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Joint Commission to check for FDA powdered glove compliance

The Joint Commission surveyors will now check to see if hospitals are compliant with the Food and Drug Administration’s (FDA) ban on powdered medical gloves. The ban went into effect in January, with the administration citing the powder’s potential to cause severe airway and wound inflammation, granulomas, and post-surgical adhesions in the tissue between internal organs. Powdered latex gloves also carry the risk of allergic reaction in patients. The Joint Commission will now issue citations on the powdered glove ban under LD 04.01.01, element of performance 2.

“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health, in a press release. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

To learn more about the FDA’s decision, read our previous coverage on the ban.

FDA: Hospitals banned from using powdered medical gloves

The Food and Drug Administration’s (FDA) ban on powdered medical gloves went into effect on January 18. The use, advertising, and marketing of powdered surgeon’s gloves, patient examination gloves, and absorbable powder for surgeon’s gloves at medical clinics and hospitals is now strictly forbidden.

Powders have been used to lubricate gloves for easy removal for more than 100 years. However, the powder currently used in medical gloves has been shown to cause severe airway and wound inflammation, granulomas, and post-surgical adhesions in the tissue between internal organs. In addition, powdered latex gloves carry the risk of allergic reaction in patients.

“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health in a press release. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

The agency’s most recent push to get rid of powdered gloves came after receiving three citizen petitions between 2008 and 2011. The proposed rule was published last March; the FDA estimates the reduction in patient harm and the rise of affordable powdered glove alternatives will save the health industry between $26.6 million and $29.3 million annually.

“We need to take every measure to ensure patient well-being, complete healing and satisfaction with their surgery,” wrote Linda Gylland, QLS, MLS (ASCP), lab safety officer at Sanford Health, N.D., in an email. “I am surprised it has taken this long (since 1997 when the FDA was aware of this) to reach this decision. We have more good glove alternatives than we had 10 years ago, so in my opinion, this shouldn’t be a factor. We need to be proactive and prevent possible problems to patients with powder.”

Senate overwhelmingly confirms new FDA Chief


Dr. Robert Califf was confirmed as the new FDA Commissioner by the Senate on Feb. 24.

Dr. Robert Califf was confirmed as the new FDA Commissioner by the Senate on Feb. 24.

On February 24, the U.S. Senate voted to confirm Robert Califf, MD, as the new Food and Drug Administration (FDA) commissioner. The Senate vote in Califf’s favor was 89-4, ending a yearlong debate over his suitability.

Califf, a former medical researcher at Duke University, was nominated for the position by President Obama back in January 2015. Despite having widespread support from many patient advocacy groups, academics, and medical societies, his confirmation had been delayed by a small group of senators who said they were concerned about how Califf’s links to the pharmaceutical industry would affect his response to the prescription opioid epidemic.


FDA releases fact sheet about new opioid action plan

Amidst the growing opioid epidemic, the Food and Drug Administration (FDA) has now released details about its Opioid Action Plan. The fact sheet details the agency’s policy changes and the outcomes it hopes will result.

Expanding use of advisory committees

  • The FDA will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties.
  • The Pediatric Advisory Committee will make recommendations regarding a framework for pediatric opioid labeling before any new labeling is approved.
  • The FDA will consult an advisory committee on abuse-deterrent formulation (ADF) opioids when it raises novel issues.

Outcome:Before the approval of any new opioid that does not have abuse-deterrent properties and expert advice on pediatric opioid labeling, it will be reviewed by external experts who will give advice on the drug. In addition, there will be opportunity for public input for every new opioid.

Develop warnings and safety information for immediate-release (IR) opioid labeling

  • The agency is developing changes to IR opioid labeling, including additional warnings and safety information, similar to the labeling for extended-release/long-acting (ER/LA) opioid analgesics.

Outcome:Better information for doctors about the risks and how to prescribe safely.

Strengthen postmarket requirements

  • There is a substantial lack of an evidence base to guide the use of opioid medications, particularly for their long-term use.
  • The agency is strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids.

Outcome:Better evidence on the serious risks of misuse and abuse associated with long-term use of opioids, predictors of opioid addiction and other important issues.

Update Risk Evaluation and Mitigation Strategy (REMS) Program

  • ER/LA opioids are currently subject to a REMS program that requires sponsors to fund low-cost or free continuing medical education courses on the appropriate use of ER/LAs.
  • The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements.

Outcome: Increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs to decrease inappropriate opioid prescribing.

Expand access to ADFs to discourage abuse

  • The FDA will issue draft guidance with its recommendations for the approval standards for generic ADFs.
  • Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs.

Outcome:Spur innovation and generic ADF product development.

Support better treatment

  • The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone.
  • The FDA also supports the Centers for Disease Control and Prevention guidelines for prescribing opioids and will facilitate the development of evidence and improved treatments.

Outcome:Broader access to overdose treatment, safer prescribing and use of opioids, and ultimately, new classes of pain medicines without the same risks as opioids.

Reassess the risk-benefit approval framework for opioid use

  • The FDA will seek advice from its Science Board in March 2016 on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them.
  • The FDA is already working with the National Academies of Sciences, Engineering, and Medicine on the same topic.
  • Once completed the reports will be made publicly available.

Outcome:Formal incorporation of the broader public health impact of opioid abuse in approval decisions.

Check out our previous coverage on the FDA and CDC’s response to the opioid crisis. 

Medical devices enter the realm of partisan politics

Duodenoscopes received a lot of publicity in 2015, most of it bad. The final straw was when a Senate committee report linked defective scope designs to 25 infection outbreaks since 2012, 19 of which involved drug-resistant superbugs.

The Food and Drug Administration (FDA) took the brunt of the blame in the Senate report for its handling of the issue. The reports show that while the FDA was aware of the potential risks of dirty scopes, it didn’t warn the public until after a 17-month investigation. By the time the FDA warning was released, there were seven more scope-caused outbreaks, with 68 patients contracting antibiotic-resistant infections.

The report dragged the issue into the public eye and now Democrats and Republicans are both condemning the FDA’s handling of the situation. The Washington Post reports that while both sides agree changes need to be made, they disagree over what needs to be done.

Democrats argue that implementing a bar code system for medical devices would allow hospitals to track what devices are linked to infections or other issues. The Washington Post reports that the bar code program is already being phased in and will cost around $250 million.

Republicans argue that instead of a new system the FDA should simply use the power it  already has, noting that the agency already has the (often unused) power to impose civil and criminal penalties against manufacturers for not reporting injuries or deaths.

You can read the full Senate committee report here,  along with some of our previous coverage on duodenoscopes. 

All Olympus duodenoscopes recalled, replaced with approved FDA model

Olympus Corp., the biggest seller of duodenoscopes in the nation, announced a recall of all its scopes on January 15. The recall was issued a day after a Senate committee report linked Olympus products to 142 antibiotic-resistant infection (ARI) cases.

Duodenoscopes are flexible cameras that are inserted into a patient’s mouth or digestive tract to diagnose cancers, and are used in over 500,000 procedures a year. Recent investigations found that a flaw in the scope’s design made it near impossible to fully disinfect, exposing patients to ARIs and resulting in 25 outbreaks in three years and four countries.

Olympus is the largest of the three companies listed in the Senate Committee on Health, Education, Labor, and Pensions report, controlling 85% of the American duodenoscope market. Olympus voluntarily issued the recall after the Food and Drug Administration (FDA) cleared the company’s new safety modifications to its TJF-Q180V model duodenoscope. 

“We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices,” said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in a press release. “The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, is intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections.”

Olympus says it will call every facility using the scopes and provide them with a free replacement for their recalled devices. There are around 4,400 TJF-Q180V models currently in use in America and Olympus hopes to have them all replaced or modified by August 2016. In the short term, healthcare facilities may continue to use unmodified TJF-Q180Vs, but are urged to meticulously follow the manufacturer’s reprocessing instructions.


Senate panel: 250 confirmed antibiotic-resistant infections now linked to duodenoscopes

In December, the FDA linked 45 antibiotic-resistant infections (ARI) cases to Olympus brand duodenoscopes since 2012, with the infections causing 24 illnesses and 21 deaths.

Now, a new Senate committee report has tripled the number of confirmed Olympus duodenoscopes infections to 142. Industrywide, there have been 250 patients since 2012 who’ve contracted ARIs from duodenoscopes made by various companies. Dirty scopes have been responsible for 25 patient outbreaks in 10 states and four countries. Several of the outbreaks involved Carbapenem-resistant Enterobacteriaceae infections, which can kill up to 50% of those it infects and can sometimes share its drug resistance with other bacteria. 

The three companies singled out in the report were Pentax Medical, Fujifilm Medical Systems, and Olympus Corp. The Senate Health, Education, Labor, and Pensions Committee also placed blame on the FDA, saying the agency’s safety reporting system was too slow and cumbersome.

You can read the full report here. 


FDA to provide more frequent info on medical device injuries and deaths

In 2016, the Food and Drug Administration (FDA) will be taking a stronger stance on reporting medical device complications and deaths. The agency’s newly published draft guidance will allow it to report early warnings signs associated with medical devices before the reports have been fully analyzed.

The FDA currently releases safety warnings and recalls on its website. That said, prior to this guidance the agency was unable to release any information on possible complications and injuries related to said warnings until after the all reports had been fully analyzed. The issue was that the agency receives hundreds of thousands of device safety reports in need of vetting each year.

Device manufacturers and other interested parties have until February 29 to comment on the draft.

Boston Scientific issues immediate recall of device guidewires

The Boston Scientific Corp. issued an urgent medical device recall of its RotaWire “Elite” core wires and wireClip Torquer guidewires on November 27. The company said the guidewires may crack and detach from the Rotablator Rotational Atherectomy System (RRAS). The RRAS is used to open narrow arteries and cut away at plaque, improving blood flow to the heart. When the guidewires crack, the pieces can be left inside the artery causing tamponade or heart attacks. Boston Medical has learned of three incidents of guidewires cracking so far, with one case resulting in a patient’s death.

The recall comes in the wake of a FDA safety communication on intravascular devices. Since 2014, the FDA has received 500 medical device reports on peeling hydrophilic and/or hydrophobic coatings on intravascular devices, with the majority of reports submitted for vascular guidewires.

The FDA encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Facilities still using these guidewires are told to stop using them immediately. All affected products should be returned to Boston Scientific and distributors should notify any customer who may have received the product.

FDA issues warning about MRI burns

The Food and Drug Administration (FDA) issued a warning yesterday about the risk of burns to patients who wear transdermal patches. These are medicated patches most often associated with smokers who are trying to quit smoking. These patches have been catching fire during MRI scans because many of them contain a metal backing that’s not always visible to the wearer, or the person administering the scan.

While the FDA is compiling a list of those patches that could ignite during a scan, it has issued the following advice to healthcare workers:

  •  identify those patients who are wearing a patch before the patients have the MRI scan
  • advise those patients about the procedures for removing and disposing of the patch before the MRI scan
  • advise those patients about replacing the patch after the MRI scan

To read the full advisory, click here.