Are Hospitals Putting Patients At Risk By Recycling Disposable Instruments And Devices?

27 Jul 2007

Patients may have one more reason to be alert to treatment provided in America's hospitals.

Under pressure from HMOs, Medicare, and insurance companies to cut costs, thousands of U.S. hospitals are quietly recycling millions of disposable sawblades, biopsy forceps, and catheters for use in procedures from cardiac angioplasties to orthopedic surgery.

The practice may be putting unwitting patients at risk for injury, infection, and worse.

While proponents say the practice is safe and saves millions of dollars, critics of reuse have called it medical experimentation without patient benefit, written consent or even patient knowledge.

The full consequences of instrument recycling may be impossible to determine, since direct cause and effect is difficult to prove at times. And, patients are almost never told about reuse in the first place. Putting two and two together is extremely difficult when the practice remains virtually invisible in hospital charts.

Documents from the Food and Drug Administration (FDA) reveal numerous incidents of patients put at risk from what appear to be recycled disposable instruments that were contaminated or defective. The reports, submitted by hospitals, outline cases of premature babies stitched with unsterile sutures; a crumbled tube lodging in the pulmonary artery of an elderly woman; a fractured catheter becoming stuck in a patient's facial artery; a biopsy patient possibly being contaminated with hepatitis B; and two catheters breaking during the brain scan of a 50-year-old woman, requiring surgery.

New technology. Before disposable devices became commonplace in the 1980s, most medical instruments were made of glass, rubber, or metal and were meant to be reused. They were easy to clean and sterilize, but they limited the doctor's ability to perform delicate procedures.

As plastics technology improved, devices became smaller, more flexible, and more intricate. Doctors could now treat patients less invasively. Cardiologists, for instance, could repair blood vessels without the risks of open-heart surgery.

Manufacturers said these new instruments, with their multiple internal passageways, tiny crevices, and coils, were impossible to clean-a problem made more threatening with the discovery of AIDS-so they made them disposable.

With the arrival of managed care, however, hospitals had to cut costs, and the medical-device budget, typically one of a hospital's largest, was an obvious target.

The $20 million-a-year reprocessing industry was born. While many hospitals clean and sterilize their disposables in-house, others contract with these reprocessing companies, hoping to improve quality and reduce costs further. It has been estimated that if hospitals took full advantage of the practice, they could save $700 million a year.

Critics say the risk is not worth the savings. It is true, however, that reprocessing companies use sophisticated methods for cleaning and sterilizing disposable devices, and in many cases, the practice is safe. The large plastic compression cuffs used to keep blood clots from forming in the arms and legs during surgery, for instance, are easily recycled. The practice also cuts down on medical waste.

But complex instruments are more problematic. Catheters break, recycled plastic staplers wear out, and orthopedic sawblades can be over-sharpened, shattering kneecaps. Refurbished biopsy jaws, passed through one patient's rectum and later down another's esophagus, can accumulate traces of blood, mucus, and feces that reprocessors may not completely remove. The crannies of multi-channeled instruments, such as spaghetti-thin catheters for clearing coronary blockages, are especially difficult to clean, and the plastics, adhesives, and slippery coatings used in many disposable devices can't always stand up to the harsh chemicals and high temperatures used in sterilization.

Does Reuse Spread Infection? Some experts blame reprocessing for a rise in the rate of infections and diseases contracted in hospitals. But poor patient tracking makes the connection impossible to prove. Hepatitis takes three to six weeks to incubate, tuberculosis takes over three months, and HIV also takes months to develop.

A survey by Harbaugh Associates, a market research firm specializing in medical products, showed that only a small minority of electrophysiology labs noted which patients had reprocessed catheters used in their care. In fact, most of the physicians surveyed said they didn't always know whether a patient had an infectious disease.

Faced with concerns like these, Congress has ordered the U.S. General Accounting Office to determine the extent of reuse and how it affects patient care. AIDS Action, whose immune-depressed constituents are especially vulnerable to infection, has called on the FDA to crack down on reuse. And manufacturers have discussed suing the agency to force it to develop efficacy and safety standards for reprocessing and to require hospitals to obtain consent from patients.

A strong sign that the FDA is listening is a letter it fired off in July to the Association of Medical Device Reprocessors, challenging what it called "false and/or misleading statements" in which reprocessors claim recycling is FDA safety approved. In the letter, agency officials say they consider reuse "unlawful" unless a reprocessor provides documented proof that its devices are safe and effective. Yet officials admit they are not enforcing the policy.

In the meantime, patients who acquire new infections while hospitalized or who become aware of a failure of a medical instrument or device in the hospital should consider that the cause may be the reuse of recycled material. An experienced attorney should be advised of the circumstances and requested to investigate further. There may very well be the basis for a lawsuit or claim based upon either medical malpractice or product liability.

The recycling process creates an interplay between the responsibilities of healthcare providers and their suppliers or contractors to the ultimate patient. An injury or death caused by recycling may represent a breach of the medical standard of care and a simple act of negligence, both of which may be actionable.