Medication delivery and monitoring system and methods

Details Medication delivery and monitoring system and methods Medication delivery and monitoring system and methods

1999-07-28

2003-07-15

Mendez, Manuel (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

Reissue Patent

active

RE038189

ABSTRACT:

FIELD OF INVENTION
The field of the invention is control and monitoring of medications delivered to a patient and more particularly to methods and apparatus involved in automatically controlling drug delivery, including controlling of drug administration rate and volume, with real-time monitoring and record keeping.
BACKGROUND
Problems related to misidentification and resulting erroneous delivery of drugs are well known in the medical care art. Other problems related to drug control, maintaining adequate drug records, contamination of drugs prepared on patient floors are also well known in the pharmaceutical art. This invention provides solutions to the above disclosed problems and many others as will become evident hereafter.
Manual dispensing of drugs from pharmacy to anesthesia is a common practice in hospitals and other surgery facilities today. Anesthesia providing departments generally fill syringes with drugs, administer the drugs directly to patients and document the drug handling process in a retrospective manner using handwritten entries. The likelihood of human imperfections makes drug diversion, medication errors, errors of omission, medication contamination and inadvertent needle sticks a constant companion to drug administration. Additionally, the process is exacerbated by emergency situations which demand hurried set up and administration of drugs, with concurrently less time to pay attention to timely and accurate record keeping.
Contemporarily, the problems related above are being addressed by approaches meant to improve drug delivery and control. These approaches comprise production and use of pre-packaged drug menus which involve return to the pharmacy of each unused package to simplify and assure better control in drug accounting; making drug dispensing machines which automatically dispense drugs and provide a record certain as drugs are removed therefrom; delivering drug “lock boxes” to a requesting physician, thereby putting direct responsibility for drug accounting upon the physician of record; and utilizing electronic recording devices whereby documentation of drug delivery data is captured via electronic data acquisition devices, such as bar code readers or keyboards. All of these approaches, used alone or in combination, exhibit deficiencies which are well known in the drug dispensing and monitoring art.
BRIEF SUMMARY AND OBJECTS OF THE INVENTION
In brief summary, this novel invention alleviates all of the known problems related to drug administration. The present invention pertains to a system which is used to assure proper identification and administration of prescribed drugs, to control access to drugs and to record drug distribution activities. The invention also permits direct use of centralized pharmaceutical resources in preparing medications in clean (e.g. air hood) environments where contamination is less likely, in producing standardized labeling and in packaging drugs for distribution within a medical facility. The invention is particularly well adapted for use in handling prescription dose quantities rather than single-dose medication(s), thereby providing opportunity for reduced cost of drug handling.
The present invention improves drug delivery and control by capturing all related data immediately upon administration of a drug through employment of an inventive automatic drug infusion monitoring system. Elemental parts of the system comprise a scanning module, a syringe label cradle, a cassette tray and a receptacle.
The scanning module employs bar code or other digital indicia scanners to read labels affixed to the syringe label cradle. Information contained on the label comprises a code identifying a drug contained in an associated syringe, size of the syringe, syringe type, preparer of the drug, and any expiration data associated with the drug. The scanning module readers are also used to monitor syringe plunger movement as a drug is administered thus acquiring drug administration dynamics in real time. Scanning by the scanning module may comprise two scanners, one for reading drug related codes and one for tracking advancement of an associated syringe plunger, thereby determining delivery rate and volume of administered drugs.
Dynamic control and delivery of drugs permits use of pre-filled syringes at the pharmacy and eliminates the need for unit dose sized medicants and the need for filling syringes by a bedside clinician. This approach yields cost efficiencies in both drug handling and clinician time. Pre-filling syringes by batch processing under sterile hoods reduces errors and nosocomial infections and allows quick and efficient response to clinical (emergency) situations.
The syringe label cradle is a holder and positioner for a drug containing syringe. A syringe disposed in the cradle is preferably securely affixed thereto by an self-adhesing, pre-printed label. Presently preferable machine readable codes are bar codes. The syringe label cradle is instrumental in holding and positioning the syringe for drug administration as well as providing access to the label.
The cassette tray secures syringe containing syringe label cradles in place for transport and storage prior to, during and after use. The cassette tray has a lock which remains locked by the system until opened by an authorized (properly identified) clinician. Generally, the cassette tray is organized to hold syringe label cradles and their contents in a logically progressive array. In use, the cassette tray is aligned with an injection port most commonly connected to a patient-connected needleless IV injection set. In any event, a clinician advances the aligned syringe label cradle to a docked position for drug infusion after which infusion is automatically monitored and recorded.
The receptacle comprises the injection port, generally referenced hereafter as an injection port module (IPM). The receptacle also comprises a scanner module, hard copy generator (printer) and a control module. The IPM secures an IV line in position to accept selected syringe label cradles for drug injection through the port.
The scanner module reads data encoded on the label, secures the syringe label cradle in position for injection and tracks syringe plunger advancement. The printer is used to generate printouts of drug administration event chronology and other critical data either as they are recorded or after they have been stored for later printout.
The control module holds syringes containing controlled drugs (such as a narcotic syringe) in an off-use holding site. The control module continuously monitors the syringes while they remain in the holding position, thereby preventing drug diversion or other undesirable manipulations of narcotics or other control substances. Information transfer to a user is upgraded and enhanced by on-line printers and liquid crystal displays (LCD's) available on the control module. Also a real-time interface is available for transmitting and receiving electronic medical records, billings, or other standard depositories of hospital information. Further the real-time interface makes customized data bases such as pre-operative interview results, potential drug interactions, allergic reactions, physician profiling, outcome analysis available to a user at the control module.
A natural benefit of the instant invention is production of an drug administration audit trail. As well, drug access is severely limited by locked, secured lids on cassette trays. The cassette trays assuredly thereby contain only original syringes and associated syringe label cradle's (SLC's) permitting an accurate quality assurance to be maintained by pharmacy. Return of unused drugs under controlled conditions allows a significant reduction in drug waste due to otherwise unwarranted disposition.
Automatically powered needle injection into IV set injection sites under protective cover provided by a shield associated with each SLC is a major factor in eliminating needle sticks which could otherwise occur. Contamination is thereby minimized as well. Additional patient prote

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