[Federal Register Volume 62, Number 159 (Monday, August 18, 1997)]
[Notices]
[Pages 44010-44011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21835]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pulmonary Artery Catheter and Clinical Outcomes Workshop: Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Pulmonary Artery Catheter and Clinical Outcomes 
Workshop'' to address critical concerns related to the use of pulmonary 
artery catheters, and to identify any other significant issues that 
clinicians, manufacturers, and other interested parties may have in 
clinical use of this device.

DATES: The public workshop will be held on Monday, August 25, 1997, 
from 8 a.m. to 5 p.m., and Tuesday, August 26, 1997, from 9 a.m. to 12 
m. Submit written notices of participation by August 21, 1997.

ADDRESSES: The public workshop will be held at the Holiday Inn Old Town 
Select, 480 King St., Alexandria, VA. Submit written notices of 
participation to the contact person listed below.


[[Page 44011]]


FOR FURTHER INFORMATION CONTACT: Carole C. Webb, Center for Devices and 
Radiological Health (HFZ-520), 1350 Piccard Dr., Rockville, MD 20850, 
301-594-3948, or internet ``[email protected]''.

SUPPLEMENTARY INFORMATION: Pulmonary artery catheters (PAC's), also 
known as right heart catheters, provide data on blood pressure, blood 
flow, and oxygen levels that many doctors consider crucial to the care 
of critically ill hospital patients. A study reported in the September 
18, 1996, Journal of the American Medical Association (JAMA), however, 
suggests use of these catheters may increase risks of morbidity and 
mortality (the JAMA article).
    PAC's have been used in the practice of critical care medicine 
since 1970. The initial marketing of these devices preceded FDA's 
authority to regulate medical devices which began in 1976. The JAMA 
article by Connors et al. examined the survival of patients monitored 
with and without this device in an intensive care setting. The Connors 
et al. study does not provide evidence that the catheter itself is 
unsafe; however, it does raise questions about the benefit to patients 
of the device as it is currently being used. Concerns about the 
benefits and risks of using PAC's are not new. As early as 1987, other 
scientists found a greater risk of morbidity and mortality in use of 
PAC's, but those early studies, as in the Connors et al. study, were 
not randomized. Although the Connors et al. study showed a relationship 
between use of PAC's and a higher risk of death, it did not show that 
use of the catheter caused those additional deaths. The additional risk 
might be related to how information gained from the catheter is used or 
the result of medical therapy a patient receives. It is possible the 
results may not apply when the catheter is used for diseases or in 
situations other than those studied by Connors et al. The device 
provides important clinical information relied upon in determining a 
course of treatment. However, FDA and the National Institutes of Health 
(NIH) believe rigorous scientific evaluations of the device may be 
needed in evaluating the context of appropriate clinical care.
    The Pulmonary Artery Catheter and Clinical Outcomes Workshop will 
be cosponsored by FDA and NIH. The goals of the workshop are to 
summarize the following:
     (1) Clinical indications, benefits, and major risks of PAC use;
     (2) Current standards for clinical practice in PAC use;
     (3) The need and specific clinical issues for PAC use in specific 
patient populations;
     (4) To identify suggestions or opportunities for future research, 
regulatory action, or clinical practice guidelines.
    The workshop will commence with introductions, overviews of goals, 
discussion of contemporary clinical knowledge of PAC use, and catheter 
technology issues. Two concurrent sessions will be convened in the 
morning and afternoon. Each session will cover two major disease and 
trauma topics in separate breakout groups. The first pair of breakout 
groups will focus on PAC use in respiratory disease and trauma/
perioperative/postoperative management. The second pair of breakout 
groups will include sepsis/multiorgan dysfunction syndrome and 
cardiovascular disease. The objective of these sessions will be to 
debate critical clinical issues specific to these areas. Attendees may 
observe any available session and may participate in open discussions. 
Following these sessions, cochairs will guide their teams to identify 
pragmatic and prioritized research considerations. On August 26, 1997, 
each group will present their report to the entire workshop. Open 
discussions and concluding remarks will follow. Cochairs will only 
remain after the formal part of the workshop to discuss areas of 
disagreement and to write the first draft of the final document. It is 
expected the final document will be delivered to Federal agencies 
within 2 weeks.

    Dated: August 13, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-21835 Filed 8-13-97; 2:56 pm]
BILLING CODE 4160-01-F