Total recall
Skip to main content
MDHC_Logotype_white
Subscribe
  • My Account
  • Login
  • Subscribe
  • News
    • This Week's News
    • COVID-19
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • People
    • Regional News
    • Digital Edition
    • Highlights of the $1.9T COVID bill nearing final passage
      54.2% of teens were fully vaccinated against HPV in 2019, compared with 51.1% in 2018. 79 million: Estimated number of Americans currently infected with HPV.
      Data Points: Another vaccination race for HPV
      Ryan McGinnis
      Finding efficiencies in the OR using tech
      Doctors performing surgery
      Doctor appears in court video call while performing surgery
    • Highlights of the $1.9T COVID bill nearing final passage
      Artist Gus Moran begins his chalk art piece Feb. 28 at the Disneyland Resort Vaccine Super Site POD.
      City of Hope commissions street art to spread positive messages
      The COVID-19 experience and its influence on post-pandemic health policy
      A close-up of President Joe Biden wearing a mask.
      Healthcare industry gearing up to try to find common ground with Biden
    • Shareholder group calls out HCA for alleged excessive emergency department admissions
      Metrologo 600x400_i.jpg
      MetroHealth forms Center for Cancer Research
      The Check Up: Dr. Marc Boom
      The Check Up: Dr. Marc Boom of Houston Methodist
      Dr. Marc Boom
      Q&A: Houston Methodist CEO praises staff efforts to keep vaccine efforts going during ice storm
    • A younger woman provider helping an older woman on a tablet.
      Insurers set sights on growth in Medicare Advantage, Medicaid managed care
      By the Numbers: Insurers owing largest MLR rebates
      5 things to know about Alignment Healthcare's proposed IPO
      Solid sign-ups for Biden's new Obamacare coverage offer
    • MedPAC likely to recommend an effective cut in Medicare Advantage spending
      MedPAC likely to recommend CMS simplify alternative payment models
      Florida governor faces growing charges of vaccine favoritism
      States rapidly expanding vaccine access as supplies surge
    • 369178053.jpg
      Shares of insurer Oscar Health fall following $1.4B IPO
      Sutter Health posts sizable 2020 loss, announces sweeping review of finances
      UPMC's patient volumes stabilize, boosting 2020 profits
      Genomics firms taking advantage of SPACs trend to go public faster
    • Abbott gets emergency use authorization for test that detects COVID-19, other infections
      Insurance regulator to issue warning on virus-test billing
      351532635.jpg
      Red-hot virtual care market propels New York City health startups to record year
      Teladoc reports $383.3M in fourth-quarter revenue, up 145%
    • Doctors performing surgery
      Doctor appears in court video call while performing surgery
      Artist Gus Moran begins his chalk art piece Feb. 28 at the Disneyland Resort Vaccine Super Site POD.
      City of Hope commissions street art to spread positive messages
      54.2% of teens were fully vaccinated against HPV in 2019, compared with 51.1% in 2018. 79 million: Estimated number of Americans currently infected with HPV.
      Data Points: Another vaccination race for HPV
      Diagnostic developers hedge on coronavirus rapid antigen tests, citing conflicting FDA messages
    • Francoise_Adan1_i.jpg
      Cleveland's UH creates position of chief whole health and well-being officer
      Alicia Wilson
      Q&A: Emerging leader Alicia Wilson on staying close to home
      Michael Jordan, Novant team up to address health equity
      Former Ascension CEO, the first to lead the health system, passes away
    • Midwest
    • Northeast
    • South
    • West
  • Insights
    • ACA 10 Years After
    • Best Practices
    • Special Reports
    • Innovations
    • The Affordable Care Act after 10 years
    • Dr. John Fischer
      Patient-reported outcomes tool for hernia surgery helps physicians improve care
      New care model helps primary-care practices treat obesity
      doctor with patient
      COVID-19 treatment protocol developed in the field helps patients recover
      Rachel Wyatt
      Project to curb pressure injuries in hospitals shows promise
    • What's next for on-demand telehealth companies?
      A map of the U.S. with images of the coronavirus.
      The digital divide becomes a new social determinant of health
      A CalOptima PACE vaccination clinic.
      Will COVID-19 be the catalyst for creating a more sustainable healthcare system?
      Ascension’s St. Mary’s Hospital Surgery Center at Towne Centre and Allegheny Health Network’s Bethel Park surgery center
      Hospitals see opportunity, risk in ambulatory surgery centers
    • Ryan McGinnis
      Finding efficiencies in the OR using tech
      Dr. Daniel Hall
      UPMC pilots machine learning, telehealth to inform patient transfers
      A woman being recorded using her inhaler on a smartphone.
      Digital check-ins, connected inhalers help control asthma
      A phone screen showing the question, "Mary we hope this information was helpful and we'd like to keep guiding you. Are you interested in knowing when it's your turn to receive the vaccine?"
      Chatbots, texting campaigns help manage influx of COVID vax questions
  • Transformation
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • What's next for on-demand telehealth companies?
      Rising prescription copays drop adherence, spike mortality, research shows
      Dr. John Fischer
      Patient-reported outcomes tool for hernia surgery helps physicians improve care
      Highmark Health inks six-year cloud, tech deal with Google
    • Ryan McGinnis
      Finding efficiencies in the OR using tech
      Hospitals' Medicare billing practices suggest upcoding, OIG says
      California hospitals prepare ethical protocol to prioritize lifesaving care
      Amazon, JPMorgan Chase, Berkshire Hathaway disband Haven
    • Dr. Daniel Hall
      UPMC pilots machine learning, telehealth to inform patient transfers
      A woman being recorded using her inhaler on a smartphone.
      Digital check-ins, connected inhalers help control asthma
      Humana partners with in-home provider for 24/7 care
      A phone screen showing the question, "Mary we hope this information was helpful and we'd like to keep guiding you. Are you interested in knowing when it's your turn to receive the vaccine?"
      Chatbots, texting campaigns help manage influx of COVID vax questions
    • MedPAC likely to recommend CMS simplify alternative payment models
      Bundled payments reduce surgery costs by 10.7%
      Coordinated payment policies could speed transition to value, experts say
      CMMI's geographic direct contracting model needs an overhaul, experts say
  • Data/Lists
    • Rankings/Lists
    • Interactive Databases
    • Data Points
    • Health Systems Financials
      Executive Compensation
      Physician Compensation
  • Op-Ed
    • Bold Moves
    • Breaking Bias
    • Commentaries
    • Letters
    • Vital Signs Blog
    • From the Editor
    • Dr. Alan Kaplan
      The risks, rewards of taking organizations 'where they haven’t gone before'
      Wellstar CEO calls adapting for the pandemic her bold move
      Howard P. Kern
      Recognizing the value of telehealth in its infancy
      Dr. Stephen Markovich
      A bold move helped take him from family doctor to OhioHealth CEO
    • Dr. Stephen Markovich
      Making sure we're aligned along the path to achieving inclusion
      Barry Ostrowsky
      Ending racism is a journey taken together; the starting point must be now
      Laura Lee Hall and Gary Puckrein
      Increased flu vaccination has never been more important for communities of color
      John Daniels Jr.
      Health equity: Making the journey from buzzword to reality
    • The COVID-19 experience and its influence on post-pandemic health policy
      Haven is history, but its mission is the future of healthcare
      Vaccinating children could be the key to ending the pandemic
      Mikelle Moore
      The promising future of rural healthcare, even amid the COVID-19 pandemic
    • Letters: Eliminating bias in healthcare needs to be ‘deliberate and organic’
      Letters: Maybe dropping out of ACOs is a good thing for patients
      Letters: White House and Congress share blame for lack of national COVID strategy
      Letters: VA making strides to improve state veterans home inspections
    • Sponsored Content Provided By Optum
      How blockchain could ease frustration with the payment process
      Sponsored Content Provided By Optum
      Three steps to better data-sharing for payer and provider CIOs
      Sponsored Content Provided By Optum
      Reduce total cost of care: 6 reasons why providers and payers should tackle the challenge together
      Sponsored Content Provided By Optum
      Why CIOs went from back-office operators to mission-critical innovators
  • Awards
    • Award Programs
    • Nominate
    • Previous Award Programs
    • Other Award Programs
    • Best Places to Work in Healthcare Logo for Navigation
      Nominations Open - Best Places to Work in Healthcare
      Nominations Open - 50 Most Influential Clinical Executives
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • Best Places to Work in Healthcare
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top 25 Emerging Leaders
    • Top 25 Innovators
    • Minorities in Healthcare
      • - Luminaries
      • - Top 25 Minority Leaders
      • - Minorities to Watch
    • Women in Healthcare
      • - Luminaries
      • - Top 25 Women Leaders
      • - Women to Watch
    • Excellence in Nursing Awards
    • Design Awards
    • Top 25 COOs in Healthcare
    • 100 Top Hospitals
    • ACHE Awards
  • Events
    • Conferences
    • Galas
    • Webinars
    • COVID-19 Event Tracker
    • podium march webinar logo lockup
      Sponsored Content Provided By Podium
      Webinar: Critical Touchpoints for Every Patient’s Journey — How Technology Plays an Important Role
      scp health logo lockup march 2021
      Sponsored Content Provided By SCP Health
      Webinar: COVID’s call to action — Reset for success in 2021
    • Women Leaders in Healthcare Conference
    • Social Determinants of Health Symposium
    • Healthcare Transformation Summit
    • Leadership Symposium
    • Virtual Briefings
      • - Hospital of the Future
      • - Mental Health
      • - Patient Safety & Quality
      • - Strategic Marketing
      • - Virtual Health
      • - Workplace of the Future
    • Best Places to Work Awards Gala
    • Health Care Hall of Fame Gala
    • Top 25 Minority Leaders Gala
    • Top 25 Women Leaders Gala
  • Listen
    • Podcast - Next Up
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Video Series - The Check Up
    • Sponsored Video Series - One on One
    • Empty boardroom
      Next Up Podcast: What's going to happen tomorrow? Succession planning during emergencies
      Next Up Podcast: Educating patients on the COVID-19 vaccine with Tanya Andreadis
      Dr. Joseph Cacchione
      Next Up Podcast: Educating patients on the COVID-19 vaccine with Dr. Joseph Cacchione
      Dr. Karen DeSalvo
      Next Up Podcast: What to expect with telehealth and healthcare technology in the next four years
    • Beyond the Byline: Insurers are betting on virtual-first plans as COVID-19 shifts care pathways
      Beyond the Byline: How residents' stories shape our coverage of the vaccination rollout in nursing homes
      Beyond the Byline: Regulators aim to boost value push with fraud and abuse law updates
      An older man wearing a mask receiving a vaccine.
      Beyond the Byline: Verifying information on the chaotic COVID-19 vaccine rollout
    • Outreach during COVID-19
      Leading intention promote diversity and inclusion
      Introducing Healthcare Insider Podcast
    • The Check Up: Dr. Marc Boom
      The Check Up: Dr. Marc Boom of Houston Methodist
      The Check Up: Dr. Imran Andrabi
      The Check Up: Dr. Imran Andrabi of ThedaCare
      The Check Up: Tanya Blackmon
      The Check Up: Tanya Blackmon of Novant Health
      The Check Up: Dr. Patrick Hwu
      The Check Up: Dr. Patrick Hwu of the Moffitt Cancer Center
    • ivana naeymi-rad one on one intelligent medical objects
      Video: Ivana Naeymi Rad of Intelligent Medical Objects
  • MORE +
    • Advertise
    • Media Kit
    • Newsletters
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Providers
August 08, 2011 01:00 AM

Total recall

Providers are taking the lead in revamping system for handling questionable drugs and medical devices

Jaimy Lee
  • Tweet
  • Share
  • Share
  • Email
  • More
    Print

    The high-profile drug and device recalls of recent years have set the backdrop for healthcare organizations to establish more efficient, proactive systems that can better identify early signs of troubled products.

    Drug and device recalls have been continually cited as causes for increased scrutiny of the Food and Drug Administration's device approval process because of safety concerns, as well as for the drug shortages affecting hospitals and health systems.

    The FDA noted in a letter to government officials that it has experienced “significant increases” in the number of recalls for the drugs, devices and diagnostics that are regulated by the federal agency.

    “In recent years, the agency has experienced significant increases in the number of recalls of FDA-regulated products, some of which involve the largest and most complex recalls in FDA history,” the agency wrote.

    Robert Pezzin, interim vice president of supply chain for Nexera, the supply-chain management and consulting firm owned by the Greater New York Hospital Association, says the financial burden of a recall, including developing the systems to manage a recall along with the costs when a product is recalled, often falls to hospitals, rather than manufacturers.

    Pezzin works on-site at West Penn Allegheny Health System, based in Pittsburgh.

    “What we see is every organization is burdened with developing its own process and system,” Pezzin says. “That takes considerable resources and finances. Right now, you don't see that being funded by the manufacturers or by the FDA to assist hospitals in standardizing this practice.”

    Along with the costs incurred for the labor and expense of pulling products from shelves and returning them to a manufacturer—some companies will refund the freight cost—finding alternative drugs or devices can carry additional costs.

    “A substitute product could carry a premium over what you were using before,” Pezzin says.

    Recalls have pushed hospitals and health systems to establish automated responses rather the manual systems that many facilities still have in place, says Kathy DeLacio, director of procurement and administration for corporate contracting at West Penn Allegheny. Depending on the product and the nature of the recall, it can take between a few days to a month to get a response to a recall from a vendor about a return authorization.

    The FDA's role is to oversee a manufacturer's management of the recall, according to the GAO, but other stakeholders that take part in the recall efforts include manufacturers, distributors, hospitals and patients.

    “There is the need to automate and compress the timeframe from which a hospital or a healthcare system is notified of a recall,” DeLacio says. “By the time you get it out to all your end users, especially when you have implantables involved, time is of the essence.”

    Johnson & Johnson is one example of a pharmaceutical and device manufacturer that has reported numerous recalls over the past several years.

    With J&J already dealing with a number of over-the-counter product recalls, DePuy Orthopaedics, a subsidiary of the New Brunswick, N.J.-based company, recalled its ASR hip system in August 2010. The company said the implant had a high early failure rate, which led to more revision surgeries. The recall prompted hundreds of lawsuits.

    “DePuy has a comprehensive process in place for evaluating and acting on any concerning product performance data and rapidly alerting customers if necessary,” DePuy spokeswoman Mindy Tinsley said in a statement responding to an interview request. “We constantly evaluate our processes for improvement.”

    The recalls, including the hip implant, were a key complaint in allegations of wrongdoing from J&J shareholders in a recent lawsuit. The recall for the implantable device affected 93,000 patients worldwide.

    The ASR hip systems recall is expected to cost J&J $184 million in “reasonable and customary costs of testing and treatment associated with the recall” over the next five years, according to a company report.

    Recent recalls have also put the FDA under examination. Following a Senate hearing in April that addressed the agency's handing of recalls, the Government Accountability Office released a report two months later that recommends the federal agency take a more proactive stance in analyzing and assessing data in order to better aid its oversight of the medical device recall process.

    “The agency has a plethora of data available on thousands of recalls, but at present, is not effectively reviewing and analyzing these data in a systematic manner,” the GAO authors wrote. “More routine analyses of these data could help FDA identify trends in the numbers and types of devices being recalled, as well as the underlying causes of device recalls.”

    The GAO reported that there were 3,510 medical device recalls from 2005 to 2009. During 2008 and 2009, manufacturing issues were the greatest cause of recalls for medical devices, according to the report.

    The FDA said it supported the GAO findings, and earlier this year the agency's Center for Devices and Radiological Health announced the creation of a recall improvement team, which is expected to support public understanding of the recall process.

    The GAO noted in the report that hundreds of hospitals and other stakeholders are increasingly relying on electronic communications technologies that provide subscription-based notifications for recalls, rather than notices from the manufacturers issuing the recall. The systems can cost several thousands of dollars a year, according to the GAO.

    Kathleen Murray, director of performance assessment and regulatory compliance at Beth Israel Deaconess Medical Center in Boston, says the hospital revamped its recall process in 2006 and implemented a system from an outside vendor to supply information about recalls.

    It also created a policy that lays out the hospital's formal response to recalls for regulated products. “Time spent managing the aftermath of the steps necessary for a recall has been reduced significantly since we have centralized and standardized and structured our program,” Murray says.

    In addition, Beth Israel Deaconess created what it calls a “first-response team” that will meet within eight hours if a recall requires patient notifications. For the recall of Medtronic's Sprint Fidelis heart lead, the hospital established a call-in number and extended clinic hours to reach a group of 260 patients, including those who had the implant placed at BIDMC and those who had the implant placed at another hospital but were patients at BIDMC. “It certainly has benefited our institution to stay abreast of all incoming notifications and to consider each one of them as what it means for our future,” Murray says.

    She says she has noticed an increase in information about implantable devices, although it may not be a recall or formal notification.

    Sharing information

    The CDRH issues two types of notifications: The public health notification provides information about a risk associated with the use of a medical device and how to avoid or reduce the risk; and a preliminary public health notification is information also provided to the healthcare community and will likely be updated. The manufacturer, in most instances, makes the recall.

    “As the technology is emerging and as the knowledge is gained through patient experience or device failures or near misses, there's been a greater sharing of that kind of information,” Murray says.

    While the technology may be advancing faster than the systems established to monitor it, small steps have been taken. The FDA is expected to issue within the next two years a final rule on the development of a unique device identifier system, a program that will better track and identify devices.

    The system stems from the passage of the Food and Drug Administration Amendments Act of 2007. Some of the issues that have been attributed to the slow rollout of a UDI system include establishing different labeling requirements, such as a linear or two-dimensional bar code, or radio frequency identification, for different devices; whether hospitals will implement the technology needed to support the systems; and the FDA's lack of authority over hospitals to require adherence to the UDI system, according to the GAO.

    The UDI system is expected rely closely on the involvement of hospitals although the GAO report expressed concern about the support of hospitals that have not yet established automated inventory systems.

    Also at work are two national registries that will gather information about knee and hip replacements. The Agency for Healthcare Research and Quality awarded a $12 million grant to the University of Massachusetts Medical School to establish a nationwide registry of 33,000 total joint replacement patients.

    The registry will gather data about joint replacement failure, technical or mechanical issues, the impact of the replacement on a patient's mobility, function, pain and quality of life, and a patient's ethnic, socioeconomic and demographic group, according to UMass.

    Another registry, the American Joint Replacement Registry, completed its first pilot with 16 hospitals in July. The organization, which was formed in 2009, has received financial support from manufacturers, trade associations and medical groups and is expected to have annual costs of $4 million. It also plans to gather data about total hip and knee replacements.

    The AJRR's first round of data collection—what the organization calls “level 1” data—gathers information about the patient, procedure, surgeon and hospital.

    It plans to collect increasingly complex data as AJRR becomes more established, but the goal is to ensure that every hospital that provides total joint replacements in the U.S. share their level 1 data, according to Dr. David Lewallen, a professor of orthopedic surgery at the Mayo Clinic and chairman of the AJRR.

    “While it doesn't provide all the answers we want as to what's going on, it allows us to ask intelligent questions,” he says.

    The registry is modeled after other national registries in countries like Norway, Sweden, Australia and the UK—the latter two national registries were responsible for identifying the problems with the ASR hip implant system that led to the recall. It is expected to release an annual report to hospitals and health systems, manufacturers, physicians, payers and other stakeholders.

    Letter
    to the
    Editor

    Send us a letter

    Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.

    Recommended for You
    Shareholder group calls out HCA for alleged excessive emergency department admissions
    Shareholder group calls out HCA for alleged excessive emergency department admissions
    MetroHealth forms Center for Cancer Research
    MetroHealth forms Center for Cancer Research
    Sponsored Content
    Get Free Newsletters

    Sign up for free enewsletters and alerts to receive breaking news and in-depth coverage of healthcare events and trends, as they happen, right to your inbox.

    Subscribe Today

    The weekly magazine, websites, research and databases provide a powerful and all-encompassing industry presence. We help you make informed business decisions and lead your organizations to success.

    Subscribe
    Connect with Us
    • LinkedIn
    • Twitter
    • Facebook
    • RSS
    • Instagram

    Stay Connected

    Join the conversation with Modern Healthcare through our social media pages

    MDHC_Logotype_white
    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Advertise with Us
    • Ad Choices Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2021. Crain Communications, Inc. All Rights Reserved.
    • News
      • This Week's News
      • COVID-19
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition
    • Insights
      • ACA 10 Years After
      • Best Practices
      • Special Reports
      • Innovations
    • Transformation
      • Patients
      • Operations
      • Care Delivery
      • Payment
    • Data/Lists
      • Rankings/Lists
      • Interactive Databases
      • Data Points
    • Op-Ed
      • Bold Moves
      • Breaking Bias
      • Commentaries
      • Letters
      • Vital Signs Blog
      • From the Editor
    • Awards
      • Award Programs
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • Best Places to Work in Healthcare
        • Health Care Hall of Fame
        • Healthcare Marketing Impact Awards
        • Top 25 Emerging Leaders
        • Top 25 Innovators
        • Minorities in Healthcare
          • - Luminaries
          • - Top 25 Minority Leaders
          • - Minorities to Watch
        • Women in Healthcare
          • - Luminaries
          • - Top 25 Women Leaders
          • - Women to Watch
      • Nominate
      • Previous Award Programs
        • Excellence in Nursing Awards
        • Design Awards
        • Top 25 COOs in Healthcare
      • Other Award Programs
        • 100 Top Hospitals
        • ACHE Awards
    • Events
      • Conferences
        • Women Leaders in Healthcare Conference
        • Social Determinants of Health Symposium
        • Healthcare Transformation Summit
        • Leadership Symposium
        • Virtual Briefings
          • - Hospital of the Future
          • - Mental Health
          • - Patient Safety & Quality
          • - Strategic Marketing
          • - Virtual Health
          • - Workplace of the Future
      • Galas
        • Best Places to Work Awards Gala
        • Health Care Hall of Fame Gala
        • Top 25 Minority Leaders Gala
        • Top 25 Women Leaders Gala
      • Webinars
      • COVID-19 Event Tracker
    • Listen
      • Podcast - Next Up
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Video Series - The Check Up
      • Sponsored Video Series - One on One
    • MORE +
      • Advertise
      • Media Kit
      • Newsletters
      • Jobs
      • People on the Move
      • Reprints & Licensing