Biomechanical and surface physico‐chemical analyses of used osteosynthesis plates and screws—Potential for reuse in developing countries?

Abstract

Reprocessing of single-use devices is an upcoming issue in the Western world, but has been for many years in developing countries. In developing countries, the number of bone fractures due to traffic or industrial accidents is high. Patients often need an osteosynthesis with plates and screws, but most patients, however, cannot afford this because of the costs involved and have to rely on the application of used plates and screws. This study aims to determine whether used plates can be safely reused in another patient from a biomechanical, surface physico-chemical, and biological point-of-view. Osteosynthesis plates weakened in a predictable way during use, regardless of the history, presumably because tests were conducted under extreme conditions in the absence of clinically applied load-sharing between bone and plate. Surface physico-chemical analyses indicated that used plates and screws were more hydrophilic than new ones; had increased amounts of calcium-phosphates at their surfaces; and possessed higher number of scratches. Pitting corrosion could be seen on SEM micrographs. Simple cleaning methods, as available in developing countries, including toothbrush, water, detergent and bleach yielded elemental surface compositions, and hydrophobicities similar to those of new ones, while biologically thus cleaned screws were not cytotoxic according to ISO-10993-5 and endotoxin release according to USP-27-NF-22 was within the requirements of the FDA. It is concluded that the reuse of osteosynthesis plates and screws is not necessarily unsafe, although preferably a register should be kept of all previous users to limit the number of reuses as mechanical weakening does occur.

Clinical translation of the assets of biomedical engineering – a retrospective analysis with looks to the future

“…Globally, large patient groups, especially in developing countries, lack access to the assets of biomedical engineering due to their high costs. Orthopedic implants are not seldom used from one patient into another [45,46] or are locally produced [47], all to reduce costs and make them more widely available. New fields of BME such as eHealth, organ-on-a-chip, and 3Dprinting are yielding cost-reductions without becoming visible as the new and spectacular advances like in the age of the giants, and lacking a clear impact on disease, morbidity and decline.…”

Biomaterials for the developing world

“…Biomaterials have many applications in noncommunicable diseases such as in heart tissue and blood vessel repair and regeneration,3 and insulin pumps, bioartificial pancreas, and implantable glucose sensors for the treatment of diabetes 4. Developing countries also have high rates of traffic and industrial accidents with patients needing implants with high‐quality biomaterials for tissue repair, such as plates and screws 5. Furthermore, the incidence of burn injuries is often higher in developing countries than in the developed world because of poverty, poor housing conditions, overcrowding, and illiteracy 6.…”

“…The high cost of most new biomaterials also causes many biomaterials and implants labeled “single use” to be reused with the risk of transferring antigenic and or infectious material from one person to another. In addition, there is the possibility that the devices might have been weakened/compromised by the previous usage 5…”

“…4 Developing countries also have high rates of traffic and industrial accidents with patients needing implants with high-quality biomaterials for tissue repair, such as plates and screws. 5 Furthermore, the incidence of burn injuries is often higher in developing countries than in the developed world because of poverty, poor housing conditions, overcrowding, and illiteracy. 6 Biomaterials are used in dressings and tissue engineered skins for skin burns.…”

“…In addition, there is the possibility that the devices might have been weakened/compromised by the previous usage. 5 Clearly, the development of biomaterials suitable for developing countries has been neglected. A Pubmed search with the key words ''biomaterials'' and ''developing countries'' returned only 31 entries (as of January 12, 2010) and most of the references were only marginally relevant.…”