Anticoagulant form for patients
Anticoagulants form for patients can help your patients remember when to stop and restart anticoagulant medications. We thank OMIC Board member Dr. Ronald Pelton for sharing it with us.
Risk management recommendations: Hemorrhage and Ophthalmic Procedures
Anticoagulant list
This Anticoagulant list includes the most common medications and over-the-counter drugs and supplements that could increase the risk of hemorrhage during surgery. We thank OMIC Board member Dr. Ronald Pelton for sharing it with us.
Risk management recommendations: Hemorrhage and Ophthalmic Procedures
Xen glaucoma device recall
CLICK ON DOWNLOAD TO ACCESS THE SAMPLE LETTER
Allergan has announced a voluntary recall of its Xen® 45 Glaucoma Treatment System (XEN 45 Gel Stent preloaded into a Xen® Injector).
Allergan announcement sent to the American Glaucoma Society
“As of Friday October 18th, 2019, Allergan reached out to surgeons to inform them that unused XEN 45 devices are on hold in the U.S. and globally. Consequently, the Company recommended surgeons postpone any upcoming surgeries using XEN and not implant any unused XEN devices currently in their practice/office/surgical suite/OR. Since then, Allergan has voluntarily recalled all lots of XEN® Glaucoma Treatment System (XEN® 45 Gel Stent preloaded into a XEN® Injector). Healthcare providers will receive a recall letter by October 31, 2019 to return unused XEN products. Allergan has informed the U.S. Food and Drug Administration of this voluntary recall.
This recall is being conducted down to the Retail (Health Care Provider) Level. It is important to note that explanting implanted devices is not being recommended; this recall is a retrieval of un-implanted inventory.
During in-process inspection, 4 (four) units in an unreleased XEN® 45 lot were observed to have trace amounts of residual polishing compounds that are used in the needle sleeve manufacturing process. A review of the field safety reports has not detected any safety signals or adverse trends associated with the residual polishing compounds.
For any question regarding XEN or to report any adverse events, please contact Product Surveillance at 1-800-624-4261. Allergan anticipates resupply of XEN45® to U.S. market in mid-December.”
Patient care advice from Allergan
On October 31, 2019, Allergan sent letters to physicians who had received the affected lots. Recalled devices were distributed from 2017 to 2019. The letter contained this advice about patient care:
- Continue your normal postoperative care.
- Explanting implanted devices is not recommended.
- Report any serious adverse events to Allergan Product Surveillance.
Notifying patients
- Send a Letter about the Xen recall to patients who have devices from recalled lots.
- Our sample letter explains that there are no known adverse patient outcomes, and that the device does not need to be removed.
- Send the letter via regular mail, and place a copy in the patient’s medical record.
OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com.
Choice of law agreement between TX physicians and NM patients
Some of OMIC’s insureds practice near the border of New Mexico and see patients from that state. The Texas Tort Claims Act (TTCA) generally provides broader protections than the New Mexico Tort Claims Act (NMTCA) to physicians sued for medical professional liability. Many Texas health care providers were considering refusing to see New Mexico residents if they would not be protected by the TTCA in a lawsuit arising from their care of New Mexico patients. In order to protect its citizens’ access to care, the New Mexico legislature passed a law to enforce choice of law and forum selection provisions in agreements between New Mexico patients and out-of-state health care providers.
If you want claims and civil actions brought against you by New Mexico patients to be brought in Texas and governed by Texas law, you must have a written agreement with the patient that contains Texas choice of law and choice of forum provisions.
We have prepared two documents for you to use. Please click on the name of the document to download it:
- SAMPLE GOVERNING LAW AND FORUM AGREEMENT.
- Here is a sample letter explaining the agreement to patients: Texas New Mexico PATIENT LETTER.
If you are considering the use of such an agreement, you should seek your attorney’s advice on the exact form of the agreement, its language, and who should sign it, as well as the language in the cover letter.
Kamra inlay
Click “download” to access the consent form for the Kamra inlay. The consent form is for on-label use of the Kamra inlay. It was approved for a very narrow range of indications.
Remove the two sentences in [yellow] if you are using the femtosecond laser to create a pocket.
