In response to Morrison‐McKell and wehrli

We read with great interest the recent article by Morrison-McKell and Wehrli regarding the instrument comparison of machines suitable for a therapeutic apheresis medical service [1]. The use of apheresis-based therapies is important for a number of medical specialties and in many cases the specific application varies greatly. For example, patients treated with collected mononuclear cells are generally very different from patients treated with plasma exchange. Thus, the opportunity for a direct comparison between devices is an important delineation for healthcare practitioners and technicians. The manuscript provided by the authors is thus of value to the field in general. To make such a comparison as useful as possible, it is important that all information be considered for the various platforms that are available. We would like to point out that the authors have listed that the Spectra Optia device only performs therapeutic plasma exchange. The device is currently approved for therapeutic plasma exchange and mononuclear cell collection in the United States (with other protocols under review by the FDA). Outside the United States there is routine use of the device to perform several procedures including, red cell exchange, red cell depletions, white cell depletions, platelet depletions, and mononuclear cell collections. Several reports on the performance of the device in this regard have already been published or presented in several forums and additional publications of this data are pending [2–6]. One of the main features that the Spectra Optia device will provide is the ability to automatically maintain a cell or plasma collection interface. The Spectra Optia represents a potential advance in apheresis technology with improved process control and ease of use for practitioners and utility (e.g., mobility), so that they can spend more time focused on patient care in the hospital environment [3,4]. The COBE Spectra and the Spectra Optia are used successfully on a global basis to deliver clinical benefit to patients with many underlying diseases, often requiring the use of procedures that are less common in frequency but often urgent and important in need [7]. Although the majority of apheresis procedures performed throughout the world are mononuclear cell collections and therapeutic plasma exchanges, these other less-frequently performed procedures are also very important for patient care. The requirement to evaluate the performance of new devices in these rare applications has posed challenges for all in defining an appropriate clinical and regulatory approval pathway in The United States. Nevertheless, the device has already been used very successfully to treat patients in various geographies outside the United States [2–5] (see also Table I). These data and experience suggest that similar treatment options will be available to physicians practicing in the United States, once appropriate regulatory approvals are obtained. This is a goal that all of us (regulatory, physician, and industry representatives) are currently and diligently working toward. TABLE I. Regulatory Approval Status on Spectra Optia Device