involvement in the selection of ESIPDs affect the activation rates for ESIPDs and therefore their efficacy. The implementation of ESIPDs is a useful measure in a comprehensive program to reduce percutaneous injuries associated with phlebotomy procedures.

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Stringer, B. et al. (2002). “Effectiveness of the hands-free technique in reducing operating theatre injuries.” Occupational and Environmental Medicine 59(10):703-7.

Background: Operating theatre personnel are at increased risk for transmission of blood borne pathogens when passing sharp instruments. The hands-free technique, whereby a tray or other means are used to eliminate simultaneous handling of sharp instruments, has been recommended. Aims: To prospectively evaluate the effectiveness of the hands-free technique in reducing the incidence of percutaneous injuries, contaminations, and glove tears arising from handling sharp instruments. Conclusions: Although not effective in all operations, use of the hands-free technique was effective in operations with more substantial blood loss.

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Regulatory

OSHA Standard Interpretations. Standard Number: 1910.1030. "11/21/2008"

"... using fingers to remove a used scalpel blade does not meet the requirements of the standard."

"Some facilities use a two-handed procedure with hemostat as a mechanical device to remove scalpel blades... Hemostats have been used as a measure which was preferable to using fingers to remove a used scalpel blade. Employers are expected to consider and use safer and more effective measures when feasible."

"... suggestion that the BBP (bloodborne pathogen) standard be changed to require that if a mechanical device is utilized, it must be a 'one-handed use of a mechanical-device' is a very good recommendation and one that would improve worker safety."

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OSHA Standard Interpretations. Standard Number: 1910.1030; 1910.1030(c)(1)(iv); 1910.1030(d)(2). “12/22/2005 - Use of passing trays and single-handed scalpel blade remover in a surgical setting.”

"In situations where an employer has demonstrated that the use of a scalpel with a reusable handle is required by a specific medical or dental procedure or that no alternative is feasible, the blade removal must be accomplished through the use of a mechanical device or a one-handed technique [29 CFR 1910.1030(d)(2)(vii)(B)]. The use of a single-handed scalpel blade remover meets these criteria."

"Preventing exposures requires a comprehensive program, including the use of engineering controls... and proper work practices (e.g., no-hands procedures in handling contaminated sharps, eliminating hand-to-hand instrument passing in the operating room)."

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Web site

 

"CDC (Centre for Disease Control and Prevention) Sharps Injury Prevention Workbook." from http://www.cdc.gov/sharpssafety/resources.html

Scalpel blades account for 7% of reported injuries (Refer Figure 4. Devices Involved in Percutanceous Injuries).

Web site

 

“Bloodborne Pathogens and Needlestick Prevention.” from OSHA web site http://www.osha.gov/SLTC/bloodbornepathogens/index.html

Web site

Australian & New Zealand Standard 3825:1998. "Procedures and devices for the removal and disposal of scalpel blades from scalpel handles."

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"Scalpel Safety - Staying Safe While Working on the Cutting Edge." Environment of Care News, March 2009, Vol 12, Issue 3, pp. 6,7 and 11. Joint Commission on Accreditation of Health care Organizations (JCAHO).

"I believe that the traditional scalpel handle will remain the first choice of the surgeon and that to ensure staff safety, a single-handed scalpel blade remover and hands-free passing technique will become the norm in all operating suites in the next five years," says Sinnott. "When that happens, there will be a whole new era of safety for operating room personnel."

It is safe to assume that Joint Commission accreditation visits will now also be interested in Scalpel Safety.

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Incidence and Cost

Fuentes, H., et al. (2008). ““Scalpel Safety”: Modeling the effectiveness of different safety devices’ ability to reduce scalpel blade injuries.” The International Journal of Risk & Safety in Medicine 20(1-2):83-89.

Background: The objective of this study was to analyse and compare the potential effectiveness of two safety strategies in reducing scalpel blade injuries. The two strategies examined were safety scalpel vs. a single-handed scalpel blade remover combined with a hands free passing technique (HFPT) (e.g. passing tray or neutral zone). Conclusion: Both safety strategies are potentially effective in reducing scalpel blade injuries. However the safety scalpels are active devices and as such are subject to widely variable activation rates. We recommend use of a single-handed scalpel blade remover in combination with an HFPT as this can potentially prevent 5 times as many injuries as safety scalpels.

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Perry, J. and J. Jagger (2003). “Scalpel blades: reducing injury risk.” Advances in Exposure Prevention 6(4):37-40.

Abstract: In EPINet data from 1993 to 2001, reusable and disposable scalpels together ranked third as a cause of sharps injuries across all healthcare settings, account for 7% of injuries. In operating rooms specifically, scalpels caused 18% of injuries. The article compares the incidence rates between reusable and disposable scalpels.

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Perry, J. (1998). “Yale to Pay $12.2 Million in Largest-Ever Award in Needlestick Case.” Advances in Exposure Prevention 3(3):26.

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Jagger, J., et al. (1990) “Estimated Cost of Needlestick Injuries for Six Major Needled Devices” Infection Control and Hospital Epidemiology 11(11):584-588.

Abstract: A major factor in the introduction of new products designed to decrease the risk of needlesticks to healthcare workers (HCWs) is whether the increased expense of a safer device is offset by the savings of preventing needlesticks. The itemized costs of needlestick injuries associated with six major needled devices were estimated and compared to the cost of the devices causing the injuries, based on 1988 dollars. Included was the cost of treatment, prophylaxis and employee health department personnel time. The average cost of needlestick injury was $405, with a narrow range of $390 to $456 for different devices. As a percent of the cost of the devices, needlesticks cost as little as 10% of the cost of the device, for the intravenous (IV) catheter, to as much as 457%, for needles used to connect IV lines. On the average, needlesticks cost 36% of the devices' cost. These data may be used to weigh the potential economic benefits of safer needle technology or other strategies intended to reduce the incidence of needlesticks.

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Eisenstein, H. C. and D. A. Smith (1992). "Epidemiology of reported sharps injuries in a tertiary care hospital." J Hosp Infect 20(4): 271-80.

Summary: A review of punctures wounds in a tertiary medical care centre showed that the nursing department accounted for the majority of all puncture injuries (68%). For nurses, medical and surgical units represented those clinical areas with the greatest number of puncture injuries. Areas with the highest incidence rates, however, included the clinical research centre, the emergency room, the surgical intensive care unit and areas where the intravenous team operated. The incidence rates of scalpel blades is much higher than disposable syringes and loose needles when compared to their respective volume: 662 scalpel incidences / 100,000 scalpel blades VS 3.2 Syringe & loose needle incidences / 100,000 Disposable syringes and loose needles.

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Watt, A. M., M. Patkin, et al. (2009). "Scalpel safety in the operative setting: A systematic review." Surgery 12: 12.

Summary: The complex environment of the operative setting provides multiple opportunities for health care workers to sustain scalpel injuries; scalpels are the second most frequent source of sharps injuries in this setting. Little evidence has been published detailing the effectiveness of proposed safety procedures and devices. The lack of available evidence highlights the need for the generation of a methodologically rigorous, clinically relevant, and statistically valid body of primary research in this area to support appropriate and effective safety interventions.

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Smith, D. R., M. Mihashi, et al. (2009). "Organizational climate and its relationship with needlestick and sharps injuries among Japanese nurses." Am J Infect Control. 37(7): 545-50. Epub 2009 Mar 9.

Summary: Although certain aspects of organizational climate have been shown to influence needlestick and sharps injuries (NSI) among nurses, this issue has not been adequately investigated in Japan. Various aspects of safety climate were associated with a reduced NSI risk, such as being involved in health and safety matters and being properly trained in risk control procedures. Nurses working in departments in which health and safety information was readily available were more likely to report any NSI they sustained, whereas nurses working in departments with minimal conflict were less likely to underreport their NSI. This study suggests that hospital safety climate has an important influence on NSI injury rates and reporting behavior among Japanese nurses. Given the multifaceted nature of identified risk, a comprehensive approach to infection control is clearly required and one that encompasses preventive strategies in both the cultural and physical domains.

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REFERENCES

1.Jagger J., et al. (1998) “A Study of patterns and prevention of blood exposure in OR personnel - operating room.” AORN Journal.
2.“CDC (Centre for Disease Control and Prevention) Sharps Injury Prevention Workbook.” from http://www.cdc.gov/SharpsSafety/workbook.html
3.Jagger, J., et al. (1990) “Estimated Cost of Needlestick Injuries for Six Major Needled Devices” Infection Control and Hospital Epidemiology 11(11):584-588.
4.Perry, J. (1998). “Yale to Pay $12.2 Million in Largest-Ever Award in Needlestick Case.” Advances in Exposure Prevention 3(3):26.
5.Eisenstein, H. C. and D. A. Smith (1992). "Epidemiology of reported sharps injuries in a tertiary care hospital." J Hosp Infect 20(4): 271-80.
6."Getting Your Surgeons to Try Safety Scalpels" Outpatient Surgery Dec 2007 Vol VIII, No.12 page 44.
7."Scalpel Safety in the Operative Setting" ASERNIP-S Report No. 59 July 07 (Australian Safety and Efficacy Register of New Interventional Procedures - Surgical)
8.Sinnott M, Wall D. "Scalpel safety": How safe (or dangerous) are safety scalpels?  International Journal of Surgery (2007), oi:10.1016/j.ijsu.2007.01.010.
9."OSHA is pressing Ors to adopt safety scalpels but surgeons resist" OR Manager Dec 2005 Vol 21 No 12 pp 1-4
10.Alvarado-Ramy F, Beltrami EM, Short LJ et al. "A comprehensive approach to percutaneous injury prevention during phlebotomy: results of a multicentre study, 1993-1995." Infect Control Hosp Epidemiol 2003; 24(2): 97-104.
11.Fuentes, H., et al. (2008). ““Scalpel Safety”: Modeling the effectiveness of different safety devices’ ability to reduce scalpel blade injuries.” The International Journal of Risk & Safety in Medicine 20(1-2):83-89.

 

 

 

 

 

 

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