CONSTELLATION Vision System

Transcription

1 CONSTELLATION Vision System Indications for Use: The CONSTELLATION Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Warnings and Precautions: The disposables used in conjunction with ALCON instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards. Attach only ALCON supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections. Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard. Vitreous traction has been known to create retinal tears and retinal detachments. The closed loop system of the CONSTELLATION Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle. Leaking sclerotomy may lead to post operative hypotony. Important Safety Information: Warnings and Cautions: A complete listing is available in the CONSTELLATION Vision System Operators Manual. To obtain a copy, please contact Alcon Customer Service. ATTENTION: Reference the Directions for Use for a complete listing of indications, warnings, and precautions. GRIESHABER DSP Instrumentation Indications for Use: GRIESHABER DSP instruments are a line of single-use vitreoretinal microinstruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Warnings and Precautions: Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery. For light fiber instruments: Minimize light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. The light fiber instruments are designed for use with an ALCON illumination source. 1

2 Potential risk from reuse or reprocessing include reduced cutting or grasping performance and foreign particle introduction into the eye. ATTENTION: Reference the Directions for Use for a complete listing of indications, warnings, and precautions. Sunil Gupta, MD has no financial interest in the products discussed. Alan Franklin, MD, PhD has no financial interest in the products discussed. John P. Myers, MD has no financial interest in the products discussed. Vera Watkins, RN, CNOR has no financial interest in the products discussed. This monograph is sponsored by a restricted educational grant from Alcon Laboratories, Inc Novartis 2/12 GUS11266MS 2

3 SPECIAL SECTION SPONSORED BY ALCON Reusables vs. Disposables: A Safe Conclusion for DSPs A brief return to reusable instruments convinced these surgeons of the importance of weighing intangible variables as well as costs. Read about the factors that influenced their return to disposable instrumentation. By Sunil Gupta, MD, Alan Franklin, MD, PhD, and John P. Myers, MD Retina Specialty Institute, Pensacola, Fla. Advances in instrumentation for vitreoretinal surgery have put remarkable power in our hands. Micro-incision vitrectomy surgery enables us to operate safely and efficiently with reduced trauma to the eye and the potential for improved outcomes and patient satisfaction. As owners of an ASC (ambulatory surgery center), we also must be aware of our costs, so we periodically evaluate current practices to ensure the facility is operating at peak efficiency and that our choices are financially responsible. We recently examined our use of disposable ancillary instruments we use the GRIESHABER DSP Single- Use instruments (Alcon, Fort Worth, Texas) and decided to test-drive a number of reusable instruments as a potential cost-cutting measure. Our experiences confirmed the tangible benefits of using a new single-use instrument for every case and also revealed some intangible benefits that we may not have fully appreciated. CONSISTENT PRECISE PERFORMANCE We found the most obvious and disconcerting drawback of reusable instruments, particularly fragile micro-incision instruments, is their tendency to bend and break, even with careful handling by an experienced ophthalmic technician. In terms of quality, functionality and consistency, one would think that disposable instruments would not measure up to those made to last for more than one case. As it turns out, we had problems more often with the reusable instruments, which reduced our efficiency and also had a financial downside. A forceps with tips that do not appose properly, for example, is detrimental to a successful surgery, thus we needed to have backup sets of forceps for every case. Additionally, with several physicians using the reusable instruments daily, the wear and tear on them was noticeable in their performance. These fragility problems were not as apparent when we were using 20-gauge instruments, but we now use 23-gauge and 25-gauge instruments exclusively in our practice. The reusable instruments in these gauges tend to have a higher failure rate. It seems these delicate and fragile instruments cannot be made strong enough for repeated multiple uses, which typically leads to degradation of their reliability and quality. The consistency of the GRIESHABER DSPs was a key factor in our decision to return to disposable instruments. Every time we open a pack, we are guaranteed the instrument will perform properly. There is no question if the tips of a forceps will appose. The manufacturer s quality control is excellent. Inspectors check each instrument under a microscope before it is packaged and sterilized. SAFETY AND PEACE OF MIND Instrument failure is not always so obvious as to require immediate replacement. Certainly, it reduces efficiency if we must stop to replace or adjust an instrument, but even tiny malfunctions or a gradual degradation scissors that have become dull over the course of several complex surgeries, for example can affect precision, which in turn, can affect safety. S1

4 SPECIAL SECTION SPONSORED BY ALCON You Can t Do Retina Surgery With a Spoon and Other Reasons Why We Chose Disposables Before our recent test-drive of reusable instruments, my last experience with them was several years ago. At that time, the cost of repairs could run $800 to $1000 per instrument per repair, and once an instrument was repaired several times, it would need to be replaced. At that time, the average cost of a forceps, for example, was approximately $3000, and we were buying a forceps about twice a year, so that s about $6000. Typically, we sent a forceps for repair three or four times a year before replacing it, so that s about eight repairs at $800 each for another $6000 or so. So our annual budget for reusable forceps was $10k to $15k. The cost increased significantly, however, when we factored in some of the intangible costs. Another safety concern with reusable instruments is the potential for cross contamination, especially when we are manipulating neural tissue. From that perspective, the safety and sterilization compliance factor is significant, as well. With single-use instruments, we do not have to worry about any cross contamination. GRIESHABER DSPs are sterile and their packaging provides for an easy sterile-field transfer. Common damage to 20-gauge reusable instruments; this damage may be more frequent on 23-and 25-gauge reusable instruments due to fragility. Consider what can happen when an instrument fails in the middle of a case. You may have eight patients lined up for surgery and only one backup instrument left. Can you be sure your backup will be able to handle the remaining cases? Even if you get through the day without incident, your staff is still faced with handling the paperwork and follow-up associated with returning a broken instrument to the vendor. That one broken instrument has not only created a stressful situation for the surgeon and the OR staff, but it has also taken up more staff time for follow-up outside the OR. There is no way to place a dollar value on stress, but I estimate the staff time alone to deal with these issues added another $5k to $10k to the cost of reusable instruments. To be prepared for reusable instrument failure, we started carrying a fair amount of disposable products as backup, because there were times when both the primary and the backup forceps failed, and you can t exactly do retina surgery with a spoon. If you are using 25-gauge and all your 25-gauge reusables are out of service, your only option is to enlarge your incisions so you can use 20-gauge. I have done that, but it defeats the purpose and negates all the patient benefits of doing micro-incision surgery. Soon we decided to abandon reusables altogether, rather than switch back and forth from reusables to disposables. Although we were adding some cost, we felt that was a small price to pay for consistent, reliably precise instrumentation and a more efficient and less stressful day in the OR. Alan Franklin, MD, PhD INTANGIBLE COSTS During our recent test-drive of reusable instruments, we obviously looked at the real costs involved, but we also asked ourselves: What are some of the intangible costs associated with reusable instruments for which a value is difficult to establish? (For a closer look at the financial aspects of disposables vs. reusables, see You Can t Do Retina Surgery With a Spoon and Other Reasons Why We Chose Disposables. ) First, there is time. One factor we all tend to overlook when doing a cost analysis is the time required to sterilize instruments properly. (See Cleaning and Sterilizing Vitrectomy Instruments: One Practice s Routine. ) In addition, we need to consider the time a case is stalled surgeon, nurse, anesthetist and OR time while we replace a damaged instrument. If you have a busy surgery center and you can do one or two additional cases in a day because you did not have to stop to replace a reusable instrument, then you have paid for any potential increased cost associated with using disposable instruments. Another intangible cost that is difficult S2

5 to measure, but real nonetheless, is the frustration experienced by the surgeon when an instrument fails. Knowing there is even a potential for instrument failure can be stressful for a surgeon. Using disposable instruments has virtually eliminated these stresses for us. When we take the DSPs out of the box, we are confident they will work. This knowledge makes it easier on the staff, easier on the doctor, easier on the case flow and, ultimately, easier on the patient. That was our thought process when we decided to go back to disposables. Everyone at our institution has been pleased with this decision. WIDE ARRAY OF CHOICES Our decision to return to disposable instruments was also based on the availability of our practice s several preferred gauges and instrument styles. Being individuals with different surgical styles and preferences, we knew it would be most efficient to choose a suite of products with gauge and tip options that would meet the needs of all of the partners. The GRIESHABER DSPs satisfy those needs: Dr. Gupta (23 gauge): The ILM Forceps is my key instrument. I do internal limiting membrane (ILM) peels on every patient, whether it s an epiretinal membrane (ERM) or a macular hole, so I must have a reliable instrument. I do not use indocyanine green to stain the ILM, so for me, it is important that the ILM comes up as a single sheet. These forceps help me peel ILM without shredding the tissue. Typically, you have to create an edge in the ILM, but the tips are designed in such a way that I can pick up either the ERM or the ILM without impacting the nerve fiber layer. In addition, having the Serrated Forceps for heavier pathologies enables me to peel the denser pre-retinal fibrotic membrane. Even if there is a subretinal band in a severe proliferative vitreoretinopathy case, I can peel that, as well. This procedure was somewhat more challenging with the finer membrane forceps. Dr. Franklin (80% 25 gauge; 20% 23 gauge): I tend to use the 25-gauge Asymmetrical Forceps. I can stain the ILM with diluted TRIESENCE Suspension (triamcinolone acetonide; Alcon Laboratories, Inc., Fort Worth, TX), and then peel it off with the forceps with very little trauma to the retina and very little time spent on the peel. The forceps do a good job on the fine membranes that you would peel in an ERM or macular hole, and for me, the tensile strength is sufficient to operate on most of my complex diabetic cases. I also use the disposable Curved Scissors on some of the more complex membranes. The new vitrectomy cutter of the CONSTELLATION Vision System (Alcon Laboratories, Inc., Fort Worth, TX) allows me to get under membranes that are tight to An OR Nurse s Perspective Having assisted at my first vitrectomy during an era when even the cutter was reusable, I am familiar with the procedures required to keep instrumentation in top condition and the potential problems if it is not. Cleaning reusable instruments is time-consuming, which delays turnover time. In addition, the delicate small-gauge instruments used in vitreoretinal surgery, such as 23 and 25 gauge, are difficult to clean. An instrument that has not been cleaned properly will not function well, and there is always a concern that instruments that were not cleaned properly may not be sterilized properly. These tiny instruments are very fragile and can be damaged easily, which affects performance and efficiency in the OR and in the practice. In the OR, a damaged instrument or one that is not performing optimally slows the surgery and could affect the outcome, so we always have multiple instruments as backup. In addition, when a reusable instrument is damaged, it must be sent out for repair, and in my experience, most damaged instruments must be replaced because repair is not cost-effective. With disposable instruments, we are assured that, number one, they are sterile, and number two, they will perform like a brand new instrument each time. I have found the GRIESHABER DSP single-use instruments to be very reliable and to hold up extremely well. In the current environment, with reimbursement as it is, I think practice owners have to take a look at expenses and decide what cost-cutting measures will be safe and effective without compromising outcomes. We know the disposables will give us excellent outcomes, and that they are reliable and their sterility is guaranteed. That is the bottom line. Vera Watkins, RN, CNOR Vera Watkins, RN, CNOR, a surgical/clinical nurse specialist and primary scrub nurse at Retina Specialty Institute in Florida, has worked with Sunil Gupta, MD, for 16 years. S3

6 SPECIAL SECTION SPONSORED BY ALCON GRIESHABER DSP Instrumentation is available in REVOLUTION DSP and Advanced DSP Tip Styles in 25+, 25, 23 and 20 gauge. the retina, but if I need to make a snip very close, I use the curved scissors. Dr. Myers (90% 23 gauge; 10% 25 gauge): I rely on the ILM forceps for about 95% of what I do. Visualization with this forceps allows me to peel the ILM easily, and because of Cleaning and Sterilizing Vitrectomy Instruments: One Practice s Routine At Andrews Institute Surgical Center, the following procedures are followed for cleaning and sterilizing reusable vitrectomy instruments: All vitrectomy instrumentation is cleaned in the Decontamination area of the Sterile Processing Department. Each instrument is hand-washed, using a low sudsing, neutral-ph triple enzymatic cleaner to ensure removal of all visible bioburden. The instruments are rinsed thoroughly, then placed in the instrument tray. In addition, the Biom lens (Insight Instruments, Inc., Stuart, Fla.), bulb syringe and cannulas are irrigated with sterile water using a 30cc syringe and then flushed with air. The vitrectomy instruments, excluding the Biom lens, are then placed in an ultrasonic bath using only water, according to recommendations by the Association for the Advancement of Medical Instrumentation (AAMI), the Association of Perioperative Registered Nurses (AORN) and the manufacturer. They are then rinsed again thoroughly. The vitrectomy instruments are then arranged in the tray so they do not touch each other. This ensures proper sterilization and prolongs the life of the instruments. Instruments are then wrapped and sterilized according to AAMI, AORN and the manufacturer s recommendations. the rigidity of the instrument, the tips do not flex when going out to the periphery. For me, this instrument just about does it all. It is a phenomenal forceps. I rarely use scissors, mainly because I can shave at the level of the retina with the 23-gauge vitrectomy probe on the CONSTELLATION System, but at times, I use the disposable pic to sever adhesions when I do not feel comfortable doing so with the vitrectomy probe. CONCLUSION Certainly, there are a few more financial pressures for an ASC, but our first priority is always optimal surgical outcomes and patient safety, and we believe disposable instrumentation is the right choice. In our experience, the GRIESHABER DSPs are precise, reliable, high-quality instruments. Even when you consider costs and add in the dollar equivalent of time and labor spent handling reusables, as well as the intangible costs of surgeon frustration and case delays, then we believe, net-net, the practice and our patients come out ahead with DSPs. Sunil Gupta, MD, is managing partner, Retina Specialty Institute in Pensacola, Fla. The four partners perform approximately 970 retina surgeries annually. Dr. Gupta is also an owner and chairman of the board for Andrews Institute Surgery Center. He is a member of the Alcon Retina Advisory Council. He can be reached at sgupta@retinasurgeons.com. Alan Franklin, MD, PhD, is a partner in Retina Specialty Institute in Pensacola, Fla. John P. Myers, MD, is a partner in Retina Specialty Institute in Pensacola, Fla. He is also an owner in Andrews Institute Surgery Center. S4