Controlling Device Reuse by UDI Labelling
Much has been written in recent years about the pros and cons of reusing medical devices originally intended for single use on a single patient. It would be unreasonable to expect manufacturers to accept responsibility for unsatisfactory performance of a device that had been reprocessed and resterilised when it was not designed for repeated use.
However, if a device is designed for multiple uses, it of paramount importance that the process of cleaning and resterilisation is performed according to the manufacturer's guidelines, the number of uses is recorded, and recycling never exceeds the number of processes permitted by the manufacturer. The required information to enable the cleaning, repackaging, and resterilisation must be validated by the manufacturer and provided in the instructions accompanying the device.
When products are not uniquely identified, it may be impossible to be certain how many times each item has been used and reprocessed. Many devices are cleaned and resterilised multiple times without being used at all; these devices are supplied to the operating theatre in the form of kits from which the surgeon will remove the items needed for a certain procedure. After that procedure, all the unused items will be cleaned and resterilised. The missing items will be replaced with new or reprocessed devices, thus making the kits ready for the next procedure.
In October, the UK Medicines and Healthcare Products Regulatory Agency reported that an ultrasound probe had gone through more autoclave cycles than recommended in the instructions. This was discovered as a result of an incident in which patient harm was reported. "Re-sterilization of devices beyond the number recommended by the manufacturer may result in unexpected failure of the device," the agency said. "Always ensure that the device is re-sterilized in accordance with the manufacturer’s instructions for use."
Clearly this type of incident could be avoided if the device and its packaging carried a unique identifier linked to a control system that tracked its use, cleaning, repackaging, resterilisation, and reuse. Such a system is described in the HIBC standard "IDC supported clinical processes, Hygiene process for instruments."
This useful document is based on the relevant ISO, HIBC, and DIN standards for automatic identification. It defines data elements and codes for unique data capture at every step of the hygiene process, thus facilitating full process documentation. The Health Industry Business Communications Council was recently accredited by the FDA as an issuing agency for unique device identifiers.
Rolande Hall, FIMMM Pkg Prof