CDRH Surgical Staplers STAMP SSSTAMP

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CDRH Surgical Staplers STAMP (SSSTAMP)

• Eileen Woo
• Chair, SSSTAMP, CDRH/OSB
• 10/24/2002

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CDRH Surgical Staplers STAMP (SSSTAMP)

• STAMP Systematic Technology Assessment of
  Medical Products
• Purpose Assess current state of knowledge and
  identify means to address ongoing
  problems
• Provide clinicians, consumers, and industries
  with medical product information
• A STAMP is not for determining regulatory
  actions

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Adverse Events and Product Problems Associated
with Surgical Staplers

• 8,000 to 9,000 per year
• 90 malfunctions, 9 injuries, lt1 deaths
• Most frequently reported patient problems
  anastomosis failure, prolonged surgery,
  hemorrhage, infection
• Most frequently reported device problems
  staplers misfire or fail to fire and staples do
  not form

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SSSTAMP Areas of Concern

• Frequency and severity of adverse events
• Adequacy of training programs
• Reuse of single use staplers
• Lack of awareness of the problems

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SSSTAMP Proposed Actions

• Rapid Response Survey determine awareness
• Publish articles to alert users about problems
• Present device and patient problem information to
  FDA Advisory Panels and professional meetings
• Develop a Surgical Stapler Website for the
  healthcare community