Medical devices dispensing

Diphoterine is a product for chemical spatters on the eye and skin. Prevor Laboratory in France manufactures this odorless, colorless liquid dispensed as an eye wash or skin decontamination spray. It is composed of an aqueous solution to wash many chemical families and pull hydrophilic chemical agents away from the surface of tissues, an amphoteric solution that acts on acids and bases and restores the tissue physiological pH, and a hypertonic solution that stops penetration of corrosive chemicals into tissues. The pH is slightly alkaline (pH 1.2-1.1) and is sterile. Although not classified as such in the USA, it is classified as a medical device in Europe, Canada, Australia, and Brazil (www.prevor.com). 

The medical device industry has developed many ways to dispense nasal formulations. Device technology is becoming more and more important, not only with... 

The NDl is the regulatory body responsible for the registration, control of the manufacturing, sales and dispensing of the pharmaceuticcds and medical devices in Bulgaria. 

Pharmaceutical Care includes the supply, preparation, control, storage and dispensation of medicinal products and medical devices, providing information and consultation for the patient and following the therapy. The licence for pharmaceutical care can only be granted to the natural person with the pharmaceutical qualification. 

Adverse drug reaction (ADR) is defined in the law. The person authorised for the drug prescription, wholesale, dispensation and manufacture is obliged to report an ADR to the SIDC. The SIDC has the right to postpone or withdraw the medicinal products or medical device from the market. 

Conduct an inventory and account for study medications/devices and arrange for extra supplies, including other items, such as CRFs, blank forms and so on, if necessary. Resolve discrepancies between inventory and accountability records, and medication/device use, as recorded in the CRFs. If a pharmacy is involved in the study, the pharmacy and pharmacist must be visited. Check that the medication/device is being dispensed in accordance with the protocol. Check that the medication/device is being stored under appropriate environmental conditions and that the expiry dates are still valid. Check that the medication/device is securely stored in a separate area that is not accessible to individuals not involved in the study. Check that any supplies shipped to the site since the last visit were received in good condition and are properly stored. 

Compliance with medication/device use (by the study subject) should be assessed in all studies. If supplies are dispensed to subjects for selfadministration, methods to assure compliance (e.g. diary cards, instructions on labeling, supervised administration) and methods to check compliance (e.g. tablet counts, plasma/urine assays, diary card review) must be in place. At each study visit, the study subjects should be asked to... 

The primary focus of this entry has been to provide a basic understanding of the field of hydrophilic polymers and their uses. These materials have a range of applications both in the bulk and as thin films. For example, hydrogel membranes are used as inhibitors of postsurgi-cal adhesion formation and also as coatings. Dispensing these polymers onto the surface of medical devices can confer desirable surface properties that the substrate... 

Maintain the security and accountability of clinical study supplies, ensure that medications/devices are labeled properly, maintain records of clinical study medication/device dispensing, including dates, quantity and use by study subjects and return or disposition (as instructed by the sponsor/CRO) after completion or termination of the study Archive all CRFs and documents associated with the study for a minimum of 15 years. Notify the sponsor/CRO of any problems with archiving in potential unusual circumstances, e.g. investigator retires, relocates, dies study subject dies, relocates, etc. 

Record of concomitant medications/devices. All notations of previous and concomitant medication/device use must be examined. All entries in the CRF should be verifiable in the medical file by name, date(s) of administration, dose and reason (or indication). All entries in the medical file during the time period specified by the protocol must be noted in the CRF. Concomitant medication/device use must be explicable by an appropriate indication and must be consistent from visit to visit. The reasons (indications) for use of concomitant medications/devices, newly prescribed during the study period, must be noted as AEs. The medical history should be reviewed to determine whether medical conditions arising during the study already existed at baseline. The dispensing records, which are normally separate from the medical file, must also be examined to determine consistency. 

From ships to submarines to mining the sea floor, certain plastics can survive sea environments, which are considered more hostile than those on earth or in space. For water-surface vehicles many different plastic products have been designed and used successfully in both fresh and the more hostile seawater. Figure 2-55 is an example where extensive use is made using unreinforced and reinforced plastics meeting structural and nonstructural product requirements. Included are compartments, electronic scanners, radomes, optically transparent devices, food storage and dispensing containers, medical products, buoyant devices, temperature insulators, and many more. 

Weighing and measuring are two of the most important aspects of dispensing, compounding, and administration of medications. The present chapter deals with the fundamental operation of a prescription balance, an understanding of sensitivity requirement, an introduction to various devices used for measuring volumes of liquids, and their pertinent calculations. A knowledge of the systems of measurement, which is covered in Chapter 2, is essential to understand the material presented in this chapter. 

Pharmacies need a number of physical resources to provide most value-added services. This usually begins with the layout of the pharmacy. Many value-added pharmacy services require at least some degree of privacy. Unfortunately, pharmacies that were designed to maximize the efficiency of the dispensing process often do not have a private office or classroom space necessary to provide patient care services. Other physical resources that may be needed to provide a professional service include computer hardware and software, testing devices, medical supplies, and office supplies. 

Murray M. 2001. Automated Medication Dispensing Devices. Available at www.ahcpr.gov/clinic/ptsafety/pdf/ chapll.pdf. 

Automated dispensing machines have become common on nursing units in many hospitals. The nurse must enter a security code and a password into the dispensing device, along with the name of the patient and the name of the medication, before the machine will allow access to remove the medication. This system allows better control of items kept on the nursing unit and serves as a check for the nurse who retrieves the... 

Automated dispensing devices create several situations that can easily result in errors. While these machines are routinely restocked, the wrong drug still can be placed into the wrong bin during this process. Devices that have multiple medications in each drawer and/or that do not require pharmacist review of orders before access have drawbacks that are identical to the flaws in traditional floor-stock systems ... 

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