CROSS-REFERENCE TO RELATED APPLICATION:

This application claims priority to United States provisional application number 62/237,459 filed October 5, 2015 the contents of which are hereby incorporated by reference.

BACKGROUND

Incorrect labeling of medications

100,000 people die each year in US hospitals due to medication error, and at least 400,000 drug-related injuries occur each year. Incorrect labeling of medications after withdrawal from their original packaging is a problem in hospital operating rooms. Human error is a significant problem when it comes to the transfer of medications from packaging to the patient throughout the hospital. It is near impossible to differentiate between medications once they have been removed or aspirated from their original packaging and/or container since they are often the same color and consistency as many other drugs. Medication from a mislabeled syringe or vial, administered at the incorrect time and amount can result in serious

consequences including death

Sterile handling of labels

In areas of the hospital or outpatient setting in which drugs are transferred sterilely, generally the circulating nurse obtains drugs from an automated medication dispensing system and then dispenses medication into a sterile cup/container. The scrub nurse/technician uses aseptic technique to aspirate the medication into a sterile syringe. The scrub nurse/technician is also responsible for labeling the sterile cup/container and/or syringe with a sterile label.

Medication/patient name, strength, amount, diluent and expiration/time are specific requirements for the sterile label. Writing out the label information is both time consuming and prone to labeling errors.

Handling of drugs in areas of the hospital/outpatient setting that are not sterile

Handling of drugs in areas of the hospital/outpatient setting is usually done differently compared to sterile areas. It is rare for a label to be placed onto the drug/drug container after it is removed from the automated medication dispensing system. When the drug is removed from its container, the patient may receive it immediately or after a delay. Sometimes the drug is administered by the person removing it from the automated medication dispensing system and sometimes that function is delegated to another staff member. Due to lack of labeling, poor labeling, dispensing delays, and multiple people in the chain of dispensing, pill and liquid medication dispensing errors are common.

Tracking of information

As noted, labeling by hand can lead to labeling mistakes, and labeling by hand cannot be tracked. It is much easier to verify drug information from a computer-based system, such as the Pyxis warning system, which has the capability of storing patient and medication information.

Relevant Art

US Patent number US6955002 describes a medication marking system that provides preprinted labels for sterile cups and syringes. The invention described in this application can print labels on demand. Also there is no computer database associated with US6955002 to track label generation. US Patent number US7815123 describes a sterile labeling system whereby the label is printed, placed between a plastic peel pack, and sterilized. With the invention described in this application, the label is already within a plastic film prior to printing. The printing is transferred through the plastic film and onto the sterile label. US Patent number US4857713 describes a hospital error avoidance system that scans the wristband barcode of a patient to know what medications that patient is receiving. A computer program tracks dosage amounts and timing of dosages. US4857713 does not describes a sterile label printing process, just a medication tracking system.

There is no device that transfers information, specifically key patient information, through an outer cover/film/sleeve encasing a sterile label resulting in a sterile custom printed label. There is also no device that incorporates the medication tracking back to the computer system. There is also no device that incorporates confirmation of informed consent integrated into a comprehensive electronic health record.

SUMMARY A printer capable of printing information through plastic cover/film/sleeve, or plastic like material, that encases sterile labels will eliminate the need to handle the sterile label before it reaches the sterile field in an operating room. The sandwich of plastic, sterile label and plastic uses heat, electricity and/or other forms of energy to transfer labeling information through the plastic, or plastic like material, and onto the sterile label. The sterile label can then be placed in the sterile field without touching it by peeling back the front and back plastic, or plastic like material, and placing/dropping the inner label with the printed information onto the sterile field. The sterile label can then be affixed to sterile syringes and sterile cups or containers. The printer is connected to an automated medication dispenser system that is hard wired to the hospital's electronic medical record (EMR) system. "Inputs" such as a patient's information like age, gender, pregnancy, height, weight, kidney function and liver function (AST, ALT, AP, total bilirubin) can be accessed from the EMR and/or automated medication dispenser system. The EMR system and/or automated medication dispenser system can also track other "input" data such as medication name, medication date usage, expiration date, other drugs that the patient is taking and allergy information. The printer can print custom "output" patient information onto the sterile label, such as age, gender, pregnancy, height, weight, kidney function and liver function (AST, ALT, AP, total bilirubin). Additional "output" information such as medication name, medication date usage, expiration date, interference with existing drugs the patient is taking and allergy information can also be printed onto the label. Other "outputs" which are critical can include based on formulas from the "input data;" for example, a patient with poor renal function may only be allowed to have a dosage of a drug 50% of someone with normal renal function. Although the invention is directed to a sterile application, it could be equally helpful in a non-sterile environment. The invention also includes a peripheral computer such as a tablet that is able to display information about medical procedures and medications to a patient. The peripheral computer software can record what information is conveyed to a patient and obtain an affirmative confirmation that the patient has read and acknowledged the information thereby tracking informed consent.

DRAWINGS

The system has these units: a printer, plastic film, sterile labels, and a computer database. FIG. 1 is a drawing of the frontal view of the sterile label within the plastic film.

FIG. 2 is a drawing of the side view of the sterile label within the plastic film.

FIG. 3 is the frontal view of the sterile label with sample patient and medication information.

FIG. 4 is a flowchart of the process.

DETAILED DESCRIPTION

FIGS. 1 and 2 show a frontal view of a sterile label 1 between two layers of plastic film. The film top layer 4 and bottom layer 5 are larger than the label and contain an adhesive to seal the sterile label 1 entirely. In an embodiment, the top layer 4 and bottom layer 5 can be peeled apart at an easy open juncture 7.The patient and medication information, stored in the computer database, are transferred from the printer and through the plastic film onto the sterile label 1.

FIG. 2 shows a side view of the sterile label 1 between the top layer 4 and bottom layer 5 joined at a sealing juncture 6. The sealing juncture 6 is actually all the way around the sterile label 1. In a preferred embodiment the label is square or rectangular with dimensions of 2"x2" or 4"x6"; however, it is understood that any shape of a label could function similarly. In a preferred embodiment the sealing juncture 6 is sealed with completely complementary plastic film. In another embodiment, there can be an easy open seal 7 recessed at least two centimeters from one of the ends of the top layer 4 and bottom layer 5 that can join the complementary plastic film. The two sheets of plastic can be peeled apart to expose the sterile label so that it can be dropped/placed onto the sterile field.

The sterile label 1 within the top layer 4 and bottom layer 5 can be sterilized by ethylene oxide or gamma irradiation to make the label sterile. The sterile label 1 will maintain sterile until opened and can be opened in the sterile field, still maintaining sterility.

The labels may come individually or as part of a roll that is perforated to separate the individual labels.

In one embodiment it is possible to connect the present invention to an existing automated medication dispensers that have computers in them and are hard wired to the hospital EMR system. The printer is connected to the automated medication dispenser. The automated medication dispenser is hard wired to the hospital EMR system. The EMR system has enough RAM to support software that keeps track of patient and medication information. It is possible for the EMR to be accessed via WiFi technology. A computer screen displays patient and medication information. An alarm system is connected to the automated medication dispenser to alert the user to when medication is ready for administration. A color coded system comprising of red, yellow and green may also alert the user as to when to take medication. The EMR is synched to a central server and backup server, both of which house patient and medication information. Sterile labels are fed into the printer via a roll or individually. Once the printer receives the command from the computer to print the sterile label 1, the printer prints through the plastic film and onto the sterile label 1. The sterile label can then be removed from the printer and transferred to the sterile field, where the top layer 4 and bottom layer 5 can be peeled apart to drop the sterile label 1 onto the sterile field.

Examples of system flags would be Toradol for patients over 65, with renal impairment or less than 50 kg the dosage is reduced compared to the standard dose. For patients with penicillin allergies Ancef may be not given. For patients with liver impairment and an elevated total bilirubin the dosage of Amiodarone needs to be reduced.

FIG. 3 is the sterile label with sample patient and medication information 8. The computer database will house this information and a computer algorithm will determine what data appears on the sterile label.

FIG. 4 is a flowchart of the entire process. A software custom label algorithm 12 is developed from the inputs the EMR 9 and/or manual entry 10 and the automated medication dispensing cabinet 11. The output of the label algorithm 12 is customized patient and drug data 13. The customized patient and drug data 13 can then be fed to the sterile label printer 14 or the non- sterile label printer 16. The sterile label printer 14 prints the sterile patient customized drug label 15. The non-sterile label printer prints the non-sterile patient customized drug label 17. Patient consent and practitioner confirmation with recording and communication to a secure EMR 9 via tablet, smartphone, mobile device or similar device.

A patient, before receiving medication, consents to receiving the medication by signing a tablet device that has access to the patient's EMR 9. The tablet device will contain the patient's medication, custom dosage, contraindications and complications. The tablet can also be used for procedure information to help educate the patient on a particular procedure such as gall bladder surgery with possible text, illustrations and video. The patient will sign the tablet device screen to agree to receive the medication and/or undergo a procedure. The computer software can record what information is conveyed to a patient and obtain an affirmative confirmation that the patient has read and acknowledged the information thereby tracking informed consent. Disclosed is a system for obtaining patient acknowledgement and consent comprising a mobile device with a touchscreen wherein a software application delivers and educational presentation and a patient can acknowledge receipt by signing the patient's name. Further disclosed is a mobile device wherein, the software can record the patient's signature with a time and date stamp. Further disclosed is a mobile device wherein, the mobile device stores the patient's signature and date stamp and can send the patient's signature and date stamp to a remote server via Wi-Fi, BlueTooth ^® , or similar wireless communication means. Wireless technology and cloud based patient monitoring and records are known to the industry.