Safety features for medical devices requiring assistance and supervision

Abstract

An automatic locking system for a medical treatment device helps to ensure that an assistant is present during treatment of a patient. Among the features disclosed biometric authentication to verify that a trained assistant is present, a presence detector to ensure the assistant is continuously present during treatment, and warning and recovery processes that allow intermittent lapses in the continuous presence of the assistant.

1 . A method for verifying proper use of a medical device, comprising:
 authenticating an authorized person other than a patient to be treated using a device attached to a treatment device used to treat said patient;   generating an enabling signal to cause said treatment device to become operable in response to a result of said authenticating;   verifying at least one time during a treatment interval that an individual other than said patient is at a treatment location where said patient and said treatment device are located;   performing a warning procedure responsively to a result of said verifying, said warning procedure including generating a signal to indicate an impending termination of treatment within a specified time;   waiting for said individual to verify a presence of said individual within said specified time;   terminating a treatment of said patient responsively to and after said step waiting.   
     
     
         2 . The method of  claim 1 , wherein the authenticating includes machine-recognizing a biometric indicator of identity. 
     
     
         3 . The method of  claim 1 , wherein the performing includes displaying requirements for a treatment procedure. 
     
     
         4 . The method of  claim 1 , wherein the performing includes displaying a message requesting the presence of the authorized person. 
     
     
         5 . The method of  claim 1 , wherein the authenticating includes reading a magnetic medium including a data key. 
     
     
         6 . The method of  claim 1 , wherein the performing includes transmitting a message to a supervisor. 
     
     
         7 . The method of  claim 1 , wherein the authenticating includes machine-classification of a video image. 
     
     
         8 . The method of  claim 1 , further comprising authenticating an authorized person at least three times during a treatment interval, the three times being spaced apart such that the third time is more than half-way through the treatment interval. 
     
     
         9 . A medical device, comprising: controls for operating the medical device;
 a lock that prevents at least some functions of the medical device from being operable through the controls;   the lock granting initial access to the medical device when a key is applied to the lock;   a message generator that indicates that the medical device will go into a failsafe mode unless the lock is applied again at at least one time during a treatment interval;   the lock permitting continued operation of the medical device in response to the key being applied at the at least one time;   the medical device being configured to go into the failsafe mode when the key is not applied during the at least one time.   
     
     
         10 . The device of  claim 9 , wherein the lock is configured to perform machine-recognition of a biometric indicator of identity. 
     
     
         11 . The device of  claim 9 , further comprising a display and a message generator that displays requirements for a treatment procedure. 
     
     
         12 . The device of  claim 9 , further comprising a communication device including one of a wireless terminal, a telephone, and a networked terminal that generates a message indicating the failure of the key to be applied to the lock at the at least one time. 
     
     
         13 . The device of  claim 9 , wherein the key includes a magnetic medium storing a data key. 
     
     
         14 . The device of  claim 9 , wherein the lock includes a video camera and a device configured for machine-classification of a video image from the video camera. 
     
     
         15 . The device of  claim 9 , further comprising authenticating an authorized person at least three times during a treatment interval. 
     
     
         16 . The device of  claim 9 , wherein the lock prevents access by locking an access panel covering the controls. 
     
     
         17 . A medical device, comprising:
 a medical treatment component;   a monitoring system configured to receive data from sensors to confirm the presence of a helper, the helper being different from a patient receiving treatment by the medical treatment component;   the monitoring system being further configured to confirm a pattern of presences of the helper during a treatment period in which the medical treatment component is operative to deliver therapy to a patient;   the monitoring system generating a signal indicative of an abnormal condition when the pattern of presences of the helper is not confirmed.   
     
     
         18 . The medical device of  claim 17 , wherein the monitoring system includes a video camera and a video classification engine that monitors a scene that includes a patient and a helper. 
     
     
         19 . The medical system of  claim 17 , wherein the sensors include an authentication device including at least one of a key code receiver, an RFID reader, a mechanical lock, a biometric reader, a magnetic stripe reader, a non-volatile memory card reader, a smart card reader, a video camera, or a bar code reader. 
     
     
         20 . The medical system of  claim 17 , wherein the monitoring system goes into a failsafe mode in response to the abnormal condition signal. 
     
     
         21 . The medical system of  claim 17 , wherein the monitoring system causes the medical treatment component to go into a failsafe mode in response to the abnormal condition signal. 
     
     
         22 . The medical system of  claim 17 , wherein the monitoring system generates an alert signal in response to the abnormal condition signal. 
     
     
         23 . The medical system of  claim 17 , wherein the monitoring system generates an alert signal and waits for the reception of an alert-cancel command after generating the alert signal, the monitoring system causing the medical treatment component to go into a failsafe mode in response to the abnormal condition signal and the failure of the alert-cancel signal command being received.