From the Philadelphia Inquirer:

‘Superbug’ infects eight patients at an Unnamed Philadelphia hospital.

What’s news?

“This article in the Philadelphia Inquirer is part of a new national discussion, not just about: (i) the risk of ‘superbug’ transmissions during gastrointestinal (GI) endoscopy, (ii) the FDA’s regulation of medical devices, and (iii) state health department’s oversight and responsibility to the public, but also about: (i) informed consent, (ii) transparency, (iii) disclosure and patient notifications of medical errors; (iv) the completeness of death certificates, and (v) the patient-physician relationship.” — Lawrence F Muscarella PhD

The Philadelphia Inquirer article

  • “A Philadelphia hospital was struck last year by an outbreak of drug-resistant bacteria associated with the use of a special kind of hard-to-clean endoscope, according to city data. Eight people examined with the scopes became infected with bacteria resistant to a class of last-resort antibiotics called carbapenems, and two died, the city Department of Public Health said. These ‘superbug’ bacteria have an estimated mortality rate ranging from 25 percent to 50 percent in those infected.”

Notable quotes

Philadelphia City Department of Public Health:

  • Both of the Philadelphia patients who died (and were infected with the superbug) had serious underlying conditions, so their deaths were deemed “not clearly related” to the infection.

Caution: This statement is not necessarily accurate — especially for a superbug like whose mortality rate is 50%. One can only conclude that a superbug was not related to an infected patient’s death if there are clinical data confirming this. Absent these confirmatory data, it is scientific to conclude that the superbug may have contributed, directly or indirectly, to the patient’s death, and the death certificates would have to reflect this (e.g., Line 112 of the Los Angles County [CA] death certificate would include this information).

It is my opinion that Dr. Moran should have said: We “cannot rule out the superbug as a possible cause of two infected patients’ deaths.”

Legal Reviews for Patients, Hospitals, Manufacturers:  Click here to read about Dr. Muscarella’s expertise and legal assessments of the causes of healthcare-associated infections, including “superbug” outbreaks linked to contaminated GI endoscopes and other reusable medical equipment.

Philadelphia City Department of Public Health (continued):

  • “It is a more prevalent problem than most people realize,” said Caroline Johnson, director of the department’s division of disease control.
  • Johnson declined to identify the Philadelphia hospital with infections linked to the scopes, saying the city did not want to discourage facilities from reporting cases.
  • “A place who tells you they have no cases may or may not really have no cases,” Johnson said.
  • Philadelphia health officials say five other clusters of cases were reported at city nursing homes in the last three years, not linked to any identifiable source.

Lawrence F Muscarella, PhD:

  • “This is a real public-health problem,” said biomedical engineer Lawrence Muscarella, a Montgomeryville infection-control consultant who has been urging the Food and Drug Administration to toughen recommendations on device design and cleaning.
  • “The design of the duodenoscope can increase the difficulty in cleaning,” the agency said in a statement.

ECRI Institute

  • Yet some hospitals have decided to go beyond what is recommended with a more time-consuming method called gas sterilization, said Chris Lavanchy, engineering director at the ECRI Institute, a Plymouth Meeting nonprofit organization that evaluates medical devices.
  • “The thinking is that the gas may permeate areas where the liquid can’t get to,” Lavanchy said.
  • Among the devices’ tough-to-clean features are their narrow channels and intricate mechanisms, which can develop cracks or imperfections over time, Lavanchy said.

New Jersey Health Department

  • No outbreaks have been reported there in the last three years, said Donna Leusner, spokeswoman for the state Health Department.

Quality Services

Click here to read about Dr. Muscarella’s quality healthcare services, which he provides to assist manufacturers and health care facilities improve patient safety through the prevention of disease transmissions.

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