Standards for Point-of-care Equipment
Advances in miniaturization, particularly in microfluidics, have enabled a new class of diagnostic equipment. “Point-of-care“ diagnostics allow a broad spectrum of diagnostic tests to be carried out at the patient´s bedside. Examinations that once required equipment located in centralized laboratories can now be conducted in a myriad of locations: at the hospital bedside, in primary- and secondary-care facilities or even at home. “Point-of-care“ diagnostic equipment provides faster examination results and can contribute to lower costs. In theory, diagnostic tests can be run regardless of the location.
However, a representative of the responsible institution must control and ensure that any governmental and institute-based quality and procedural guidelines and regulations are adhered to. It´s therefore imperative that “Point-of-care“ equipment providers incorporate mechanisms that make it possible to integrate their products into existing institute-wide systems for controlling quality and managing diagnostic information. The need for integration forms the starting point for standardization in this area.
For the descriptions that follow, “Point-of-care tests“ refers to all examinations carried out at the location where the patient is being cared for. This can involve a wide variety of locations ranging from the hospital bedside and physician´s office to any private or public environment in which the examinations are conducted automatically or carried out or initiated by the patient. “Point-of-care“ connectivity standards should have utility in all of these situations to the extent they are technically feasible.