SA Orthopaedic Journal
On-line version ISSN 2309-8309
Print version ISSN 1681-150X
DU PLESSIS, TA. The shelf life of sterile medical devices. SA orthop. j. [online]. 2014, vol.13, n.4, pp.32-34. ISSN 2309-8309.
The issues of the shelf life of sterile medical devices and the concept of end-product sterility testing of a sample of devices to prove the sterility of a batch of sterile devices are discussed against the background of the probabilistic approach to sterility and sterilisation. The particular role that the sterilisation technique and the packaging materials used play in maintaining sterility are discussed against the background that sterility and the maintenance thereof is event- and not time-related, and the implications thereof on the shelf life of sterile medical devices.
Keywords : sterile medical devices; sterility maintenance; shelf life.