U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

From: Office for Human Research Protections (OHRP) [OHRP-L@LIST.NIH.GOV]
on behalf of Glen Drew [glen.drew@HHS.GOV]
Sent: Friday, February 15, 2008 2:25 PM
To: OHRP-L@LIST.NIH.GOV
Subject: OHRP CONCLUDES CASE REGARDING JOHNS HOPKINS UNIVERSITY RESEARCH
ON HOSPITAL INFECTIONS

. . . Encourages Continuance of Work to Reduce Incidence of Catheter- Related Infections; Offers New Guidance for Future Research . . .

The Office for Human Research Protections (OHRP) -- part of the U.S.
Department of Health and Human Services -- has concluded that Michigan
hospitals can continue implementing a checklist to reduce the rate of
catheter-related infections in intensive care unit settings (ICUs) without
falling under regulations governing human subjects research. Dr. Kristina
C. Borror, director of the office's Division of Compliance Oversight, sent
separate letters to the lead architects of the study, Johns Hopkins
University and the Michigan Health & Hospital Association, outlining
findings and offering researchers additional guidance for future work.

"We do not want to stand in the way of quality improvement activities that
pose minimal risks to subjects," said Dr. Ivor Pritchard, acting director
of OHRP. "HHS regulations provide great flexibility and should not have
inhibited this activity. The regulations are designed to protect human
subjects."

The Johns Hopkins study demonstrated that a comprehensive five-step
program can dramatically reduce the incidence of catheter-borne infections
in ICUs. HHS strongly encourages hospitals nationwide to adopt the
program, which can save thousands of lives and millions of dollars each
year.

OHRP noted that the Johns Hopkins project has evolved to the point where
the intervention, including the checklist, is now being used at certain
Michigan hospitals solely for clinical purposes, not medical research or
experimentation. Consequently, the regulations that govern human subjects
research no longer apply and neither Johns Hopkins nor the Michigan
hospitals need the approval of an institutional review board (IRB) to
conduct the current phase of the project.

In addition, the letters offer new guidance for future quality improvement
research that poses minimal risk to human subjects, such as the Johns
Hopkins study. Dr. Borror wrote that such research would likely have been
eligible for both expedited IRB review and a waiver of the informed
consent requirement.

In response to a written complaint about this research, OHRP opened a
compliance oversight evaluation with the Johns Hopkins University and the
Michigan Health & Hospital Association, regarding allegations of non- compliance with HHS regulations for the protection of human subjects (45
CFR part 46, see

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). The
complainant alleged that the research was conducted without prior review
and approval by an IRB and without the informed consent of the human
subjects who participated.

HHS is reviewing the application of these rules to evidence-based quality
improvement activities, like the Johns Hopkins project, and whether any
changes are needed to encourage such work while safeguarding the rights
and welfare of human subjects in research.

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 19 Feb 2008 05:42:29 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: February 19, 2008

The following new items were added to the CDRH web pages on February 15, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses; Availability.
	Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 19 Feb 2008 10:33:25 -0600 (CST)
Subject: MedWatch - Fentanyl transdermal patches: recall due to gel leak that may lead to respiratory depression and overdose

Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and labelled with an Abrika or Actavis label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. The lots covered by this recall include doses of 25, 50, 75, and 100 mcg/hr and are listed in the firm's press release.

See the complete MedWatch 2008 safety summary, including a link to the firm's press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fentanyl

 

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