The Fda's Global Unique Device Identification Analysis

Although the EHR is still in a transitional state, this major shift that electronic medical records are taking is bringing many concerns to the table. Two concerns at the top of the list are privacy and standardization issues. In 1996, U.S. Congress enacted a non-for-profit organization called Health Insurance Portability and Accountability Act (HIPAA). This law establishes national standards for privacy and security of health information. HIPAA deals with information standards, data integrity, confidentiality, accessing and handling your medical information. They also were designed to guarantee transferred information be protected from one facility to the next (Meridan, 2007). But even with the HIPAA privacy rules, they too have their shortcomings. HIPAA can’t fully safeguard the limitations of who’s accessible to your information. A short stay at your local

The CPOE system failed due to lack of provider by-in. The use of the Medical Informatics Directors Working Group (MIDWG) will help to establish appropriate ownership and control over the process, as well as deliver a design workflow process and order sets that will be accepted and used by the medical staff.

The stage 1 of the meaningful use includes thirteen core criteria and ten menu set objectives. The first core criteria is the computerized provider order entry (CPOE). CPOE entails the provider’s use of computer assistance to directly enter medication orders from a computer or mobile device. The use of CPOE and the electronic prescription process is a technology that has been found to be helpful in preventing medication prescribing errors in several ways (Mominah & Househ, 2013). Having an accurate electronic patient medication profile will help prescribers and pharmacists review the medication history easily and consequently alert the pharmacist to communicate with the prescriber in case any unexplained change in the prescribed medication to the patient and then conforming the change with the prescriber. Applying CPOE technology reduces medication errors.

In the 1990’s, it became apparent that the Consumer Protection Act was insufficient for the protection of patient’s electronic health information. For several years, plans developed, and the result was HIPAA, which was enacted in 1996. It took until 1999 to finalize the Privacy Rule. The following year, the Security Rule, Transactions and Code Sets Rule, and National Provider Identifier Rule were finalized. The required compliance date for the Security Rule was 4/20/2005 to allow providers the necessary time to put policies and procedures in place. In 2006, enforcement was enacted. It quickly became apparent that technology was advancing beyond the scope of the Security Rule, and in 2009, the HITECH Act was enacted to support the Security Rule. (Sayles, 2014)

This affects the delivery of healthcare in that the information needed by providers, physicians, medical staff, and the patients themselves, may not be delivered correctly, timely, and of course securely. Various systems will be discussed and each how they affect healthcare delivery, in particular Electronic Health Record (EHR), Electronic Medical Records (EMR) and Computerized Physician Order Entry (CPOE) (also sometimes referred to as Computerized Provider Order Entry).

The pharmacy, pharmacists, and the technicians are screaming, “Out with the old, in with new!” It is time for an upgrade to make things go more smoothly, save time and any types of errors in the prescription, which saves the pharmacy, pharmacists, and technicians time as well, and who wouldn’t want to save money!? The pharmacies future is progressing to make these goals come true. Today, tomorrow, and every day after that, they will forever try to improve our future goals and make sure the pharmacies future will be content and secure, for all of our patients and employees.

Encourage the use of computer-generated or electronic medication administration records. Plan for the implementation of computerized prescriber order entry systems. Consider the use of machine-readable code (i.e., bar coding) in the medication administration process. Use computerized drug profiling in the pharmacy. Be a demanding customer of pharmacy system software; encourage vendors to incorporate and assist in implementing an adequate standardized set of checks into computerized hospital pharmacy systems (e.g., screening for duplicate drug therapies, patient allergies, potential drug interactions, drug/lab interactions, dose ranges, etc.)”. (Association,

The technology product will be used as onboarding training for new PAS and as refresher on competencies for experienced PAS. The the content will include lessons on all electronic health record platforms and resources that are used in researching medications and compiling the PTA medication list for use in reconciliation. Team member orientation also involves learning the process of completing the PAS standard work. This work includes monitoring patient lists, interviewing patients or other knowledgeable individuals about the medication taken by the patient, verifying the infomation with the pharmacy, primary physician, insurance company, etc., and updating the patient chart to reflect the information. Time management and documentation are also included.

Data privacy is vital to healthcare organizations and the health information they store. Johns (YEAR) defines data security as “a collection of protection measures and practices that safeguard data, computers, and associated resources from undesired occurrences and exposures” (p. 207). To protect their information, organizations must develop a data security program to meet the needs of Health Information Portability Accountability Act (HIPAA), stakeholders, and the business’s needs. Additionally following the guidelines set by HIPAA is key to being in compliance with the law. These programs differ depending on the organizations that are required to establish them, however, they all follow the same steps in creating and implementing this program

Dimensions in which technology are improving and expanding and are ever evolving, the following are some of the current ways in which patient safety is being enhanced; Patient identity, the use of barcodes and other such identification systems ensures that the provider is providing the correct care to

In May of 1976, new regulatory policies emerged in the Food & Drug Administration (FDA) to ensure the safety of medical devices, known as the Federal Food, Drug and Cosmetic Act (FDCA). The act regulated labeling and branding, with an eye toward protecting consumers from misleading claims. In addition, the Medical Device Amendments (MDA) set further protections by requiring that companies seek “pre-market approval” for new devices from the FDA [9]. Re-categorized, tampons and sanitary napkins were now no longer cosmetics but medical devices, just like toothbrushes and pacemakers. The Rely tampon, however, was first test-marketed in Fort Wayne, Indiana, in 1974, predating the new 1976 FDA regulations that spared it from testing

All medical device company and or life science institutions are required to track and report any transfer of value information pertaining to U.S. physicians, teaching hospitals, or teaching medical organizations under the Federal Sunshine Act. Starting January 2016, the U.S. Federal Government modified the U.S. Sunshine Act reporting requirements for medical device companies. Medical device companies must thoroughly detail the product marketed name associated with transfer of value that is reported when interaction with a physician takes place in and outside any health care setting. In the past, medical device companies were only required by the federal government to report the family to which a specific product belonged or was associated with to report transfer of value. The Sunshine Act requires Medtronic and other medical device companies or life science companies to track and manage any and all data pertaining to all educational or marketing material presented to physicians and allied care providers. All Sunshine Act reporting information recorded by field professionals or any individuals who come into contact with healthcare providers is recorded, managed, and stored by Medtronic’s compliance and the Medtronic legal department. Medtronic has to follow Sunshine Act Section 6002. Section 6002 is the transparency reports and reporting of physician ownership or investment interest of the Patient Protection and Affordable Care Act. Sunshine Act Section 6002 was put into

Wristband print quality is now even more important as bar coding has become common in healthcare. The quality and consistency depend heavily on the printing technology and the wristband material used. This study specifically highlights how these variables impact wristband quality, positive patient identification, and patient safety, and provides guidance for wristband solutions that can deliver accuracy, safety, and convenience throughout the patient care track. Wristband quality directly affects accuracy in patient identification. Patient misidentification was the root cause of 72 percent of adverse event according to a U.S. Veterans Administration (VA) Health System study. Numerous patient safety studies, organizations, and government agencies

There is also a slight issue between consumer and manufacturer as both are in dis-agreement of keeping up with cool chain requirements. This is an operational issue as from an employer and employee perspective their always needs to be a good relationship between manufacture and consumer as the pharmaceutical products needs to have high level in security measures and the manufacturer intrusts the consumer with his products. This is related to another issue found with theft in organisation MISHAIR.

Medtronic is a worldwide medical device manufacturer and supplier with over 80,000 employees, touching almost every country in the world in one way or another. Medtronic requires that every staff member and employee comply with international, national, regional, and local laws and regulations pertaining to data privacy and confidentiality. One example of maintaining confidentiality and privacy of information is during a Medtronic Fort Worth, Texas, VOC Product Development Events. VOC Product Development Events are events in which Product Managers engage surgeons under contracts to validate non-released product prototypes. Surgeons are required to sign non-disclosure agreement before engaging in any verbal or written conversation in regards to prototypes. All staff that is part of any VOC Product Development Event must sign a confidentiality and non-disclosure agreement during project briefings. The staff confidentiality agreement only allows individuals that are part of the VOC Event to discuss VOC Event information with individuals that play a role in development of the prototype or will take part in the product Development VOC Event. Product Development VOC Events are in a need to know basis and are treated as confidential and non-public information. If an individual is caught disclosing VOC Event confidential information to non-pertinent personnel within or outside the company, Medtronic could potentially take legal action or terminate an individual. Engineers and