Experience

Dr. Muscarella has more than 20 years of experience in:

  • managing, overseeing, and participating in:
    • research and product development;
    • quality control and assurance, and product trending;
    • document control;
    • medical-device engineering;
    • design control;
    • customer complaints, medical device reporting, and other FDA regulatory requirements;
    • 510(k) applications and clearances;
    • infection control;
    • risk management and assessment of the risk of patient harm associated with a specific medical error;
    • legal and regulatory affairs;
    • root cause analyses;
    • marketing and sales;
    • product branding;
    • writing medical articles for publication in the peer-reviewed medical literature; and
    • manufacturing processes.

Dr. Muscarella also has experience in legal affairs, reviewing legal documents discussing the potential causes of possible patient harms (including healthcare-associated infections) involving medical devices. Click here for more information.

Dr. Muscarella specializes in – and educates and advises healthcare facilities (and manufacturers) about – the following topics, among others:

  • infection-control in the gastrointestinal (GI) endoscopy department (as well as in the urology, respiratory therapy, and other flexible endoscopy departments);
  • investigating infectious outbreaks and healthcare-associated infections (HAIs) in these aforementioned departments;
  • manual and automated endoscope- and instrument-reprocessing;
  • surgical and endoscope cleaning technologies;
  • disinfection and sterilization;
  • prevention of medical errors (including of healthcare-associated infections;
  • isolation precautions;
  • root cause analysis (click here for more information);
  • risk assessments (click here for more information);
  • reviewing infection-control policies and procedures to ensure compliance with national standards (click here fore more information); and
  • observing and auditing infection-control practices to ensure their compliance with documented policies and procedures (click here for more information).

Dr. Muscarella also educates manufacturers on these other topics, among others (including some of those discussed above):​

  • how to perform a FMEA (failure mode effects analysis), to ensure a medical device’s design (or a change to the design) is controlled, safe and effective;
  • design control;
  • verification and validation of the safety and effectiveness of a medical device (or of a change to the device’s design);
  • submission of 510(k) applications to market medical devices labeled for, for example (and not limited to):
    • washer/disinfectors for flexible endoscopes;
    • flexible endoscopes and their accessories;
    • high-level disinfectants;
    • liquid chemical sterilants;
  • developing and performing both simulated and clinical in-use protocols to both validate and verify the effectiveness of its reusable medical devices (e.g., their ability to be thoroughly cleaned and either disinfected or sterilized); and
  • evaluating the safety of a reusable medical device’s design; and
  • reviewing the device’s associated instrument-reprocessing instructions to ensure their completeness and compliance with the FDA’s regulations.

Questions? Email Dr. Muscarella: Larry@LFM-HCS.com

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