Premier Inc. Statement for the Hearing Record
Statement for the Hearing Record
Submitted by
Premier, Inc.
U.S. House Committee on Energy and Commerce
Subcommittee on Health
“Reauthorization of the Medical Device User Fee and
Modernization Act”
May 16, 2007
12225 El Camino Real 2320 Cascade Pointe Blvd. 444 N. Capitol Street, N.W.
San Diego, CA 92130 Charlotte, NC 28208 Suite 625
Phone: 858.481.2727 Phone: 704.357.0022 Washington, DC 20001
Phone: 202.393.0860
On behalf of its nearly 2,000 allied not-for-profit hospitals and health systems across the U.S., Premier, Inc. appreciates the opportunity to provide a statement for the record of the House Energy and Commerce Committee Subcommittee on Health hearing, entitled “Reauthorization of the Medical Device User Fee and Modernization Act.” Premier is dedicated to facilitating its hospitals’ and affiliated care sites’ achievement of high clinical quality and financial performance. A mandatory, national unique device identification (UDI) system is an integral part of that goal because it will reduce medical errors, improve the accuracy and efficiency of device recalls and enhance adverse event reporting.
Serving 2,000 hospitals and almost 53,000 plus other healthcare sites, Premier Inc. is the largest healthcare alliance in the United States dedicated to improving patient outcomes while safely reducing the cost of care. Owned by not-for-profit hospitals, Premier operates the nation's largest healthcare purchasing network, the most comprehensive repository of hospital clinical and financial information and one of the largest policy-holder owned, hospital professional liability risk-retention groups in healthcare.
Unique identification of medical devices is paramount to improving patient safety, reducing medical errors and improving patient safety
The Food and Drug Administration (FDA) is currently exploring requiring a unique identification system for medical devices, similar to that already required for drugs and biologicals. Premier strongly supports a mandatory national UDI system to improve patient safety, reduce medical errors, facilitate recall processes and improve adverse event reporting and post market surveillance.
Patient Safety:
Clearly, a compelling patient safety interest lies in requiring a UDI system for medical devices, especially when a defective device is recalled. Today, the majority of hospitals must conduct recalls manually—a labor intensive and time consuming endeavor that does not guarantee a 100 percent success rate. Moreover, it is not possible to associate the use of a device with a particular patient. This greatly delays timely notification of patients if a particular device is recalled and can put patient safety at great risk.
For example, one large teaching hospital learned about a recall of potentially contaminated bronchoscopes after noticing a higher than expected patient infection rate. Hundreds of patients had to be contacted and evaluated for possible infections and two may have died as a result of the contamination. This can be a widespread problem. A study based on the FDA’s records over the last 10 years found that 164,000 emergency defibrillators – about one out of every five sold – had been subject to an FDA recall or alert. Automatic, standardized identification would facilitate and improve upon the tracking of these devices in the event of a recall or other safety concern.
Manufacturers also issue many “device corrections” that can have serious consequences for patients if not handled correctly, which can be facilitated, tracked and undertaken more expeditiously with the use of UDI. They are not technically recalls because they can be corrected by the user, but can often be just as serious as a Class I recall. For example, the majority of problems over the last several years with IV pumps were device correction issues. These involved battery failures that could result in severe patient outcomes if all the equipment was not located and the corrections were not made by the users.
According to ECRI, a not-for-profit health services agency in Pennsylvania, some of the more serious device problems such as ventilator alarm failures, tracheal tube surgical fires and gas embolism deaths during use of argon beam coagulation were never classified as FDA recalls.
Reducing Medical Errors through Improved Recall Processes:
Being able to correctly identify devices, track them through the healthcare system and inform the proper practitioner about any potential dangers will reduce errors and improve patient care. According to a March 2006 report by the Eastern Research Group (ERG), UDI has the potential to facilitate the identification of device compatibility problems. Some implantable materials have turned out to be incompatible with magnetic resonance imaging (MRI) devices resulting in injuries and deaths. ERG concluded that UDI systems might help reduce such episodes by facilitating communication of more information about implants and implant accessories and by helping to get the additional information into patients’ medical records. Additionally, UDI systems could improve methods for ensuring patients with allergies are not treated with or touched by medical devices to which they are allergic (i.e., latex gloves).
We can simply and quickly identify each and every jar of peanut butter that might have salmonella and remove them from store shelves in hours. We can also identify where contaminated spinach was grown, but we cannot do that reliably today with potentially life threatening defective medical devices.
Improving Adverse Event Reporting/Post Market Surveillance:
Accurate and reliable device tracking would also enable data mining so that FDA and manufacturers could better identify potential problems or device defects. Because of the increasing complexity and variety of devices, the potential for problems is escalating.
Implementation of a UDI would be a valuable step in improving processes for monitoring adverse events related to medical devices, something that is currently being done by the FDA related to drug safety because of clarity in identifying drugs.
Current systems such as MedSun – a collaborative pilot project launched by the FDA and a group of 350 healthcare facilities to share information about the use of medical devices – only focus on providing information on safety issues with devices and do not address the user issue of tracking the use of the device and locating it easily if there is a recall because of an identified safety problem.
Health professionals say mandatory unique device identification system would improve patient safety
Premier’s Safety Institute conducted a survey of nearly 1,000 healthcare professionals and more than 80 percent of survey respondents believe an industry-wide unique device identification (UDI) system can enhance patient safety.
According to the survey, a manual system is the most common method used to record medical device implant information in the patient record. Sixty percent of healthcare professionals surveyed transfer a label from the device packaging to the patient’s paper record and/or 51 percent insert a handwritten note. When recalls occur, the majority of hospitals are conducting manual searches of records or log listings to identify patients who received a recalled device or product.
Although many device manufacturers bar code their products, there is no industry-wide device identification system with a common vocabulary, which results in many manufacturers using the same number. This prevents hospitals from reliably tracking devices. Without an industry-wide identification and tracking system, healthcare providers can’t identify device incompatibilities – such as pace makers that negatively interact with an MRI machine’s magnetic fields – in time to avoid devastating patient safety errors.
The counterfeiting of medical devices is on the rise, threatening to compromise the safety of patients. An example was an October 2006 FDA warning about counterfeit blood glucose strips that were identified in the market. Another and more potentially detrimental example was when counterfeit surgical mesh entered the healthcare supply chain and was implanted in multiple patients. A consistent and unique method of identifying medical devices could have helped in the detection and prevention of these counterfeit items before they passed into the supply chain.
In addition to the patient safety implications, implementing a national unique device identification system would enable more efficient device identification processes such as bar coding, product identification and billing which could save the U.S. healthcare system $16 billion, according to an Arizona State University study.
Healthcare industry leaders support a mandatory, national UDI system to improve patient safety
Healthcare industry leaders have united to create the “Advancing Patient Safety Coalition” to provide supporting evidence and rally support for the adoption of a national UDI system. Premier is proud to be part of this broad based coalition which is comprised of 35 prominent hospital, physician, nursing, research, quality and patient advocacy organizations. The “Advancing Patient Safety Coalition” is committed to improving safety processes for our nation’s hospitals and the patients they serve.
Premier appreciates the opportunity to provide testimony to the Subcommittee on Health on this important patient safety issue. If you have any questions or need additional information please contact Blair Childs, senior vice president of public affairs at 202.393.0860.
About Premier, 2006 Malcolm Baldrige National Quality Award recipient, www.premierbaldrige.com
Serving 2,000 hospitals and 53,000 plus other healthcare sites, Premier Inc. is the largest healthcare alliance in the United States dedicated to improving patient outcomes while safely reducing the cost of care. Owned by not-for-profit hospitals, Premier operates the nation's largest healthcare purchasing network, the most comprehensive repository of hospital clinical and financial information and one of the largest policy-holder owned, hospital professional liability risk retention groups in healthcare. Premier’s Safety Institute provides publicly available safety resources and tools to promote a safe healthcare delivery environment for patients, workers, and their communities. Headquartered in San Diego, Premier has offices in Charlotte, N.C. and
Washington. For more information, visit www.premierinc.com.
