Browsing articles in "Articles"

2018 September Alert: CyPass Advice

 //  No Comments

September 16, 2018 Alert

Clinical Advice on CyPass Issued

Dear OMIC Policyholder,

We are contacting you with an update to our email of September 21, 2018. Please check https://www.omic.com/alcon-voluntary-withdrawal-of-cypass-glaucoma-device/ for future updates, as well as links to the materials discussed below.

Risk management recommendations
OMIC recommends that you take the following steps to promote patient safety and reduce your liability exposure:

  • Notify patients with CyPass of the market withdrawal in a letter sent via regular mail. Our sample letter to patients is available at https://www.omic.com/alcon-voluntary-withdrawal-of-cypass-glaucoma-device/.
  • Place a copy of the letter in the patient’s medical record, and send a copy to the referring ophthalmologist or optometrist.
  • When you do examine the patient, determine if there are any signs of unexpected endothelial cell loss or other problems.
  • Share your findings with the patient, and explain your plan for monitoring the eye.
  • Document the findings and discussion.

Clinical guidance and additional information are available from both Alcon and ASCRS.

OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com.

2019 March Alert: RainDrop Near Vision

 //  No Comments

March 2019 Risk Management ALERT

FDA Recalls RAINDROP Near Vision Inlay

The FDA issued a Safety Alert about the Raindrop Near Vision Inlay on October 23, 2018. On March 5, 2019, the FDA recalled the device and updated the Safety Alert (https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623973.htm), which states:

“People who undergo implantation of the Raindrop Near Vision Inlay device are at risk for the development of corneal haze that can affect clear vision. Haze can cause blurry vision or glare by clouding the cornea, or by changing the focusing power of the eye. The impact of haze on the patient’s vision is dependent on the severity of haze and its location in the cornea.”

The FDA made the following recommendations:

  • Do not implant Raindrop inlays.
  • Contact Optics Medical (Phone: 949-330-6511) for instructions on returning any unused product to the firm.
  • Be aware of the new data from the ongoing post-approval study, which is showing 1) high rates of corneal haze in both implanted and explanted patients, 2) an increasing rate of device removal, and 3) that some cases of haze did not develop until 60 months post-implant.
  • Monitor patients with the implant, and those whose device has been explanted, for the development of corneal haze.

Risk management recommendations

OMIC recommends that you take the following steps to promote patient safety and reduce your liability exposure:

  • PATIENTS ALREADY NOTIFED OF THE SAFETY ALERT AND EVALUATED
    • Update patients when they present for their next appointment.
    • Share your current findings, and explain your plan for monitoring the eye.
    • Educate them about symptoms that should be reported to you.
    • Document the discussion.
  • PATIENTS WHO WERE NOT NOTIFIED OR EVALUATED
    • Notify patients via a letter sent regular mail, and ask them to call your office to make an appointment (available at https://www.omic.com/fda-recalls-raindrop-near-vision-inlay/).
    • Place a copy of the letter in the patient’s medical record, and send a copy to the referring ophthalmologist or optometrist.
    • When you do examine the patient, determine if there are any signs of corneal haze or other problems.
    • Share your findings with the patient, and explain your plan for monitoring the eye.
    • Educate them about symptoms that should be reported to you.
    • Document the findings and discussion.

2018 November Bulletin: Giant Cell Arteritis (based on 2015 GCA Claims Study)

 //  No Comments

November 2018 Risk Management Bulletin

Giant Cell Arteritis (GCA)

The short window for diagnosis and treatment and the risk of severe bilateral vision loss underscore the high stakes of this relatively rare condition.

Lawsuits for delay in diagnosis of GCA involve ophthalmologists who had treated patients with it, knew its signs and symptoms well, and understood that emergent treatment is needed to prevent imminent, bilateral vision loss. What, then, led these ophthalmologists astray?

Our resources explore the reasons for these poor outcomes, the standard to which medical experts hold physicians who treat these patients, and the measures ophthalmologists can take to improve the likelihood of a correct and timely diagnosis.

RESOURCES

Giant cell arteritis claims are costly and difficult to defend

Giant Cell Arteritis Checklist

2019 February Bulletin: Retina Ischemia

 //  No Comments

February 2019 Risk Management Bulletin

Management of Acute Retinal Ischemia

We would like to draw your attention to new guidelines on the management of acute retinal ischemia that indicate an urgent need to change how ophthalmologists approach patients with this condition. We also discuss what to do if your community does not have the recommended resources.

According to the guidelines published recently in Ophthalmology, “acute retinal arterial ischemia, including vascular transient monocular vision loss (TMVL) and branch (BRAO) and central retinal arterial occlusions (CRAO), are ocular and systemic emergencies requiring immediate diagnosis and treatment. Because the risk of stroke is maximum within the first few days after the onset of visual loss, prompt diagnosis and triage are mandatory. Eye care professionals must make a rapid and accurate diagnosis and recognize the need for timely expert intervention by immediately referring patients with acute retinal arterial ischemia to specialized stroke centers without attempting to perform any further testing themselves.”

If Your Community Does Not Have a Certified Stroke Center

The new guidelines suggest as an alternative immediately referring patients with TMVL, BRAO, or CRAO to observation units in Emergency Departments, or admitting them to hospitals.

  • Determine what resources the nearest Emergency Department and hospitals have for evaluating patients with possible strokes.
  • Explore the most efficient process for such patients. While a particular hospital might be closer, the patient may be better served by seeking care at a more distant facility with a predefined accelerated diagnostic protocol for such patients.

Formulating a plan now on how to implement these guidelines will promote patient safety and reduce your liability exposure.

RESOURCES

2019 January Alert: OZURDEX Recall

 //  No Comments

January 15, 2019 OMIC Announcement

Allergan Voluntary Recall of OZURDEX

On December 28, 2018, Allergan issued an “Urgent Drug Recall” of 22 lots of OZURDEX. The recall was prompted by the finding of a silicone particulate of 300 microns diameter in dispensed OZURDEX implants. Allergan determined that the particulate originated from the needle sleeve.

Allergen identified the following safety risks: “Mild transient visual disturbances or intraocular inflammatory reaction in sensitive patients” and “…a remote possibility of corneal reaction if the particulate migrates to the anterior chamber.” Allergan categorized the risk probability as low, based on the infrequent dosing of OZURDEX.

However, OMIC has received 1 report to date of a reaction in a bilaterally treated patient who experienced a reaction in one eye, resulting in hand motion vision. Therefore, the potential side effects should not be minimized, and patients should be counseled carefully about watching for and immediately reporting signs and symptoms.

Insureds who have lots of OZURDEX should follow Allergans’ advice regarding inspecting the lot numbers in your inventory and returning any recalled lots to Allergan, preserving evidence, and reporting adverse reactions.

OMIC recommends that insureds respond by doing the following:

    • Follow the recommendations of the manufacturer.
    • Disclose the recall to the affected patients (see attached sample letter to patients) and add the letter to the patient’s medical record.
    • Monitor patients for signs and symptoms.
    • Report adverse reaction to Allergan.
    • Treat the symptoms.
    • Document your discussions and treatment in the medical record.

OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com.

 

Denise R. Chamblee, MD
Chair, OMIC Risk Management Committee		 Linda D. Harrison, PhD
Director, OMIC Risk Management
Pages:«1...17181920212223...90»




Six reasons OMIC is the best choice for ophthalmologists in America.

Consistent return of premium.

Publicly-traded insurance companies exist to make profits for shareholders while physician-owned carriers often return profits to their policyholders. Don’t underestimate this benefit; it can add up to tens of thousands of dollars over the course of your career. OMIC has one of the most generous dividend programs for ophthalmologists and has returned more than $90 Million to our members through dividends.

61864684