Medical Devices

Washington Post staff writer Alec Klein was online to discuss his series of articles on the reuse of single-use medical devices.

His series of articles began Sunday:

Hospitals Save Money, But Safety Is Questioned

The Consequences of Cuts

And concluded today:

Reused Devices Attract Entrepreneurs, Scrutiny

Klein also narrated a photo gallery on the subject.

A transcript follows.

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Alec Klein: First, I'd like to thank everyone for joining this discussion of the reuse of single-use devices. There are a lot of questions, so I'll try to answer as many as I can.

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Columbia, Maryland: Thank you, Mr. Klein, this expose is very important.

How many times might a "single" use instrument be reprocessed?

Have hospitals done a cost-benefit study to see how much they are actually saving by reusing these devices - given the cost of third party reprocessing?

Do you know of any attempts on the part of hospitals to monitor quality - e.g., infection rates in patients on whom these devices have been used?

Thank you.

Ann Neale

Alec Klein: Thanks for your questions. First, I'd like to point out what the reprocessors say. They say there is no credible evidence that refurbished single-use devices are riskier than new ones. The reprocessors also say that there is some level of risk, whether the device is new or reused. The reprocessors say that they track the number of times a device is reprocessed, and that number varies, based on what I have been told. Many hospitals vouch for the safety of the practice of reprocessing single-use devices and cite considerable cost savings. Experts tell me that isolating the cause of an infection is difficult to do because there can be several factors, which can include the original device, or the device after reprocessing, or other conditions during surgery.

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Hawley, Pennsylvania: Is there any movement afoot to force hospitals to stop reusing single-use devices?

It's a scandal that many other countries forbid the reuse of single-use devices, but the U.S. permits them with little oversight!

Will you continue to do follow-up articles on this dangerous practice?

Mary Huber

Alec Klein: The reprocessing of single-use devices is growing, and it's believed to be practiced in all 50 states, the District of Columbia and many of the nation's leading hospitals. The FDA oversees the practice, requiring reprocessors to register with it. In addition, the reprocessors must get clearance from the FDA for each kind of device it reprocesses. In Massachusetts, a state bill has been introduced that would require hospitals in that state to obtain permission from patients before reusing single-use devices on them. There is no such patient-consent requirement elsewhere in the United States. U.S. hospitals are not required to tell patients when they are reusing single-use devices on them. The reuse of single-use devices is banned in France and is strongly discouraged in other parts of Europe, such as Great Britain.

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Bethesda, MD: I am a research physician (unconnected with either the reprocessing or medical device industry) and am shocked by your story. If money is being saved by using reprocessed single-use devices, it should be passed on to the patient who is taking the risk, and of course, the patient should be informed. Why isn't charging full price for off-label use of less expensive reprocessed devices considered to be fraud? The lame excuse that this fraud allows the hospitals to spend more money on staff or other equipment doesn't change the fact that the patient is overcharged. And when insurance companies or Medicare are involved, why aren't these criminals who deliberately abuse the trust of their patients, the insurance companies, and the government put in jail for insurance fraud or Medicare fraud?

Alec Klein: Hospitals that reprocess single-use devices say that while the savings do not directly go to patients, they help to buy more medical equipment or hire more personnel. The FDA allows the reprocessing of many single-use devices. There are no rules or regulations requiring hospitals to inform patients when they are reusing single-use devices on them, and there are no rules or regulations requiring hospitals to obtain the consent of patients before using such devices.

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Atlanta, GA: Thanks for the well researched & well written articles.

Do I understand correctly that hospitals use recycled, cheaper devices, but charge patients for new, more expensive devices? Sounds like fraud to me. Insurance companies should be all over this.

Also, is the money saved actually spent on more equipment, as was stated? Make them prove it. More likely, it funds the bonuses of managers who reach their cost cutting targets for the year.

Alec Klein: Hospitals that reprocess--and there are many of them--tout the benefits of reusing single-use devices. They say that the reprocessed devices are just as safe as new devices, that they help to reduce hospital waste and that the savings allow them to buy more medical equipment and hire more personnel.

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Alexandria: Thanks for an excellent article. This seems very scary. Are there any hospitals in Virginia that do NOT re-use single-use devices? I want to re-think what hospital I'd go to, if necessary.

Alec Klein: There are hospitals in the area that do not reprocess single-use devices, including Sibley and Georgetown University Hospital. Hospitals say that if patients want to know whether reprocessed single-use devices will be used on them, they should ask their doctor first. Hospitals are under no obligation to tell patients when they are reusing such devices or to seek patients permission before using reusing those devices. The FDA oversees the reprocessors and they must get clearance from the federal agency for each kind of device reprocessed. That clearance means that the FDA considers the reprocessed device to be "substantially equivalent" to the new single-use device.

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Manassas, Va.:

In Sunday's article, why weren't the (4) Inova hospitals located in Northern Va. identified? The other hospitals were named in full.

Alec Klein: All hospitals in the Inova Health System use reprocessed single-use devices, except the Loudoun hospital, according to the hospital system.

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Jerome, Michigan: What is the best way to obtain information from our hospital regarding reprocessing medical devices, to make sure it is accurate and complete? How can we make sure we are informed if they plan to use some reprocessed equipment before they use it. My aunt was notified AFTER the fact that she may have been expose to HIV because of non-sterile devices.

Alec Klein: If patients want to know whether reprocessed single-use devices will be used on them, hospitals suggest that they ask their doctor first. Many doctors say they do not know when they are using reprocessed devices because until August of last year there was no requirement for devices to have the name of the reprocessor on the device itself. It was usually on the outside packaging, which was usually discarded by the time the device ended up on the operating room table.

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Boston, Mass: Alec, I work for an OEM that designs and manufactures single-use only devices

Nice job on the details of what we call medicine's dirtiest little secret.

In fact, we sponsored a survey of surgeons and OR nurses regarding this practice. The results indicated that 71% of surgeons and 82% of nurses would not use a reprocessed single-use only device on themselves or a family member. Pretty telling information

The reprocessors regularly "claim" that their devices are cleaner and sharper than the single-use only OEM devices. Because of economic concerns, hospitals take their word for it. Have you come across any hospital that REGULARLY tests - for patient saftey concerns -- reprocessed single-use only devices to ensure their functionality and sterility?

Alec Klein: Hospitals that reprocess cite the FDA's oversight of reprocessors, which includes the federal agency's requirement that reprocessors register with it and get clearance for each kind of device being reprocessed. The original device makers say they cannot vouch for the safety of reprocessed single-use devices. They say that the single-use label is a legitimate warning to not reuse the device because such devices are frequently built with sophisticated plastics and other materials, and most reprocessors do not have access to the original design requirements.

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Vienna, VA: Of the two problems, mechanical damage and incomplete sterilization, I think the mechanical issue can be addressed by working with the original manufacturers.

But who is responsible for quality control of sterilization? Does the government conduct periodic tests, as with food? The companies themselves may or may not have adequate quality control. I seriously doubt the hospitals themselves are periodically testing to see if the re-used items are clean. Who's in charge?

Alec Klein: There are few reprocessors who work in concert with the original device makers in large part because the device makers say that the devices are intended only to be used once. The reprocessors note that they have sophisticated facilities to clean and refurbish single-use devices, and they say they test every device that is reprocessed. Hospitals also rely on the FDA's oversight of the industry.

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Columbia, Maryland: Hospitals may be under no legal obligation to inform patients about reusing single use items. I would suggest, however, that they have a moral obligation to do so, especially if directly asked by a patient.

Alec Klein: It's true, there is no legal obligation. If asked, hospitals say they would disclose the practice. However, many doctors say they are unaware that the devices they are using have been reprocessed.

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Andover KS: Based on fifty years as an anesthesiologist caring for the lives of patients undergoing heart surgery, I believe that the reuse of single-use devices is just another part of the transition from physician-knowledge based medical care to mechanistic-administrative patient care designed to reduce the cost of delivering politically motivated care of human citizen-voters. What defense do bureaucratic and financially motivated administrators have for threatening the further degradation of medical care in favor of political and financial gain

Alec Klein: The decision to reprocess single-use devices is largely made by hospital administrators, according to interviews. They say they consult with medical experts to ensure that they have the support of their doctors. However, they say the ultimate decision is made by the administrators.

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Yuba City, CA: Given the time spent in reproccessing the medical devices and comparing the costs of new devices with reprocessed devices, it appears the new devices are way over-priced if they can be used only once. Secondly, hospitals should be required to get a patient's written consent before using a recycled medical device.

Alec Klein: The reprocessors say that the original device makers use the single-only label as a way to get hospitals to buy more of their devices. Many hospitals agree with that and say that the reprocessed devices are just as good as new. As for patient consent, the reprocessors have evolved their position in recent months, at first saying that they did not believe it was necessary because the reprocessed devices are safe. Now they say they would support such patient consent as long as it also cites the potential risks of the original devices.

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Washington, D.C.: Do reprocessers get access to the manufacturer's specifications/manufacturing procedures to assure that the reprocessed single use device is identical to that released by the OEM?

Alec Klein: Most reprocessors do not have access to the original device makers' design and manufacturing requirements. The reprocessors say that they have sophisticated research & development departments, where they take the devices apart to figure out how they were designed and how to clean them. The reprocessors call this reverse engineering. The original device makers said they call this guess work.

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Birmingham, Mich.: Mr. Klein,

I was hoping you might talk about what you found regarding injuries to patients from new equipment. My uncle falls into that category. Is it more common for injuries to happen from these reprocessed devices, less common that from original devices, or about the same? What's known? Thanks.

Alec Klein: The reprocessors say that there is no credible evidence that their refurbished devices are riskier than new ones. There are injuries and device malfuctions involving both new and reused devices, according to federal records. Based on available data, it is impossible to compare how often reprocessed devices malfuction in their first operation compared to their subsequent use because the FDA did not require until last year that hospitals report whether a malfuctioning device had been reprocessed. In addition, doctors only voluntarily report problems with faulty medical devices. And medical facilities are required to report deaths but not device malfuctions to the FDA.

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Burke, Va.: I didn't see that you answered the questions regarding "fraud". Surely the practice of billing the same,whether the device is new or used, should be questioned. Insurance companies should be up in arms as well as uninsured patients, or patients whose surgery is self-pay for one reason or another.

As for me, I will alter any consent form I am given to prohibit the use of any reprocessed single item device.

Alec Klein: That's a question others may answer. As for the issue of patient consent, hospitals say that patients have a right to ask whether such devices are being used on them, although the hospitals are not under an obligation to consent to a request that reused devices not be used on patients.

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Minneapolis MN: Alec,

I am currently an employee of one of the major third party reprocessors, prior to this position I directed Radiology and Nuclear Medicine Imaging dapartments as well as managed an OEM Sales force.

It is my opinion that tactics employed by OEM representatives are nothing more than medical terrorism, meant to frighten, mislead and solidify thier own business interests.

I have not found a clinical objection that has not been overcome by educating hospital staff as to the science and regulations that govern my industry.

Alec Klein: Others in the reprocessing field have echoed your sentiment, and it was noted in our series.

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Alec Klein: Our time is up. Unfortunately, given the large volume of questions, I couldn't get to every question. But I'd like to thank everyone for participating in this discussion. If you have any follow up questions, please feel free to e-mail me at kleina@washpost.com.

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