A review of the advertisements found in the various anesthesiology journals reveals a consistent underlying theme among manufacturers: that the monitoring device or devices which are featured in a particular advertisement will serve to improve the ability of the anesthestist to deliver anesthesia. Reviewed here are some industry trends which led to the advertised claims. Also offered is one view as to what industry might do in the future to fin further respond to demands to help increase patient safety in the operating room.
The success of the pulse oximeter has had a significant influence on the medical device industry. The importance of devices which feature simple operation and address the prevention of anesthetic mishaps has led to a series of new technologies which have achieved relatively rapid acceptance in the anesthesia community. As an example,the catastrophic potential of breathing system failures has led to a variety of products with technologies aimed at measuring physiologic paraneters such as mixed venous oxygen saturation and end tidal carbon dioxide. These physiologic parameters aid in the assessment of the adequacy of tissue oxygenation and patient ventilation.
With the advent of new devices for monitoring in addition to the monitors which have been widely used for many years, the anesthesia community has started work to develop methods of organizing the resulting large array of independently functioning displays and alarms. Companies in the medical device industry are working actively with anesthesiologists on organizing the mass of data from monitors in ways which facilitate the rapid recognition of critical incidents by anesthetists.
Several companies have recently introduced products which show some of the fruits of this work in the form of novel display formats and integrated alarm systems. In addition, many companies are cooperating in the formulation of a standard aimed at allowing monitoring devices in the operating room to communicate with one another and share information. This standard, called the Medical Information Bus, once approved, will provide further opportunities for device manufacturers who are working to improve data displays and alarm enunciations in the future.
In the future, industry will continue to focus on technologies to provide products to the anesthetist which will improve patient safety during anesthesia. It is recognized that devices will never replace the expertise of the clinician, but it is also acknowledged that products can be good “electronic assistants ” if they are designed with an understanding of what a clinician requires of such an assistant.
It should be recognized that the medical device industry will have to tackle some significant issues in the future. The resolution of these issues will serve to allow manufacturers to provide anesthesia work station which further addresses issues of patient saw. Some of these issues are:
The impeded coordination and management of data by a fragmented industry, an industry where anesthesia machine, cardiovascular monitor, and respiratory monitor companies have evolved largely independent of one another.
The cautions posture maintained by the medical device industry due to the current nature of regulatory and product liability issues.
The difficulty in implementing methods by which dances can handle contextual information. Contextual information consists of data which in intra-operative situations dictates that certain combinations of physiologic parameters are acceptable under one set of clinical circumstances while those same combinations of physiologic parameters are totally unacceptable under other sets of clinical circumstances.
The problems in addressing the prevention, control, and handling of artifactual information.
The medical device industry has learned about what is needed to help maintain anesthesia patient safety from the clinician. In the future, the anesthetist” will continue to be a critical source of input for medical device companies who seek to implement new ways of helping to improve patient safety. Organizations such as the Anesthesia Patient Safety Foundation serve as an important link between clinicians and industry who are together engaged in shaping “electronic assistants” for the anesthetist in the operating room.
Mr. Gerwer is Manager, Product Research Group; Nihon Kohden America, Inc., Irvine, CA.