Sharps Safety Legislation


The passage of the Needlestick Safety and Prevention Act (NSPA) of 2000[i] brought significant changes to OSHA’s Bloodborne Pathogen Standard,[ii] including the requirement for healthcare facilities to evaluate safety-engineered devices (including both safety needles and safety scalpels) on an annual basis and implement the best choices unless they are deemed unsafe.  Manufacturers introduced several safety needles and safety scalpels to the market following the NSPA.

Results



While this change brought about significant results in reducing needlestick injury rates through the large acceptance of safety needles, healthcare workers have largely rejected safety scalpel designs[iii] (e.g., only 5-15% conversion to safety scalpels in the acute care market), leading to unimproved scalpel injury rates[iv] (and even worsened rates in some settings[v]) and risk of disease transmission (higher with scalpel injuries).[v],[vi],[vii],[viii] Those most injured (76% of injuries) are personnel other than the original user of the device, such as surgical attendants and nurses.[ix]

The Call for Innovation

The need for greater innovation and variety in safety
scalpel designs was a key point of the 2010 “Consensus Statement and Call to
Action,” drafted by members of the International Healthcare Workers Safety
Committee and other safety professionals at the tenth-anniversary conference
assessing the impact of the NSPA.[x] The following year, Ron Stoker, Executive
Director of the International Sharps Injury Prevention Society, published an
article in Outpatient Surgery recounting 186 clinician interviews aimed at identifying
the reasons for the low adoption of safety scalpels.[xi] These and several similar articles,[ix],[xii],[xiii],[xiv] have addressed several reasons for the safety scalpel
adoption problem, with a myriad of design problems being the primary issue:

  • Cumbersome blade activation
  • Lack of user friendliness
  • Lack of ambidexterity
  • A tendency to bend
  • Low weight
  • Balance issues
  • Grip problems
  • Poor line of sight
  • Lack of safety (ironically)



Enter PenBlade®


PenBlade, Inc. has created a novel safety scalpel that is intuitive, ergonomic, and rigid.  PenBlade is a safety scalpel with unique advantages:

 1. The blade extension mechanism uses existing muscle memory (that of a click pen) as opposed to a sheath-sliding motion (commonly used in safety scalpels), increasing intuitiveness and reducing chance of injury – single-hand use is easy.

 2. The device has an integrated groove for trimming sutures and PICCs, which eliminates chance of injury during this step (the blade is retracted when using the groove). For most kit-based suture procedures, safe suture cutting eliminates an additional blade exposure. 

 3. Making the device safe after use does not require repositioning the hand (the blade retraction button is on the front of the device), which increases probability of blade retraction.  The motion required to make the device safe is minimized.

 4. To our knowledge, PenBlade is the only safety scalpel that provides an option for semi passive blade retraction (hold down the button while cutting, and the blade automatically retracts when released), ensuring blade is retracted when finished.

 5. PenBlade has a human-factor-engineered design that dramatically improves rigidity and ergonomics (flimsiness has been a common complaint with other safety scalpels, leading to them not being used at all).

 6. PenBlade helps to mitigate the common low-weight complaint by offering a weight that is 50% heavier than the industry-leading plastic safety scalpel.

 7. This device uses a high-quality British stainless steel blade.  Users have reported improved sharpness and durability compared to the leading safety scalpel currently on the market.  Improved sharpness and durability mean less pressure is needed to cut, improving control and reducing chance of injury.

[i] Needlestick Safety and Prevention Act of 2000, Pub. L. No. 106-430, 114 Stat. 1901, 106th Congress (2000). 

[ii] Occupational Safety & Health Administration. U.S. Department of Labor, (2001). Occupational exposure to bloodborne pathogens; needlestick and other sharps injuries; final rule (66:5317-5325). Retrieved from website: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGISTER&p_id=16265

[iii] Jagger, J., Perry, J., Gomaa, A., & Phillips, E. K. (2008). The impact of US policies to protect healthcare workers from bloodborne pathogens: the critical role of safety-engineered devices. Journal of Infection and Public Health, 1(2), 62-71.

[iv] Hogan, A. (2005). Gaps and successes of safety device market conversion. Materials Management in Health Care, 14(11), 33.

[v] Jagger, J., Berguer, R., Phillips, E. K., Parker, G., & Gomaa, A. E. (2011). Increase in sharps injuries in surgical settings versus nonsurgical settings after passage of national needlestick legislation. AORN, 93(3), 322-330.

[vi] Weiss, E. S., Makary, M. A., Wang, T., Syin, D., Pronovost, P. J., Chang, D., & Cornwell III, E. E. (2005). Prevalence of blood-borne pathogens in an urban, university-based general surgical practice. Annals of surgery, 241(5), 803.

[vii] Gerberding, J. L. (1995). Management of occupational exposures to blood-borne viruses. New England Journal of Medicine, 332(7), 444-451.

[viii] Perry, J. L., Pearson, R. D., & Jagger, J. (2006). Infected health care workers and patient safety: a double standard. American journal of infection control, 34(5), 313-319.

[ix] Perry, J., Parker, G., & Jagger, J. (2003). Scalpel blades: reducing injury risk. Advances in Exposure Prevention, 6(4), 37-48.

[x] Steering Committee. (2010, Novem). Jagger Janine (Chair). Moving the sharps safety agenda forward in the united states: Consensus statement and call to action. 10th anniversary of the needlestick safety and prevention act: mapping progress, charting a future path, Charlottesville, VA.

[xi] Stoker, R. (2011). Are Safety Scalpels Making the Cut With Surgeons and Nurses? OR Manager.

[xii] OR Manager (2005). OSHA is pressing ORs to adopt safety scalpels but surgeons resist. OR Manager, 21(12).

[xiii] Bernard, D. (2013, May). Where do you stand with safety scalpels?. Outpatient surgery magazine, 14(5), Retrieved from http://www.outpatientsurgery.net/issues/2013/05/where-do-you-stand-with-safety-scalpels

[xiv] Joint Commission on Accreditation of Healthcare Organizations. (2009). Scalpel Safety. Environment of Care News, 12(3).