Hospitals Are Dangerous Places

According to a December 11, 2005 article in the Washington Post, a nine-year-old boy died as a direct result of an English hospital's reuse of what should have been one-time-use medical equipment:

The Consequences of Cuts:
Reused Oxygen Tube Was Cheaper but Led to Death of Boy During Routine Surgery

"DAGENHAM, England -- The boy's name was Tony. But he liked to call himself 'Alfredo' just because. He baked banana bread. He daydreamed so often that his teachers worried. His mom would catch him kneeling by his bed praying, but he never talked about it. That was his secret.

"And his bike -- oh, did he love that bike. On Christmas morning in 2000, he hopped on it for the first time, teetered and chirped in delight, 'Whoohey'!

"That moment they still have. It's on home video. Tony's mom and dad don't watch it much anymore, not since July 17, 2001. That's the day Tony severely cut the tip of his right index finger on the chain of the bike. He was supposed to get stitched up. It was supposed to be routine. Except by the next morning, Tony was dead at the age of 9.

"The cause of Tony Clowes's death was 'irreversible cerebral anoxia,' oxygen starvation of the brain, according to hospital records. His parents believe their son was the victim of cost cutting.

"The hospital where Tony was to undergo minor surgery had reused oxygen tubes designated as single-use devices, according to police, government investigators and a coroner's jury. Asleep on the pre-operating room table, Tony could not breathe because the cap of another device had accidentally lodged itself inside his oxygen tube. A nurse had found that reused tube stuffed in the back of a hospital drawer.

"New, the oxygen tube cost less than $2. Used, it cost the hospital pennies.

"Although British regulators strongly discouraged the practice, Broomfield Hospital, where Tony was treated, acknowledged then that it was reusing single-use devices against the recommendation of the devices' manufacturers. Hospital officials declined to comment for this article.

"Since Tony's death, Britain has cracked down on the reuse of single-use medical instruments. But the practice has flourished in other parts of the globe, driven by cash-strapped hospitals' need to find savings.

"...Last month, the trust that runs the hospital pleaded guilty to failing to ensure Tony's health and safety; the penalty has not yet been decided.

"It has been more than four years since the accident, but Tony's mother, Carol, now 43 years old, still cannot bring herself to collect Tony's cremated remains, though they sit not five minutes away at A.G. Butler Funeral Directors.

"'I'm not ready to say this is just ashes,' she said."

The article also points out that this same practice of reusing certain medical devices has spread to other countries, including France, Germany, China, and the United States. In fact,

"...[I]t is becoming increasingly common in the United States, where the practice originated, and is condoned by government regulators despite periodic reports of patient injuries...."

A second article in the same edition of the Washington Post contains the following information:

"A growing number of U.S. hospitals, including at least eight in the Washington area, are saving money by reusing medical devices designated for one-time use, ignoring the warnings of manufacturers, which will not vouch for the safety of their reconditioned products.

"Hospitals are not required to tell patients that reconditioned devices will be used in surgery -- surgeons themselves often do not know. The Food and Drug Administration regulates the practice, and many hospital administrators say reusing single-use devices is not only cost effective but also poses no threat to patients because the instruments are cleaned with such care that they are as good as new.

"But single-use devices have malfunctioned during reuse, federal records and interviews show. In one instance, an electrode from a catheter broke off in a patient's heart. In another, a patient's eyeball was impaled. And an infant who for months gagged and retched on a resterilized tracheal tube now can take food only from a tube attached to his stomach....

"The FDA allows manufacturers to choose between getting approval for a device to be used once or multiple times. Companies are frequently choosing one-time use, which means their products do not have to be as sturdy, their liability is diminished after the first use and they are ensured a steady stream of replacement orders. The manufacturers often ship the devices sealed individually in sterile packaging, marked with warnings that they are not to be reused....

"Hospitals in all 50 states and the District, including many of the nation's leading hospitals, are believed to reprocess at least some single-use devices. In the Washington region, the National Naval Medical Center in Bethesda, where the president gets his checkup, at first said it did not use reprocessed devices. But after The Post independently confirmed that it does, the medical center said it does use them on a limited basis. So do Suburban Hospital Healthcare System in Bethesda, four Northern Virginia hospitals in the Inova Health System, and George Washington University Hospital and Greater Southeast Community Hospital in the District. 'Because of the rising cost of health care and medical supplies, reprocessing is a cost effective way to provide a high quality product to our patients,' GWU said in a statement. The other hospitals echoed the sentiment....

"Device makers say the single-use tag is not just a label. 'Single-use devices typically contain difficult-to-access areas that create barriers to cleaning and permit blood, tissue or other bodily fluids to contaminate the reprocessed device, allowing potential transmission of viral and bacterial infections,' said Stephen J. Ubl, president and chief executive of the Advanced Medical Technology Association, which represents device makers worldwide..."

Early this year, I lost one of my most favorite relatives, my cousin-in-law Jim. As far as I know, the cause of his death wasn't a reused medical device. Yet Jim's death and the above-cited article have a connection: unnecesary medical risks were taken and not on the part of the patient.

A few years back, the doctor noticed that Jim's cholesterol level was a bit elevated. Therefore, even though Jim's cholesterol was only marginally high, as a preventive measure, the doctor prescribed a statin. Jim had never been seriously sick a day in his life, but he followed his doctor's orders. The result: an unusual and severe reaction to the statin. The reaction went undiagnosed for some time--that's how rare the complication was!

As a result of the wasting of muscle tissue, Jim began having chest pains and was admitted to the hospital. All cardiac tests were normal, but by this time, the doctors had realized their neglect of the reaction to the statin. As a precaution, Jim underwent the procedure for the insertion of a pacemaker which, it turned out later, he didn't even need. Despite its supposed sterility, this pacemaker had antibiotic-resistant staph contaminating it.

Jim, a big jokester and a fine athlete, became disheartened at his ever mounting aches and pains. He wasn't the man he once had been. Over a period of some months of massive doses of various medications for the stubborn staph infection, Jim sank into chronic illness with cardiac and respiratory complications, became housebound, and had to retire early--on disability.

Last March, after some four years of one type of misery or the other, Jim succumbed to congestive heart failure. When I got the phone call that Jim had passed, I couldn't believe it! His wife and I are first cousins, but not of the see-each-other-every-day or whine-about-your-problems type, so that phone call caught me unawares. When I saw my cousin's number ocme up on Caller I.D., my first thought was "One of the girls is getting married!" But when I learned the horrible details of Jim's course of illness, I became angry--very angry. Certainly Jim's many doctors had had the best of intentions, but what happened was medical error compounded by medical error.

Jim's funeral was not a celebration of life, though the occasion was time for the whole family to gather. We gathered under a cloud of sadness and injustice. Jim was too young to have died in such a manner. He left behind his wife of some forty years and seven children: two of his own and five adopted boarder babies. Those children ranged in age from thirty-eight to seven years of age, and the youngest ones will never get to know their wonderful Dad as well as they should have.

This Christmas will be this family's first without husband and father. I suspect that it will be a sad time for that family, despite the September birth of the widow's first grandchild, with whom Jim's second daughter was, unbeknownst to any of us, pregnant at the time of his death.

Then, this past weekend, I read those above-cited article in the Washington Post. Today, December 12, 2005, "Reused Devices Attract Entrepreneurs, Scrutiny" appeared in the the newspaper and made the point that recycling these medical devices is big business. In many ways, this article is more of the same as the first two, with hollow promises of more oversight by the FDA. The final paragraph is chilling:

"Some think more oversight is needed. Massachusetts has introduced a bill that would require hospitals in that state to obtain permission from patients before using a refurbished single-use device on them. U.S. hospitals are not required to obtain such patient consent. The Massachusetts Medical Device Industry Council said not enough has been done to 'protect patients from potential contamination and injury from reprocessed' single-use devices. The trade group said the savings hospitals accrue from reprocessing 'may come at the price of jeopardizing patient safety.'"

Whatever happened to "First, do no harm"? Patients here in the United States have come to expect state-of-the-art medical care. These reused medical devices, however, put patients in jeopardy and bring unnecessary grief to their families. Who will be held accountable?