Digest Vol 29 No 2 2019
Ophthalmologists regularly use equipment and medical devices (EMDs) while caring for their patients. Sometimes, things go wrong. Injured patients may allege that an EMD malfunctioned or was used improperly. They may sue the ophthalmologist, the surgery center, and the manufacturer of the EMD.
This issue of the Digest will use select closed claims to illustrate the initial steps the ophthalmologist, staff, and surgery center should take to manage these EMD events. The claims have been chosen for their instructive value even if the EMD is no longer in use or has been redesigned or retired.
2020 February Bulletin: The end of Windows 7
If your practice was using Windows 7 and migrated to Windows 10 in advance of January 14, 2020, congratulations!
January 14th was the date that Microsoft ceased its free support of Windows 7. The continued use of unsupported operating systems is a violation of HIPAA. If a vulnerability in Windows 7 leads to a breach of protected health information after the January 14 deadline, you could face a regulatory fine.
Microsoft will continue to offer extended security updates to enterprise Windows 7 users for a fee. Extended security updates for fee-paying enterprises will come to an end in January 2023.
Consult with your IT department or consultant, or contact Microsoft for assistance.
LINKS TO MICROSOFT INFORMATION:
Windows 7 Support ended Jan 14, 2020
https://support.microsoft.com/en-us/help/4057281/windows-7-support-ended-on-january-14-2020
Extended security for Windows 7 enterprise users
https://support.microsoft.com/en-us/help/4497181/lifecycle-faq-extended-security-updates
Management of acute ophthalmic presentations
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Acute ophthalmic conditions present diagnostic and management challenges. To assist in assessing patients with acute presentations, including retinal ischemia, OMIC Committee member Dr. Gaurav Shah and retina fellow Dr. Alex Boutini of Retina Consultants, Ltd (St. Louis, MO) developed an algorithm called Acute Ophthalmic Presentations. We thank them for allowing us to share this decision tree.
Consider sending this decision tree to Emergency Department physicians at hospitals where you take call.
See also the latest AAO recommendations on acute retinal ischemia at https://www.omic.com/management-of-acute-retinal-ischemia/
FDA Alert – Artificial Tears
On Feb. 3, the US Food and Drug Administration (FDA) issued a warning statement to consumers and health care practitioners to not purchase and to immediately stop using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, due to potential bacterial contamination. Both products have been voluntarily recalled.
The Centers for Disease Control (CDC) has developed related resources for health care providers:
The CDC continues to investigate the multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa associated with artificial tears.
Xen glaucoma device recall
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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.
