MEDSUN REPRESENTATIVES CONFERENCE 8 9 October 2003 The Device Manufacturers Role in Providing Safety

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MEDSUN REPRESENTATIVES CONFERENCE8 9 October
2003The Device Manufacturers Rolein Providing
Safety Information
Kenneth F. Kopesky V.P. Corporate Compliance and
Audit
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• Obligation to protect public health through the
  development and manufacturing of product that are
  safe and perform as intended
• We need to have safe product available for the
  user

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• Information concerning the performance or safety
  of the product is necessary for manufacturers to
  improve their process and product
• It is important for you as a user to report event
  information through the MedSun Project Internet
  based reporting to FDA and manufacturers

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• Our responsibility as a manufacturer is to ensure
  that safety information is provided to users
• This is done through technical publications,
  product manuals, and Instructions for Use

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• Based on information we receive from users we are
  obligated by Quality System Regulation to
• Review information received from users
• Conduct evaluations to determine if complaint,
  MDR or vigilance reports are necessary
• If there is a hazard, assess the severity
• Determine the root cause
• Identify corrective action
• If necessary, this may include taking action to
  address the concern at the user

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• Actions taken regarding a serious safety or
  performance concern are conducted under the CFR
  806 Corrections and Removal or Recall
  Notification
• How it can be managed including what should be
  done with the product

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• These activities are monitored through FDA
  inspections and the MDR and/or Vigilance
  Reporting
• There are situations where there is no safety
  concern, the user may not be satisfied with a
  product, service or even excess inventory
• These may result in the product being sent back
  to the manufacturer

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• If there is no hazard or safety concern
  identified, then the return of the product is not
  considered a recall
• Manufacturers routinely report recalls or actions
  involving safety information to the FDA

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• Recalls and notifications are published and
  available via FOI
• We need to work together to ensure the products
  for patients and users are safe