Abstract
While many developing countries may not afford state-of-the-art medical equipment, they may take advantage of the significant price reduction and other benefits of remanufacturing to solve their perennial healthcare problems that are aggravated by the shortage of medical equipment. As a first step towards implementing medical equipment remanufacturing in developing countries, the regulatory perspectives which plays a crucial role in the industry should be understood. However, since regulation of medical equipment is weak or inexistent in most developing countries, the regulatory perspectives with respect to remanufacturing or related activities in both the European Union (EU) and the United States of America (US) are first examined to determine their impacts. Unfortunately, there appears to be a lack of precise definition of remanufacturing for medical devices. An unambiguous definition is necessary to promote effective research, improve understanding, ensure uniformity of standards, drive quacks out of the remanufacturing market and thus, enhance customer confidence in remanufactured products. This paper proposes a definition for medical equipment remanufacture. The principal advantage of this definition is that it could be adopted in future research toward increasing access to functional medical equipment to developing countries through remanufacturing.
Highlights
It is difficult for many developing countries to access medical equipment necessary for healthcare
This paper proposes a definition for medical equipment remanufacture
The medical equipment sector is one crucial area where its practice would yield tremendous benefits contributing to the sustainable development goals of health and poverty alleviation
Summary
It is difficult for many developing countries to access medical equipment necessary for healthcare. The model is primarily useful in resolving ethical, liability, environmental and cost issues associated with reusing single-use medical devices While these papers address medical equipment remanufacturing from various perspectives, none has reported the manner in which it is practised in the industry, especially from the perspective of fulfilling regulatory requirements which determine medical equipment market entry. This paper intends to analyse the EU and US regulatory perspectives with respect to medical equipment remanufacturing or related practices and to propose a definition for remanufacturing which can help to achieve the goal of increasing access to functional medical equipment in developing countries. This is important as current approaches are unsustainable. The European remanufacturing network market studies show that many developing countries are destinations for used medical equipment sold ‘as is’ or following poorly conducted recovery process [18], a situation which has contributed to the abundance of poor quality medical equipment that either cannot be put to use or would no longer be safe
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
