BILL ANALYSIS
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|SENATE RULES COMMITTEE | AB 995|
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THIRD READING
Bill No: AB 995
Author: Block (D)
Amended: 7/13/09 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 10-0, 7/15/09
AYES: Alquist, Strickland, Aanestad, Cedillo, Cox,
DeSaulnier, Leno, Negrete McLeod, Pavley, Wolk
NO VOTE RECORDED: Maldonado
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : Not relevant
SUBJECT : Tissue bank licensing
SOURCE : Author
DIGEST : This bill exempts licensed physicians or
podiatrists from registering as a California tissue bank,
if they keep a medical device or biologic product in their
office for more than 24 hours before implanting or applying
the product to their patient.
ANALYSIS :
Existing law:
1. Requires the Department of Public Health (DPH) to
license and regulate tissue banks and gives DPH the
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authority to revoke or suspend the license of any tissue
bank that violates licensing standards pertaining to
tissue banks.
2. Defines "tissue" as any human cell, group of cells,
tissue or organ including the cornea, sclera, or
vitreous humor and other segments of, or the whole eye,
bones, skin, arteries, sperm, blood, other fluids, and
any other portion of a human body.
3. Requires DPH to adopt, on or before July 1, 2004,
regulations governing licensed tissue banks engaged in
the collection of human musculoskeletal tissue, skin,
and veins for transplantation in humans. Requires the
regulations to be substantially based on accreditation
standards issued by tissue bank trade associations, as
specified.
4. Requires regulations for tissue banks to include minimum
standards related to preservation, storage, and handling
of tissue; equipment, methods, and personnel
qualifications of tissue banks; and testing of donors,
as specified.
The author's office states, creating an additional
licensing requirement and fee as required under current law
for physicians and podiatrists who lawfully obtain these
products from a California licensed tissue bank, and use
and store them in accordance with existing federal laws and
U.S. FDA approved manufacturer guidelines for direct
patient care, could ultimately jeopardize a patient's
access to care and deny them these advanced products
delaying the healing process.
These medical devices and biologic products are approved by
the U.S. FDA to treat diabetic foot ulcers and venous leg
ulcers. These wounds are very painful, last many years,
and are the most frequently occurring chronic wounds
suffered by patients today.
These newly developed bioactive devices and products
deliver living, cell-based products to stimulate the body's
own natural healing process in these hard to heal places.
This bill continues to protect the health and safety of
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consumers and patients by requiring that the medical device
or biologic product is obtained from a licensed tissue bank
and is stored in strict accordance with the manufacturer's
instructions and guidelines.
Advanced biologic products and devices are manufactured for
use by licensed physicians and strictly regulated. These
products are subject to strict premarket approval and
post-approval requirements that not only include oversight
of the manufacturing process, but also approval of the
shipping method and container, storage requirements,
expiration dates, and instructions for proper use and
storage of the product.
This bill clarifies that the product must be used solely
for the purpose of implantation into or application onto a
patient of the physician or podiatrist and it cannot be
sold or distributed to anyone other than the original
manufacturer if returned.
Finally, this bill requires that the practitioner notify
the Department of Public Health, in writing, that they meet
the requirements for the exemption under the law.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 8/19/09)
California Podiatric Medical Association
Advanced BioHealing, Inc.
Organogenesis, Inc.
CTW:DLW:do 8/20/09 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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