Latest posts by Lawrence F Muscarella PhD (see all)
- A Duodenoscope Has Been Linked to ‘Probable Transmission’ of a Colistin-Resistant Superbug In January, the FDA had issued a safety alert reporting a "design issue" with this endoscope "that could increase the risk of patient infection." - December 8, 2017
- FDA Clears A Duodenoscope with a Detachable Cap Almost 20 years ago, the FDA cleared two other duodenoscope models with a reusable distal cover for sale in the U.S. - September 25, 2017
- Air Force Advises 135 Patients of HIV, Hepatitis Infection Risk a Year Later A number of questions about this lapse remain unanswered. - June 26, 2017
Medical Device Manufacturers
Reduce costs and improve quality by outsourcing your research and quality work to Lawrence F Muscarella, PhD, whose expertise in the fields of infection control, medical device design, and instrument reprocessing is well-known.
Dr. Muscarella specializes in providing advice to manufacturers about preventing ‘superbug’ infections linked to contaminated gastrointestinal endoscopes, particularly duodenoscopes, reprocessed manually or using an automated endoscope reprocessor, or AER.
Download a copy of Dr. Muscarella’s brochure explaining several of the quality, research, marketing, and regulatory services that he provides for manufacturers.
Dr. Muscarella’ services are designed for manufacturers to:
- reduce costs
- improve quality and safety
- ensure confidentiality and trust
- minimize risk
Dr. Muscarella’s services provide manufacturers with an ideal opportunity for outsourcing work projects.
Dr. Muscarella is the president of LFM Healthcare Solutions, LLC. Click here to learn more about him.
As detailed in his brochure, Dr. Muscarella’s services include:
- writing detailed technical bulletins, white papers, and product monographs that explain to the marketplace (in an easy-to-understand format) the performance of a medical device;
- writing peer-reviewed articles that, in addition to providing the manufacturer with market exposure, feature unique recommendations for the prevention of disease transmission when using in the clinical setting a reusable medical device;
- assisting in the development, branding, sales and marketing of medical devices;
- assisting in the opening and completion of preventive and corrective actions (“CAPAs”) as required to comply with federal regulations;
- reviewing for completeness and regulatory compliance the quality and regulatory records and documentation associated with a marketed medical device;
- performing validation and verification design-control activities;
- assessing the risk of disease transmission and other types of patient harms associated with a medical device;
- performing a failure mode and effects analysis (FMEA) of a medical device;
- performing a root cause analysis (RCA) to assist a manufacturer’s identification of the cause(s) of an adverse event associated with a marketed medical device; and
- given manufacturer-sponsored lectures to potential purchasers (e.g., nurses, doctors) of medical equipment, providing both continuing education units (CEUs) for attendees and advertising exposure for the sponsor.
Email Dr. Muscarella directly with your questions: Larry@LFM-HCS.com
Dr. Muscarella’s confidentiality and privacy policies are strict. No confidential correspondence of any type, at any time, is disclosed directly or indirectly — click here for more details.
Lawrence F Muscarella, PhD, is the president of LFM Healthcare Solutions, LLC | P.O. Box 684 | Montgomeryville PA | 18936.
Email Dr. Muscarella at: Larry@LFM-HCS.com