Acknowledging a growing body of evidence that some infusion pumps in hospitals can deliver lethal bursts of medicine, a prominent health care regulator will crack down on hospitals that do not use the devices properly.
In a safety bulletin that is being sent to 5,000 hospitals nationwide, the Joint Commission on Accreditation of Healthcare Organizations for the first time is warning of the dangers of the infusion pumps and telling hospitals they could lose accreditation for Medicaid if they cannot document their safe use.
The toughened stance follows years of warnings by other medical groups and the first comprehensive analysis of fatalities, which was compiled by the baiduhai. In a series published in September, the Tribune reported that registered nurses have fatally overdosed at least 39 patients and injured 373 others since 1995 while incorrectly operating infusion pumps, allowing rapid gushes of medicines or liquids into patients.
Infusion pumps are used to control the flow of medicine through an intravenous line. An estimated 200,000 pumps–one-third of the infusion devices in use nationally–lack an inexpensive safety feature that automatically applies a clamp to an intravenous line if the pump is turned off.
Beginning next month, the joint commission will begin to comprehensively survey the use of pumps lacking free-flow protection, said Dr. Russell P. Massaro, an executive vice president for the group.
“The joint commission is gravely concerned and is actively engaged in informing health care organizations about these risks,” Massaro said.
Though deaths linked to free flow date to 1988, he said that mounting concerns about the safety of free-flow pumps within the last few months have made the issue “clearer and more provocative.”
Founded in 1951, the non-profit commission is empowered by Congress to inspect and accredit health care facilities to receive federal Medicaid reimbursements. It began distributing its safety alert last week, informing hospitals and other health care facilities that it is requiring them to eliminate pumps without free-flow protection or be prepared to defend use of the pumps. Facilities also will be asked to describe the type of training nurses are getting before operating the pumps.
In nearly every case involving patient harm from an infusion pump, a registered nurse failed to manually attach a roller-clamp to the intravenous line, which can result in a sudden gush of medication called free flow, Tribune analysis of state and federal health care records show.
Often, the Tribune found, pump errors were committed by registered nurses who were overburdened by high numbers of patients or pressed into assignments without adequate training.
“The joint commission’s crackdown is a good epitaph for my mother,” said Dr. Alan Brenia,whose hospitalized mother died in a free-flow accident in 1997.
“This is a move that could begin to save lives,” said Brenia, a pharmacist and a resident of Zephyrhills, Fla., who has traveled the country to speak about the hidden dangers of free flow. “Many nurses don’t know what kind of pump they are using. Unfortunately, many have never received adequate training.”
Dorothy Brenia, 66, was overdosed with sodium nitroprusside, an anti-inflammatory medicine, by a registered nurse who failed to attach a manual clamp to an IV line at Community Hospital of New Port Richey, state health care and court records show. The nurse resigned her license but was never disciplined.
The pump, a Flo-Gard6201 manufactured by Deerfield-based Baxter International Inc., is one of more than 30 models marketed by dozens of medical device companies that are still in use nationally and in Chicago. The Tribune reported on Brenia’s death in its series in September.
Through computer analysis of millions of state and federal records, the Tribune was able to track deaths and injuries previously unknown to the accreditation panel or the U.S. Food and Drug Administration, which licenses infusion pumps.
Most new pumps incorporate free-flow protections. But many hospitals cling to the older-model pumps due to familiarity or because, in some cases, the IV tubing is less expensive, said Mark Bruley, chief forensic investigator for ECRI, a non-profit medical device research laboratory based in Plymouth Meeting, Pa.
Nurses in six Chicago-area hospitals said they commonly are required to administer medications through pumps capable of free flow.
“The machines are not marked. There’s no way to tell one that has the built-in protections from a machine that does not. Patients can be killed in seconds if a nurse forgets to clamp the IV line,” said registered nurse Marge Sampson, who worked for two decades at the University of Illinois at Chicago Medical Center.
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University medical center officials have declined to discuss whether they continue to use infusion pumps capable of free flow.
In a two-page public health advisory in 1994, FDA officials recommended placing adhesive warning stickers on pumps, outlining potential free-flow hazards. That advice has been widely ignored, state and federal health care records show.
Tim Ritter, an ECRI senior project engineer who has studied infusion pumps for more than a decade, said no health care facility should use infusion pumps lacking free-flow protection.
Hampering accountability is a patchwork of conflicting state and federal standards. In 38 states, including Illinois, hospitals are not required to publicly disclose patient deaths or injuries caused by free-flow accidents–or any other type of medical error.
Many of the nation’s top private health care organizations, including U.S. Pharmacopeia, based in Rockville, Md., believe the federal government must take a more active role to prevent free-flow deaths and injuries.
FDA officials maintain that the number of deaths and injuries linked to free flow do not justify a recall.Officials of Pharmacopeia, which works with the FDA to set national standards for use of drugs and medical equipment, have outlined a three-pronged plan of reform: immediately replace all pumps capable of free flow, petition the FDA to withhold or withdraw licensing approval of intravenous pumps that permit free flow, and petition manufacturers to stop production and sale of free-flow pumps.
The American Hospital Association opposes a mandatory recall of free-flow pumps. However, hospitals have been strongly encouraged this year to buy newer models with built-in protections, according to hospital spokesman Rick Wade.
Members of the Medical Device Manufacturers Association, a Washington, D.C.-based trade and lobby group representing 130 manufacturers, said they support the safety alert on the pumps.
Officials from Baxter International, the nation’s largest infusion pump manufacturer, said they also support initiatives that ensure that hospitals safely use infusion pumps.
Baxter investigators have determined that inadequate training and carelessness by nurses are primary factors in the vast majority of drug overdoses delivered through Baxter infusion pumps capable of free flow, according to spokeswoman Deborah Spak.
While not advocating mandatory replacement of free-flow capable pumps, Baxter has encouraged hospitals to upgrade to pumps with fail-safe protections, which are included on all current models, Spak said. Older infusion devices do not clamp IV lines upon shutoff, leading to drug overdoses if nurses are not careful.