# US 9,436,802 B2 · Prevention of use of a contaminated medical product > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,436,802 B2 - Document ID: US9436802B2 - Status: Granted - Kind: B2 - Application number: 14/920,282 - Filed: 2015-10-22 - Published: 2016-02-11 - Granted: 2016-09-06 - Earliest claimed: 2014-06-19 - Applicants: Norman Romanick - Inventors: Norman Romanick - Web page: https://patentgrep.com/patent/US9436802B2 ## CPC - A61M 1/3621: {Extra-corporeal blood circuits (single-needle circuits A61M1/30)} - A61L 2/10: Ultraviolet [UV] radiation - A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour - G05B 15/02: electric - G05B 19/409: characterised by using manual data input [MDI] or by using control panel, e.g. controlling functions with the panel; characterised by control panel details or by setting parameters (G05B19/408, G05B19/4093 take precedence) - G06F 21/30: Authentication, i.e. establishing the identity or authorisation of security principals - G16H 40/63: for local operation - A61M 2205/11: with means for preventing cross-contamination when used for multiple patients - A61M 2205/273: preventing reuse, e.g. of disposables - A61M 2205/276: preventing unwanted use - A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means - A61M 2205/6063: Optical identification systems - G05B 2219/32287: Medical, chemical, biological laboratory - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G) - G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract This disclosure relates generally to contaminable medical products. In particular, this disclosure provides systems, apparatuses, and methods for preventing contaminated use of medical products that become contaminated upon being used for an intended purpose that requires the operation of a medical treatment apparatus, medical treatment system, or both. A medical product may have a unique identity and a permissive operation session, that is associated with the unique identity, may be created to allow a use of the medical device when uncontaminated, while preventing the use of the medical product after it has been presumably contaminated during the permissive operation session. ## Claims ### Claim 1 A system comprising: a medical product having an identification tag defining a unique identity that corresponds to the medical product, the unique identity being maintained in a usage log along with other unique identities that correspond to other medical products, wherein the medical product becomes contaminated upon a use of the medical product for an intended purpose; a medical treatment apparatus that enables, during a treatment session, the use of the medical product for the intended purpose, wherein the use requires the medical treatment apparatus to operate; and a controller programmed to: prevent the medical treatment apparatus from operating before a session commencement time of a permissive operation session and prevent the medical treatment apparatus from operating after a session termination time of the permissive operation session, wherein the permissive operation session is at least partially based on a usage status indicating whether the medical product is used or un-used, transmit, to a usage logger, a request for the usage status, the request including the unique identity that corresponds to the medical product, receive, from the usage logger, a response that indicates the usage status, and create, based on the response indicating that the medical product is un-used, the permissive operation session, wherein the permissive operation session extends for a period of time circumscribed by the session commencement time and the session termination time, and wherein operation of the medical treatment apparatus is unrestricted after the session commencement time until being restricted at the session termination time. ### Claim 2 (depends on 1) The system of claim 1, further comprising a tag reader, in communication with the controller, to determine the unique identity that corresponds to the medical product, wherein the controller is programmed to determine the usage status based upon the unique identity being determined by the tag reader. ### Claim 3 (depends on 2) The system of claim 2, further comprising a support element configured to temporarily maintain the medical product in an exposure region during the treatment session, wherein the tag reader is fixed, in location, relative to the support element, and wherein the identification tag is disposed on the medical product at a predetermined location to result in the identification tag being adjacent to the tag reader when the medical product is installed onto the support element, the identification tag being out of a range of the tag reader when the medical product is not installed onto the support element, the controller further programmed to prevent the medical treatment apparatus from operating based on the identification tag being out of the range of the tag reader. ### Claim 4 (depends on 1) The system of claim 1, wherein the identification tag defining the unique identity that corresponds to the medical product includes at least one of an electromagnetic radiation emitting tag or a visual graphic tag. ### Claim 5 (depends on 1) The system of claim 1, wherein the controller is further programmed to transmit to the usage logger, based at least partially on the controller creating the permissive operation session, a usage status update including the unique identity of the medical product and an indication of a first use of the medical product. ### Claim 6 (depends on 1) The system of claim 1, wherein the usage status further indicates whether the medical product is refurbished such that the medical product may be re-used for the intended purpose. ### Claim 7 (depends on 1) The system of claim 1, further comprising a blood pump to perfuse blood through the medical product during the treatment session, wherein the controller is further programmed to prevent the blood pump from operating outside of the permissive operation session. ### Claim 8 (depends on 1) The system of claim 1, wherein the intended purpose includes operating at least one electromechanical speaker to direct sound waves toward the medical product during the treatment session. ### Claim 9 (depends on 1) The system of claim 1, wherein the intended purpose includes operating at least one electromagnetic field (EMF) generator to controllably raise a level of magnetic flux density exposure to blood circulating through the medical product during the treatment session. ### Claim 10 A method executed on one or more computers for preventing a contaminated use of a medical product that becomes contaminated upon being used for an intended purpose, the intended purpose requiring operation of a medical treatment apparatus, the method comprising the steps of: receiving a request to create a permissive operation session of the medical treatment apparatus to enable the medical product to be used for the intended purpose, the request including a unique identity that corresponds to the medical product; determining a usage status of the medical product by looking up the unique identity in a usage log, the usage status being associated with the unique identity; transmitting a response to the request based at least in part on the usage status, the response either: granting the request by creating the permissive operation session in response to one or more processors determining that the usage status is below a usage threshold, wherein the permissive operation session extends for a period of time circumscribed by a session commencement time and a session termination time, and wherein the operation of the medical treatment apparatus is unrestricted after the session commencement time until being restricted at the session termination time; or denying the request by not creating the permissive operation session in response to the one or more processors determining that the usage status is equal to or greater than the usage threshold, and updating the usage status or the usage threshold, or both, of the medical product to allow for a subsequent request to be granted by creating a subsequent permissive operation session. ### Claim 11 (depends on 10) The method of claim 10, wherein the medical product is disposable and the usage threshold is a single permissive operation session such that the transmitting the response includes either: granting the request by creating the permissive operation session in response to determining that the usage status indicates that the disposable medical product has not been used in a past permissive operation session; or denying the request by not creating the permissive operation session in response to determining that the usage status indicates that the disposable medical product has been used in a past permissive operation session. ### Claim 12 (depends on 10) The method of claim 10, further comprising updating the usage status of the medical product in the usage log in response to the granting the request by creating the permissive operation session. ### Claim 13 (depends on 10) The method of claim 10, wherein the updating is based on an indication that the medical product has been refurbished following a past permissive operation session. ### Claim 14 (depends on 10) The method of claim 10, further comprising: prior to the session termination time of the permissive operation session, indicating that the permissive operation session is nearing the session termination time. ### Claim 15 (depends on 10) The method of claim 10, wherein the unique identity associated with the medical product is embodied in an identification tag that is integrated into the medical product and the identification tag is readable by an electronic tag reader. ### Claim 16 (depends on 10) The method of claim 10, wherein the intended purpose includes the medical product coming into contact with at least one bodily fluid of a patient. ### Claim 17 (depends on 16) The method of claim 16, wherein the medical product is a suction device for removing the at least one bodily fluid of the patient and the medical treatment apparatus includes a vacuum configured to provide suction to the suction device. ### Claim 18 (depends on 10) The method of claim 10, wherein the usage log includes session time data corresponding to a plurality of individual medical products, particular ones of the plurality individual medical products being of a different type than other ones of the plurality of individual medical products. ### Claim 19 (depends on 17) The method of claim 17, wherein the suction device is a surgical suction apparatus for removing at least one of surgical fluids, loose tissues, gases, or bodily fluids during a surgical procedure.