|
A common practice in healthcare, reuse of single-use medical devices
(SUDs),offers hospitals significant cost savings opportunities without
impacting patient care. Hospitals typically implement reuse programs by
contracting with third-party companies who collect used SUDs, reprocess
them in accordance with strict FDA guidelines, and return them to
facilities ready to use. The success of any reuse program depends on
careful matching of the facility’s needs with the reprocessor’s
capabilities as well as thorough education and participation of staff
members. Additionally, ongoing reassessment of the program is necessary
to judge the degree of success as well as to look for opportunities to
expand savings.
In spite of the success that the healthcare community has achieved
with reuse, the practice remains controversial and poorly understood.
Misleading portrayals in the lay media and marketing efforts made by the
original manufacturers of SUDs have fostered negative perceptions and
resistance among patients and, in many cases, healthcare practitioners.
Additionally, recent legislative action at the state level may have a
significant impact on the practice in the near future.
This program will discuss the regulatory framework governing reuse
and offer recommendations to help implement and assess reuse programs.
It will review the current body of evidence addressing the safety and
efficacy of reprocessed SUDs and offer tips on judging the quality of
reports or studies addressing the topic. Finally, the program will cover
the legal implications of reuse, including that of recent state
legislative efforts.
Objectives
At the conclusion of this program, participants should be able to:
- Examine the current regulatory environment governing reuse of
single-use devices (SUDs).
- Evaluate the current evidence of safety and efficacy of
reprocessing SUDs.
- Develop strategies to implement or reassess reuse programs.
- Describe for the impact of legal requirements on reuse programs.
Presenter
Daniel C. Alt - Senior Project Officer & Problem
Reporting Network Manager, ECRI Health Devices Group
Dan Alt joined ECRI in September 1997. He is the manager of ECRI’s
Product Reporting Network, which gathers and investigates reports of
incidents involving medical devices from healthcare providers, patients,
and manufacturers around the world. In his additional role as Senior
Project Engineer, Mr. Alt has performed or assisted in over thirty
accident investigations for healthcare facilities. He is responsible for
evaluating or analyzing technologies and topics involving surgery,
flexible endoscopy, anesthesia and respiratory care, and the reuse of
single-use medical devices.
Mr. Alt obtained his bachelor of science degree in mechanical
engineering from Clarkson University in May 1992. He has done additional
undergraduate and graduate work at the University of Vermont. Before
joining ECRI, he worked for several years in the aerospace and
semiconductor industries.
Madelyn S. Quattrone, Esq. - Senior Risk Management
Analyst
Ms. Quattrone joined ECRI in 1999 as a Senior Risk Management
Analyst. She is editor of ECRI’s Continuing Care Risk Management, a risk
management publication and service for long-term care providers. She
also contributes regularly to ECRI’s Healthcare Risk Control System, a
risk management and patient safety resource for acute care.
Before joining ECRI, Ms. Quattrone was a shareholder in the law firm
of George, Korin, Quattrone, Blumberg & Chant, P.A., in Woodbury, New
Jersey, where, from 1982-1999 she defended physicians, hospitals, and
nursing homes at trial and on appeal.
The Supreme Court of New Jersey awarded Ms. Quattrone designation as a
board certified civil trial attorney in 1990. She was selected for
membership in the American Board of Trial Advocates in 1993. Ms.
Quattrone served as a member of the New Jersey Supreme Court Committee
on Trial Attorney Certification from 1997-1999. She has been a member of
the bars of the Commonwealth of Pennsylvania and the State of New Jersey
since 1981 and is admitted to the bars of the U.S. District Court of New
Jersey, the 3rd Circuit Court of Appeals, and the U.S. Supreme Court. As
an adjunct professor of law at Rutgers University School of Law in
Camden, New Jersey, Ms. Quattrone taught Pre-trial Advocacy.
Before joining ECRI, Ms. Quattrone provided risk management
consultation to hospitals, physicians and professional liability
insurers, and contributed to the development of a Clinicolegal
Correspondence Course for the Medical Inter-Insurance Exchange of New
Jersey. She also was a co-editor and a regular contributor to the
Emergency Physician Legal Bulletin, the Emergency Nurse Legal Bulletin
and the Emergency Medical Technician Legal Bulletin, and a contributing
editor to the Journal of Emergency Nursing.
Ms. Quattrone served on the Institutional Review Board of Kennedy
Memorial Hospital, Stratford, New Jersey. She has presented on a wide
range of legal and risk management issues to attorneys, insurers, health
care risk managers, and healthcare providers. Among the subjects she has
addressed are effective communication in healthcare, informed consent,
ethical and legal issues involving human reproduction, obstetrics,
end-of-life decision making., medication safety, transmission of
bloodborne pathogens, delivery of pre-hospital emergency care, oncology
services, medical record documentation, and the privacy and security
regulations of the Health Insurance Portability and Accountability Act (HIPAA).
She has provided direct in-service training on fall prevention to long
term care staff. She has developed and participated in mock medical
malpractice trials for audiences of medical students, residents, and
physicians at the University of Medicine and Dentistry, Stratford, New
Jersey and to clinical engineers through the Association for the
Advancement of Medical Instrumentation (AAMI). At the American Society
of Healthcare Risk Management’s annual conference in 2000, Ms. Quattrone,
along with ECRI’s forensic experts, discussed criminal issues that may
arise in the aftermath of medical adverse events.
Continuing Education Credit:
Available through – July 24, 2008
A Nursing Continuing Education Activity (1.0 hours) 0109-7075
This session has been approved for continuing nursing education
contact hours through the Illinois Nurses Association, an accredited
approver by the American Nurses Credentialing Center’s Commission on
Accreditation.
|
 |
|