Per the FDA, the draft guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." Such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. The draft guidance also provides recommendations for information that should be included in labeling to help assure the continued quality, safety and effectiveness of devices that are intended to be serviced over their useful life.
Resource Library
491 Results Found
Advocacy
On-Demand Educational Webinars
From common pre-planning challenges like ICRA collaboration to challenges which often emerge within the first weeks of a project, such as dust and debris containment and ILSM adherence, our panelists will offer actionable advice,
Monograph
Support your efforts to strengthen your energy procurement and resiliency policies and finance your sustainability projects.
Education & Events
An overview of safety considerations for contractors and electricians working in health care facilities.
On-Demand Educational Webinars
Book
A step-by-step guide for developing a comprehensive integrated fire protection and life safety inspection, testing and maintenance (ITM) program for health care facilities. This timely publication will support facilities managers ahead of CMS’s adoption of NFPA 101-2018 (or later), which will require integrated life safety ITM for all high-rise buildings.
Monograph
Best practices for financing energy sustainability are described with an emphasis on helping hospitals and associated decision-makers – including professionals from supply chain, facilities, finance, sustainability, and public health – navigate the challenges associated with investing in the carbon reduction goals that health care is being asked to implement.
Monograph
Get insights into the regulatory requirements and maintenance recommendations for smoke control systems in hospitals.
On-Demand Educational Webinars
Review peer-reviewed literature on the efficacy and potential for byproduct formation from ions and other chemically additive cleaners.
On-Demand Educational Webinars
While zero Legionella in hospital water systems might not be attainable, zero cases of Legionnaires’ disease can be.
On-Demand Educational Webinars
Learn from fellow health care operations professionals the keys to acing your next compliance survey. Gain insights on utilizing technology to help you feel confidently compliant while increasing operational efficiencies in your hospital organization.
On-Demand Educational Webinars
In this webinar, Dr. Thomas Doerdelmann will introduce a new in-air pathogen surveillance solution that can identify the presence of SARS-CoV-2, FLU A&B and/or RSV A&B in indoor air to help you monitor and strengthen facility safety protocols. By attending, you’ll gain an understanding of the aerosol collection technology, the workflow of facility implementation and use case applications.
On-Demand Educational Webinars
This course discusses how once basic interior sliding doors systems have evolved into a sophisticated solution for a range of commercial spaces with their ability to attenuate sound, improve wayfinding, comply with ADA requirements and defend against fire.
On-Demand Educational Webinars
This lunch and learn will talk about impact and usage of sensors, as well as, highlight novel implementations.
Education & Events
Strengthen your facility's readiness for compliance surveys with ASHE's Physical Environment Survey Readiness Program. Register now for upcoming live programs!
Book
Introduction to Health Care Facilities Management: This award-winning, in-depth 130+ page introductory book provides an orientation to the dynamic field of health care facilities management. Along the way, we provide tips and anecdotes from seasoned health care professionals that will be valuable to newcomers, engaging to experienced HFMs and thought-provoking to other health care professionals.
On-Demand Educational Webinars
Walk through the electrical safety roadmap from pre-design through installation and post-installation.
On-Demand Educational Webinars
This course will walk participants through site acceptance and in-service testing and will review best practices that will empower facility owners and managers to administer appropriate test strategies and service programs to maintain a reliable power system.
Compliance Tools
Make facility master planning easier with our sample template. Customize your plan using our subcategories. Join ASHE for more resources and support.
On-Demand Educational Webinars
in this session we will explore the unintended consequences of having so many sinks. We will explore the dynamics of transmission from patient to drain and back to patient. We will present the current understanding of the problem, assess challenges created by antibiotic resistant bacteria in wastewater premise plumbing and explore potential solutions.