With over 30 years of experience, Dr. Muscarella’s healthcare and quality services include comprehensive reviews and analyses of adverse events reported to FDA in compliance with federal regulations.

Dr. Muscarella’s “adverse events” services are designed to identify potentially unsafe medical devices.

The following articles are examples of Dr. Muscarella’s research focusing on adverse event reports:

  1. Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap.” (August 2023)
  1. Resistant Infections Linked to Gastroscopes — Is the Concern Sufficiently Recognized?” (January 2023)
  1. Study of FDA reports that describe both the use of hydrogen peroxide (H2O2) as a vapor or gas plasma to achieve sterilization and actual or potential exposure/harm to healthcare workers. (April 2022)
  2. Contamination of Flexible Endoscopes and Associated Infections: A Comprehensive Review and Analysis of FDA Adverse Event Reports. (January 2022)

The first bulleted article, published in August 2023, is likely the most comprehensive review, analysis and data codification of FDA adverse event reports describing: (i) mucosal tissue injuries, and (2) endcap detachment inside the patient during use of new duodenoscope models featuring a disposable distal cover.

The third bulleted article, published in January 2022, aims to be the most comprehensive review, analysis and data codification of FDA adverse event reports describing the potential for a flexible endoscope to remain contaminated and transmit infections.

In summary, Dr. Muscarella’s expert adverse-event services are designed to:

  • Obtain customized reviews and reports of the FDA’s adverse events (“MAUDE”) database
  • Identify unsafe medical devices
  • Receive detailed analyses that include graphs of device trending data through the years
  • Complement case reviews and expert opinions focusing on a device’s design and safety
  • Identify when a device first began to pose a risk to patients
  • Provide important historical perspective about a device’s safety
  • Define corrective actions intended to improve the device’s safety

Several articles discuss Dr. Muscarella’s research on adverse event reports describing endoscope contamination, including:

Email Dr. Muscarella — Larry@LFM-HCS.com — with your questions about his adverse-event reporting analyses and related services.

Call Dr. Muscarella with questions: (267) 613-4567

Other examples of Dr. Muscarella’s device trending research and adverse event work include:

Dr. Muscarella’s reports for clients include not only the raw adverse-event data collected from the FDA’s MAUDE device database, but also a confidential analysis that codifies and organizes the data, and describes the data’s significance.

Click the links below to learn more about Dr. Muscarella’s other expert safety services and to download his consulting brochures:

Dr. Muscarella provides the healthcare community with expert guidance in and direction in the fields and disciplines of, among others:

  • hospital infection causes and prevention
  • medical device design
  • disinfection and sterilization, and instrument reprocessing
  • case reviews
  • risk assessments and analyses
  • decontamination protocols, and data and process validation
  • regulatory submissions
  • quality control and assurance
  • marketing and branding

Dr. Muscarella’s knowledge and expertise in the fields of infection control, sterilization, disinfection, quality assurance, aseptic technique, regulatory affairs, marketing, medical device design and instrument reprocessing, among others, are internationally recognized.

Bio — Dr. Muscarella’s “bio” may be read by clicking here.

Contact — Call | Email | Text | Skype

Confidentiality —  Click here.

C.V. — Download a shortened version of Dr. Muscarella’s current curriculum vitae by clicking here.

Experience — Dr. Muscarella’s experience may be read by clicking here.

Peer-Reviewed Publications: Many of Dr. Muscarella’s published papers may be viewed by clicking here.

Lawrence F Muscarella, PhD, is the president of LFM Healthcare Solutions, LLC | P.O. Box 684, Montgomeryville PA 18936.