Warning: Reprocessing disposables is accepted, but there are still some risks

Best choice: Outsource the work and choose a provider carefully

Reprocessing medical devices labeled for single use offers substantial savings, but the practice has been controversial since it first started gaining popularity more than 10 years ago. Now, with years of experience to look back on, risk managers and clinical experts say reprocessing can be a sensible cost-cutting strategy as long as you pay attention to certain potential risks.

Risk managers must be fully aware of any reprocessing that takes place in the organization and ensure that it is done appropriately, says John Metcalfe, JD, vice president of risk management services at Memorial Health Services in Long Beach, CA, which has been reprocessing for 10 years. While there appears to be little risk to the patient, if any, from using reprocessed devices, he notes that is true only when appropriate quality standards are met. The decision to reprocess often is made by clinicians who look at the research and decide whether the cost savings is justified, but Metcalfe says risk managers must be in the loop.

Metcalfe's system contracts with an outside company to reprocess some single-use medical devices and says he is comfortable with the arrangement. In 10 years, there has been no patient injury or other problem related to the reprocessed devices and no lawsuits alleging such harm, he says. The Food and Drug Administration (FDA) database also shows no adverse events traced to the use of reprocessed single-use devices.

It was a real debate years ago, but as time goes on, it looks like it was making a mountain out of a mole hill. There was good reason to be cautious, but time has shown the risk just hasn't materialized," Metcalfe says.

However, not all risk managers and hospitals agree that reprocessing is safe. Children's National Medical Center in Washington, DC, for example, does not reprocess single-use medical devices. A spokesman told Healthcare Risk Management that hospital leaders decided against reprocessing so patients could be certain that care was provided with the most sterile and highest quality instruments possible.

A surprising number of risk managers don't even know whether their institutions reprocess single-use devices, much less what procedures are followed, says Elizabeth Litten, JD, an attorney with the law firm Fox Rothschild in Princeton, NJ.

There is very little case law on this, but the potential risk if something goes wrong can be substantial," she says. This is something that should be a priority for risk managers. Top on the list should be finding out whether you reuse these devices and exactly how."

Risk managers also should ensure that policies and procedures are formal and adequate to ensure patient safety, she says.

Can save 50% on devices

Dan Vukelich, executive director of the Association of Medical Device Reprocessors (AMDR) in Washington, DC, says third-party reprocessing offers significant cost savings.

On average, reprocessed medical devices offer a 50% cost savings, he says, as compared to purchasing a new device. Third-party reprocessing provides at least as high, and perhaps even a higher degree, of sterility assurance than in-hospital reprocessing, he says. Because of economies of scale, third-party reprocessors often have more capital available than hospitals to invest in high-tech cleaning, sterilization, and testing equipment.

In addition, Vukelich says third-party reprocessing offers hospitals significant risk management benefits. Hospitals that outsource their reprocessing needs effectively free themselves from malpractice costs that could arise in connection with improper reprocessing. Metcalfe also cites that transfer of liability as a major benefit of outsourced reprocessing. We transferred all the potential liability for almost anything and everything that can happen with that device to the reprocessing agency," Metcalfe says. So that can be the best of all worlds."

However, some legal experts caution that the theory is not rock-solid. The hospital still may be held liable in the unlikely event that a patient is injured by a reprocessed device, they say. (See box below for more on the legal analysis.)

Risk is not always on processor, lawyer warns

Don't be so sure that you're off the hook for any potential liability just because you are using a third party to reprocess single-use devices, cautions Elizabeth Litten, JD, an attorney with the law firm Fox Rothschild in Princeton, NJ.

There are still too many unknowns regarding reprocessed devices to be sure that you can transfer the risk, Litten says. After an adverse event, the disclosure that a reprocessed device was used could just make things worse, she says. Even if the device — or the fact that it was reprocessed — had nothing to do with causing the adverse outcome, the patient can respond negatively to the "ick" factor of a reused device. And of course, the plaintiff's attorney can play on that same sentiment in court even if there is no actual evidence of increased risk.

"If you didn't notify the patient that you were using reprocessed devices, and most people don't, then you've got the added issue of whether you deceived your patient," she says. "Plus, there is the possible allegation that you billed for a new device when it wasn't really new, which could be billing fraud."

Strictly from a risk management perspective, it might be a good idea to notify patients in the informed consent process that reprocessed devices will be used, Litten says. From a practical standpoint, many organizations resist that disclosure because it may scare patients or invite lawsuits. Litten cautions that it could be foolhardy to assume that you are transferring all liability risk to a third-party reprocessor.

"There aren't sharp, bright lines yet in terms of who is responsible when something goes wrong. I would not advise my clients that they're off the hook and all the liability will fall on the reprocessing company," she says. "One determinant will be who knew about the reprocessing and approved of it. If the cardiac surgeon says he had no idea you were reprocessing this item and doesn't think that was safe, you could end up with a bigger problem than you expected."

Vukelich notes that government-regulated, third-party reprocessors in the United States have reprocessed more than 40 million devices with no evidence of an increased risk to patient safety. Reprocessors' safety record is every bit as good as, if not better than, the safety record of the original equipment manufacturers," he says.

However, Vukelich cautions that not everything can be reprocessed. AMDR members have collectively reprocessed tens of millions of devices with few problems. Though numerous devices labeled for single use can be safely reprocessed, it is AMDR's view that not every device should be," Vukelich says. Devices with certain design features, such as narrow tubing, lumens, and interlocking parts, can harbor debris, which makes them inappropriate for reprocessing. Some examples are noncompression heart stabilizers, used in cardiovascular surgery for the purpose of moving, lifting, and positioning the heart while sustaining hemodynamic stability, and many endoscopic and laparoscopic tools. AMDR member companies reprocess only a small percentage of the numerous devices used by hospitals," Vukelich reports.

Though in past years more hospitals did their own reprocessing, he says today the vast majority of reprocessing of single use devices in the is done by third-party companies, which are stringently regulated by the FDA.

Vukelich notes that the single-use" label is used at the manufacturer's discretion, often as a way to sell more devices, and that the designation of a device as single use" is not an FDA requirement. Indeed, single use" does not always mean that a device is not suitable for reprocessing, as evidenced by the fact that some original equipment manufacturers now reprocess their own single-use" devices, and some have changed the labels on certain reusable" devices to single use" without significantly changing the devices.

Also, the government-regulated standards for reprocessing are stringent and sometimes even higher than those required of new products, says Arthur Goodrich, vice president of business development with Ascent Healthcare Solutions, an independent third-party reprocessor in Phoenix. Ascent has reprocessed more than 50 million devices for more than 1,700 health care facilities nationwide.

If we have received clearance from the FDA to reprocess an item, we have had to submit a dossier on the procedures for processing that device that is, in most cases, more complex and detailed than the original manufacturer had to submit when that device was put on the market," he says.

One risk manager with experience in this area recommends using only outside reprocessors rather than taking on the task yourself. Ches Alper, MD, is manager of risk management education with Health Care Indemnity, the captive insurance company for Hospital Corporation of America (HCA), based in Nashville, TN. When HCA investigated reprocessing six years ago, the risk management department told affiliate hospitals that there was no undue risk or potential liability as long as they outsourced the work.

We visited the top reprocessors and were very comfortable with what we saw. But we decided that no hospital is capable of meeting the reprocessing requirements set up by the government and that it would not be wise to take on that responsibility," he says. In six years, we have not had any reported problems or claims arising from reprocessed items." (Editor's note: Another equipment issue that risk managers should be aware of is the risk of encountering counterfeit medical devices. See story the end of this article.)

Sources

For more information on reprocessing single-use medical devices, contact:

  • Ches Alper, MD, Manager of Risk Management Education, HCA, One Park Plaza, Building 2-4E, Nashville, TN 37203. Phone: (615) 344-1144. E-mail: Ches.Alper@HCAhealthcare.com.
  • Arthur Goodrich, Vice President of Business Development, Ascent Healthcare Solutions, 10232 S. 51st St., Phoenix, AZ 85044. Phone: (888) 888-3433, ext. 5321. E-mail: Agoodrich@ascenths.com.
  • Elizabeth Litten, JD, Fox Rothschild, P.O. Box 5231, Princeton, NJ 08543-5231. Phone: (609) 895-3320. E-mail: Elitten@foxrothschild.com.
  • John Metcalfe, Director of Risk Management Services, Memorial Health Services, 2801 Atlantic Ave., P.O. Box 1428, Long Beach, CA 90801-1428. Phone: (562) 933-2000. E-mail: jmetcalfe@memorialcare.org.
  • Dan Vukelich, Executive Director, Association of Medical Device Reprocessors, 1400 16th St., Suite 400, Washington, DC 20036. Phone: (202) 518-6796. E-mail: dvukelich@amdr.org.

Beware of risks from counterfeit medical devices

While you're checking your organization's policy on reprocessing single-use medical devices, it's a good idea to review how your supply infrastructure wards off counterfeit items.

Counterfeit items can creep into the health care supply if you do not use safeguards to keep them out, warns Vincent Volpi, CEO of PICA Corp., a company that conducts corporate investigations and security consulting for health care providers and other companies. Because the fake items — which include stolen and illegally packaged or imported products — are not of the same quality and not properly regulated, they pose a substantial risk to patient safety, he says.

The most common counterfeit products are simple items like sutures, Volpi says. But there also are diverted products that are sold through secondary sources, not the original manufacturers or their authorized distributors. A third group is reprocessed and repackaged products that are sold as new and unused.

Many hospitals and health care organizations buy products in the secondary markets because they are cheaper. Most often, the reasons they are cheaper are that they are destined for sale overseas where the price points are lower, or they're stolen, usually from hospitals or health care organizations," Volpi explains. The products also may be expired and designated for donation to poor countries or destruction, or they may be repackaged."

Volpi urges risk managers to investigate how purchasing departments cut costs when buying medical supplies. The pressure to cut costs can sometimes lead staff to make bad decisions, he says, and risk managers might be shocked at what they find when they go digging.

Betraying the trust of your patients to save a few bucks is not only immoral, it is a bad business decision," he says. It exposes the organization and its members to liability, ridicule and a diminished reputation in an industry where faith and confidence is the prevailing currency."

Tips for avoiding counterfeit devices

To avoid counterfeit, diverted, or repackaged product that potentially increases risk and liability, Volpi says risk managers should follow these steps:

  • Always buy from reputable sources, ideally approved by the manufacturer in accordance with Food and Drug Administration (FDA) guidelines.
  • Educate the purchasing departments about the dangers of buying from unapproved and questionable sources. These sources range from eBay and other Internet sources to consolidators who maintain product in self-storage units, to overseas distributors with no real physical address or known person associated.
  • Secure inventories of medical products the same way retailers do with high-value merchandise. Controlling these inventories will radically diminish theft and keep hospitals and health care providers from buying back their own inventories, with the risk associated with acquiring them from less-than-reputable sources.

Source

For more information on counterfeit medical devices, contact:

  • Vincent Volpi, CEO, PICA Corp., 551 S. Third St., Columbus, OH, 43215. Phone: (614)-228-7422. E-mail: protect@pica.net.