B.H. Barkalow & Associates, LLC (BHBA)
, has been established to provide consulting and support services in areas of Medical Technology, Software, and Devices
as regulated by the FDA. BHBA provides services to a range of clients from healthcare organizations, other consulting firms, the FDA, insurance companies, medical device manufacturers, and law firms throughout the country.
- BHBA provides expert assistance and consultation for matters related to medical technology and medical devices. Their services include confidential case review, incident simulations and investigations, export reports, and deposition and trial testimony when necessary.
Healthcare Organization Related Expertise
Medical Device Related
- In-house, shared service, vendor, or other third party medical device support
- Analysis of hospital medical technology profile, identification of problem areas, defining required support resources, compliance with JCAHO medical device related standards, identification of medical technology risk exposure, and case-related technical advice as to the quality and quantity of medical technology support
- Medical Device support personnel job descriptions and performance review
- JCAHO medical device related compliance
- Federal and State compliance with medical technology codes and standards
- Medical Device related User Training and Physician Credentialing criteria
Alan Lipschultz, MS, PE, CCE, CSP
- Medical Device Failure Analysis
- Medical Device Incident Simulations
- Medical Device Labeling including: labels on the device; operator's manuals; and service manuals
- Representations of the medical device function and suitability for use
- User training
- Warranty and after warranty service support
- FDA 21 CFR related compliance
, Clinical Engineering Expert Consultant for BHBA, is a Professional Engineer (PE), Certified Clinical Engineer (CCE) and Certified Safety Professional (CSP). During his nearly 40 years of experience as a Clinical Engineer, he has served as Director of Clinical Engineering for two large hospitals on the east coast. Mr. Lipschultz is the co-chair of the AAMI (Association for the Advancement of Medical Instrumentation) Standards Board and serves on several other AAMI committees (BI&T Editorial Board, Electrical Safety, Infusion Device, Medical Device Alarm and Technology Management).
Mr. Lipschultz's Medical technology experience includes familiarity with the design, use and malfunctions associated with defibrillators, electrosurgical units (ESU), infusion pumps, patient monitors and many other medical devices found in hospitals.
Matthew F. Baretich PhD, PE, CCE
, Senior Clinical Engineering Expert Consultant for BHBA, has over 30 years of clinical engineering and biomedical engineering experience. He has served as Director of Clinical Engineering for Children’s Hospital of the King’s Daughters as well as Director of Biomedical Engineering for the University of Colorado Health Sciences Center. He is a Certified Clinical Engineer (CCE), Certified Healthcare Facilities Manager (CHFM), as well as a Certified Professional in Healthcare Risk Management (CPHRM). Among Dr. Baretich’s credentials and professional activities are Founder and Past-President of the American College of Clinical Engineering and member of the World Health Organization’s Technical Advisory Group on Health Technology.
Dr. Baretich's medical technology experience includes familiarity with the design, use and malfunctions associated with a variety of medical equipment and building systems. Experience includes surgical equipment, dialysis equipment, critical care equipment, infusion pumps, pulse oximeters, emergency and isolated power systems, and other medical and building equipment and systems.
Theodore Cohen, MS, CCE, FACCE
, serves as a Clinical Engineering Expert Consultant for BHBA. Mr. Cohen is a Certified Clinical Engineer (CCE) and Fellow of the American College of Clinical Engineering (ACCE). He has more than 36 years of hospital-based experience in the field of clinical engineering, and served as Manager of Clinical Engineering at the University of California Davis Health System.
Mr. Cohen is familiar with the design, application and uses of most FDA-regulated medical devices and technology. This includes such areas of application as for patient monitoring, surgery, clinical laboratory, cardiology, radiology, pulmonary (including respiratory therapy) as well as compliance with Joint Commission, CMMS and FDA standards and regulations. Mr. Cohen is also familiar with, and has experience in, teaching application of medical devices for physicians, nurses, and technicians. Among his accomplishments and professional activities are a Lifetime Achievement Award from the American College of Clinical Engineering, serving as co-editor of ACCE News
, and subject matter expert for the AAMI HTM Benchmarking Solutions and AAMI HTM Levels projects.
View BHBA's Consulting Profile