Infusion device debate pumps up, vendors plan to upgrade units – free-flow over-infusion risks make infusion device safety measures a must
Joan M. Diekman
Infusion device manufacturers may be forced to upgrade the safety features on their equipment because of risks associated with free-flow over-infusion. Although most incidents are harmless, several have resulted in deaths and cost hospitals millions of dollars in lawsuits.
Eight more infusion lawsuits are pending, according to Stephen Trosty, vice president of quality, risk and insurance management for Sisters of Charity Healthcare Systems in Cincinnati. A manufacturer is named in each of them. The suits may possibly establish protected pumps as accepted quality of care if it can be demonstrated that use of a protected pump could have prevented the error, he said.
Free flow is an error that may occur if the user forgets to pinch off the tubing with a manual clamp. New data indicates that incidents may be considerably more common than previously thought, and that half of the units in place at hospitals may be at risk. Furthermore, the quicker-acting and more highly concentrated drugs available today make a runaway I.V. even more dangerous.
Most sources agreed that free-flow concerns will play a larger role in future pump and set decisions although unprotected equipment will continue to be marketed.
“A year from now, manufacturers probably will not be developing any new unprotected units and more hospitals will be purchasing protected sets,” predicted Tim VanderVeen, director of clinical services at Imed Corp., San Diego. For example, MIRC estimated the world market for infusion pumps will grow 15% by 1997 because of the growing demand for safety features and flexibility.
Manufacturers may already be scaling up the protection in their product lines. McGaw Inc., Irvine, Calif., recently introduced the Horizon pump sets, which have a protective device that the user must activate to initiate flow, according to a company spokesperson.
3M, St. Paul, Minn., also is steering their line of infusion pumps toward units with more protection, according to Chuck Mick, technical service engineer for infusion therapy professional services.
Finally, Baxter Healthcare Inc., Deerfield, Ill., is coming out with a new line of pumps by the end of the year but would not comment on the new line’s safety options.
Safety features offered on infusion pumps and sets break down into two types. The first requires the user to work a manual clamp to stop the flow of drugs. Since there is no pump- or set-based mechanism to stop flow if the user forgets this step, such equipment is called “unprotected.”
The second type requires an action to initiate the flow. The machine or I.V. set clamps off the tubing automatically when the pump door is opened and/or when the I.V. set is removed. Protection of the second kind significantly reduces the chances of free flow, but is substantially more expensive and may make units less flexible in their applications.
Only about half of the 500,000 electronic infusion devices currently in place at U.S. hospitals offer the second level of protection, according to Michael R. Cohen, a pharmacist for 24 years and president of the Institute for Safe Medication Practice, a medication-error consulting firm.
Data on free-flow incidents was gathered from hospital free-flow reports sent via the electronic mail programs PharmNet and Formulary Information Exchange. Seven or eight hospitals have reported 20 incidents, and at least three have been fatal, Cohen said. The project is now being handled by the U.S. Pharmacopoeia, the agency that sets Food and Drug Administration standards for pharmaceuticals.
The findings are supported by data from Emergency Care Research Institutes (ECRI), Plymouth Meeting, Pa. The September 1992 issue of ECRI’s Health Devices updates their rating of general purpose infusion pumps that do not use protected sets to “conditionally acceptable; not recommended,” according to Tim Ritter, senior project engineer. ECRI’s former rating of “conditionally acceptable” was revised in response to increased awareness of free flow, Ritter said. ECRI is not suggesting that hospitals replace their current pumps before they wear out, but recommends that facilities forego purchasing new unprotected pumps, he said.
General purpose infusion pumps
Lifecare 2, 3, 3 HB, 4, 4P No
Lifecare 5000 Plum No
Omni-Flow 4000, 4000+ Yes
480, 880 No
Flo-Gard 6100/6200/6300 Yes
Flo-Gard 8000, 8200, 8500 No
927, 960, 965, 980 No
Gemini PC-1, PC-2 No
560, 570 Yes/No(*)
580, 590, 599 Yes
Ivlon (formerly Valleylab)
521, 522 Yes
Minimed III No
Smith & Nephew SIGMA
6000, 6000+ Yes
*Both nonprotected and free-flow protected compatible sets can
Source: Hospital Pharmacy, Vol. 27, May 1992
Vendors disagree on risks
Infusion pump manufacturers disagree on the risk associated with using unprotected sets. Two companies, Imed and Siemens Infusion Systems, Sylmar, Calif., only produce pumps with the second type of protection due to free-flow concerns. But a number of other vendors offer both kinds of pumps, and some consider free-flow protection an added feature, not a major issue in the purchasing decision.
Imed is the market leader in protected pumps and the number two player in the whole pump market with 23%, according to VanderVeen. He thinks the market may be turning Imed’s way as people become more aware of free-flow problems.
“In the past, the decision to buy protected or unprotected systems was strictly a purchasing issue because materials managers have been uninformed about free flow,” he said. “They’re worried about costs, and infusion sets are one place they’ve been able to save money. But one lawsuit could wipe out the savings. Now that people know more about the risks, purchasers are beginning to re-evaluate their decisions.”
A 1989 survey commissioned by Imed found that 52% of more than 400 I.V. therapy, critical care, oncology and executive nurses who mainly used unprotected devices said they were aware of actual free-flow incidents, Cohen said. The study was conducted by Hospital Research Associates, Fairfield, N.J.
Siemens Infusion Systems, formerly MiniMed Technologies, manufactures the MiniMed III infusion system, a protected pump. Hundreds of nurses and anesthesiologists queried by the company said they wanted free-flow protection in pumps, according to Cliff Hague, vice president of marketing. The protection is a significant factor in making sales, he said.
3M also acknowledges the free-flow risk. Although the company makes both types of pumps, their primary marketing emphasis is on protected pumps and sets, according to Mick. 3M will continue to provide product for unprotected sets to customers who want it, but will not develop any new units that are not free-flow protected.
“We try to anticipate possible user errors,” Mick said. “When a product’s design can mitigate the chance for errors, it is good to use that design.”
Other manufacturers disagree on the free-flow issue. “We have had virtually no complaints about free-flow,” said Janice Stewart, product manager at Baxter, the market leader in infusion pumps with about a 25% share of the market.
“Competitors using free-flow protection in their marketing are using scare tactics,” Stewart said.
Baxter produces pumps with different safety features because end-users’ preferences are different, said Michael Gluth, vice president of marketing, Parenterals Group. For example, in case of an emergency, a nurse may need free flow because a patient may require a larger dose of drugs. “Some nurses think that one more safety feature or clamp can be a nuisance in an emergency,” said Ken GaNung, clinical marketing specialist at Baxter and a nurse for 13 years.
A spokesperson for McGaw agreed that the protection issue has been overblown. “Comments like ‘half the pumps are at risk’ are overstated,” he said. “The issue of free flow has been around for a long time. The number of incidents isn’t any higher; it’s just that now more people are saying technology can eliminate them.”
Cost is more of a concern than free flow, he said. For example, the device ECRI said has the least free-flow protection has sold the best for the past several years, he said. Furthermore, ECRI’s highest-ranked device has had only 12% of the market, indicating that the recommendations do not carry as much weight as one may think, he said.
“Purchase decisions are not based primarily on free flow issues,” he said. “Protection is just an added feature.” When buying, facilities should take a look at their own experience to see if free flow is or is not a problem there, and buy accordingly, he said.
McGaw controls 10% of the total infusion pump market, the spokesman said.
User or device error?
At the crux of the free-flow debate is the extent to which users and devices are at fault for over-infusion. Manufacturers emphasize that pumps are safe if used correctly, while nursing and patient safety organizations think that the devices themselves should offer more protection.
Education is the key to free-flow prevention, according to Baxter, McGaw and Ivac, Eli Lilly’s San Diego-based pump manufacturing subsidiary.
“Every single set on the market has a manual clamp,” said Baxter’s Stewart. “No matter what machine is being used, the nurse knows a manual clamp should be used to prevent free flow. Also, hospitals need to make sure that only educated and licensed users operate the machines.”
In fact, Stewart thinks that manufacturers who produce pumps with sophisticated free-flow protection are ultimately doing a disservice to users by promoting their units as panaceas.
“They are making users dependent on the machine to stop free flow when what users really need is to remember to always close the clamp,” she said. “When nurses use those machines, they may get out of the habit of closing the clamp, which may lead to free flow when that nurse uses another machine.”
She also said that manufacturers of protected pumps and sets print in bold on their packaging that the manual clamp should always be used.
McGaw’s spokesperson said that manufacturers and hospitals will probably take more steps to educate users as more free-flow data becomes available.” Any equipment may be misused,” he said. “It is incumbent upon hospitals to make sure the equipment is adequately protected, supervised and housed. Free flow results from omission of known procedure. Manufacturers have to assume that trained professionals will perform correctly rather than the opposite.”
Eli Lilly, speaking on behalf of Ivac, stated that technology “will not negate good technique by the user.”
Infusion nursing is a new, certified specialty among registered nurses, according to William H. Ginsburg, senior partner at Ginsburg, Stephan, Oringher and Richman, a health care product liability defense law firm. “Hospitals should encourage nurses involved in the infusion process to become certified, thus potentially eliminating many of the pitfalls in the infusion process.”
Experts and other manufacturers agree that education is an important element in preventing free flow, but not the complete answer.
“Free flow is an error that is indicative of other problems, such as reduced staffing and stringent cost containment measures,” said Marvin Feldman, vice president of the consulting firm Concepts in Healthcare, Ashland, Mass. “It is disturbing that hospitals are going with less staff and less expensive items in order to cut costs.”
Free flow is slated for discussion and communication efforts by the Consortium on Infusion Management Safety, a group founded last May to examine and raise awareness about “silent epidemics.” The organization takes the position that technology is equally responsible for over-infusion.
It is “an absurd and untenable position” to suggest that user education is the whole answer, according to Susan Meister, organizer of the consortium. “It demonstrates a profound misunderstanding of the environment of infusion management practice,” she said.
Furthermore, companies should take human error factors into account when designing the device, she said. The consortium’s multi-discipline membership includes a human error research specialist, she added.
Another problem with the infusion environment is that nurses often are not the only ones using the pumps. In fact, almost none of the incidents recorded in the Institute for Safe Medication Practice’s data involved nurses, according to Cohen.
“Family members, orderlies, X-ray technicians and even the patients themselves made the errors, and they are not the ones targeted with education efforts,” Cohen said. ECRI’s Ritter agreed. “It is not realistic to expect that all end-users will be properly trained or that unauthorized users will not remove a set (to change a gown, for example).”
Imed and Siemens agree with other experts that improved safety features are essential to limiting free-flow risks. “People are always at risk for forgetting to close the manual clamp,” said Hague. “No amount of education will keep them from forgetting. We tried to design a set that is forgiving to those who forget.”
Market moves toward safety
Sales of infusion devices and I.V. sets have been climbing for several years. World revenues in 1990 for infusion pumps were $340 million, up 18% from $287.4 million in 1987, according to Market Research Intelligence Corp., Mountain View, Calif.
However, a few sources indicated that the cost of protected sets may be coming down. Hospital of the Good Samaritan, Los Angeles, with 411 beds, used to purchase unprotected devices from Abbott, but now they buy protected ones from Baxter and have not seen their costs go up, according to Max Villalobos, assistant vice president of materials management.
(For more information on hospitals’ responses to the infusion issue, see HIT’s sister publication, Hospital Materials Management, August, 1992, p. 1.)
3M’s Mick also said that the company’s free-flow protected sets are not that much more expensive than unprotected ones.
“We wanted our customers to be able to buy free-flow protected equipment with a minimal increase in cost,” he said. 3M’s protected pumps cost only about 15% more than their unprotected ones, and the designated sets cost 5% more.
Purchasing organizations may also influence protected pump development and pricing. Voluntary Hospitals of America, Irving, Texas, has written to their three infusion pump vendors requesting them to address the free-flow issue. The vendors are Imed, Abbott Laboratories, Abbott Park, Ill., and 3M, according to Mac Haning, a spokesperson for VHA.
AmeriNet Inc., St. Louis, will also be addressing the issue shortly. The group has contracts with Ivac, Imed and Abbott, according to Greg Mosely, senior contract administrator.
COPYRIGHT 1992 J.B. Lippincott Company
COPYRIGHT 2004 Gale Group