When FDA Leaves Doctors to Their Own Devices
By Kimberly Wittchow, JD
Ms. Wittchow is a staff attorney with OMIC’s Risk Management/Legal Department.
Digest, Spring 2003
To view the two tables referenced in this article, go to the link http://www.omic.com/new/digest/DigestSpri_03.pdf
With the constant development of new devices in the global health care marketplace, ophthalmologists in the U.S. are privy to various treatment alternatives, many of which are tested and employed by their peers around the world long before they are approved for use in the U.S. What are the liability risks and risk management issues that arise if American doctors opt to use devices not yet approved by the Food and Drug Administration (FDA)?
Off-label use—the practice of using an FDA-approved drug or device for a purpose that the FDA has not approved—was explored in “Medicolegal Implications of Using Off-label Drugs and Devices,” (OMIC Digest, Winter 1996). The FDA states that doctors, in the exercise of their best judgment, may use approved drugs or devices off-label if they are well informed about the product, base its use on firm scientific rationale and sound medical evidence, and maintain records of its use and effects.
A related, riskier issue—the use of unapproved devices—was recently brought to OMIC’s attention by an insured who inquired about the soft tissue filler, Restylane, an injectable, gel-like substance containing hyaluronic acid that is currently used throughout Europe and Canada for lip augmentation and facial contouring. The FDA has received the results of US clinical trials of Restylane and is expected to approve it this summer (2003).
Compared to the FDA position on off-label use, the appropriateness of unapproved use is less clear. To understand the liability risks of using a device not approved by the FDA, it is necessary to understand the FDA device approval process. The Food, Drug and Cosmetic Act (FDCA) states that if a device is labeled, promoted or used in the US, it will be regulated by the FDA and is subject to pre-marketing and post-marketing regulatory controls to assure safety and effectiveness. Devices are broken down into three classes. Like collagen, Restylane, used for purposes similar to dermal collagen implants, is a Class III device (the most stringent regulatory category). Pre-market Approval (PMA) is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Clinical trials using un- approved medical devices on human subjects are performed under an Investigational Device Exemption (IDE). They must be approved by the FDA and by an Institutional Review Board (IRB) before the study can begin. The IDE allows the device to be used in order to collect the safety and effectiveness data required to support the PMA application to the FDA. Ophthalmologists must be aware that gathering new information on multiple patients for publication purposes, or to obtain approval for a new device or new use of an approved device, probably constitutes research and will require an IDE. However, if the use is based on firm scientific rationale and sound medical evidence, it is probably the practice of medicine, which is theoretically unregulated.
While the FDA approves and regulates the production, sale, and clinical research of medical devices, it does not directly regulate the practice of medicine. OMIC’s recent inquiries of FDA staff in the ophthalmic devices division reiterated this posi- tion. However, some courts will look for exceptions to a completely “hands off” position. For instance, the Pennsylvania Superior Court held that since the FDA had never approved the use of liquid silicone injections, the trial court erred when it gave a jury the instruction that the FDA has no authority to regulate the practice of medicine. The court noted that this instruction gave the jury the incorrect impression that a physician “can use any drug he wants, irrespective of whether it has been approved or disapproved by the FDA.”
Whether the FDA can or will regulate physicians using unapproved devices may be less important than the consequences resulting when a physician uses such a device to treat a patient and the patient files a malpractice lawsuit or disciplinary action with a state licensing board. The crucial question then becomes whether the physician met the standard of care based upon what reasonable physicians in the same specialty would do at the same time under similar circumstances.
Case law has shown that violating the FDCA may be evidence of a breach of the standard of care and consequently result in a determination that malpractice has occurred. A plaintiff attorney could argue that the use of an unapproved device constitutes negligence per se (negligence per se or legal negligence is negligence established as a matter of law, usually arising from a statutory violation). If state laws are stricter than the federal FDCA and specifically prohibit the use of unapproved devices, it would be easier for the plaintiff to prove a violation of the law and argue either negligence per se or breach of the standard of care.
In order to provide the best alterna- tive to the patient and stay one step ahead of the market competition, ophthalmologists may be tempted to offer the very latest in products or services. Before deciding whether to use the newest device available, several factors should be considered (see Questions to Ask Before Using a Non-FDA Approved Device). The analysis for non-FDA approved devices is based upon the same exer- cise of professional judgment that should be used in determining whether to use approved or off-label treatment alternatives. Physicians
should take special care before using a device for an elective cosmetic procedure. Defense attorneys postulate that juries more closely scrutinize the care of the physician when problems arise in an elective procedure, rather than in an emergency or life-saving procedure. A 2001 OMIC survey found that 73% of ophthalmologists polled believed that elective surgery patients are more likely than other patients to sue their surgeon. Given the higher risk that elective procedures pose, ophthalmologists should consider additional factors in order to make sound decisions to use non-FDA approved devices (see Additional Questions to Ask Before an Elective Cosmetic Procedure).
Applying this risk analysis to three different devices shows how fact- dependent the outcome of the analysis can be. First, in the case of Restylane, it appears that its use prior to FDA approval would be difficult to defend in a lawsuit. Even though physicians throughout Europe and Canada have been using Restylane with positive results since the mid-1990s, surgeons in the U.S. will need to gather data based on larger numbers of patients over extended periods of time in order to determine its long-term safety and efficacy. Patient expectations also will have a profound influence on the risk of using Restylane. Web sites already tout Restylane as a method that is “fast and safe and leaves no scars or other traces on the face.” Because the efficacy of Restylane is dependent on many variables, such as age, skin type, lifestyle, and muscle activity, patients with unrealistic expectations may be disappointed if they do not achieve the volume, smoothness, or long-lasting effects they anticipated. These factors create an especially risky environment in which to use a non-FDA approved device; prudent physicians would be well advised not to use Restylane (outside of an approved clinical trial) until it is approved by the FDA. A disappointed patient and plaintiff attorney will not have to look hard for theories of liability or experts to support a lawsuit against an ophthalmologist who injects this “unproven” material.
The second device group assessed for use prior to FDA approval is cap- sular tension rings, Class III devices marketed by Morcher and Ophtec and currently undergoing pre-market approval review with the FDA. These devices are being used in cataract surgery with some regularity and ophthalmologists are sharing their results with their peers. Because these devices are being used therapeutically for medical treatment, some of the patient expectation variables that arise in cosmetic pro- cedures are avoided. Nevertheless, because they are relatively new to the market, ophthalmologists should use them with caution.
The final example is cyanoacrylate adhesive, used by ophthalmologists for the medical treatment of corneal perforations. One variant of this product, Dermabond Topical Skin Adhesive (2-octyl cyanoacrylate), was approved by the FDA in 2002 to seal out infection-causing bacteria. Yet cyanoacrylate adhesives have been used in the US for wound repair as an alternative to sutures since the Vietnam War in the mid- 1960s. Even before Dermabond’s FDA approval, variations of this adhesive had a long and proven track record and near universal acceptance in the ophthalmic community. Because of its wide-spread peer use and longevity, ophthalmic use of cyanoacrylate adhesive for the treatment of small perforations or leaks would most likely be considered standard medical practice in the community even when applying the most conservative analysis criteria.
After review, if the ophthalmologist decides that there is sound medical evidence and it is in the patient’s best interest to use a non-FDA approved device, he or she should conduct and document a thorough and careful informed consent discussion. The patient should be informed of the nature of the technique or device being used, its scientific basis, its benefits, and any possible drawbacks or criticisms from other practitioners. Especially with cosmetic procedures, other options should be discussed, and the patient should be encouraged to seek a second opinion before proceeding.
If the unapproved device in question is used under an IDE, the federal government requires that the physician have a special, detailed informed consent discussion with the patient which addresses its unapproved status. If the device is not being used under an IDE, physicians should consult with legal counsel about whether state law requires them to disclose the device’s unapproved status to the patient as part of the informed consent discussion. Regardless of state or federal law, from a risk management perspective, it is always advisable to respect the patient’s right to obtain the information needed to make reasoned decisions about his or her own health care. If the physician reasonably believes that the approval status of the device to be used in the patient’s treatment will be a factor in the patient’s decision to undergo the procedure, this information should be disclosed.
Finally, ophthalmologists should always check with the Underwriting Department of their professional liability carrier to ensure that they will be covered for any off-label or non-FDA approved procedure they are contemplating.
Message from the Chairman discusses FDA and Allergan’s Trivaris drug
I have often used this Message to point out the many services OMIC provides to its policyholders, and indeed our profession, that other professional liability carriers cannot. Here is another very recent example of the prompt, specialty-specific advice OMIC is poised to provide.
Within days of the 18 June 2008 announcement in the American Academy of Ophthalmology’s Academy Express that the FDA had approved an injectable triamcinolone acetonide suspension (TA) for ophthalmic use, OMIC began to revise its consent form and anticipate associated medicolegal issues.
Trivaris,TM manufactured by Allergan Inc., is the second approved drug; it joins Alcon’s Triesence.TM These drug approvals come just 18 months after ophthalmologists received a “Dear Doctor” letter from Bristol-Myers Squibb advising them that KenalogTM was not approved for ocular use. In 2006, OMIC policyholders called our confidential Risk Management Hotline to ask if their policy would cover them if they still administered Kenalog.TM OMIC reassured ophthalmologists and assisted them by preparing and distributing a sample consent form to help patients understand that the use of an approved drug in an “off-label” fashion is a legal and often necessary aspect of the practice of medicine.
As a result of the limited indications for which TriesenceTM and TrivarisTM were approved, much ophthalmic use of these forms of TA will continue to be “off-label.” Moreover, now that there are approved formulations of TA, policy- holders are calling the Hotline again to ask, “Can I still use KenalogTM?” Why would physicians want to use a drug off-label if it was available in an approved, single dose form? Retina specialists whose patients were being successfully treated with bevacizumab (Avastin TM) grappled with this issue when Genentech got approval for another of its own products, ranibizumab (LucentisTM).
The answer then and now is related to the topics addressed elsewhere in this issue of the Digest: the cost of health care and the vagaries of reimbursement. Pharmaceutical companies devote years and considerable capital to research and manufacture new drugs. Thus, it is not surprising that freshly approved drugs are generally more expensive than ones already in use. The dilemma for physicians and patients alike, however, is that these drugs may not now—or ever—be included in the formularies of the patient’s health insurance plan. If an ophthalmologist feels the medication is indicated but learns that the cost won’t be borne by the insurance company or can’t be paid by the patient, what should he or she do?
OMIC’s board and committee members are ophthalmologists; we know it is our ethical and professional responsibility to put the patient’s interests above our own and provide what we feel is the most appropriate care. So our answer to our policyholders remains the same: discuss the situation openly with your patient, use your medical judgment, document your decision-making process, and know that OMIC will support you if your care is challenged. Be sure to call our Hotline to discuss particular concerns, and download
the TA consent form and risk management recommendations at www.omic.com.
Our ability to support your care may, however, be jeopardized if you do not properly evaluate and reduce the risks associated with other health care products, such as Medispas, cosmetic skin care, and forensic consulting. While you may gain needed revenue from this type of professional activity, it may come at too high a cost. Indeed, these services raise a number of questions that are addressed in detail in this Digest. Some legal issues can only be resolved by contacting your medical board, practice attorney, or the requesting party. Some malpractice claims coverage questions have clear cut answers, others will depend upon your relationship with the patient and the specific allegations. This issue of the OMIC Digest will at least help you begin your risk assessment.
Joe R. McFarlane Jr., MD, JD OMIC Chairman of the Board
Floppy Iris Syndrome
A syndrome named intraoperative floppy iris syndrome or IFIS has been linked to a medication called Flomax, which is prescribed for men with prostatic hypertrophy and women with urinary retention.
Click here to link to an AAO article by Dr.David F. Chang that gives recommendations on how to prepare for and manage it.
Endophthalmitis/TASS Recommendations and AAO/ASCRS Reports
Anne M. Menke, R.N., Ph.D.
OMIC Risk Manager
DISCLAIMER: This information is intended solely to provide risk management recommendations. It is not intended to constitute legal advice and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be consulted. This information is not intended to be a modification of the terms and conditions of your OMIC policy of insurance. Please refer to your OMIC policy for these terms and conditions.
Uncomplicated cataract surgery was performed on an elderly woman. At the end of the procedure, the ophthalmologist was informed by the nurse that the sterilization indicator on the instruments had not changed. It was feared that the instruments had been washed but not sterilized. The physician and ASC medical director decided not to inform the patient of the potential problem, opting instead to increase the frequency of topical antibiotics. No signs of infection were noted at the first postoperative visit, but two days later, endophthalmitis developed. Ten days after surgery, the two physicians informed the patient and her family that the same strain of pseudomonas aeruginosa had grown in the eye and the ultrasonic bath water at the ASC, leading them to conclude that problems with sterilization were the likely cause of her endophthalmitis and phthisical eye. The patient’s lawsuit was settled on behalf of the ASC for $650,000.
Poor outcomes like this make infectious endophthalmitis one of the most feared complications of ophthalmic surgery. Recently, a type of inflammatory response known as TASS, or Toxic Anterior Segment Syndrome, has garnered attention and prompted calls to OMIC’s Risk Management Hotline. While not all adverse events can be prevented, there is much ophthalmologists can do to reduce the incidence of endophthalmitis and TASS. In its review of OMIC’s claims experience and the lessons learned from it, this article offers risk management guidance on more effective prevention, recognition, and response to these sight-threatening conditions.
ENDOPHTHALMITIS/TASS CLAIMS EXPERIENCE
Since OMIC’s inception in 1987, endophthalmitis has accounted for 0.6% of claims frequency (150 claims out of 2,559 total) and 5% of claims severity ($3,345,964 paid indemnity out of $63,191,199 total). Of these 150 endophthalmitis cases, 25 remain open; of the 125 closed endophthalmitis cases, only 8 were taken to trial, and in all but one, the jury returned a defense verdict. A poll of the jury after the sole plaintiff verdict of $735,000 revealed that the award was in response to the defendant group’s practice of locking up medical records on weekends, thus preventing access to key patient information needed to assess the plaintiff’s condition. Since the practice’s name did not appear on the jury’s form, a settlement on its behalf was effected for the amount of the verdict, and the plaintiff award against the ophthalmologist was vacated.
More than three-quarters (78%) of OMIC’s endophthalmitis cases have closed without an indemnity payment. The percentage of cases that have settled (22%) and the median settlement amount ($75,000) are comparable to OMIC’s overall data. Despite the severity of the outcome for the patient, endophthalmitis settlements have ranged from $9,000 to $735,000 compared to a low of $500 and a high of $1.8 million for all settlements. Reflecting the relative novelty of TASS, allegations in all but 3 of the 150 claims involve an infectious rather than an inflammatory process.
Table 1. Indemnity Payments by Type of Case
TYPE OF CASE
TOTAL CLOSED
CLAIMS
CLOSED WITHOUT INDEMNITY
CLOSED
WITH
INDEMNITY
SETTLEMENT
RANGE
MEDIAN
SETTLEMENT
Cataract
77
59
18
$9,000 – 735,000
$75,000
Retina
23
19
4
$58,000 – 101,476
$75,000
Cornea
14
13
1
$300,000
Trauma
7
3
4
$24,999 – 248,000
$31,000
Glaucoma
2
2
0
Endogenous
1
0
1
$15,000
Uveitis
1
1
0
Given the estimated 2 million cataract procedures performed annually in the United States, it is hardly surprising that cataract surgery would account for 61% of all endophthalmitis cases. Less expected, however, is that only 23% of cataract-related endophthalmitis cases resulted in an indemnity payment. During the informed consent process for cataract surgery, ophthalmologists routinely disclose this rare complication, and most actively try to prevent its occurrence by treating preexisting conditions such as blepharitis, preparing the eye with povidone iodine, and administering antibiotics. Indeed, assuming cataract surgery was indicated in the first place and the endophthalmitis was promptly recognized and treated, expert witnesses view this complication as a tragic maloccurrence rather than malpractice. On the other hand, cases of endophthalmitis resulting from trauma are rare (6%), but they result in settlement 57% of the time. Clearly, ophthalmologists who do not administer antibiotics and/or carefully monitor the eye for signs of endophthalmitis after trauma are not supported by defense or plaintiff experts.
ANALYSIS OF RISK ISSUES
It is helpful to analyze the risk issues associated with substandard care by dividing them into four categories. “Clinical” issues include debates in the ophthalmic community on the standard of care and the natural history of the disease or condition. “Systems” issues involve complicated processes of care, such as medications (research, manufacture, distribution, ordering, etc.), equipment, and follow-up and telephone screening methods. Finally, the acts, omissions, and decisions of individual physicians and patients also impact care outcomes. The following table indicates the type and frequency of risk issues in OMIC’s endophthalmitis and TASS cases.
Table 2. Incidence of Risk Issues in Endophthalmitis/TASS Cases
Clinical 4
• Antibiotics
o Route
o Timing
Systems 32
• Telephone care (16)
o After-hours (12)
o Staff (4)
• Sterilization (6)
o Not done (2)
o Ultrasound bath contaminated
o Cracked irrigation bottle
o Saline flush contaminated
o Donor tissue not cultured
• Equipment malfunction (3)
• Product liability (2)
• Access to medical records (1)
Physician 57
• Diagnostic process (18)
o Diagnosis did not account for symptoms
o Exam elements
• Documentation (7)
o Missing
o Late
o Altered
• Surgery not indicated or contraindicated (6)
• Treatment (6)
• Follow-up interval (5)
• Referral delay (5)
• Informed consent and disclosure (4)
• Coordination of Care with PCP (3)
• Supervision of OD (2)
• Discharge instructions (1)
Patient 5
• Noncompliance
Amid ongoing debate of evidence-based guidelines for prevention of endophthalmitis, it is noteworthy that antibiotic administration was not a key issue in any case; nor was patient noncompliance a significant factor. Instead, systems issues and physician-driven processes predominate. The remainder of this document provides risk management recommendations targeted at these issues.
CAUSES AND PREVENTION OF ENDOPHTHALMITIS/TASS
Systems for ordering, cleaning, sterilizing, and maintaining ophthalmic equipment and products were a factor in 11 OMIC cases. Our claims experience confirms the research findings of Dr. Nick Mamalis and his colleagues at the John Moran Eye Center/Intermountain Ocular Research Center of the University of Utah. Funded by a grant from ASCRS (American Society for Cataract and Refractive Surgery), the ophthalmologists at the Center have been evaluating endophthalmitis and TASS for the past 15 years, searching for what causes these conditions and what steps should be taken to prevent them. In their work on TASS, they found that preparations of BSS, antibiotics, anesthetics, and other medications were not the correct pH and/or osmolality, or that they contained endotoxins or preservatives that triggered anterior segment inflammation. Numerous problems during the cleaning and sterilization of instruments were also noted, such as the use of enzymatic cleaners and inadequate rinsing.
In their capacity as users, surgical directors, board members, and owners, ophthalmologists have a leadership role to play in addressing these systems issues that adversely impact care outcomes. They can review equipment maintenance and infection control measures in hospitals and ASCs, focusing particular attention on flash sterilization, re-use of single-use items, and the ordering, preparation, and use of ophthalmic products, devices, and medications. Table 3 summarizes the causes of endophthalmitis and TASS and the actions needed to prevent them.
Table 3. Steps Ophthalmologists Can Take to Reduce the Incidence of Endophthalmitis/TASS
TASS
ENDOPHTALMITIS
CAUSE
Noninfectious reaction to toxic agent present in:
• BSS solution
• Antibiotic injection
• IOL
• Endotoxin
• Residue
• Preservative
Failure to correct
• pH
• Osmolality
Bacterial, fungal, or viral infection
PREVENTION
• Whole team approach to ordering, cleaning, sterilizing, and preparation of instruments, viscoelastic, medications, and irrigation solution to ensure proper pH, osmolality, non-toxicity
• Avoid re-use, especially of cannulas and damaged instruments
• Rinse I/A tips and phaco hand pieces at conclusion of each cleaning step with sterile, deionized water through both ports
• Replace ultrasound water baths daily
• Change the steam autoclave sterilizer at least weekly
• Careful wound construction
• Avoid ophthalmic ointment and patches with clear corneal incisions
• Treat preexisting blepharitis
• Eyelid preparation with 5% povidone iodine
• Perioperative antibiotics
• Careful wound construction
• Avoid ophthalmic ointment and patches with clear corneal incisions
• Discharge instructions on wound care, signs and symptoms to report, contact information
• Careful telephone screening of ophthalmic complaints
SCREENING OF PATIENT COMPLAINTS KEY TO IMPROVED CARE
The two primary issues in OMIC’s endophthalmitis cases—telephone care and the diagnostic process—indicate the need to carefully screen patients who present with ophthalmic complaints, especially postoperatively, and to educate them about which symptoms to report. Each of these identified risks is squarely within physician control and thus can be modified. “Telephone Screening of Ophthalmic Problems” (in the Risk Management Recommendations section of www.omic.com) provides screening protocols and contact forms for both staff and physicians taking after-hours calls.
“A Witty (WIT-D) Approach to Avoiding Mistakes” proposes an easy-to-remember and effective strategy for improving the diagnostic process. Establish a prioritized differential diagnosis in order to rule out the worst case scenario; determine the information you need to obtain during the history and examination, or through studies, to rule that in or out; tell the patient and other health care providers to ensure that you are notified of all signs and symptoms that could help establish the diagnosis and determine the treatment plan; and document your decision-making process and follow-up plan. More information is available in “Failure to Diagnose Cases: Focus on Traumatic Eye Injuries,” available in the Risk Management Recommendations section of www.omic.com).
ENDOPHTHALMITIS OR TASS?
Failure to rule out endophthalmitis has resulted in harm to patients and significant liability exposure for OMIC policyholders. Emerging research indicates that the ophthalmologist should also include inflammatory reactions such as TASS in the differential diagnosis. Indeed, mistaking one for the other could lead not only to a delay in treatment but may worsen the outcome. The following table summarizes some of the distinguishing features and the recommended treatment. Although this table may be helpful, it can still be difficult or impossible at times to discriminate between endophthalmitis and TASS.
Table 4. Differential Diagnosis : TASS or Endophthalmitis?
TASS
ENDOPHTHALMITIS
Onset
12-24 hours
4-7 days
Signs/Symptoms
*distinguishing feature
• Blurry vision
• Pain: none, or mild to moderate
• Corneal edema: diffuse, limbus to limbus*
• Pupil: dilated, irregular, nonreactive*
• Increased IOP*
• Anterior chamber: mild to severe reaction with cells, flare, hypopyon, fibrin
• Signs and symptoms are limited to anterior chamber*
• Gram stain and culture negative
• Decreased VA
• Pain (25% have no pain)
• Lid swelling with edema
• Conjunctival injection
• Hyperemia
• Anterior chamber: marked inflammatory response with hypopyon
• Vitreous involvement
• Inflammation in entire ocular cavity*
Treatment
• Rule out infection: culture anterior chamber
• Intensive corticosteroids
• Monitor IOP closely for signs of damage to trabecular meshwork and side effects of steroids
• Watch closely for next few hours for signs of bacterial infection
• Culture anterior chamber and vitreous
• Intravitreal and topical antibiotics
• Vitrectomy
DISCLOSURE OF A STERILIZATION BREAKDOWN
The malpractice case featured earlier in this document stemmed from a series of breakdowns in the facility’s sterilization process. When notified of it, the physician consulted with the ASC’s Medical Director and together they decided not to alarm the patient until they knew the facts. By not warning the patient of the symptoms to watch for, they arguably missed an opportunity to diagnose the problem earlier.
As we note in “Responding to Unanticipated Outcomes” (available in the Risk Management Recommendations section of www.omic.com), ophthalmologists are well-advised to tell patients about complications as well as potential problems with sterilization. Patients have a need and a right to know about their own condition, and can help monitor for the development of symptoms. Such disclosure of adverse events is best understood as a continuation of the informed consent process begun before the surgery.
Moreover, communicating with the patient sympathetically and non-defensively within the shortest appropriate time period may help dispel much of the anger, confusion, and distrust that complications may engender, while preventing allegations of fraudulent concealment that could extend the statute of limitations or allow for punitive damages.
When talking to patients, stick to the currently known facts, avoiding speculation or blame. Use language such as this: “I was informed by the nurse at the end of the procedure that one of the sterilization indicators on the instruments had not changed color. This means that the instruments may not have been sterile. If they were not sterile, you are at an increased risk for an infection. The surgery center is evaluating what happened, and I will share information with you as it becomes available. For now, I want to go over with you the medication you are on to prevent an infection, and what symptoms to report to me.”
Document all disclosure conversations in the medical record, noting the names of all family or staff members present. Unless the ASC informs you that certain information is confidential, you can document facts disclosed to you about the investigation and note them in the record. As more information becomes available, share it with the patient and document it.
RESPONSE TO A CLUSTER OF ENDOPHTHALMITIS OR TASS CASES
An effective response depends upon careful coordination and cooperation among the facility, surgeon, and patient. OMIC policyholders are urged to call our risk management department for confidential assistance as soon as possible. The facility should contact all affected surgeons, and document the notification efforts. Ophthalmologists in turn need to call all patients operated on that day or during that period, and notify them of the events, screen for symptoms, and educate them about when and why to contact the physician.
As in any disclosure discussion, the physician should stick to the facts and avoid speculation or blame: “I don’t want to alarm you, but I felt you should know that several patients have contracted a serious infection OR experienced a serious reaction after their cataract surgery two days ago. You may or may not have this infection/reaction. To find out, I’m going to ask you some questions, go over your medications and explain what I want you to watch out for.” Document the discussion, instructions, and follow-up plan in the patient’s medical record.
Until endophthalmitis or TASS is ruled out and the patient’s condition has stabilized, see or speak with the patient on a regular basis. Some ophthalmologists call their patients daily during the at-risk period to both gather accurate information and to reassure the patient. Pay particular attention to follow-up periods for patients whose surgery falls right before a weekend or holiday. Encourage them to call you to report symptoms or ask questions.
The facility needs to sequester all involved materials, interview staff, and evaluate equipment, devices, solutions, medications, and the sterilization process. All aspects of the investigation should be carefully documented. The investigation will help locate the responsible organism or toxic agent, ascertain liability, and determine what steps to take to remedy any identified problems. Dr. Mamalis’s group developed an Excel-based protocol that can be used for individual or clustered cases of infectious or sterile endophthalmitis. The protocol is in an Excel format that allows reporting of multiple cases in one document; it is available on the OMIC website, via e-mail nick.mamalis@hsc.utah.edu, or by calling 801.581-6586. Detailed information about each patient’s pre- and postoperative course, the facility, equipment, supplies, medication preparation and sterilization technique are entered into the spreadsheet, compiled, and then sent to the Center for review. Research fellows are available for on-site evaluations, and charge only airfare and nominal expenses.
DECIDING WHEN TO POSTPONE OR RESUME SURGERY AT A SURGICAL FACILITY
Faced with a cluster of either endophthalmitis or TASS cases, both the surgical facility and the individual surgeon will need to decide whether or not it is safe to proceed with other scheduled ophthalmic cases at that location. Ophthalmologists who have an ownership interest in an ambulatory surgical facility may also be involved in these deliberations, and should act as patient advocates promoting quality care. Patient safety should be the driving factor, and all parties must feel confident that the causative factors have been identified and addressed. At times, the surgery center may need the assistance of outside consultants such as Dr. Mamalis or legal counsel in order to conduct the investigation and make the decision to cancel or resume procedures. OMIC’s Risk Manager can be a valuable resource.
Most elective cases can be postponed. Patients may be inconvenienced but will appreciate that you are working to ensure the best outcome for their eye condition. For urgent and emergent ones, you will need to find an alternative facility. If you do not have privileges at other facilities, you will need to refer the patient to an ophthalmologist who does. Contact the affected patients: “The _____ surgical facility is evaluating a potential safety issue. For your protection, your surgery will be postponed OR your surgery will need to be done at ___________ surgical facility. Since I do not operate at that facility, would you like for me to refer you or do you have another ophthalmologist you would like to see for your surgery?”
When the causes of the endophthalmitis or TASS have been identified and addressed, the surgeon and facility may want to notify patients of the prior problem. A sample letter is included at the end of this document.
AAO AND ASCRS REQUEST PHYSICIANS’ HELP TRACKING TASS
In response to over 80 TASS cases nationwide, the AAO (American Academy of Ophthalmology) and ASCRS announced the formation of a task force to help determine the causes and share best practices. Chaired by Dr. Mamalis, it includes Dr. Henry Edelhauser from Emory University, Dr. Arjun Srinivasan from the Centers for Disease Control, Dr. Walter Hellinger (Epidemiologist from Mayo Clinic), Dr. Sam Masket, President of the ASCRS, and members of the ophthalmic product industry.
Ophthalmologists with TASS cases are urged to complete the two short questionnaires that follow about the products involved during cataract surgery and the actual process of cleaning and preparing instruments and patients for surgery and forward them to Dr. Mamalis.
A preliminary report on over 100 cases was communicated to AAO and ASCRS members on June 22, 2006. There is no single cause, but potential sources have been identified. These include pre-operative non-steroidal anti-inflammatory drugs; intracameral anesthetics that remain in the anterior chamber longer due to ophthalmic visco surgical devices (OVD), or those that have been improperly dosed, mixed, or injected; epinephrine stabilized by bisulphites or other preservations added to balanced salt solutions (BSS); and reusable cannulas or viscoelastic that retain residues, enzymatic detergents, or ultrasonic cleaners.
High surgical volume can put pressure on the sterilization process, leading to inadequate rinsing and incomplete cycles. Cases reported on OMIC’s Risk Management Hotline point to an inadequate supply of instruments and a reliance on flash sterilization, which was designed to quickly reprocess instruments that had been dropped or contaminated, not those that have been used and need to be cleaned.
OMIC policyholders who have additional questions or concerns about this issue may call our risk management department for assistance at (800) 562-6642, extension 652.
Product Questionnaire Page 1 of 3
Cataract surgical center contact:
Name of center: _______________________
Contact person: ______________________
Telephone number: ____________________
Fax number: _________________
Address: __________________
___________________
On behalf of the American Society of Cataract & Refractive Surgery, please return to:
Nick Mamalis, MD
Intermountain Ocular Research Center
John A. Moran Eye Center
University of Utah
Salt Lake City, Utah 84132
Fax# (801) 581-3357
Please indicate below the products and procedures which were used during surgeries that were followed by cases of TASS in the year 2006.
Preoperative topical mydriatic: ____________________ (trade name)
Preoperative topical cycloplegic: ___________________ (trade name)
Preoperative topical NSAID: _____________________ (trade name)
Preoperative topical cleaning agent (eg Ocusoft, Baby Shampoo): _______________ (trade name)
Preoperative topical anti-septic (circle one): Betadine 5% (ophthalmic) / Betadine 10% /
Phisohex / Chlorhexidene 2% / Other:_____
Preoperative topical antibiotic (w/o concentration): ___________________ (trade name)
Preoperative topical anesthetic (w/o concentration): ___________________ (trade name)
Intracameral anesthetic: Yes No
Intracameral anesthetic preservative free: Yes No
Retrobulbar or peribulbar anesthetic block: Yes No
Flexible iris retractor: Yes No
Intraocular miotic (circle one): Miostatin / Miochol / Other:_____________ (trade name)
Viscoelastic #1 (circle one): Discovisc / Duovisc / Provisc / Viscoat / Cellulgel / Healon
/ Healon GV / Amvisc+ / Other: ___________ (trade name)
Page 2 of 3
Contact tel # (from pg. 1): ____________
Viscoelastic #2 (circle one): Discovisc / Duovisc / Provisc / Viscoat / Cellulgel / Healon
/ Healon GV / Amvisc+ / Other: ___________ (trade name)
BSS (500cc) intraocular irrigant (circle one): AMO / Acorn / Cytosol / Alcon / Baxter /
Other: __________________ (trade name)
Topical (15cc) irrigant (circle one): AMO / Acorn / Cytosol / Alcon / Baxter /
Other: _________
Epinephrine added to BSS: ________________________ (trade name & concentration)
None added
Intraocular antibiotic #1 added to BSS: ___________________________ (trade name)
Intraocular antibiotic #2 added to BSS: ___________________________ (trade name)
Intracameral antibiotic #1: ________________________ (trade name)
Intracameral antibiotic #2: ________________________ (trade name)
Incision (circle one): Clear cornea / Scleral tunnel / Other: __________________
Suture of incision: Yes No
Type of Blade/Knife (circle one): Reused non-diamond / Reused diamond /
Disposed after each case
Blade/Knife Brand (circle one): ASICO / Alcon / Sharpoint / Rhein / Other: ________
Phaco delivery system (circle one): Legacy / Infinity / Sovereign / White Star /
Millenium / Other: ____________________
Phaco tip reused: Yes No
Phaco tubing reused: Yes No
I/A tip reused: Yes No
Insertor tip reused: Yes No
Insertor reused: Yes No
Cartridge for loading IOL to insertor: Alcon / AMO / White Star / Bausch & Lomb
Other: ____________________________
Other cannulated equipment reused: Yes No
Custom Pack (circle one): Alcon / Allegiance / Cardinal / Medline / Other: __________
Page 3 of 3
Contact tel # (from page 1): ____________
IOL Type (circle one): Silicon / Acrylic hydrophilic / Acrylic hydrophobic / PMMA /
Other: _______________________
IOL Manufacturer: Alcon / AMO / Bausch & Lomb / Staar / Other: ______________
Capsule staining (select one): Trypan blue / ICG / Other: _______________________
Post-operative topical antibiotic: _____________________ (trade name)
Post-operative topical steroid: ______________________ (trade name)
Post-operative topical NSAID: _____________________ (trade name)
Instrument Re-processing Questionnaire Page 1 of 2
Cataract surgical center contact:
Name of center: _______________________
Contact person: ______________________
Telephone number: ____________________
Fax number: _________________
Address: __________________
___________________
On behalf of the American Society of Cataract & Refractive Surgery, please return to:
Nick Mamalis, MD
Intermountain Ocular Research Center
John A. Moran Eye Center
University of Utah
Salt Lake City, Utah 84132
Fax# (801) 581-3357
1. How many operating rooms do you use on days of cataract surgery? ____
2. How many cases of cataract surgery do you perform on an average day? ____
3. Have you observed a pattern to your cases of TASS (surgical case of day, surgery day of week, OR number)? Y, N
4. How many trays of cataract surgical equipment do you have? ____
5. Do you have a written protocol which specifies the time, duration, detergents, enzymatics, type of water (tap vs sterile) and rinsing for cleaning the following re-used equipment:
Phaco handpiece Y N Don’t Know Not reused
Volume of water used to flush handpiece: _______
Phaco tubing Y N Don’t Know Not reused
I/A tips Y N Don’t Know Not reused
Have you had occluded I/A tips? Y N
Insertor Y N Don’t Know Not reused
Other cannulated equipment Y N Don’t Know Not reused
Forceps for loading IOL Y N Don’t Know Not reused
6. Is any of your re-used equipment cleansed with enzymatic detergents?
Y N Don’t Know
7. Is any of your re-used equipment cleansed or rinsed in an ultrasonic bath? Y, N
Page 2 of 2
Contact tel # (from pg. 1): ____________
8. If you use an ultrasonic bath, is it cleaned:
Between each use ≥Once daily ≥Once weekly <Once weekly
Don’t Know
9. Is re-used cataract surgical equipment separated from non-ophthalmologic surgical equipment through all steps of cleaning before sterilization?
Y N Don’t Know
10. Which method is used for sterilizing your re-used equipment:
Autoclave
ETO (ethylene oxide gas)
Plasma gas
Glutaraldehyde
Other: ___________________________
11. If you sterilize your equipment with an autoclave, please indicate all that apply:
Regular inspection & cleaning documented Y N Don’t Know
Recent operational problems Y N Don’t Know
Steam produced by facility-wide boiler Y N Don’t Know
Steam produced only for autoclave Y N Don’t Know
NOTE: This is a sample disclosure form intended for use once the causes of the infection or toxic reaction have been identified and addressed, and the responsible parties at the ASC have determined that it is safe to proceed with surgery. Modify it for the particular clinical situation and circumstances. For example, in some cases, the Infection Control Committee may be involved instead of public health officials.
____________________________ Surgery Center
Consent and Disclosure About Endophthalmitis or TASS Cases
I have been advised that on _____________________, patients undergoing cataract surgery at _______________ Surgery Center contracted a serious bacterial/fungal/viral infection OR experienced an inflammatory reaction in their eye and that some of these patients are still under care for their condition. I understand that public health officials and outside medical experts have reviewed this matter and believe it is safe to proceed with surgery. I have been given the opportunity to ask questions regarding these infections/inflammatory reactions, the investigation into them, my surgery, and any other questions I have had, and my questions have been answered to my satisfaction. Accordingly, I desire to and consent to undergoing surgery at _______________________ Surgery Center at this time.
Date: _________________________
Patient’s signature_______________________________________
Wrong Site/Wrong IOL (AAO)
OMIC would like to call your attention to the important work being done by various organizations to prevent wrong site surgery and wrong IOL placement. Refer to the links below:
The American Academy of Ophthalmology- AAO.org
The ASORN( American Society of Ophthalmic Registered Nurses)- ASORN.org
The Joint commission on Accrditation of Health (JCAHO)- JCAHO.org
Universal Protocol for Eliminating Wrong Site, Wrong Procedure, and Wrong Patient Surgery http://www.jointcommission.org/standards_information/up.aspx
