Tina Powell MedSun Project Director for CODA, Inc'

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Tina Powell MedSun Project Director for CODA,
Inc.
MedSuns Second Year
Stability ? Refinements ? Innovation
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MedSun Facts

• 2002 - 80 Facilities
• 71 Hospitals 9 Nursing Homes
• 2003 Goal was to Reach 180 Facilities
• 90 More Hospitals
• 10 More Nursing Homes
• Exceeded Goal of 180, with a waiting list
• Funded by FDAs Center for Devices and
  Radiological Health
• Operated by CODA, a private contractor

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Stability

• We exceeded our goal of 180 hospitals and nursing
  homes in MedSun this year, and we have hospitals
  on the waiting list for next years recruitment.
• There is momentum in recruitment as well as in
  reporting, with 820 reports received thus far,
  and 119 of those just since the beginning of
  September.
• Feedback provided monthly in the MedSun News,
  which has been received favorably.
• Survey of MedSuns first round of participants
  indicated benefits to participation.

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Refinements

• We will work on our review and follow-up
  procedures to give attention to new problems that
  FDA has not seen in great numbers before.
• We will continue to work with ECRI and feedback
  to MedSun sites about ECRIs findings through the
  monthly newsletter.
• Materials are being developed to make it easier
  for MedSun Representative to spread the word
  about the project in their hospitals and nursing
  homes.

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Innovation

• Biomedical Conference Calls
• Medical Device Engineering Network
• Infusion Pump Study concerning Programming Issues
• Rapid Response Surveys and other data collection
  concerning particular devices
• New Participant Website and Videos
• Improvements to Data Entry Website

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MedSun Important Actions

• As a result of MedSun reports
• After reporting to FDA and to the manufacturer
  through MedSun about erosion of biliary catheters
  in patients, one hospital is working with the
  manufacturer on testing a new version of the
  catheter.
• After reporting to FDA and the manufacturer on
  problems with pain and peritonitis with the use
  of Gynecare Intergel in gynecological surgeries,
  the product was withdrawn from the market.

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MedSun Important Actions

• As a result of MedSun reports
• After reporting to FDA and the manufacturer about
  problems with syringe stoppers contributing to
  lack of cell growth in amniotic fluid samples
  that were used for amniocentesis procedures, the
  manufacturer sent a warning letter to OB/GYNs
  indicating that this problem had been found.

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(No Transcript)
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March 28, 2003 URGENT VOLUNTARY MARKET WITHDRAWAL
OF GYNECARE INTERGEL ADHESION PREVENTION
SOLUTION Dear Director of Materials
Management GYNECARE is conducting an urgent,
voluntary global withdrawal of GYNECARE INTERGEL
Adhesion Prevention Solution, a device indicated
for use in patients undergoing open,
conservative gynecologic surgery as an adjunct to
good surgical technique to reduce post-surgical
adhesions. You should immediately discontinue use
of the device. GYNECARE is conducting this
voluntary withdrawal in order to complete an
assessment of information obtained during
post-marketing experience with the device,
including adverse events associated with
off-label use in laparoscopy and
non-conservative surgical procedures (such as
hysterectomy). GYNECARE has received post-market
reports of late-onset, post-operative pain, and
repeat surgeries following the onset of pain,
non-infectious foreign body reactions, and tissue
adherence. In some patients, a residual material
was observed during the repeat surgery. The
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Categorization of MedSun Reports
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Examples of Devices

• HO General Hospital
• IV equipment, Infusion pumps, Patient lifts,
  Warming blankets
• SU General/Plastic Surgery
• Electrosurgical units, Staples, Breast implants,
  Sutures

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Event Outcomes of MedSun Reports
Event Outcome Number of
Reports Death 18 Serious
Injury 56 Minor Injury
145 Potential for Harm to Patient
493 Potential for Harm to Health Care
Provider 37 Outcome Pending or Unknown 103
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Key Areas of Report Information

• 1. What happened to the persons affected?
• 2. The problems with the device(s)
• 3. Original medical procedures
• 4. Follow-up medical procedures
• 5. Names of manufacturer
• 6. Relevant manufacturer device identification
  numbers

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Key Areas of Report Information

• 1. (If there was an injury) What happened to the
  persons affected? (e.g., 2nd degree burn to
  patient)
• 2. What, if any, were the problems with the
  device(s) involved? (e.g., epidural catheter
  found crimped)
• 3. What, if any, were the original medical
  procedures for which the devices were used?

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Key Areas of Report Information
4. What, if any, were the follow-up medical
procedures required because of the event?
(e.g., repeat surgery, administration of
antibiotics) 5. What are the names of the
manufacturers of the devices involved? 6. What
are the relevant manufacturer device
identification numbers? (e.g., serial, model,
lot, catalog, and any other specific product
information)