Clinical Engineering is a specialty within Biomedical Engineering. According to The American College of Clinical Engineering, "A Clinical Engineer is a professional who supports advances to patient care by applying engineering and managerial skills to healthcare technology."
In 2011, Technology Management Council of AAMI (Association for the Advancement of Medical Instrumentation) recommended a new term, Healthcare Technology Management as "the official name of the field responsible for managing the selection, maintenance and safe and effective use of medical equipment and systems." It is largely for this reason that we chose HealthCare Technology Consulting as the name of the firm.
In the clinical environment things sometimes go very wrong. Devices may fail in a multitude of ways and for a variety of reasons, users may make errors, and patients may be injured. Forensic engineering is a process whereby the cause(s) of the failures are discovered. The information learned is communicated to the various stakeholders such that improvement may be achieved and the likelihood of recurrence reduced.
We are used to the role of explaining technical subjects to non-technical people. When working for hospitals or other healthcare organizations, we will work collaboratively with clinicians and risk managers to determine root and secondary causes of events. When working for patients or manufacturers, we know how healthcare organizations are supposed to work and therefore what questions should be asked.
If warranted, we have access to several testing laboratories to do physical analysis of devices or accessories involved in an event.
We can prepare written statements as to our findings. If needed, these written statements can be used during legal proceedings.
|Medical devices are designed by a diverse team. Users are often asked for input on design concepts, however medical professionals often speak a different language than the design engineers creating the products. We are engineers with a lifetime of experience embedded with clinicians - we speak both languages fluently and can bridge the gap for you and your customers. Medical device manufacturers have used us both before devices are on the market and/or reviewing their "Safety Case" for a product. Our role is to be an outside technical reviewer with real world perspective in order to supplement the internal design team. We are able to assist medical device manufacturers prepare a Safety Assurance Case.|
About the President of HealthCare Technology Consulting
Alan Lipschultz, PE, CCE, CSP, CPPS, FACCE, AAMIF
Alan has 47 years of professional experience in the healthcare technology industry, including serving as Director of Clinical Engineering at two major hospitals for 37 years.
Detailed information on Alan Lipschultz
Alan holds several professional certifications:
- Professional Engineer (PE) – State of Delaware, License # 7875
- Certified in Clinical Engineering (CCE) by Healthcare Technology Certification Commission, Certificate # 66
- Certified Safety Professional (CSP) by Board of Certified Safety Professionals
- Certified Professional in Patient Safety (CPPS) – Certification Board for Professionals in Patient Safety, part of the Institute for Healthcare Improvement (IHI)
- Fellow, American College of Clinical Engineering (FACCE)
- Association for the Advancement of Medical Instrumentation (AAMI) Fellow (AAMIF)
Alan is active at the national level, including the following awards and memberships:
- Recipient, 2006 Clinical/Biomedical Engineering Achievement Award from Association for the Advancement of Medical Instrumentation (AAMI)
- Recipient, 2012 Marv Shepherd Patient Safety Award
- Co-Chair, AAMI Standards Board (1993–2015)
- Editorial Board of Biomedical Instrumentation and Technology (AAMI Journal) (1987-2018)
- AAMI Technology Management Council (2004-2018)
- Chair, National Fire Protection Association (NFPA) Medical Equipment Technical Committee (2007–2015) & Member (2015-present)
- Fellow, American College of Clinical Engineering (ACCE) (2015-present) & Member (1991-present)
- Vice President, ACCE Board of Directors (2016-2018), Member at Large (2012-2016)
- Fellow, AAMI (2020-present) & Member, AAMI (1971-present)
- Professional Member, American Society of Professionals in Patient Safety (ASPPS); part of the Institute for HealthCare Improvement (IHI) (2012-present)
- Member, Forensic Expert Witness Association (2015-present)
- Member, AAMI Electrical Safety Committee (1975-present)
- Member, AAMI Infusion Device Committee (2010-present)
- Member, AAMI Medical Device Alarms Committee (2011-present)
- Member, National Coalition for Alarm Management (2014-2018)
- Member, National Coalition for Infusion Therapy Safety (2015-2018)
- Member, National Coalition to Promote Continuous Monitoring of Patients on Opioids (2014‑2018)
- Member, National Coalition to Promote the Safe Use of Complex Healthcare Technology (2017‑2019