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In prescribing such regulations, the Secretary shall have due regard for
the professional ethics of the medical profession and the interests of
patients. The prohibitions of paragraph (7) of this subsection continue to
apply to records, reports, and information concerning any individual who has
been a patient, irrespective of whether or when he ceases to be a patient.
The Secretary shall by regulation require distributors to keep records and
make such records available to the Secretary upon request. Paragraphs (4)
and (8) apply to distributors to the same extent and in the same manner as
such paragraphs apply to manufacturers and importers. (USC, 2005)
AN ENGINEERING PERSPECTIVE
In 1980, Bjork became aware that valve-strut failures were occurring and
demanded corrective action. Although known as a surgeon, Bjork was in
essence also a biomedical engineer who co-designed the Bjork-Shiley valve.
Bjork threatened to publish cases of valve-strut failures. A panicked Shiley
executive telexed: “ATTN PROF BJORK. WE WOULD PREFER THAT
YOU DID NOT PUBLISH THE DATA RELATIVE TO STRUT FRAC-
TURE.” The executive’s reason for holding off public exposure of the failure
was “WE EXPECT A FEW MORE.” Bjork kept silent (Palast, 1998) until
he began publishing his corrective action investigations in 1985 (Bjork, 1985).
Bjork, V. O., The development of the Bjork-Shiley artificial heart valve. Clin Cardiol, Jan,
1984, 7, 3–5.
Bjork, V. O., Metallurgic and design development in response to mechanical dysfunction of
Bjork-Shiley heart valves. Scand J Thorac Cardiovasc Surg, Jan, 1985, 19, 1–12.
de Mol, B. A., Kallewaard, M., McLellan, R. B., van Herwerden, L. A., Defauw, J. J., and van
der Graaf, Y., Single-leg strut fractures in explanted Bjork-Shiley valves. Lancet, Jan 1,
1994, 343, 9–12.
Food and Drug Administration (FDA), Support Statement for Medical Devices: Current Good
Manufacturing Practice (CGMP), Quality System (Q/S) Regulation. 21 CFR Part 820,
OMG No. 0910–0073. 2004. http://www.fda.gov/ohrms/dockets/98fr/04n-0034-ss00001.pdf.
Lindblom, D., Bjork,V. O., and Semb, B. K. H., Mechanical failure of the Bjork-Shiley valve.
J Thorac Cardiovasc Surg, May, 1986, 92, 894–907.
Lindblom, D., Rodriguez, L., and Bjork, V. O., Mechanical failure of the Bjork-Shiley valve.
J Thorac Cardiovasc Surg, Jan, 1989, 97, 95–97.
Meier, B., Pfizer unit to settle charges of lying about heart valve; Pfizer unit to settle U.S. charges.
NY Times, A33, July 2, 1994.
Michaud, A., Shiley Inc. settles false-claims suit courts: Irvine-based firm and its parent to
pay $10.75 million to U.S. in case involving flawed artificial heart valves. LA Times, A1,
July 1, 1994.
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