Injection device and case with reporting ability

INJECTION DEVICE AND CASE WITH REPORTING ABILITY BACKGROUND OF THE INVENTION

This application is a continuation-in-part of U.S. patent applications serial nos. 11/485,820,11/485,828 and 11/485,829, each filed on July 13,2006, and having a common inventor and assignee herewith.

The present invention relates to a case for injecting medicament, and more particularly, is directed to a case having data collection and reporting ability that reports events to a central facility.

For medical products, such as pharmaceuticals and devices, some government regulations define information about the product as being part of the product. Regulations from different governments may conflict

Certain government regulations further define the “label for a medical product as comprising certain information affixed to the product’s container as well as certain information accompanying the product, such as a written sheet with usage instructions or other information.

Government regulations for medical products differ by country, and may include requirements such as:

• making information available in Braille or audio for blind or partially-sighted customers, • providing usage instructions in particular language(s), • recording and reporting, within a first time period, of fatal or life-threatening experiences with the medical product, • recording and reporting, within a second time period, of serious, unexpected, adverse experiences with the medical product, • recording and reporting, within a third time period, of all adverse experiences with the medical product, • storing, for a fourth time period, of all correspondence relating to experiences with the medical product, and • ability to track a medical product through its life-cycle, defined as all or part of manufacturing, distribution and usage.

Further, a single medical product may be subject to different regulatory or procedural regimes, depending on how the product is used, e.g., given by a physician, or used by a consumer at home.

Best practices suggest that recording negative quality experiences, adverse reactions and other infonnation associated with lot numbers or serial numbers helps focus quality initiatives.

In regions such as Europe, a medical products manufacturer or distributor may have to comply with preparing product labels in approximately 20 different languages.

A product distributor is a party other than the manufacturer, end user, or end user’s medical services provider. Thus, a pharmacy can serve as a distributor.

Internet Publication http://www.devicelink.com/pmpn/archive/98/O9/OO5.html discloses a medical packaging system for a medical products manufacturer, which utilizes a multilingual labeling sub-system in order to comply with European multiple-language labeling requirements. The sub-system scans a route sheet for a specific product code, and then compiles variable text, including language(s) for labels. A medical products manufacturer uses a language database, programs its printers to pull infonnation from the database, and prints on packages produced from form-fill-seal machines.

It will be appreciated that the needs and capabilities of a manufacturer are different than those of a distributor. For branded products from certain manufacturers that are distributed by multiple distributors, being able to prove that problem products were distributed by other than a specified distributor is of interest. Specifically, in products liability lawsuits where it is substantially impossible to prove which distributor distributed the problem products, it may be the case that liability is assigned to all distributors typically in proportion to their market share. Thus, the distributors with the largest market share have an interest in proving that the problem products came from distributors other than themselves.

U.S. Publication No. 20030229543 to Shannon M. Zimmerman et al. relates to centralized management of packaging data with rule-based content validation, which provides an online environment whereby manufacturers manage packaging data for their products. FIG. 14 illustrates translations data entry window 108E of user interface 101 that allows the user to select one or more languages 136 for translation and printing on a label of the packaging data. In this manner, any text printed on the label may be multilingual.

t Another concern for medical products is that the device be properly programmed and used. For example, infusion pumps should be programmed to dispense the correct dose. At present, each device has its own user interface and terminology including dosing units. Further, nurses calibrate devices in different ways: manually, via monitors, or via the device itself. Some hospitals develop rule libraries of drug dosing units and dosage limits, and they load the rule libraries into the devices, along with actions required and/or suggested if something is out of range. It has been proposed to add monitoring and interruption capability to patient-controlled infusion devices.

Some medical devices are too small to have barcode labels affixed to the device. Affixing such labels particularly increases labeling, storage and transportation costs. Some small manufacturers are unwilling to invest in labeling systems to comply with lot and expiration barcode requirements, or affixing radio frequency identification (RFID) tags.

It is known to print information such as a bar code with electrically conductive ink. As used herein and in the claims, bar code refers to a conventional bar code, a data matrix, and techniques for representing printed information in condensed form relative to alphanumeric text.

Mobile communications have been proposed in the health area. SIMpill, a South African firm, makes a small device that clips on to a medication bottle and sends a text message to a central computer when the cap is removed. If no message arrives, the central computer sends a text message reminder to the patient’s mobile phone.

As another example, LG, a South Korean handset manufacturer, sells a phone with a built-in blood glucose meter, for use by diabetics, that transmits readings to a computer for further analysis.

A further example is the AlleCare P3 holster for an Epipen, described at www.allecare.com. An Epipen is an injector containing Epinephrine that delays anaphylactic reaction to allergy, the anaphylactic reaction possibly leading to death. The P3 holster transmits a satellite location signal when the Epipen is removed therefrom. If the signal is not deactivated within a minute, an operator notifies emergency services that the user is in crisis.

Another example is U.S. Patent No. 6,992,580, assigned to Motorola, Inc., that discloses a portable communication device with two sensors, for sensing the user’s environment and/or a biometric characteristic of the user, such as heart rate. An example,

PCI7US2007/015922 from the automotive field, of transmitting sensor readings in conjunction with location is the General Motors OnStar system. Within seconds of a moderate to severe vehicle crash, the vehicle’s OnStar module will send a message to the OnStar Call Center (OCC) through a cellular connection, informing an advisor at the call center that a crash has occurred. A voice connection between the advisor and the vehicle occupants is established. The advisor then can conference in 911 dispatch or a public safety answering point (PSAP), which determines if emergency services are necessary. If there is no response from the occupants, the advisor can provide the emergency dispatcher with the crash information from the vehicle’s sensing and diagnostic module that reveals the severity of the crash. The dispatcher can identify what emergency services may be appropriate. Using the Global Positioning System (GPS) satellites, OnStar advisors are able to tell emergency workers the location of the vehicle.

As another example, it is known to place a GPS sensor on a portable x-ray machine. It is expected that government regulations, the needs of customers for more information, as well as the desire to provide more features to customers, will result in increasing demands relating to the scope and availability of product information. For example, when customers can track their goods through the distribution process, the customers can treat distributor facilities as the customers’ inventory warehouses.

Accordingly, there is room for improved communication regarding the status of emergency devices.

SUMMARY OF THE INVENTION

In accordance with an aspect of this invention, there is provided a container for a product, having a location circuit for determining the location of the container, a storage element for storing a container identification code, a plurality of data acquisition components for acquiring status of at least two characteristics of at least one of the container, the product and a user of the product, and a communication interface for generating and sending an emergency communication signal including (a) the container identification code from the storage element, (b) the location of the container from the location circuit, and (c) the status of the at least two characteristics from the data acquisition components.

The container may be an auto-injector for containing a medicament, or a case for containing an item such as an auto-injector. Generally, wherein the location circuit uses the global positioning system (GPS). The data acquisition components are chosen from a camera, and at least one sensor for sensing at least one of a thermal image, vibration, temperature, humidity, a chemical and an audio signal. The characteristic may be use of the product, or lack of use of at least one of the container and the product.

In accordance with another aspect of this invention, there is provided a container for a product, the container for use with an external device having long-range communication capability and short-range communication capability and location sensing capability, comprising a storage element for storing an access code for a central facility and a container identification code, a plurality of data acquisition components for acquiring status of at least two characteristics of at least one of the container, the product and a user of the product, a local communication interface for communicating with the external device using the shortrange communication capability of the external device, and a processor for producing information and directing the local communication interface to send the information to the external device. The information produced by the processor and sent to the external device includes (a) the access code for the central facility, (b) the container identification code, (c) the status of at least two characteristics from the data acquisition components, (d) instructions for the external device to use its location sensing capability to sense its location and to report its sensed location to the central facility along with (b) and (c), using its longrange communication capability and (a).

It is not intended that the invention be summarized here in its entirety. Rather, further features, aspects and advantages of the invention are set forth in or are apparent from the following description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a block diagram showing product management system 10;

Figs. 2A-2F are block diagrams showing embodiments of field device 70;

Fig. 3 is a flowchart showing pre-shipment processing;

Fig. 4 is a flowchart showing post-shipment processing;

Figs. 5A-5D are views of a conventional dental handpiece;

Fig. 5E is a view of a handpiece with a problem indicator;

Figs. 6A-6B are views of one embodiment of a clip-on girdle for a handpiece;

Figs. 7 A-7B are views of another embodiment of a clip-on girdle for a handpiece;

Figs. 8 A-8B are views of a handpiece according to the present invention;

Figs. 9A-9B are views of a conventional sterilization pouch;

Fig. 10 is a view of an embodiment of a sterilization pouch;

Fig. 11 A-l IB are views of injectors according to the present invention; and Figs. 12A-12C are views of cases according to the present invention.

DETAILED DESCRIPTION

Referring now to the drawings, and in particular to Fig. 1, there are illustrated communication network 5, product management system 10, customer 20, customer practice management system 25, shipping module 60, field device 70 and regulator 95.

Communication network 5 may be any wireline or wireless network, such as the Internet, a private virtual network, a private dedicated network and so on. Further, communication network 5 may be embodied as a plurality of networks, for example, a wireline data network and a wireless voice network.

Product management system 10 includes communications interface 15, product information tag (ΡΓΓ) preparation module 30, ΡΓΓ preparation rules 35, ΡΓΓ database 50, database viewer 55, report preparation module 80, report preparation rules 85, and analyst 90.

Product management system 10 is embodied as a general-purpose computer programmed in accordance with the present description. The general-purpose computer can be one computer or many computers networked together. System 10 can operate on dedicated or shared hardware, and may be at a user’s premises or available as a so-called “web service” through communication network 5 or other communication facility. When system 10 is available as a web service, analyst 90 communicates therewith via communication network 5, in similar manner as regulator 95.

Customer 20 is able to communicate with product management system 10 via communication network 5. In some embodiments, customer 20 has a general purpose computing device, such as a personal computer. In other embodiments, customer 20 has practice management system 25 which may be any conventional system for storing medical or dental patient records, modified to also store PIT and other information described below, for example, the DENTRIX® system available from Henry Schein, Inc. A typical practice management system has a front-office portion for handling appointment scheduling and payments, a mid-office portion for handling patient records and a back-office portion for handling diagnostic and treatment information, as well as a patient portal enabling a patient to access their appointments and medical information via a communication network such as the Internet. In the examples described below, it is contemplated that information associated with products by a products distributor is captured by practice management system 25 and associated with the appropriate patient record.

Tn some embodiments, practice management system 25 uses communication network 5 to provide information to product management system 10, such as product usage and location information, and/or to receive information from product management system 10, such as recommended operating instructions and product supply chain information.

ΡΓΓ preparation module 30 is adapted to generate PITs for products in accordance with customer order 20 and PIT preparation rules 35. Products typically are medical or pharmaceutical supplies, such as drugs or devices.

As used herein and in the claims, “ΡΓΓ* means a record relating to a product that logically accompanies the product, and that may or may not physically accompany the product in whole or in part. In contrast, a “label”, as the term is customarily used in the medical products industry, must physically accompany the product and include required standardized information.

A ΡΓΓ may be embodied in any of the following ways: (a) as a printed paper affixed to a product or a product’s container, (b) as a printed paper accompanying a product, (c) as an electromagnetic device affixed to or accompanying a product that stores information, (d) as an electromagnetic device affixed to or accompanying a product that enables access to information stored about the product, the information being stored in other than the electronic device that serves as the PIT, (e) combinations of the above, or (f) other configurations apparent to one of ordinary skill. Thus, a ΡΓΓ may be information associated with a paper, such as a bar code, and/or information associated with an electronic or magnetic device.

Electronic devices suitable for a ΡΓΓ include a radio frequency identification (RFID) tag, a “smart card” typically comprising a credit-card sized device with a processor and memory, a pattern that is magnetically readable as a bar code, and other devices that will be apparent to those of ordinary skill in the art.

Generally, the PIT serves to uniquely identify the product relative to other products in ΡΓΓ database 50.

PCT7US2007/015922

Custom«20 ־ provides an order that typically includes identification of the desired product, quantity, a ship-to address, an order date and sometimes a delivery date and/or other special instructions. The instructions may be provided directly or indirectly. An example of indirect instructions is when a customer is in a country whose regulations stipulate certain requirements; the customer is deemed to have indirectly provided the certain requirements. The customer order may specify features of the product, for example, the type of container, and optional features such as stickers for patient charts, the stickers bearing product-related information, and characteristics of the patient that affect the packaging, such as disabilities (need for Braille stickers), childproof containers and so on.

ΡΓΓ preparation rules 35 include product handling information based on the type of product, e.g., refrigerated, customer predefined preferences, shipping company requirements, regulatory requirements in the country of origin, regulatory requirements in the destination country, destination country characteristics such as official language(s), customs requirements, climate characteristics of the shipping path and destination (e.g., cold or hot packs heeded), and special instructions in or related to the customer order.

The information in PIT preparation rules 35 relates to:

• package layout and appearance;

• what type of PIT or PITs should be used, i.e., sticker on product, sticker on patient’s chart, product insert, electronic tag, bar code, device to be attached to patient, reorder stickers or devices;

• what historical information about the product content must be on its PIT: lot code, manufacturer date, serial number, UPC code and so on;

• patient-specific requests and/or requirements, such as Braille labels, audible label devices, childproof containers, easy-open containers, and so on;

• PIT information for the product container whether refrigerated shipping is needed, individual container, package container, carton container, shipping pallet and so on;

• when the product is a refill, how to reset or relabel the refilled container;

• associated products, e.g., syringes for fluids;

• product trademark requirements;

• proper representation of trademarks and associated designs in translations (e.g., font, accompanying designs, different trademarks in different countries);

• promotional materials;

• advice to include restrictions to be applied (ex: how to use, how to distribute, how to store);

• whether a sensor is to be applied, and what type sensor may be appropriate;

• training materials;

• training schedules;

• maintenance and repair instructions;

• maintenance and repair schedules;

• programming rules for the PET, such as which phone number or Internet protocol (IP) address to contact when triggered (see discussion below of injector 600 and case 700), or when training is required for an associated healthcare professional, patient or caregiver (that is, individuals for some items should be periodically or as-needed trained or retrained on use of the item);

• information related to communicating post-shipment information, such as if a product complaint has to be forwarded within a predetermined number of days after the complaint is received, if the complaint should generate a warning message or a reminder to appropriate parties such as the manufacturer;

• repair reminders after a certain number of uses and.or elapsed time since last repair; and • sending compliance and/or training reminders to patients, medical providers and so on, as directed by manufacturers, regulations, doctors or as requested by patients. For example, let it be assumed that the customer order specifies that 100 units of high speed dental operatory handpieces are to be sent to a location in Moldova and are to have RFID tags with serial numbers. PIT preparation rules 35 specify that Moldova requires medical device instructions to be in Russian and in French, that the manufacturer of such handpiece as identified under Moldavian regulations be determinable, although not necessarily from the product PIT; that the customer wants its instruction sheets to have its name on the sheets and other monitoring information, and the instructions in German and English, and its name affixed to the product itself; and that the regulatory requirements for Korea, the country of manufacture, specify that the date of manufacture must be on the ΡΓΓ for the device.

In this example, ΡΓΓ preparation module 30 creates PITs having stickers to be affixed to the handpieces having the customer name and the date of manufacture, creates inserts on paper having instructions for use in Russian, French, German and English, and creates RFID tags and sterilization indicators to be affixed to the handpieces containing the serial number of the respective handpieces.

When ΡΓΓ preparation module 30 generates PIT 40, it also generates a PIT record and places the PIT record in ΡΓΓ database 50. The PIT record includes at least the information provided in the PIT, and typically includes additional information. The ΡΓΓ record serves as an audit trail for the past, present and future information about the product. Generally, the past information refers to the manufacturing history of the product, including manufacturer, product type, product serial number and UPC code, product version number, manufacture date, expiration date (if any), previous owners of the product, whether the product has been subject to recalls and field corrective actions, the number of previous sterilization procedures, vibration, shock, radiation, temperature and/or humidity extremes in storage conditions, and so on. The present information refers to instructions for use, which can be in one or more languages, or contain one or more pointers to instructional language, the present location of the product, and so on. The future information refers to the customer, the product’s actual use, the shipper, the shipment route (if appropriate) and so on.

The customer may be a health care professional, such as a product prescriber or dispenser and/or a patient (product user) and/or a patient’s caregiver.

Supply chain information refers to information relating to how a product arrived at its current location, particularly, who had possession of the product, when, and the conditions experienced by the product while in a party’s possession, such as ambient temperature and humidity ranges. A location sensing system, such as the global positioning system (GPS), can be a source of supply chain information. Information relating to where and when a product was can be correlated with third-party information such as transit route information and/or weather service data, to determine cumulative time that a product was outside a temperature range, ambient conditions at the time of use, and so on.

In. some embodiments, the ΡΓΓ record includes information provided to the customer, as well as information provided from the customer, or the product itself while in the customer’s possession.

During the lifetime of the product, the definition of present and future adapts. That is, after the product is received by the customer, the shipper becomes part of the past information. Usage and exception reports are then provided by the customer and/or the . product, as discussed below.

Database viewer 55 enables a person, such as analyst 90, to view the contents of ΡΓΤ database 50. Database viewer 55 is embodied as software for interacting with PIT database 50. Analyst 90 represents and suitable hardware for enabling a person to view information, such as a terminal or personal computer and/or printer. Database viewer 55 typically enables analyst 90 to formulate queries and apply them to PIT database 50. Many commercial database packages are known and suitable, such as Microsoft Access, MySQL, Oracle and so on.

ΡΓΓ database 50 may be used for the following purposes:

• to provide information to manufacturers for sales programs and recalls, • to provide information for product liability lawsuits quantifying the amount of product from a particular products distributor involved in malfunctions and the like, • for data mining, • to project product failure rates and the need to replace the product and/or maintain an inventory of spare replacement parts, • to indicate which customers to focus on based on the customer’s activity with regard to various procedures, • to recommend complementary or substitute products, • to provide different levels of customer support depending on the value of the customer, • to update training, maintenance or repair instructions or schedules, • to help decide where to locate sales and/or service centers, typically near the most frequent users of products.

Shipping module 60 enables the shipping service to update the ΡΓΓ record, to indicate the present location of the product. Package tracking services are well known, and employed by, for example, UPS, Federal Express and the United States Post Office. In some embodiments, shipping module 60 is part of system 10, and queries the shipper s package tracking service for the status of products in transit. Shipping module enables a person or system associated with a shipping service to update the PIT record. Additionally, if a shipper has field device 70, PIT 40 may update the PIT record.

Field device 70 enables a customer or other authorized party to access a PIT record, and to update a PIT record with usage and exception information. Each PIT record may contain not only actual product usage information, but also supply chain information for the product. In some embodiments, field device 70 also transmits ΡΓΓ and possibly other information directly to practice management system 25, so that the PIT and other information can be associated with patient records, enabling a patient record to directly provide product supply chain information. Figs. 2A-2F show embodiments of field device 70.

Field device 70 can be located at any point along the product supply chain, including shipper premises, doctor premises and patient premises.

Usage information refers to customary activity that the product is involved in. For example, if the product is a device or medicine, the fact that it was subjected to temperatures above a first threshold or below a second threshold at any time is a usage event. If the product is a medicine, the fact that it was used (ingested, applied, etc.) by a patient on a certain date and time is a usage event. Lack of usage is also a form of usage information. Another example of a usage event is being dropped.

Exception information relates to an abnormal event associated with the product. For example, if the product is a device, a device failure is an exception event. If the product is a medicine, a side-effect in the patient, such as an allergic reaction, is an exception event.

In a simple case, the customer submits a usage, and/or exception event via a written or faxed letter, possibly using a form.

Fig. 2A shows field device 70 as comprising customer personal computer (PC) 110 and printer 115. Here, the customer communicates with PIT database 50 via electronic mail, or via a website. In some cases, the product ΡΓΓ may need to be updated, and the updating occurs using printer 115. It will be appreciated that PC 110 may be a desktop, laptop, tablet or handheld personal computer, or a personal digital assistant, or even a cellular telephone with suitable processing ability.

Field device 70 is shown coupled to communication network 5. It will be understood that this coupling represents a path to a central computer, such as product management system 10, and/or, in some embodiments, to a local computer such as practice management system 25.

Fig. 2B shows field device 70 as comprising customer PC 120 and reader/writer 125. Here, the product bears or is associated with electronic PIT 42, such as an RFID tag or smart card. Reader/writer 125 reads information from electronic PIT 42, and passes the read information to PC 120, which in turn uses the read information to access the desired PIT record from PIT database 50. When PC 120 updates the ΡΓΓ record, ΡΓΓ database 50, or a program running in PC 120, may update electronic PIT 42 accordingly.

Fig. 2C shows field device 70 as comprising PC 130 and reader/writer 135. PC 130 and reader/writer 125 can communicate with each other, and each can communicate directly with ΡΤΓ database 50. Here, the product bears or is associated with electronic ΡΓΓ 43 and sensor(s) 44. Sensor 44 is adapted to detect regular usage events and some exception events, and to provide this information to electronic PIT 43. In some embodiments, sensor 44 also provides detected usage events and exception events directly to PIT database 50, for example, via wireless communication or via daily “synchronization” sessions or via asneeded synchronization sessions. In a synchronization session, the product communicates with ΡΓΓ database 50, generally to provide information to PIT database 50. PC 130 is able to query ΡΓΓ database 50, and also to report usage and/or exception events that are beyond the capability of sensor 44.

For example, if the product is a dental handpiece for holding drill bits, also referred to as burrs, sensor 44 may detect temperatures over a high threshold, such as 220°F, indicating that the handpiece has been subjected to a sterilization procedure; and also may detect temperatures under a low threshold, such as 40°F, indicating that the handpiece has been subjected to a lubrication procedure. That is, handpiece lubrication is often performed using a spray having a propellant that creates low temperatures.

As another example, high value implants such as heart pacemakers, titanium posts screwed into bones, dental implants, artificial knees and the like may have an embedded sensor that can be wirelessly read, in combination with a product information tag, to provide device status.

Fig. 2D shows field device 70 as comprising cellphone 140. Here, the customer uses cellphone 140 to call system 10 and verbally inquire about the ΡΓΤ record and/or verbally provide a usage and/or exception event. Security measures may be employed, such as ensuring that the calling customer is actually the customer to whom the product was shipped.

־14

Cellphone 140 may have a camera and/or location sensing ability, such as GPS capability. When this is the situation, cellphone 140’s features may be used in data collection and reporting, such as usage or exception evetns.

Fig. 2E shows field device 70 comprising cellphone 141 and sensor 142 that automatically places a call to provide sensed information. In other embodiments (not shown) field device 70 comprises a multi-media device, able to send and receive video and audio information, and also data, and possibly able to print data. When field device 70 is a multi-media device, the ΡΓΓ information may comprise multi-media. For example, the usage instructions may be a video with closed-caption text and audio, explaining how to use the medical product. This form of presentation is particularly helpful for handicapped and/or illiterate people.

Field device 70 may be a programmable infusion pump for providing a drug. Typically, an infusion pump is programmed to provide a quantity of drug based on the bodyweight of the patient, sometimes with the ability for a patient to manually request more drug up to a predetermined maximum amount. ,The usage pattern of this device, combining its programming and the patient’s manual requests, can be captured as part of a clinicial trial, to correlate usage to outcome.

.Similarly, for a dental restoration (filling), the usage of a combination of devices,

e.g., a composite resin or other restorative material and at least one of a desterilizer, bonding agent, dental drill, laser apparatus and etchant, can be correlated with the clinical record and the patient outcome, to identify best usage techniques. In general, when a combination of medical devices and/or drugs are used together, it is helpful to know of the concurrent usage.

Fig. 2F shows field device 70 comprising internal communication network 148, ΡΓΓ 149, device 150, sensor 151, display 152, remote interface 153, local interface 154, processor with memory 155, and location assembly 156. Internal communication network 148 may be a bus or a plurality of point-to-point connections. Sensor 151 senses at least one operating condition of device 150. In one instance, device 150 is a dental handpiece, and sensor 151 is a bimetallic sensor that disengages one or more burr-moving elements of the handpiece when a predetermined temperature is reached, to prevent overheating, as shown in more detail in Fig. 8A below. Audiovisual display 152 displays an indication of the operating condition of device 150 to its user, such as a dentist. When sensor 151 is triggered into sensing an event, either by usage of device 150 or by a poll received from remote interface 153 or local interface 154, sensor 151 activates location assembly 156 to communicate with location network 7, such as the global positioning system, to obtain the location of device 150 as a location stamp. Processor with memory 155 stores readings from sensor 151 in association with a time stamp and the location stamp, and provides the stored sensor readings and associated time stamp and location stamp to one or both of remote interface 153 and local interface 154, for transmission to product management system 10 and practice management system 25, via remote communication network 5 and local communication network 6, respectively.

The device of Fig. 11 is an embodiment of the configuration of Fig. 2F.

In some embodiments, a biometric reader, such as a fingerprint reader, voice recognizer, retinal scanner or the like, is used to determine who is using device 150, and/or the identity of the patient receiving services via device 150. In other embodiments, a barcode scanner is used to input the identity of the user and/or patient. The identity information is typically associated with the PIT information in practice management system 25, but may be anonymized or absent from product management system 10 due to privacy concerns.

In some embodiments, interfaces 153,154 and processor with memory 155 are in a cradle that device 150 having sensor 151 is placed into.

In combination with the PIT information, the sensor readings are analyzed to assess the cause for unexpected failure of a device or class of devices. Analysis occurs as product management system 10, practice management system 25, field device 70, or combinations thereof. A cause of failure may include usage patterns. Such assessment could be the basis for notifying the operator of a potential problem, offering maintenance training to operators predicting future product failures, and avoiding product liability.

One ofthe concerns of dentists in using certain light cured materials, such as material used to fill a tooth cavity, is the degree of cure accomplished during curing. To measure the amount of curing, a sensor is supplied with or built into the formulation of such light cured material.

An example of a sensor supplied with the material is a membrane radiometer placed proximal to the material, between the material on and/or in the tooth and the light source that measures the amount of light reaching the material, estimates therefrom the amount of curing and indicates when the estimated amount of curing (or amount of light) has reached a predetermined threshold. Another example of a sensor supplied with the material is an external transducer for measuring the hardness of the cured material.

An example of a sensor built into the light cured material is a material that changes color when a certain temperature is reached. Another example of a built-in sensor is a tiny 5 transducer that measures pressure change, indicating the hardness of the cured material.

Tn some cases, multiple sensors are simultaneously operative. For example, device 150 may be a pouch that an instrument is placed into, and then the pouch is placed in a sterilization device, such as an autoclave, an oven or other device, to raise the contents of the pouch to a sterilization temperature. Here, the pouch has a sensor, the instrument has a 10 sensor, and the sterilization device has a sensor. One example of a pouch sensor is an ink that changes color based on its temperature. Another example of a pouch sensor is a socalled integrator ink that changes color based on the amount of time it has been at or above a temperature threshold and a predefined relative humidity. Pouch sensors can include chemical, optical, electronic, mechanical, or electromechanical devices, and so on.

Fig. 3 is a flowchart showing pre-shipment processing.

At step 205, a customer order is received. At step 210, ΡΓΓ preparation module 30 retrieves PIT preparation rules from PIT preparation rules 35. At step 215, module 30 creates PITs in accordance with the customer order and ΡΓΓ preparation rules. At step 220, module 30 creates a PIT record in ΡΓΓ database 50.

Fig. 4 is a flowchart showing post-shipment processing.

In one scenario, at step 305, a PIT record is accessed, via database viewer 55 or field device 70. The requested record is provided, and processing is complete.

In another scenario, at step 310, a usage event is written to a ΡΓΓ record. The usage event may be provided via field device 70, or manual input (not shown) corresponding to the 25 situations where the usage event is provided via telephone, fax or paper mail.

In another scenario, at step 315, an exception event is written to a PIT record. The exception event may be provided via field device 70, or manual input (not shown) corresponding to the situations where the exception event is provided via telephone, fax or paper mail.

In another scenario, at step 320, a trigger is received, such as a periodic trigger corresponding to time of day/week/month, or a one-time trigger corresponding to receipt of an exception event. At step 325, report preparation module 80 retrieves report preparation rules from report preparation rules 85. At step 330, module 80 retrieves one or more PIT records. At step 335, module 80 creates report(s) 90 in accordance with the ΡΓΓ records and report preparation rules 85.

Report(s) 90 comprise:

• regulatory reports, such as reports of exception events, particularly adverse patient reactions, that may be electronically delivered to regulator 95, • customer activity reports that are directed to how much and/or how often a product is being used, typically delivered to analyst 90, • repair reports in the form of reminders, return shipping documents or the like, • training response reports indicating satisfactory completion of training, • customer satisfaction reports that indicate problems and customer comments both good and bad, typically delivered to analyst 90, and • re-order reports that are automatically generated as a product is used □p or reaches the end of its lifetime and are electronically delivered to customer 20.

Report(s) 90 are based on data collected from and/or in association with ΡΓΓ 40 while the product associated with ΡΓΓ 40 is possessed by the product distribution, and other parties having possession of the product subsequent to the product distributor, including the shipper, the medical services provider such as doctor or dentist, and perhaps the ultimate patient.

To a distributor, an important piece of information is the customer’s probable need or desire to reorder. Some distributors sell or supply scanners to customers, the scanners are for reading barcode labels identifying the products, so that reordering is accomplished via . scanning. Typically, the barcode is unique to each manufacturer and carries the manufacturer’s part number. Some distributors also affix their own bar code labels to a product, so that the product has two bar code labels, one from the manufacturer and the other from the distributor. In some cases, the customer, such as a large hospital chain or a dental school, may also affix its own bar code label to the product, so that the product has three bar code labels. Since the various bar code labels use different formats, depending on the source of the label,,it is helpful to have an automated translation table between the various bar codes, to ensure, inter alia, that a product is properly recognized.

With suitable access authorization, analyst 90 can update PIT preparation rules 35 and report preparation rules 85.

A bandpiece is a unit, typically used in the medical and dental professions, that is held in the hand of the party providing services to the target. The handpiece has a rapidly rotating member for altering the target, such as a patient’s tooth. Each handpiece has a power source; there are three types of power sources: air turbine, electric motor and air motor. An air turbine is used in a high speed turbine handpiece. An electric motor or air motor is used with a gear drive handpiece attachment, such as a contra-angle attachment.

An air turbine has a rotor located in the head of the handpiece. An air turbine handpiece’s rotor is usually supported on each side by a bearings. When there is a problem, such as dirt build-up, the turbine typically stops working altogether. Prior to ceasing operation, the heat caused by the handpiece may bum a patient. Its repair cost is fairly small. Typically, the turbine is repaired about 6-12 times during the 7-10 year life of the handpiece.

For each of the electric motor and the air motor, the motor itself is attached to the gear drive handpiece attachment at its distal end, away from the burr and thus away from the patient. A drive shaft connects to the gear drive handpiece in both air and electric driven motors. The gear drive handpiece has a series of gears and bearings to deliver reduced, unaltered or accelerated rotational speed, or a combination of speeds with other movements, depending on the type of procedure to be performed. The final gears, where the cutting burrs are attached, are supported by multiple bearings. When there is a problem, such as damage to a part of the gear drive, dirt build-up or partial or significant bearing failure, an electric or air motor continues to apply drive that creates excess friction that in turn creates excess heat, and the gear drive handpiece can become so hot that the patient is burned. An electric or air motor by its nature applies more torque for cutting. The repair cost of a gear drive handpiece can be up to ten times the repair cost of an air turbine rotor. An advantage of using a micromotor (an air motor or electric motor) is that with the correct ratio, such as 1 to 5 increasing speed gear ratio of a gear drive handpiece, it is possible to reach controlled sustained speeds, such as 200 krpm, at the cutting burr with 5-6 times more torque than is possible with a high speed turbine handpiece, which in turn provides greater control of the cutting power, decreased cutting time and better dentistry.

Figs. 5A-5B show conventional dental handpiece 400 having head 410, stem 425, handle 426, base 427, tube 428 and foot pedal 429. Head 410 is generally in the shape of a cylinder having face 415 and push button 405 opposite face 415. Burr 420 is a removable drill bit inserted into the center of face 415. Burr 420 can be fluted metal or unfluted diamond particles fused to a stainless steel shaft. Push button 405 is used to release burr 420 from handpiece 400. Head 410 includes internal light guide 411 terminating at light cap 412 in face 415, which serves as a light for illuminating what is being drilled by burr 420. ]

Handpiece 400 can be a high speed turbine handpiece or a gear drive handpiece. A high speed turbine handpiece generally has stem 425, handle 426 and base 427 formed as one unit. A gear drive handpiece generally has stem 425 and handle 426 formed as one unit, while base 427 is a separate unit having a motor.

In some cases, instead of light emanating from head 410, stem 425 has an internal light guide terminating at light cap 422, located so that light emanating from right cap 422 10 illuminates what is being drilled.

In operation, a dentist actuates foot pedal 429, causing power to be supplied via tube 428 to a high speed turbine handpiece, or to an air or electric driven micro-motor attached to a gear drive handpiece, that causes burr 420 to rotate. In some cases, tube 428 also supplies power to a light source, e.g., a bulb or light emitting diode (LED), that generates light transmitted through light guides inside handpiece 400. Each of a high speed turbine handpiece and a gear drive handpiece has bearings inside its head.

Fig. 5C shows high speed turbine handpiece 430 with a turbine rotor, having head casing 431, turbine rotor 432 with bearings 432A, 432B attached on each side thereof, and back cap 433. Rotor 432 is air-driven, with speeds reaching 400,000 rpm. Air is driven into 20 the bottom of handpiece 430, shown on the right side in the drawing. It is possible for head casing 431 or back cap 433, that is in close proximity to the revolving rotor, to become heated by a failure or degradation event such as the failure of the bearings, dirt, wear or mechanical damage such as dropping the handpiece, use of an eccentric burr, or a partial depression of the back cap by a dentist.

Fig. 5D is an exploded view of the head gear assembly of a gear drive handpiece.

Head cover 434 contains bearings 435A, 435B, washer 436, final gear drive 437, spacer 438, membrane 439 and back ring 440. When assembled, membrane 439 and back ring 440 form a back cap. One of the causes of failure or degradation, generally referred together as failure, of a handpiece is normal wear and tear. Other causes of failure of a handpiece are poor maintenance, poor cleaning, inappropriate repair and/or dropping or mis-use. In some cases, poor maintenance manifests itself by a change in the operating characteristics of the product. An example of this would be the build up of heat in handpieces which have not

PC17US2007/015922 been properly cleaned and lubricated internally. With the movement of dental practitioners toward an electric rather than an air-powered handpiece, this maintenance becomes even more important. With an electric or air powered handpiece, the electric drive motor will continue to move the gears even though there is a build-up of foreign material within the handpiece. The foreign material will cause friction and result in heat build-up. It has been reported that this has caused temperatures to rise to the extent that patients have been injured.

Measuring the heat of the handpiece, and/or its vibration and/or its speed, is useful for detecting whether a handpiece is performing properly. Speed can be measured indirectly through vibration or noise frequency. Vibration can indicate rotational speed too high for a given procedure.

Fig. 5E shows handpiece head 414 of either a high speed turbine handpiece or a gear drive handpiece. Handpiece head 414 is similar to handpiece head 410, described above, except that handpiece head 414 includes problem indicator 413, such as a filter or lens between light guide 411 and light cap 412. In operation, when a problem such as failure or degradation occurs, problem indicator 413 interferes with the light from tight guide 411, such as by changing the color of the light or blocking the light entirely, to alert the dentist or other handpiece user that a problem exists.

Figs. 6A-6B are views of girdle 450 intended to clip on to handpiece 400, <1pw.ifir.aHy, to wrap around handpiece bead 410. Girdle 450 has spine 451, back support 454 having flexible membrane 452, back detection band 456 and front detection band 458. Detection band 456 has vibration sensor 462 at one end, and temperature sensor 464 at its other end. Detection band 458 has vibration sensor 466 at one end, and temperature sensor 468 at its other end. Sensors 462,464,466,468 are generally in respective planes orthogonal to the planes ofthe ends of detection bands 458,456; in some embodiments, the sensors are in the same plane as the detection bands. Spine 451 has product information tag 460 and sterilization sensor 469.

Girdle 450 may be formed of any suitable substance or combination of substances, such as a lightweight flexible metal for detection bands 456,458, bimetallic material for sensors 464,468 and piezoelectric material for vibration sensors 462,466. Sterilization sensor 469 may be ink that changes color in response to temperature. Temperature sensors 464,468 can change shape in response to temperature, as is typical for a bimetallic material, and/or can change color. Vibration sensors 462,466 can change color in response to vibration.

Operation of girdle 450 will now be discussed.

Handpiece 400 is typically sterilized after each use. Similarly, girdle 450 is sterilized after each ose, such as by putting girdle 450 in an autoclave (steam sterilizer) or other device designed to sterilize, such as an electron beam sterilizer, a gamma radiation sterilizer, or submersion in a liquid sterilant or an ethylene oxide sterilizer. In some cases, sterilization raises the ambient temperature so that the temperature on the surface of girdle 450 reaches a predetermined temperature, or the ambient temperature reaches a predetermined temperature. Sterilization sensor 469, which may be printed ink that changes color when the predetetmined conditions have been reached, serves to verify that sterilization of girdle 450 has occurred. Sterilization sensor 469 may be reset by applying pressure thereto, or via another suitable reset method.

After sterilization, girdle 450 is placed on head 410 so that flexible membrane 452 covers push button 405, back detection band 456 is generally over the back bearing, and front detection band 458 is generally over the front.bearing.

Flexible membrane 452 enables the dentist to remove burr 420 from handpiece 400 by pressing push button 405. Flexible membrane 452 may advantageously block some force applied to push button 405, such as when a dentist improperly rests push button 405 against a surface, or uses handpiece 400 as a patient cheek retractor.

When handpiece 400 reaches a temperature above its normal operating temperature, the normal operating temperature being defined relative to each type of handpiece, the back of head 410 typically is hottest, and this temperature is picked up by back support 454 and communicated to detection bands 456, 458 via spine 451.

Detection band 456, being flexible, is responsive to the vibration and temperature caused by the back bearing. When the vibration of detection band 456 exceeds a first vibration threshold, vibration sensor 462 triggers, such as by changing shape or color. When the temperature of detection band 456 exceeds a first temperature threshold, temperature sensor 464 triggers, such as by changing shape or color. The triggering of a sensor indicates to the dentist that maintenance is needed.

Handpiece vibration can be caused by a chipped, worn, damaged or eccentric burr, by faulty construction, by build-up of dirt, or by another cause.

Detection band 458 operates in similar manner as detection band 456, except that band 458 is responsive to the front bearing.

In some embodiments, the sensor triggering is communicated to product information tag 460 and/or a processor or controller, such as in Fig. 2C, via wireline or wireless communication. Depending on the legal regulations of the country and design factors, the processor may then cut off power to the handpiece, or otherwise disengage burr-moving elements, to ensure that the handpiece is not permitted to operate while it is too hot, thereby preventing harm to the patient.

Figs. 7A-7B are views of girdle 470, which is similar to girdle 450 except that girdle 470 has stabilizer clip 472 at its rear, instead of a flexible membrane, and has only one sensor.

Figs. 8A-8B are views of handpiece 490, which is generally similar to handpiece 400. For brevity, only the differences will now be discussed.

Handpiece 490 has head 491 having built-in detection bands 492,494, product information tag 493, temperature indicator 496, vibration indicator 498, and sterilization indicator 499. Detection bands 492,494 may be on the outside of head 491, the inside of head 491, or located in cut-out areas of head 491, as shown. Similar to detection bands 456, 458, detection bands 492,494 respectively serve to detect temperature and vibration from the back and front bearings of handpiece 490. Respective temperature and vibration sensors, similar to those described above with respect to girdle 450, are located inside head 491, and cause indicators 496,498 to light when appropriate thresholds are passed. Sterilization sensor499 is similar to sterilization sensor 469 of girdle 450.

Handpiece 490 has base 443 having cords or pipes 441,442 extending therefrom to a controller (not shown in Figs. 8A-8B, but generally shown in Fig. 2C). Cords or pipes 441, 442 represent a flexible shaft and/or an air delivery mechanism and/or a electrical power connection and/or an electrical connection for communication, depending on the type of handpiece. Cord 441 provides power, similar to cord 428 of handpiece 400. Pipe 442 provides electrical signals from the temperature and vibration sensors of head 491, and possibly signals to and from ΡΓΓ 493, as generally shown in Fig. 2C. The controller is able to terminate power to the handpiece when the operating characteristics of the handpiece are deemed to be unacceptable.

In some embodiments, the sensors in handpiece 490 terminate power to the handpiece when the appropriate thresholds are passed.

In some embodiments, the user of handpiece 490 is given the opportunity - but is not required - to indicate to the controller that usage instructions were read prior to use. The controller stores the indication, if provided, which is useful for subsequent investigations if a problem arises with the handpiece. In other embodiments, the controller requires that the user of handpiece 490 certify that usage instructions were read before enabling power to handpiece 490.

Figs. 9A-9B are views of conventional sterilization pouch 500 having back 505, front 510 and adhesive strip 515. Typically, back 505 is formed of paper while front 510 is formed of transparent plastic. Front 510 is permanently affixed to back 505 along three edges. The unaffixed edge of front 510 is opposite adhesive strip 515. When the portion of back 505 bearing adhesive strip 515 is folded over the unaffixed edge of front 510, the unaffixed edge becomes affixed and a pouch is formed. Imprinted on the side of back 505 facing the pouch is temperature sensor 520, formed of thermally sensitive ink, which changes color when a predetermined temperature is reached. On the side of back 505 outside the pouch is sensor 525, formed of sensitive ink in a first color, which changes to a second color is the presence of chemical vapor or steam, and changes to a third color in the presence of ethylene oxide.

U.S. Patent No. 5,344,017 shows another known sterilization pouch, in which the equivalent of sensor 520 is encased in a diamond shape formed by affixing the back to the front along lines forming a diamond.

Fig. 10 is a view of sterilization pouch 550. Sterilization pouch 550 is generally similar to pouch 500, and for brevity, only differences will be discussed.

Sterilization pouch 550 includes sensors 571,572,573 formed of thermally sensitive ink that changes color when different temperature thresholds t$71, t572, t573 are reached. Together, sensors 571,572,573 form an integrator. Sensors 571,572,572 are located behind panel 581, which ensures that the ink &om the sensors does not contaminate the device b'eing sterilized. In some embodiments, panel 581 is omitted. Panel 581 is typically transparent plastic.

Sterilization pouch 550 also includes sensors 574,575, 576 that trigger when different temperature thresholds t574, t575, t576 are reached. Sensors 574,575,578 are adapted

PCT7US2007/015922 to be read either electronically, magnetically or electromagnetically by an external sensor reader (see Fig. 2C). Sensors 574, 575,578 are located behind panel 582, which ensures that the sensors remain separate from the device being sterilized.

Sterilization pouch 550 also includes PIT 590.

As used herein and in the claims, injector refers to a syringe or an auto-injector. A syringe is a device having a fluid and a hypodermic (hollow) needle wherein manual action of the user provides force for forcing the fluid through the hypodermic needle. An autoinjector is a device having a fluid, a spring and a hypodermic needle wherein the user merely places the device against his or her skin to activate the unit, thereby forcing the medicament, typically a fluid but sometimes a powder, through the hypodermic needle. In some instances, an auto-injector is an air-pressure driven gun that drives medicament through a device orifice into skin or onto a mucous membrane, without a needle. Auto-injectors are well known, for example, U.S. Patent Nos. 5,092,843 and 5,354,286, having a common inventor herewith, the disclosure of which is hereby incorporated by reference. As used herein, an auto-injector includes a compressed gas driving mechanism, a battery powered mechanism, or other mechanism not limited to a spring.

In some situations, such as exposure to toxins, bee stings for persons allergic thereto, seizures or out-of-desirable-range levels of biomafkers, receiving an injection is critical for a person to stay alive. Persons at risk of such situations often carry an injector with them, since after realizing they have been exposed to danger, they have only a few moments of consciousness and so it is critical that an injector be nearby. In general, in a high threat situation with a rescue device, it is desirable for the rescue device, upon being used, to send a rescue signal indicating its location, so that rescue personnel can more readily know that their services are needed and find the harmed person. Additionally, for persons who should be carrying a rescue device, it may be desirable to remind such persons if their rescue device is not being carried, and/or if training is advisable. Similar considerations exists for caregivers of at-risk persons.

Fig. 11A is a side view of injector 600. Injector 600 is shown as a syringe but, in other embodiments, is an auto-injector. When injector 600 is used to dispense its dosage, it determines its location, and sends a message to a central facility, such as a rescue center or product management system 10, giving its unique identification number and its location. The central facility uses the unique identification number to determine the contents of injector 600 and thus what sort of threat may have occurred so that suitable rescue personnel may be dispatched. The unique identification number may also be associated with a likely user of the device, and the user’s organization may be notified that a problem has occurred and help is on its way. Injector 600 is an embodiment of the configuration of Fig. 2F.

Injector 600 includes housing 605, stem 610, plunger 615, movable disc 620, end cap 630, dosage chamber 640, hypodermic needle 645, needle cap 650, sensor 660, processor with memory 665, communications interface 670, ΡΓΓ 675, battery 680 and location interface 685. Dosage chamber 640 is at least partially filled with rescue fluid.

When a user feels the need for rescue fluid, the user removes end cap 630 and needle cap 650 from injector 600, inserts needle 645 into the user’s skin, then presses plunger 615 towards housing 605. The force applied to plunger 615 is transmitted to disc 620 via stem 610. The movement of disc 620 towards needle 645 forces the rescue fluid through needle 645 and into the user.

Usage of an auto-injector is described in U.S. Patent Nos. 5,092,843 and 5,354,286.

Sensor 660 is inside housing 605, and is triggered by the movement of disc 620. In some embodiments, sensor 660 is triggered by the movement of stem 610. When sensor 660 triggers, it provides a signal to processor 665 via magnetic coupling or a physical contact made through a hole in the wall of housing 605. Processor 665 activates location interface 685 to obtain the location of injector 600, such as global positioning system (GPS) coordinates. Processor 665 then activates communication interface 670, such as by initiating a cellphone call to a predetermined telephone number associated with a central facility, and when communications are established, provides a unique identification number stored in ΡΓΓ 675 along with the location from location interface 685 and possibly a timestamp. Tn some embodiments, instead of using a voiceband cellular channel, communication interface 670 uses an emergency frequency or a control channel or another wireless channel. Battery 680 can be in a standby or non-use state until sensor 660 is triggered, and only needs to provide power for the aforementioned activities, so battery 680 can be small. Tn one case, disc 620 has a coating on its backside (side away from dosage chamber 640) that couples with sensor 660 to provide a first resistance to processor 665; when disc 620 is de-coupled from sensor 660 during use of injector 600, sensor 660 alone provides a second resistance to processor 665. The change in resistance, or the second resistance, seen by processor 665 serves as the trigger signal.

Fig. 1 IB shows injector 600’ which is similar to injector 600 except that injector 600’ is used with an external device, such as external device 850 or practice management system 26, having long-range communication capability and short-range communication capability, and possibly location sensing ability and image capture ability.

. Device 850, such as a cellphone or personal digital assistant, has wireless communication ability, such as cellular, via antenna 856, ability to communicate with case 800 via interface 858 operative according to a short-range protocol (discussed below), a built-in GPS sensor (not shown), a built-in camera (not shown), display 855 and information entry means 857 such as a keypad.

Injector 600* includes communication interface 670’ for communicating with device 850 via a suitable short-range communication protocol such as Bluetooth, WiFi or other local, preferably low-power, protocol. The communication protocol between injector 600’ and device 850 enables injector 600’ to (a) instruct device 850 to open a communication channel to the central facility, or other location, (b) send information to device 850 for relaying to the central facility, or other location, (c) instruct device 850 to display text on display 855, such as an instruction to a caregiver to take a picture then press * or to press # to begin and then end video streaming, (d) instruct device 850 to respond to events, such as depression of a * key, in a particular manner, and (e) instruct device 850 to transmit information such as its GPS coordinates to the central facility, or other location.

In some embodiments, injector 600' communicates with practice management system 26 instead of device 850. Practice management system 26 is similar to practice management system 25, discussed above, except that practice management system 26 has ’ both long-range communication capability and short-range communication capability. System 26’s short-range communication capability uses antenna 27 which operates according to a suitable short range protocol, such as Bluetooth or WiFi, to receive information from injector 600׳. System 26’s long-range communication capability is via connection to communication network 5, discussed above, which is one or more networks such as wireline or wireless data or voice networks.

In operation, injector 600’ communicates information, such as its usage, to system 26 via antenna 27. System 26 then responds according to a predetermined procedure, such as alerting a private individual and/or placing a call to an emergency provider and so on. System 26 reports the location of injector 600’ as being the location of system 26.

Fig. 12A shows the outside of case 700. Let it be assumed that case 700 holds a medical device or drug product, such aninjector. In this embodiment, when the case is opened to remove the injector, the opening serves as the trigger signal to communicate at least one of the fact of opening, subsequent removal, subsequent usage, and location of case

700 to a central facility. Removal and use of an auto-injector can be sensed, for example, when case 700 has an audio sensor for detecting distinctive noises made by the auto-injector when it is removed and when it is used, particularly when the auto-injector is designed to produce such distinctive noises.

Case 700 includes lid 701, bottom part 702, top closure 703, bottom closure 704 and electronics 705. Electronics 705 incorporates PIT functionality, discussed above. When lid

701 is separate from bottom part 702, top closure 703 is separated from bottom closure 704. The separation is sensed by electronics 705, which obtains the GPS location of case 700 and its own self-stored identification code, and initiates communication with a central facility as discussed above.

In other embodiments, the case may contain multiple devices, such as injectors with different injectants, and when one of the devices is removed, the case communicates its location to the central facility and which device was removed. Other examples are pills, pills in a container that electrically communicates when the container is removed from the case, and a weight sensor for a multi-dose unit.

Fig. 12B shows the inside of case 700. Case 700 contains camera 706 and sensors 707,708. Camera 706 transfers image information to electronics 705, which is able to receive, store and send the image information in association with other information such as GPS coordinates. Accordingly, an image can be sent to the central facility to assist in verifying that a device was used, and how much of a device was used. In some embodiments, camera 706 is positionable, such as by a caregiver, to provide a video picture or image stream of a removed auto-injector and/or the person having a problem.

Sensors 707,708 are chosen from a thermal image sensor, a vibration sensor, a temperature sensor, a humidity sensor, a chemical sensor, an audio sensor and so on. There may be multiple instance of each of sensors 707,708. Sensor 707 transfers information directly to electronics 705, while sensor 708 is observed by camera 706 which in tum provides an image of sensor 708 to electronics 705. For example, sensor 708 may be paper or ink that changes color when exposed to a particular substance or ambient condition. Accordingly, sensor readings can be sent to the central facility.

In some embodiments, instead of being used for individual items, case 700 serves as a shipping container. In these embodiments, case 700 may report to product management system 10 periodically, in response to requests, and/or when selected events occur.

Other emergency care devices or kits may be similar configured to report usage, such as a cardiac defibrillator, tracheotomy device, or emergency pharmaceuticals such as socalled heart clot busters: tissue plasminogen activator or streptokinase.

Any of the functions, such as sensing, reporting and alerting, discussed herein for an injector are also applicable to case 700, and vice-versa.

Fig. 12C shows case 800, which is similar to case 700, the differences being discussed below. Similarities are not discussed for brevity. Generally, case 800 functions in similar manner as case 700, except that case 800 uses features of an external device, such as external device 850 or practice management system 26. Device 850 and practice management system 26 are described above, during the discussion of Fig, 11B.

Case 800 includes communication interface 810 for communicating with device 850 via a suitable protocol such as Bluetooth or other local, preferably low-power, protocol. The communication protocol between case 800 and device 850 enables case 800 to (a) instruct device 850 to open a communication channel to the central facility, or other location, (b) send information to device 850 for relaying to the central facility, or other location, (c) instruct device 850 to display text on display 855, such as an instruction to a caregiver to take a picture then press * or to press # to begin and then end video streaming, (d) instruct device 850 to respond to events, such as depression of a * key, in a particular manner, and (e) instruct device 850 to transmit information such as its GPS coordinates to the central facility, or other location.

When the central facility is product management system 10, communication network 5 is the public switched telephone network coupled to the cellular telephone network that receives the call from processor 665 via communications interface 670. Communications interface 15 of product management system 10 serves to receive the call and store the event of the call in ΡΓΓ database 50. ΡΓΓ database 50 includes, in the record relating to the injector, the contents of the injector and an identity of a person having the injector. Rules database 85 includes a rule that when a call from injector 600 is received, an alert report is to be immediately prepared and delivered to analyst 90. In some embodiments, the rule or the database record relating to the injector specifies other parties that the alert report is to be delivered to, such as customer 20. Analyst 90 then arranges for dispatching of rescue personnel to the location of injector 600.

In some embodiments, rules database 85 includes rules for screening the situation, such as by a verification call to a person or device, or by inspecting an image or sensor reading, to minimize unnecessary dispatching of rescue personnel. The rules can be suggestions to analyst 90, automatically applied procedures executed by product management system 10, and any combination thereof.

In some embodiments, injector 600 is configured so that the central facility is alerted when injector 600 is not being carried by the user, and can contact the user, such as by telephone or email, to remind the user to carry injector 600. As used herein and in the claims, detecting usage of an injector encompasses detecting when fluid is being forced through the injector’s hypodermic needle, and detecting when the device is or is not being carried by the user.

In some cases, injector 600 periodically reports its location to the central facility, either by initiating a location transmission or responding to a location poll from the central facility. The central facility then compares at least two successive location reports to determine whether injector 600 is moving. Lack of motion indicates that the user might have forgotten to cany the injector.

In some cases, injector 600 periodically checks its location, stores its current location, and compares at least one of its stored previous locations with its current location, and notifies the central facility only if the comparison indicates no change, that is lack of motion.

With respect to movement detection, the location sensor can use GPS coordinates or can use a local metric, such as the position of a drop of fluid in a chamber, or any other metric that changes based on movement of the injector.

Although illustrative embodiments of the present invention, and various modifications thereof, have been described in detail herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to these precise embodiments and the described modifications, and that various changes and further modifications may be effected therein by one skilled in the art .without departing from the ‘ scope or spirit of the invention as defined in the appended claims.