Guest post by Mohan Ponnudurai, director at Sparta Systems.
The release of the FDA’s final rule requiring most medical devices to carry a unique device identifier (UDI) will allow regulators to track goods and expedite necessary recalls in order to manage quality and promote patient safety. This process will be streamlined with the population of the global unique device identification database (GUDID, pronounced good-I.D.), which will include a standard set of identifying elements for each device given a UDI. The system will allow healthcare providers to look up information about a medical device, then amend the electronic health record of a patient as needed.
GUDID has no mandate in terms of automatic connectivity to EHR; no matter what device is implanted into a patient, his/her healthcare professional must manually input that information cross-referencing the UDI record with his/her EHR. Without this data entry, the point-of-use component leading to better patient safety and monitoring becomes a moot point. Just like manufacturing and design are inexplicably linked, and quality is an essential part of both for safer products, GUDID and EHR must be connected for better patient safety.
According to the FDA, most of the information contained within the GUDID will be made available to the public, meaning individuals can easily look up information about their medical device. The UDI does not indicate, and the database will not contain, any information about who uses a device, including personal privacy information. While the GUDID is a step in the right direction to promoting patient safety, healthcare providers should look to the database as a model for keeping all EHRs.
Currently, there is a lack of standardization in updating and maintaining EHRs from state to state, and even from healthcare facility to facility. Further, some facilities have yet to adopt any form of electronic record keeping, leaving records in analogue form. This method of record keeping leaves plenty of room for error: a stack of papers could fall and become jumbled on the floor, considered “scrap” and thrown out, or notes from one clinician to another could be misinterpreted due to poor handwriting.
While the federal government has taken steps to standardize EMRs by identifying four basic functions – computerized orders for prescriptions, computerized orders for tests, reporting of test results, and physician notes – the format of EHRs is still the decision of individual practices. This lack of standardization proves difficult when an EHR begins with a primary care provider who enters information one way, while the patient, lab, insurance company and/or clinician may have their own preferred style for record keeping. These disparate formats will lead to overall greater cost for decreased patient safety and effectiveness.
This lack of standardization often leads to a breakdown in communication between care facilities, as not all EHR systems are able to share information with other EHRs, ultimately degrading the quality of care the facilities are able to offer. Often, doctors aren’t willing to purchase a new EHR system that may be more compatible or more easily managed out of fear that another, more effective system will soon be named “The” EHR go-to. This is an archaic way of thinking, however, and does not focus enough on the patients’ best interests – health and safety.
Similar to the 2009 Economic Stimulus efforts, which encouraged healthcare facilities to keep electronic health records by any means possible, the federal government could offer care facilities additional incentives to adopt one particular technology in a timely manner – once one EHR system is identified (or created) as the end-all-be-all system.
According to the U.S. Department of Health and Human Services, more than 291,000 physicians have received incentive payments from the federal government for the implementation of electronic health records. However, 60 percent of physicians recently surveyed by Software Advice indicate that they are considering replacing their EHR system because they are simply dissatisfied with the product, which supports the belief that, in general, EHRs are not meeting the needs of the healthcare industry.
One example of an EHR system that has been adopted across the enterprise is the Veterans Health Information Systems and Technology Architecture, also known as VistA. VistA is used by the Veterans Health Administration (VHA) to manage the largest medical system in the United States – veteran care. More than 60 percent of all physicians trained in the United States rotate through the VHA on clinical electives, making VistA the most familiar and widely used EHR in the U.S. VistA records are accessible to veterans and their healthcare providers regardless of location, similar to the way GUDID will soon be available.
Interestingly enough, a recent study by Accenture indicates that 68 percent of U.S. doctors do not want patients to have full access to their own EHR. Their reasons vary; however, patients having access to their own medical records can be vital in certain situations, such as when they are traveling or in an emergency. There are clear benefits of involving patients in their own well-being through education, knowledge sharing and encouraging them to proactively engage with their own EHR data-based push notifications. For example, a patient who has an implanted cardioverter defibrillator (ICD) whose routine blood test showed increased blood pressure and bad cholesterol levels (LDL) can be notified and sent recommended measures to address this adverse trend. The patient can in turn link this information with other lifestyle apps like NikeFit or RunKeeper to maintain a healthy lifestyle. With proper security enablement and encryption, access to EHR by the patients will only increase the intrinsic value in the age of ubiquitous smart devices, and a standard EHR format could help increase early adoption.
Akin to the steps taken by pharmaceutical companies or medical device manufacturers to adopt quality management systems, healthcare providers must look to systems like VistA and GUDID as models for keeping their own EHRs in order to maximize the benefits of managing records electronically in order to promote patient safety to the highest degree.