One of the strategies many surgeons have come to rely on to help maintain economic viability in the OR is the reprocessing and reuse of some instruments and supplies that the original manufacturer has labeled "for single use." As with standard hand instruments, certain single-use devices (SUDs) may be safely reprocessed or resterilized by following clearly established standards and procedures. However, the reprocessing and reuse of SUDs is now coming under increasing government scrutiny. Perhaps more important, good medical practice -- and an active malpractice plaintiffs' bar -- dictate that responsible surgeons should carefully examine their reprocessing and reuse practices. In this article, we'd like to explain what's been happening in the regulatory arena and provide some examples of the ways these changes are likely to affect you and your practice in the near future. We'll also offer some concrete suggestions and strategies you can use to maximize efficiency and economy in your OR -- without increased health risks to your patients.

The FDA rule

In August, 2000, the FDA published its final guidance on "Enforcement Priorities for Single Use Devices Reprocessed by Third Parties and Hospitals." The FDA has regulated the original manufacturers of single-use devices for many years. Now the FDA will be regulating hospitals and other third parties that reprocess these devices -- treating them, in essence, as manufacturers.

What led to this change in FDA policy? The primary catalyst appears to have been complaints from some device manufacturers that SUDs were being reprocessed in an unsafe manner, leading to potential problems. Evidence that reprocessing has caused injury is minimal at best, but the FDA decided that concerns about potential problems were significant enough to warrant more regulation.

For now, this new level of regulation hasn't been extended to ASCs; it's limited in focus to SUDs reprocessed by third party reprocessors and hospitals. However, as the agency states in its final guidance document, "FDA intends to examine whether other establishments that reprocess SUDs should be included." To the extent that concerns about patient safety and quality care are the genesis for the FDA's actions, it's not hard to conceive of similar standards being imposed on non-hospital facilities that are performing the same procedures.

How much regulation?

Once the FDA decided to regulate hospitals and third party reprocessors, it was faced with a tough challenge: how to set standards for reprocessing procedures such as disinfecting, cleaning and testing that, until now, were never regulated.

The FDA thought it would be appropriate to base standards for reprocessing on the degree of risk associated with reprocessing each specific device. Consequently, the FDA developed a list of commonly reprocessed SUDs and formulated a list of factors to use to determine the degree of risk associated with reprocessing each of those devices. It then used these factors to place each device into one of three categories intended to indicate the potential difficulty of reprocessing (low, moderate, and high) and tied different levels of premarket submission requirements to each category.

But soon after the FDA presented this system to the industry for comments, problems began cropping up. While the device manufacturers liked the idea behind this categorization method, many companies tried using the resulting list of factors to evaluate their products. Their evaluations often resulted in a different risk category than the one the FDA had arrived at.

To solve this problem, the FDA agreed that, rather than establish a new system to classify the degree of risk associated with reprocessing a device, it would simply use a device's current FDA classification: class I, class II or class III.

On the current FDA list, ophthalmic devices in class I include:

�         A microkeratome blades

�         A ophthalmic knives.

Ophthalmic devices in class II include:

�         endoilluminators

�         surgical drapes

�         phacofragmentation units

�         phacoemulsification needles

�         devices used for fluidics.

The impact on healthcare providers

This simplification of categories didn't do much to offset the second major problem posed by the new regulations: Because of financial constraints and lack of experience, the FDA's requirements are more of a burden than many hospitals will be able to manage (to say nothing of the burden they would place on an ASC). In short, the new regulations are likely to make it cost-prohibitive for healthcare providers to reprocess and reuse medical devices.

For example, suppose you own an ASC, and these requirements are extended to include you within the next few years. Under the new Enforcement Guidance, if you wish to reprocess and reuse one of the devices on the FDA's list, you'll be required to take the following steps:

�         File a premarket notification demonstrating safety. You'd have to file a premarket notification, (i.e., 510[k]) containing valid scientific information showing that the device can be safely and effectively reprocessed for a limited (or specified) number of times by the methods proposed.

�         Register your organization and list devices. You'd be required to register your ASC with the FDA and provide the FDA with a complete list of the devices you plan to reprocess.

�         Follow medical device reporting requirements. You'd need to follow reporting requirements (such as adverse event reports) for devices you reprocess.

�         Establish a medical device tracking system. In the event that a recall or other notification regarding a particular device became necessary, you'd need to be able to promptly locate all devices and specify their history of use.

�         Fulfill quality system regulation requirements. You'd have to follow FDA standards for good manufacturing practices. These govern the methods used in -- and the facilities and controls used for -- the design, manufacture, packaging, labeling, storage, installation and servicing of all finished devices.

�         Follow all labeling requirements. Like manufacturers, you'd be required to follow general labeling requirements for all devices, such as providing the name and place of manufacture and adequate directions for use.

The FDA has given hospitals and other reprocessors some lead time to manage the transition to these new rules. For the more complex class II devices (such as ophthalmic endoilluminators and phacofragmentation units), the requirement to file a premarket notification and meet these other mandates begins on August 1, 2001. Hospitals and other companies who reprocess class I devices have an additional 6 months to come into compliance. (Should the FDA move to include ASCs next, it will probably allow some lead time for you to make the same transition.)

If you reuse: some clues

Reuse of single-use devices raises a myriad of technical, legal, regulatory, and risk management issues. These concerns take on unusual overtones because, unlike the vast majority of clinical practices, reuse is strictly a cost-saving measure. It offers no direct clinical benefit to patients.

If you decide to reprocess and reuse SUDs in the months and years ahead, the following strategies should help you minimize any potential trouble:

�         Consider how the FDA guidelines might affect you. If you become subject to these guidelines within the next few years, you don't want to be caught unprepared.

�         Get manufacturer instructions. Manufacturers have an obligation to provide instructions on proper cleaning, examination, testing, packaging, and sterilization of the product if multiple use is anticipated. If this information isn't provided, request it. (Don't assume that one reprocessing technique will work well for every device.)

�         Adopt standards. If you plan to reprocess SUDs, it's a good idea to adopt standards for reprocessing, preferably following available FDA guidelines and those of leading organizations in the field (e.g., Association for the Advancement of Medical Instrumentation, the Joint Commission on Accreditation of Healthcare Organizations and the Accreditation Association for Ambulatory Health Care).

�         Be prepared to defend your policy. Implement procedures that will allow you to demonstrate (and document) that:

o       the device can be adequately cleaned and sterilized

o       the physical characteristics or quality of the device are not adversely affected by your reprocessing method

o       the device remains safe and effective for its intended use.

�         Establish clear reprocessing protocols. Make careful decisions about which SUDs to reuse. Then implement policies that detail each step of the process, including:

o       A methods of cleaning, sterilizing and preparing the device

o       A training personnel to perform the procedure

o       A checking for defects before reuse

o       A carefully selecting a reprocessing company (if you decide to use one).

�         Inform the patient. Check state law to see whether you must inform your patient when you reuse an SUD. Even if you're not required to do so by law, you should consider informing your patient anyway, so that he or she is fully aware of any risks involved. (You must inform a patient and obtain consent if the reuse occurs in a research setting.)

�         Submit adverse event reports. Make a report under the Safe Medical Devices Act if a device may have caused or contributed to a death or serious injury, or if it has malfunctioned and the device would be likely to cause or contribute to a death or serious injury should the malfunction recur.

�         Follow OSHA guidelines. If you're an employer, make sure that any reuse you engage in complies with the OSHA bloodborne pathogens rules. Your facility must incorporate protocols, engineering and work practice controls, and personal protective equipment to ensure that employees who reprocess devices are safe from bloodborne pathogens.

Into the future

The next chapter in the ongoing saga of SUDs will soon be written. Many hospitals will find adherence to the FDA's new requirements too costly and burdensome; they'll be forced to discontinue the practice of reprocessing devices, or at least switch to using more third-party reprocessors.

If you own or work in an ASC, or if you operate office-based surgical facilities that reuse SUDs, you should closely scrutinize the FDA's implementation of these new regulations -- and the hospital industry's response to them.

You may well be next!

David J. McIntyre has practiced ophthalmology since 1963. A Fellow of the American College of Surgeons, he's widely known as an innovator and teacher of extracapsular surgical techniques. He received the Innovator's Award from the American Society of Cataract and Refractive Surgery in 1999. Nadine Woolman, COA⁺, has worked with Dr. McIntyre for 17 years as an ophthalmic assistant and surgical technician. She also manages the McIntyre Surgical Center. Michael Romansky is a partner in the Washington, D.C. office of McDermott, Will and Emery. He serves as Washington counsel to the Outpatient Ophthalmic Surgery Society, as well as other ASC, physician, and health trade associations. Nathan Beaver is an associate in McDermott, Will and Emery.

Lessons We've Learned about Reprocessing

Over the years, experience with reprocessing has taught us a number of extremely important lessons:

�         Some instruments must be processed very carefully. Ordinary stainless steel hand instruments can be cleaned and resterilized rapidly and effectively, but some instruments require special attention. For example, cleaning cannulae in ultrasonic equipment fills the lumen with detergent solution but doesn't effectively remove it -- and detergent cleaning solutions are highly toxic to the corneal endothelium. Cannulated instruments must be copiously flushed to remove residual detergents before sterilizing.

�         There are many reasons -- including economic factors -- for choosing a particular sterilization method. Three sterilization techniques have become common: steam autoclave, Chemiclave, and ethylene oxide. The Chemiclave (which runs at a slightly higher pressure and temperature than the steam autoclave) uses a very low water content, which makes the process noncorrosive. Ethylene oxide (ETO) is also noncorrosive; however, it requires 12 to 24 hours for complete aeration. (Although it's not commonly known, inexpensive supplies and equipment are available,
making ethylene oxide sterilization practical in small facilities.)

�         Decontamination and sterilization are two very different things. Heat- and ETO-stable toxins may remain on the surface of instruments if "cleaned" in a contaminated solution. This can result in sterile but toxic endophthalmitis.

�         Some supplies can't be safely sterilized using common in-house methods. For example, ETO must never be used where aeration is inhibited. One facility reportedly used ethylene oxide to reprocess Miochol in its stoppered vial. Ethylene oxide entered the solution through the rubber stopper and was retained during the aeration process. As a result, the patient's corneal endothelium was destroyed.

�         Unknown hazards will continue to appear. Complicated mechanical equipment may contain nooks and crannies where contamination accumulates and pathogenic organisms may culture. This has been reported in the valving systems of some aspiration pumps used in cataract surgery.

����������������������� -- David McIntyre, M.D., F.A.C.S.

A Brief History of Reuse

We tend to think of the practice of reprocessing and reusing of SUDs as relatively new. But the first commonly used "disposables" appeared during World War II, including bottles of intravenous solutions and scalpels with replaceable disposable blades. Hypodermic needles were permanent, all-metal, resharpenable, and supplied with stylet wires; syringes were glass with serial numbers because their plungers were not interchangeable.

More recently, cost containment, coupled with advancing technology in both production and packaging, has contributed to the evolution of what sometimes looks like a virtually all-dispos- able medical supply system. The resulting flood of SUDs has been sold by an eager support industry, arguing that by reducing central supply to a limited stocking and distribution activity, the decreased labor would result in real savings for hospitals, ambulatory surgery centers and office surgical facilities.

However, the economic advantages for the manufacturer are evident. Just as the Gillette razor company will give you the razor if you buy the blades, ophthalmics manufacturers are willing to dramatically cut prices on capital equipment like phacoemulsifiers and lasers to sell disposable packs, surgical supplies, pharmaceuticals and solutions.

But why is it that devices from two manufacturers can be essentially identical, but only one is marked SUD? The single-use legend is, at least in part, the result of increasing regulation. In recent years, the FDA has become more specific about labeling and user instructions. If the manufacturer expects the healthcare provider to use the product more than once, it's the company's responsibility to provide complete information on methods of cleaning, inspection, packaging, sterilization and so forth. This places a burden on manufacturers -- a burden that doesn't exist if the product is marked "single use."

Effective Strategies to Help Lower Costs

Here are a few strategies we've used in our practice to maximize safety and efficiency while minimizing unnecessary expense:

�         Use simple, reliable instruments. Thriftiness begins with the choice of surgical techniques and instrumentation and patient preparations. The Phacosection technique we've used for the past 10 years utilizes extremely simple instruments. It produces outstanding surgical safety, excellent patient results, rapid healing and optical prescription within a week, if desired. With this technique, there are no mechanical devices to capitalize and maintain and no expensive disposable components.
Along with this procedure:

o       the periocular area is sprayed with Iodophor prep and kept moist throughout the entire preparation period

o       draping is minimized and prophylactic antibiotics are introduced in the BSS, rather than by periocular injections

o       during the procedure we use refillable silicone squeeze bulbs, rather than individual 15-cc BSS.

�         Purchase supplies in larger quantities than you require for individual procedures. The two major items we purchase in this manner are viscoelastic agents and 500-cc BSS. The BSS, to which we add antibiotics and epinephrine, is re-spiked with fresh intravenous delivery sets for consecutive procedures. This allows us to use it on several patients.
We divide viscoelastic into separate, individual, 1-cc syringes under sterile conditions. The syringes are held in containers which have been ethylene oxide (ETO) sterilized and then added to the instrument tray when required during a case. (Each syringe contains only about 0.2 cc.)

�         Resterilize clean, unused, leftover supplies. In our practice, this normally includes paper supplies, drapes, leftover halves of 10/0 suture with the swedged needle and sponge spears. We repackage these items and sterilize them with ethylene oxide.

�         Reprocess devices such as corneal trephines and vitrectomy cutters. These are cleaned, carefully dried, inspected, function-tested (if necessary), and then wrapped and sterilized with ETO.

�         Know which supplies not to reprocess. We don't attempt to reprocess, salvage, or reuse certain supplies:

o       A IOLs which are opened but not used

o       A gloves, which rapidly become permeable with use

o       A plastic hubbed hypodermic needles

o       A paper products that have been on the field

o       A intravenous delivery sets, which are difficult to clean and dry

o       A plastic syringes, which rapidly lose their plunger lubrication.

�         Seek out good prices on large volume items. We periodically seek bids for our custom packs, IOLs and other large-volume items. We obtain many of our smaller items from local
suppliers and pharmacists who are happy and willing to meet competitive prices, while also giving us local, personalized service. (We've found that supply channels, shipping and billing require constant surveillance.)

����������������������������������� -- Nadine Woolman, COA

Setting a Standard of Care

By Gail Broadhurst, Lewisville, TX

In recent years, the practice of reprocessing and reusing instruments labeled for single use by the manufacturer has become fairly common. In fact, an ASC's business manager may see this as a significant factor in a practice's economic survival.

At this point, little evidence exists that reuse of ophthalmic tools (after appropriate cleaning and sterilization) is harmful to patients. However, even if your patients aren't being injured as a result of this practice, you're taking a liability risk. And you may soon be facing a different danger to your practice: repercussions resulting from new government guidelines established by the FDA.

Shifting targets

During the next year or two, regulations aimed (for now) at hospitals and third-party reprocessors will be phased in. What does this mean to you as an ophthalmologist? If you're operating in the hospital, with no ownership interest, it will be the hospital's responsibility (not yours) to comply with the new rules. However, if you own an ASC, these changes are likely to be extended to include your facility within the next few years. (A spokesperson for the FDA told me that ASCs will indeed be covered by these regulations at some point in the near future.)

Reason for concern

But what about today? If ambulatory surgery centers aren't on the FDA's targeted list for oversight, should you be concerned?

I think you should. Aside from the fact that these guidelines may soon apply to you, liability is always an issue. In November of 1977, the FDA issued a guidance (Compliance Policy Guide #300.500) stating: "When health care facilities reprocess SUDs, they assume full liability and responsibility for their reprocessing actions and should ensure that the products are adequately cleaned and sterilized, and that device safety, effectiveness, and quality are maintained. If a serious adverse event involving a reprocessed (or any other) device occurs, however, FDA can and does investigate and take appropriate action."

Add to this liability issue the likelihood of falling under the new FDA regulations within the next few years and you do indeed have reason to be concerned about the ramifications of reprocessing and reusing SUDs.

Agency involvement

For now, David W. Feigal, M.D. (director of the Center for Devices and Radiological Health in the FDA's Department of Health and Human Services) has stated that the FDA plans to collaborate with third parties to assist in enforcement of the new guidelines. The FDA has invited agencies such as the Joint Commission on Allied Health Organization (JCAHO), HCFA, and other regulatory bodies that currently perform oversight of the healthcare sector, to participate.

The FDA's intended collaboration with these agencies -- which oversee ambulatory care as well as hospitals -- is one more piece of evidence that ASCs will eventually be included. And because these agencies have significant influence in the medical arena, it's worth considering what they have to say about the reprocessing and reuse of SUDs.

Input from other agencies

From November 2000 to March 2001, the Joint Commission on Accreditation of Healthcare Organizations will assist the FDA by distributing educational materials to hospitals regarding the re-use of SUDs, and by collecting information during on-site surveys about hospital reuse activities. JCAHO hasn't yet taken a definitive stand on the reprocessing and reuse of SUDs. A statement the organization issued simply says that it's considering how this issue should be addressed in the accreditation process. Nevertheless, the fact that JCAHO is working with the FDA indicates some degree of sympathy with the new guidelines.

The Association of Operating Room Nurses (AORN) has been more direct in its comments on reprocessing and reuse of SUDs. AORN's opinion is especially significant because it sets the recognized standards of care for operating rooms. (Although the standards aren't legally binding, courts have shut down surgery centers for not meeting them.)

Playing it safe

Even though AORN acknowledges the importance of economic considerations, it doesn't recommend reprocessing of any instrument unless one of these conditions can be met:

�         the manufacturer provides written instructions for resterilizing single-use devices (which is unlikely)

�         the healthcare facility can demonstrate and document that patient safety, device effectiveness and device integrity aren't compromised by the instrument's reuse. (This is a tall order, and not something that most ASCs are prepared to do.)

AORN's comments, posted on its Web site, state that the decision to reprocess single-use, disposable devices should not be made lightly. In some instances it may be extremely difficult, if not impossible, to document that a device can be reprocessed without residual toxicity and still function safely and effectively.

If reprocessing is done, AORN recommends that it be consistent throughout the facility, with all reprocessing conforming to established protocols. (AORN specifies a lengthy, complex protocol for ensuring that your reprocessing is safe and effective. For complete details, visit http://www.aorn.org/
_results/clinicalDisplay.asp on the Web.)

AORN points out that unless the manufacturer approves reprocessing and provides written information about reprocessing, you bear full liability for any item you reprocess, including being in compliance with any regulatory requirements at the local, state, and federal levels.

The view from here

And what's my take on this situation? Speaking as a registered nurse with 25 years of ophthalmic surgical experience, I don't believe that reprocessing and reuse of products labeled for single use has a negative effect on our patients. At the same time, I recognize the importance of risk management.

The number and extent of regulations being imposed by the FDA will probably force most hospitals to stop reprocessing SUDs. However, third-party reprocessing companies have a strong economic incentive to stay in the game. Meeting the FDA requirements may cause them to raise their prices, but I would expect that their reprocessed instruments will still be less expensive that the original SUDs. For that reason, I anticipate that most hospitals will switch from reprocessing their own instruments to purchasing from a third-party reprocessor. If these rules are extended to ASCs, which seems likely, doctors may be forced to follow the same route.

So what, if anything, should you do right now? If you reuse SUDs, and you plan to continue doing so, I'd recommend taking the following steps to protect yourself:

�         Try to get written approval for reuse from the manufacturer, along with written protocols on sterilization.

�         Develop a quality assurance tool to evaluate and document patient responses to these devices. For example, make a comparison between the rates of infection and inflammation when you use new blades and reprocessed blades. Evidence that reprocessed blades have no discernable negative effect would go a long way to offset any problems down the line.

Gail Broadhurst is vice president of surgical services for Surgery Center Services of America, in Lewisville, Texas