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2013 Legislative, Regulatory and Policy Update


Continued from page 1

Medical Devices

FDA Examines Labeling of Medical Devices

The Food and Drug Administration (FDA) is currently examining the content and format of labeling for medical devices, and seeking insight from healthcare professionals about what is important and useful information for prescribing and using medical devices. Presently, there are few regulations that define and describe requirements for medical device labeling, including the instructions for use. The FDA is taking a closer look at what details should be provided with medical devices, as well as how that information should be organized and communicated.

The impetus for this effort began several years ago when an FDA official, also a nurse, began investigating home use of medical devices. "I was looking at the safe migration of medical devices into the home and being used by lay caretakers," says Mary Weick-Brady, MSN, RN, senior policy analyst in the Office of the Center Director, Center for Devices and Radiological Health at the FDA. "From my personal experiences, having been a home care nurse years ago, I knew it was sometimes difficult to find the labeling -- it would either get lost or the device would be transferred from one person to another and the labeling wouldn't go with it."

Weick-Brady explains that when talking about "labeling," it means the package insert or the instructions for use for the end user -- not the package label itself, nor the operator/service manual. Section 201(k) of the Federal Food, Drug and Cosmetic Act (FFDCA) -- the law under which the FDA takes action against regulated products -- defines "label" as a "display of written, printed, or graphic matter upon the immediate container of any article." The term "immediate container" does not include package liners. According to the FFDCA, any word, statement or other information appearing on the immediate container must also appear on the outside container or wrapper of the retained package of such article, or is easily legible through the outside container of the wrapper. Section 201(m) of the FFDCA defines 'labeling' as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce. The term "accompanying" is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. "Accompanying" also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce, according to the FFDCA.

"As we looked into the labeling issue, it wasn't just happening in the home environment," Weick-Brady says. "People with medical devices were coming into the emergency department of the hospital and the treating healthcare professional would not know how to operate that particular device because they didn't have the right labeling. People coming into the ED were very sick and couldn't show clinicians how to operate the device, whether it was an insulin pump or a pacemaker. When we checked even further, we found that a lot of people in clinical environments were unable to find the labeling -- it was either in the biomedical engineer's office or it was in the nurse educator's office, they weren't really sure. Clinicians want access to medical device labeling information but they didn't want to have to root through a lot of other information to get to what they specifically needed. They were saying, 'I need good, usable labeling, and if it is not usable, it is not useful.'"

Weick-Brady explains that the oversight of the Center for Devices and Radiological Health runs the gamut of medical devices -- meaning anything from a heating pad, to a ventilator to an implant of any kind, to hemodialysis. "Depending on the type of device, labeling increases in complexity," she says. "Over-the-counter device labeling, or what we would call the package insert, could easily fit on the back of the label itself, of the package labeling. Whereas if you have a hemodialysis machine, for either the home or in the clinic, you probably have several hundred pages of user instructions. Labeling for a device such as an infusion pump, where you can program it many ways depending on the drug and the time it needs to be infused, you would have an increased level of complexity and an increased number of alarms you would need to look for, and probably things to look for in trouble-shooting the device -- so that means a very complex labeling that is essential for users to have."

Weick-Brady says she is in the process of determining the viability of an online repository for all medical device labeling information. "The FDA would like to know if this repository would be beneficial to those who actually use the labeling -- one place as a source for all labeling information," she says. "Unlike drugs, devices are out there for many years, and they go form one person to another.  Manufacturers, justifiably so, want to sell newer products, so frequently they will support on their websites the newer product labeling and not necessarily the older product labeling. I can't fault them for that, but the problem is that labeling still must be out there for people to use. People come to love their devices and they don't want to switch them out, so having access to the older product labeling would be part of this particular labeling repository. Information would be archived and users could easily look up products."

In August 2012, the FDA partnered with RTI International to conduct a survey of healthcare professionals as part of the aforementioned labeling efforts. "In the first phase of this study we conducted focus groups," Weick-Brady says. "We asked physicians, nurses and technicians working infusion therapy, respiratory therapy and wound care -- all the people who use device labeling in one way or another -- what their experiences were with labeling. What we kept hearing from them is, 'I don't have time to read all of that labeling -- all I want is information to find out how to operate this device safely and effectively, learn what the alarms are, and what I need to do when those alarms sound.' They also said, 'I need to know how to clean this device, I need to know how to put this device together, I need to know what kind of accessories might be needed.'  We also heard that labeling is all over the place, unlike drug labeling where you know where your indications are going to be -- there is no standard content or format for medical device labeling. They told us 'I want to know if I am looking at labeling, whether for a pump or a ventilator, I want to know where the warnings are, I don't want to go looking throughout the whole document.' It was clear that clinicians are looking for standard format and content on labeling."

Weick-Brady continues, "Because of that feedback I put together the second phase of the survey where we developed a shortened version of generic labeling for an infusion pump and offered three different versions of this labeling for people to look at. We wanted people to respond to these labeling templates to see if this is what they are looking for, would they help clinicians -- because if we are going to undertake this online medical device labeling repository, we need as much feedback as possible."
Weick-Brady says the FDA hopes to wrap up its efforts by January 2013, issuing a report on its findings and also holding a public workshop in the spring. "We want to involve healthcare practitioners, consumers and industry members in discussing the findings of the survey and focus groups, and help the FDA determine where we should be going with this concept. We have ideas, but we need confirmation that we are going in the right direction. For something as big as this, we shouldn't be operating in a vacuum, we should be speaking with the public."
Unique Device Identification (UDI) Final Rule is Pending

The Food and Drug Administration (FDA) has released a proposed rule that most medical devices distributed in the United States carry a unique device identifier (UDI). Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices. A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date. According to the FDA, a UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the agency identify product problems more quickly, better target recalls and improve patient safety.

The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate and FDA’s database will not contain any information about who uses a device, including personal privacy information.

In developing the proposed rule, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies. The final rule is scheduled for release in May 2013.

When fully implemented, the UDI system may:
- Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduce medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- Enhance the FDA's analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post-market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
- Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
- Lead to the development of a medical device identification system that is recognized around the world.

A number of organizations have submitted comments to the FDA about UDI.
The ECRI Institute, an independent nonprofit that researches the best approaches to improving patient care, says it believes that UDI is a good idea and although it fully supports its intent, ECRI says it is concerned about some unintended and costly consequences that could affect everyone involved with healthcare facilities and the supply chain. According to ECRI, "If implemented correctly, UDI should help healthcare organizations do a better job of tracking and managing their inventories of medical devices. This can help control costs, achieve better standardization, and identify product safety concerns. Patient safety and product development researchers should be able to better identify trends in device problems and develop early safety warnings and product design improvements. However, in order for UDI to achieve its expected benefits, it needs to be based on solid, sustainable, and accessible naming conventions and database design structures. ECRI Institute is concerned that FDA’s UDI design will not achieve these goals because the rule is based on a single medical device naming convention—one which has not been publicly available for general review and commentary. More importantly, it has been used by only a very small number of healthcare organizations and medical device manufacturers in the United States, and does not have a publicly available model for how it will be technically and financially maintained and updated over time."

Premier healthcare alliance says it "strongly supports the implementation of a UDI system and commends the FDA for issuing the proposed rule. UDI is the missing link to protect patient safety. Enabling healthcare providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting. In addition, automating the now manual process of tracking of medical devices is projected to save the healthcare industry approximately $16 billion each year from greatly improved efficiencies." Among other comments, Premier emphasized in its comments to the FDA that the proposed seven-year implementation timeframe is too long, especially since the medical community has already waited five years for UDI.  Premier explains, "The seven-year timeline applies to unclassified devices, many of which play roles akin to those of class II or III devices and raise important patient safety issues. Premier comments that such unclassified devices should not be treated any differently than comparable class II or III devices. Premier’s comments stress that the recently enacted FDA Safety and Innovation Act clearly demonstrates Congressional interest in seeing relatively prompt implementation of UDI requirements. Premier urges FDA to complete the implementation of UDI requirements for all affected devices (with respect to labels/packaging) within two years of the effective date of the final rule."

Premier also noted that items in convenience kits need UDIs: "FDA proposes that a combination product whose primary mode of action is that of a device would be subject to UDI labeling requirements, and each device constituent part of a combination product would need to have its own UDI unless it is not possible for the device constituent part to be used except as part of the use of the combination product. FDA also proposes to require a UDI on the label and device package of each convenience kit, as well as a distinct UDI for each device in a convenience kit, unless an included device is intended for a single use. To ensure patient safety, any item within a combination product that may be used independently or any item within a convenience kit that may be used more than once (whether or not intended for single use) should be individually labeled with a UDI." To read the proposed rule, visit:!documentDetail;D=FDA-2011-N-0090-0001

AAMI Announces Launch of Quality Systems for Device Reprocessing Working Group

The Association for the Advancement of Medical Instrumentation (AAMI) is seeking volunteers to help with the creation of a new standard: AAMI ST90: Reprocessing of reusable medical devices -- Quality management systems for reprocessing for healthcare delivery organizations.

The organization is seeking participation from users (such as sterile processing professionals, nurses and other clinicians), healthcare technology managers, device manufacturers, independent service organizations, quality systems experts, hospital leadership, purchasing organizations, regulatory agencies, and any other interested parties.

Applications are invited both from current standards committee participants and from new participants. In addition, AAMI invites nominations for user/general interest and industry co-chairs for both groups. Self-nominations are acceptable. Nominations can be sent to

This document will specify minimum requirements for quality management systems where an organization needs to demonstrate its ability to effectively, efficiently and consistently reprocessing (clean, decontaminate, disinfect, sterilize) reusable medical devices in order to prevent infections, pyrogenic reactions or other adverse patient events.  

This standard will be developed by ST/WG 86, Quality systems for device reprocessing working group, under the auspices of the AAMI Sterilization Standards Committee. To apply to this working group, visit and select AAMI/ST/WG 86 from the drop down menu in Item #5.
There are AAMI membership requirements for participation; visit:

Mandatory Reporting

Healthcare Personnel Influenza Vaccination Reporting to Begin

Healthcare personnel flu vaccination reporting that is mandated by the Centers for Medicare and Medicaid Services (CMS) via the CDC's National Healthcare Safety Network (NHSN) begins on Jan. 1, 2013. Beginning in January for the 2012-2013 influenza season, acute-care hospitals participating in the CMS Inpatient Prospective Payment System (IPPS) Hospital Inpatient Quality Reporting Program are required to submit data on influenza vaccination of healthcare workers via NHSN; however, use of this measure for payment determination will not begin until FY 2015.

The NHSN module for this reporting mandate has been available since mid-September 2012, with the CDC making available various training materials, protocol, forms and instructions.

Hospitals are expected to report vaccinations received by healthcare workers at the facility, vaccinations received outside the facility, medical contraindications and declinations. Data must be reported for all employees on payroll, licensed independent practitioners (who are physicians, advanced practice nurses and physician assistants affiliated with the hospital but not on payroll), and students, trainees, and volunteers aged 18 or older. Only healthcare personnel physically working in the facility for at least 30 days between Oct. 1 and March 31 should be counted.

Acute-care hospitals planning to report healthcare personnel influenza vaccination summary data should make sure their facility is enrolled in NHSN, the Healthcare Personnel Safety Component is activated, and that personnel who will be entering these data for the hospital (e.g. employee health staff) are given user rights to the component. Within the Healthcare Personnel Safety Component, monthly reporting plans must be created or updated to include healthcare personnel influenza vaccination summary reporting before data can be entered.
Performance Mandates

Quality, Readmissions, Hospital-Acquired Conditions Among CMS FY 2013 IPPS Performance Measures 

On Aug. 1, the Centers for Medicare & Medicaid Services (CMS) issued its fiscal year (FY) 2013 Medicare inpatient prospective payment system (PPS)/long-term care hospital (LTCH) PPS final rule. In the rule, CMS projects that Medicare operating payments to acute-care hospitals for discharges occurring in FY 2013 would increase by 2.3 percent. This includes, among other adjustments, a restoration to the base rates of 2.9 percent to ensure that a prior documentation and coding adjustment does not continue to cut hospital payments into the future. Also included are several new provisions related to quality measure reporting and payment updates based on hospitals' performance.

- Hospital value-based purchasing (VBP) program and reduced payment for readmissions
Beginning in FY 2013, the Affordable Care Act (ACA) reduces by up to 1 percent inpatient payments based on each hospital's readmission rates for acute myocardial infarction, chronic heart failure and pneumonia. The readmission payment adjustment will be applied to claims beginning Oct. 1, 2012. It also establishes a Medicare value-based purchasing program that ties 1 percent of payments to a hospital's performance on a set of quality measures. For the value-based purchasing program in 2015, CMS is finalizing its proposal to add three new measures, including the Medicare Spending per Beneficiary measure and two new outcomes measures: Central Line-Associated Bloodstream Infection (CLABSI) measure and the Patient Safety Indicator (PSI-90) composite measure.

- Hospital-acquired condition (HAC) payment policy
For the HAC payment for FY 2013, CMS is adding Surgical Site Infection (SSI) Following Cardiac Implantable Electronic Device (CIED) Procedures and Pneumothorax with Venous Catheterization to the HAC payment provision for FY 2013. SSI following CIED will be added to the existing SSI category, rather than exist as its own category as CMS proposed. CMS is also adding diagnosis codes 999.32 (Bloodstream infection due to central venous catheter) and 999.33 (Local infection due to central venous catheter) to the existing Vascular Catheter-Associated Infection HAC category for FY 2013.

- Hospital inpatient quality reporting (IQR) proposed measures
 For FY 2015 payment determination, under the hospital inpatient quality reporting (IQR) program, CMS is reducing the total number of measures from the current 72 measures to 59 measures. This includes: adding three claims-based readmissions measures; adding a three-part care transition measure to HCAPHS survey along with two questions for the "about you section" – admission through the emergency department and overall emotional and mental health; adding one chart abstracted measure on Elective Delivery; adding (For FY 2016) one structural measure (Use of Safe Surgery Checklist) for a total of 60 measures; and retiring 17 measures, including eight hospital-acquired conditions, five Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators (PSIs), and three AHRQ Inpatient Quality Indicators (IQIs).


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