Brief Summary from the General and Plastic Surgery Devices Panel Meeting - August 25-26, 2005
The General and Plastic Surgery Devices Panel (GPS Panel) met on August 25 & 26, 2005 in Salons A, B & C of the Ballroom of the Washington DC North/Gaithersburg Hilton Hotel located at 620 Perry Parkway in Gaithersburg, Maryland to provide advice and recommendations to the Agency on the classification of 5 unclassified preamendment medical devices; bone wax, medical maggots, medicinal leeches, tissue expanders and wound dressings with a drug.
After the initial welcome from the Executive Secretary, the Conflict of Interest Statement was read by Ms. Jenny Slaughter, Supervisor of the Program Integrity Staff in the Office of the FDA Commissioner. This was followed by the awarding of plaques to Dr. Michael J. Miller, a Voting Member and Dr. LeeLee Doyle, the Consumer Representative, whose terms were expiring on August 31, 2005. The letter accompanying the plaques thanked the members for their service to the committee and was signed by Sheila Dearybury Walcoff, Esq., the Associate Commissioner for External Relations.
On August 25, the meeting opened with the panel update presented by CDR. Stephen Rhodes (Branch Chief, Plastic and Reconstructive Surgery Devices Branch) during which the panel members were informed on actions taken by the FDA in response to previous recommendations made by the GPS panel, including an approvable with conditions letter sent to Mentor Corporation for their silicone gel-filled breast implants. Also, CDR. Rhodes informed the panel that Mark Melkerson was now the Acting Director of the Division of General, Restorative & Neurological Devices and Dr. Barbara Buch was the Acting Deputy Division Director for the General Surgery and Plastic and Reconstructive Surgery Branches. Following Mr. Rhodes, Dr. Sousan Altaie gave a brief presentation on the “Critical Path Initiative in Medical Devices” and Dr. Susan Gardner gave a brief presentation on “Condition of Approval Studies: Recent Changes in CDRH”.
The Thursday morning session continued with a hearing on the classification of bone wax. Before the bone wax discussion the panel heard an industry presentation from Dr. Richard Kronenthal titled: “A Brief History of Bone Wax – From Horsley to Today”. Following a discussion of bone wax classification, the panel heard testimony from Dr. Tad Wellisz of the University of Southern California. Then the panel voted unanimously to recommend that the Agency classify bone wax as non-exempt, Class II medical devices with special controls; the special control being a detailed guidance document. The major risk identified by the panel was the possibility of bone wax interfering with bone regrowth at the site of application. Also, the panel members felt it was important for the labeling to clearly distinguish between absorbable and non-absorbable bone wax.
The Thursday afternoon session consisted of hearings on the classification of medical maggots and medicinal leeches. Following a panel discussion, the panel voted unanimously to recommend that the Agency classify medical maggots as non-exempt, Class II medical devices with special controls; the special control being a detailed guidance document. The panel members felt is important to include clear instructions for use that prevented escape of adult flies. Also, disposal and environmental factors were discussed. Following a panel discussion on medicinal leeches, the panel voted unanimously to recommend that the Agency classify medicinal leeches as non-exempt, Class II medical devices with special controls; the special control being a detailed guidance document. The panel members felt the instructions for use should clearly state that discarded leeches should be treated as biohazard waste due their contact with blood. The Thursday session was then adjourned.
The Friday session consisted of hearings on the classification of two additional preamendments medical devices; tissue expanders and wound dressings with a drug. Before the panel discussed tissue expanders, they heard an industry presentation by Mr. Eric Caillé and Mr. Deron Singer of PMT Corporation entitled: “Tissue Expanders in Support of Class II Classification”. Following discussion, the panel voted unanimously to recommend that the Agency classify tissue expanders as non-exempt, Class II medical devices with special controls; the special control being a detailed guidance document. The panel members indicated that specialized labeling might be necessary to caution surgeons about the use of these devices in children and in locations where blood vessel or airway constrictions could occur, such as the head and neck.
Before a discussion of wound dressings with drugs, the panel heard industry presentations from Merry Lee Bain of Cook Biotech entitled: “Industry Prospective on Classification of Wound Care Products” and from Dr. Sergio Gadaleta of Ethicon, Incorporated entitled: “Classification of Pre-Amendments Device: Wound Dressing with a Drug”. Following discussion, the panel voted unanimously to recommend that the Agency classify wound dressings with a drug as non-exempt, Class II medical devices with special controls; the special control being a detailed guidance document. The major concerns expressed by the panel members during the discussion were the possibility that the drug could sensitize the skin, contribute to drug resistance, interfere with wound healing, or result in selective colonization. The meeting was then adjourned.
David Krause, PhD
Executive Secretary
General and Plastic Surgery Devices Panel
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