ANNAPOLIS – Reused “single-use” medical devices accounted for less than 1 percent of first-quarter 2000 cases of possible device malfunctions, according to an analysis of newly released Food and Drug Administration data.
Despite the small number of questionable cases, critics charge that any number of failures of reused single-use medical devices is too many.
The issue of reusing devices labeled “for single-use only” is a controversial one. Members of the Maryland General Assembly tried to regulate such uses, but the bill never made it out of committee this session.
Opponents of the procedure believe no evidence supports that these devices – everything from heart catheters, surgical saw blades and orthodontic braces to biopsy needles and forceps – can be properly cleaned and sterilized.
Reuse proponents say manufacturers invite the practice by indiscriminately labeling products “single use” knowing full well they can be used again, saving money for patients and insurers.
Sen. Thomas L. Bromwell, D-Baltimore County, was the sponsor of the Maryland bill to require hospitals to inform patients when a disposable device was being reused and to allow patients to refuse the practice.
“When you say that less than 1 percent of all cars you buy malfunction, that’s not very staggering,” Bromwell said. “When you are dealing with reusable medical devices, especially those devices that are intrusive, I’d hate to think I was that 1 percent.”
The new data, released for the first time this year by the FDA, comes from manufacturer reports of any death, serious injury or malfunction that could be related to its product. The FDA has required such reports since 1984, and has collected data on single-use device reuse for some time without making its information public.
A Capital News Service analysis of this year’s first-quarter reports revealed only 144 incidences involving a reused disposable device out of 14,796 records filed between January and March this year.
Those numbers are consistent with a previous examination by the FDA that found only 464 adverse incidents out of about 300,000 cases reported between August and December in 1999.
It is unclear from the data whether reuse of the devices caused the problems reported – only that the device was being reused at the time the incident occurred.
Also, some 15 percent of the records did not include enough information to determine whether the device in question was a reusable one.
Manufacturers say they label a product “single use” when the device should be used on one patient for a single procedure. However, proponents of reuse said manufacturers’ really use the label to reduce liability and to sell more products.
“The big issue is who is defining ‘single use’,” said Nancy Fiedler, spokeswoman for the Maryland Hospital Association.
Without official guidelines, manufacturers can label products arbitrarily, in an effort to push up profits, Fiedler said.
No more than six or seven hospitals in Marryland will reuse a single-use device, she said, and only after careful examination to determine the safety of the device.
Bromwell said he didn’t intend his proposal to prohibit the practice, but to guarantee a patient’s right to be informed.
“If you do this, just tell the patient,” said Bromwell.
There are agendas at work on either side of the issue, Bromwell said: “It’s all about money.”
Devices included in this year’s 144 reuse cases included a surgery drill, several tracheostomy tubes – inserted in a temporary incision to help a patient unable to breathe normally – and a meter to test blood-sugar levels.
Meanwhile, reusable devices on their second or subsequent use were involved in 1,746 cases, almost 12 percent of the total cases.
The FDA has not made a determination as to the cause of the device problems and warns users of its data not to conclude reuse is safe because of the small failure rates.
The warning, sent to places like hospitals and nursing homes nationwide, said the data does not represent an “accurate assessment of the failure rates, since device failures in general are underreported.”
Also, infections caused by an improperly sterilized device would be difficult to trace back to the offending device.
Bromwell was unsure if he will reintroduce the bill next year, but was happy that the Legislature began a discussion on the issue.
“There are a lot of unanswered questions,” Bromwell said, adding he hoped the FDA would continue to monitor the situation.