Abstract
The socio-economic conditions in many developing countries impede widespread general use of the assets of biomedical technology. In orthopedics this becomes evident from the large-scale, though illegal, reuse of osteosynthesis plates and screws. Scientific research into the issue of the safe reuse of osteosynthesis materials from a biological point of view has never been done. Therefore the aim of this study is to determine whether plates and screws after simple cleaning, applying means which are available in developing countries, are safe from a biological point of view. Cleaning methods evaluated include a toothbrush, water, detergent and bleach. X-ray photoelectron spectroscopy analysis of cleaned surfaces and water contact angle measurements indicate that application of these methods yield surface characteristics similar to those of new, sterilized plates. If desired, bleach can be applied without affecting the surface properties of the materials.
Subsequently, the reactivity of a mammalian monolayer in response to a used screw (ISO-10993-5) and endotoxin release (USP 27-NF 22) was evaluated, showing that all screws tested are non-cytotoxic with endotoxin release within the requirements of the FDA. This study shows that reuse is not necessarily unsafe from a biological point of view.
Correspondence should be addressed to Diane Przepiorski at ISTA, PO Box 6564, Auburn, CA 95604, USA. Phone: +1 916-454-9884; Fax: +1 916-454-9882; E-mail: ista@pacbell.net
