Staff & patient safety

Every single Biogel® surgical glove is powder-free, and has been for over 30 years

By: Mölnlycke Health Care, January 6 2016Posted in: Staff & patient safety

Surgon's hand with surgical glove holding an instrumentBiogel® sold the world’s first powder-free surgical glove in 1983, and over 30 years later, Biogel is still the only major surgical glove brand with an exclusively powder-free range.

With the innovative development of the world’s first polymer coating with hydrophilic properties, Biogel was able to eliminate powder and the adverse health effects that can result from glove powder, including: postoperative adhesions, granulomas, wound contamination and delayed wound healing.1

For more information about the adverse health effects that can results from glove powder, please review Biogel’s publication Surgical Glove Powder: An Unnecessary Hazard.

The dangers of glove powder can also cause the following adverse health effects

 

Increased risk of Surgical Site Infections (SSIs)

Glove powder can and will at times trigger: reduced resistance to infection, bacterial environmental contamination, foreign body reaction, delayed wound healing, adhesion formation and granuloma formation.2, 3 All of these potential consequences can increase the risk of Surgical Site Infections (SSIs).

Latex Allergy and Occupational Asthma

Powdered latex gloves have been implicated as the largest single contributor to the latex aeroallergen levels in a healthcare facility.4, 5  Latex can be aerosolized by attaching to glove powder. This not only can increase the risk of acquiring a latex allergy, but can also increase the risk of acquiring occupational asthma.6

Glove powder increases latex allergy sensitization potentially eliciting delayed hypersensitivity reactions. Powdered surgical gloves show higher levels of natural rubber latex allergens than gloves that are powder-free. This allows for the potential increase in latex sensitization and/or Type I reactions upon direct and indirect contact.2, 7, 8, 9, 10, 11

For more information about the dangers of powder, please review Biogel’s publication of the Top Clinical Reasons to Wear Powder-Free Gloves.

FDA Final Decision to Ban Powdered Surgical Gloves

The FDA has finalized their decision to ban powdered gloves effective January 18, 2017. This move is remarkable given the fact that the FDA has only banned one other medical device in recent history which was prosthetic hair fibers in 1983.12

"The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices."

Recent new additions to our product line include Biogel® PI Micro and Biogel® PI Micro Indicator® Underglove which are thinner options that offer an easy synthetic transition from powdered gloves. Mölnlycke® offers a wide range of natural rubber latex and synthetic surgical glove options to meet  various clinical applications and user preferences. To find how Mölnlycke can support your transition to a powder-free glove portfolio please email info.us@molnlycke.com or download the full Biogel surgical gloves range brochure.

References

  1. Truscott W. “Citizens petition to the FDA to ban cornstarch powder on medical gloves.” Feb. 2009.
  2. Edlich RF, Long WB, Gubler DK, et al. Dangers of cornstarch powder on medical gloves. Ann Plast Surg. 2009;63: 822–826.
  3. van den Tol MP, et al. Glove powder promotes adhesion formation and facilitates tumour cell adhesion and growth. British Journal of Surgery. 2001;88:1258-1263.
  4. 2012 AORN Latex Guideline; Perioperative Standards and Recommended Practices. 605-620. 2012.
  5. 2013 AORN. Recommended Practices for a Safe Environment of Care. 217-242.
  6. Hoy RF. Occupational exposures and the development of new-onset asthma. JOEM. 2013;55(3): 235-239.
  7. Barbara. J. etal. (2004) Inhaled cornstarch glove powder increases latex induced airway hypersensitivity in guinea pigs. Clin Exp Allergy. 34: 978-983.
  8. Grunewald, J. etal (2003). Lung accumulations of eosinophil granulocytes after exposure to cornstarch glove powder. European Respiratory Journal 21: 646-651.
  9. Filon L. etal (2006) Latex Allergy..A follow up study of 1040 healthcare workers. Occup Envionm Med 63:121-125.
  10. Kelly, K. etal (2011) Prevention of IgE Sensitization to Latex in Health Care Workers After Reduction of Antigen Exposures. JOEM. Volume 53, Number 8.
  11. Hunt, T.K., etal (1994). Starch Powder Contaminants of Surgical Wounds. Archives of Surgery. Vol 129. p.824-827.
  12. "Banned Devices: Powdered Surgeon's Gloves. Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Gloves; Final Rule." 81 FR 91722 (19 December 2016), pp. 91722-91731.
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