Patent Application
20180341749
The present invention relates generally to surgical techniques and instructions/directions for use for medical devices and pharmaceutical products that require regulatory approval from the Food and Drug Administration (FDA) to be commercialized in the United States as well as consumer products that require directions for use.
Medical devices are classified by the FDA as class I, class II or class III medical devices. Most class II medical devices today are approved to be marketed (sold on the US market) as “substantially equivalent” devices through a regulatory process called “Pre-market notification” or 510(k). Most pharmaceuticals and class III medical devices are approved to be marketed (sold on the US market) through the Pre-market Approval (PMA) process. Clinical studies are most often conducted to support a PMA. An investigational device exemption (IDE) allows the investigation device to be used in clinical studies to collect safety and efficacy data for the device submitted for regulatory approval. Among the documents submitted by a device or pharma manufacturer to support the regulatory submission for the product are the instructions or directions for use for the proposed device. The regulatory agency reviews and provides feedback to the manufacturer for the proposed directions for use and approves the final copy that will be supplied to the user.
The directions for use contain several pieces of information that are of utmost importance to the user: indications for use, device description, contraindications and warnings, clinical trial results, data related to ratings and environmental effects, directions for device disposal (for single use devices), cleaning, re-sterilization (for reusable devices), complaint handling and customer service, contact information, etc. The global harmonization task force issued the “Label and instructions for use for medical devices” document in September 2011. This document is intended to provide guidance for use in the regulation of medical devices. The document outlines the content of instructions for use with the detailed list of information that needs to be included by the device manufacturer.
Currently the FDA and other regulatory bodies allow for electronic directions for use beside the traditional paper-based directions for use. The electronic directions for use are usually delivered though a website maintained by the manufacturer and are, by enlarge, an electronic (usually PDF) copy of the paper based directions for use. Both the paper and electronic directions for use are difficult to read due to the small font size and disorganized information that is delivered to the user. There is no good way to search through the intricate and stuffy material so that a user can extract the relevant information needed to use the device. At the same time, most operating rooms do not have readily available a decent size monitor connected to a computer to download the directions for use as they need to be accessed. In cases where the user is not familiar with the device or in “mission critical” situations where the user needs to use the device available within minutes or hours, deciphering the paper based or web based directions for use becomes a daunting task. The label and instructions for use for medical devices document states that instructions for use may be provided to the user either in paper or non-paper format such as displayed on a screen, incorporated into the device, downloaded from a website and readable using a machine such as a mobile tablet or smart phone.
Therefore, it would be advancement in the state of the art to provide interactive, context sensitive directions for use application for medical devices or pharmaceutical products that addresses the needs of the ever-expanding health care industry and regulatory bodies (such as FDA, TUV, etc). The various embodiments of the present invention were developed to address this need.
Accordingly, one embodiment of the present invention is a method for tagging a medical device product with a 2D code located on the said medical device label, comprising the steps of printing on a product label a uniquely assigned identifier for that said product, retrieving the printed information from the product label through a mobile receiver (cell phone, barcode scanner, tablet, IPhone, Android phone, Windows phone, Blackberry, digital camera, laptop), having a one to one mapping with said product which when invoked, responds with a unique directions for use that are interactively delivered to the user. The identifier used to tag the product could be a barcode, text, image, RFID, NFC chip, or any other unique code assigned by the manufacturer to the said product or product line. A computer program is used to retrieve unique directions for use from a database to the said product. The directions for use for the said product are submitted by the device manufacturer to a third party in the form of a text file, image, sequence of images, direct input through a web portal and a uniquely assigned user name and password. The directions for use for the product may be delivered to the said user as context-sensitive directions for use.
Another embodiment of the present invention is the method for tagging a medical device with a 2D code located on the said medical device user interface, comprising the steps of retrieving context-sensitive information about the said product, displaying directions for use for the said product or procedure performed with the said product.
Another embodiment of the present invention is the method for tagging a medical device with a 2D code located on the graphical user interface of the said product, comprising the steps of retrieving context-sensitive information about the said product graphical user interface as it relates to a an error or fault displayed on the said graphical user interface, displaying help or troubleshooting information as it relates to the said product, using a computer program to connect to an expert system or human customer service representative to assist the user in troubleshooting the error or the fault in order to continue the procedure.
Another embodiment of the present invention is the method for displaying, searching, sorting, playing directions for use for a medical product either using text input from the user or voice input from the user. The text or voice input from the user may be specific to the geography where the user is located and may be delivered in the user's native language or English.
Another embodiment of the present invention is the method for displaying the most recent electronic version of directions for use of a product and informing the user of any recalls or holds for the said product with instructions on how to handle the hold or recall.
Another embodiment of the present invention is the method for displaying directions for use for a medical product further comprising the step of providing a date and time stamp of when the most recent directions for use were accessed via a mobile device.
Another embodiment of the present invention is the method for displaying the directions for use for a medical device where the user is a health care professional.
Another embodiment of the present invention is the method for displaying the directions for use for a pharmaceutical product where the user is a pharmacist or an end user.
Another embodiment of the present invention is the method for displaying directions for use for a medical product based on a geographic location of the user using translations of the original directions for use in English.
Another embodiment of the present invention is the method for displaying directions for use for medical product wherein said directions for use also display product safety information and expiration date.
This invention will be understood by the following detailed description used in conjunction with the accompanying drawings, where in like reference numerals designate like structural elements.
In
The draft directions for use developed by the medical device manufacturer in step 101 are then submitted to the regulatory body as part of the submission package together with the required documentation for the product in step 102. The manufacturer of the product may involve a third-party firm to develop the directions for use for the device as an integrated part of the product development cycle. The approved directions for use at the end of step 102 is then converted into an appropriate interactive form by a third party or the product manufacturer and are submitted for device manufacturer approval and vetting in step 103. The approved interactive directions for use from step 103 are uniquely liked to the product line through a unique identifier such as universal product number, customer facing number, 2D bar code or radiofrequency identifier, or near field connection sensor in step 104. The interactive directions for use are stored in a secure data base at the end of step 104. A user can use a computer program through a customized mobile application to scan the provided unique identifier for the commercialized product and load, display, interrogate the directions for use that are uniquely linked to the commercialized product in step 105. The mobile application used to scan and display the directions for use for the commercialized product may send back an acknowledgment of accessed directions for use to the product manufacturer in step 106 and the data may be stored, processed, analyzed by either a third party or device manufacturer itself.
While the methods described herein have been described and shown with reference to particular operations that are performed in a particular sequence, it will be understood that these operations may be combined, divided, or reordered to create similar methods without departing from the present invention. Accordingly, unless specifically indicated herein, the order and grouping of the operations is not a limitation of the present invention.
While the present invention has been particularly shown and described with reference to embodiments thereof, it will be understood by those skilled in the arts that various other embodiments may be in scope of the present invention as defined by the claims.
