Health care safety was a strong theme voiced in the U.S. in a variety of ways during 2000, with the end of the year especially seeing increased calls for improvement in various areas of patient care that put patients and health workers at risk.

Blood-handling technologies came under particular fire in November from the activist group Public Citizen (Washington), with the organization addressing long-standing issues serving to reshape the sector. But those changes aren't coming fast enough, according to the group. In one initiative, Public Citizen released letters it sent to the FDA demanding that the agency ratchet up its efforts to force the American Red Cross (ARC; Washington) to correct problems in its handling and processing of blood-problems, it says, that pose a threat to patient health. And in conjunction with the Service Employees International Union (SEIU; Washington), Public Citizen also asked the FDA, to pull from the market traditional needles and other sharps that the two groups said pose continued risks for blood-borne diseases as the result of needlestick accidents.

In response to the charges against the ARC, the FDA increased its pressure on that organization which reportedly collects and processes about one-half of the nation's blood supply. It renewed its oft-repeated threats to levy heavy fines against the Red Cross for failure to correct long-standing problems in its quality processes. In reply, the ARC filed court papers attempting to block any fines and asked for mediation of the compliance measures sought. The Red Cross has been under FDA scrutiny over a 15-year period and received repeated warnings for failing safety inspections and has shut down at least one ARC blood center.

In a letter to FDA Commissioner Jane Henney, Sidney Wolfe, MD, the director of Public Citizen's Health Research Group, charged the agency with engaging in "dangerous, cooperative, polite games" with ARC rather than forcing compliance. "Unless the FDA exercises [its] legal responsibility, there is little evidence that [ARC] will come into compliance," he said in an issued statement. Bernadine Healey, named ARC's president and chief executive last year, termed the blood it processes and supplies as "the safest in the world" but also acknowledged possible problems she termed "near misses." These problems constituted "red flags and we are jumping on them," she said. Healey said the organization took out a $300 million loan in 1991 for improving its facilities and management systems and that 36 centers are being upgraded to comply with FDA regulations.

FDA official Jay Epstein, MD, said that the Red Cross's problems translate to "potential for harm" to patients, and the agency rejected mediation of the issues, saying this was unlikely to correct the ongoing problems. One of the FDA's most recent warning letters was sent this past July, citing 25 violations at a blood center in Atlanta, Georgia, and another 63 violations were found by the agency at the Red Cross headquarters facility in Washington. Violations have included improper release of blood products that tested positive for cytomegalovirus and failure to follow procedures for retesting blood that initially tested positives for the AIDS virus. ARC said that the HIV-suspected blood was never distributed and the cytomegalovirus-positive blood was not used.

Public Citizen also focused on the continued use of standard needles and sharps, with the SEIU supporting its claim that their continued use puts health care workers at risk. With more than 710,000 members, SEIU claims to be the largest health care workers union in the U.S. While there have been a variety of actions on this front – including new guidelines by the Occupational Safety and Health Administration, recent new laws in 17 states and federal legislation, all pushing medical centers to upgrade to safety needle technologies – the two groups said they believe that movement to safer sharps will be speeded up by removing traditional sharps from the market. The groups targeted intravenous catheters, blood collection devices, butterfly syringes, glass capillary tubes and IV infusion equipment as a continuing threat to health care workers and patients. They also asked the FDA to issue performance standards to block market entrance of new, unsafe devices. Not unexpectedly, various manufacturers making improved sharps and needle systems praised the the joint Public Citizen/SEIU initiative.

Infusion pump alert comes from JCAHO

A recent issue of Sentinel Events Alert, a publication of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO; Washington), said that the agency will be taking a much closer look at infusion pumps used to deliver pain medication because of various errors that may occur in controlling medication flow. JCAHO said that the problem has resulted in reports of fatalities and near-fatal incidents, with the primary cause being human error. The errors include giving incorrect concentrations and dosages of drugs, incorrectly programming the devices, as well as providing the wrong medication. And the agency noted a variety of other issues causing these problems: inadequate standards for using the devices, the large number of concentrations used in administering critical drugs, and pressures on workers, including inadequate staffing.

JCAHO said that the problem could be prevented with the use of infusion pumps requiring set-based, free-flow protection and a system in which two people use the pump, one setting it, the other checking the setting. And the agency said it is recommending that users petition manufacturers to stop production of free-flow pumps and ask the FDA both to withdraw approval of these pumps and refuse further approvals.

FDA says consumer refund a first

More than 500,000 people who purchased gas grill igniters brand-named the Stimulator are due a refund, according to a federal judge who ruled that the devices don't relieve pain, as advertised by the manufacturer. Universal Management Services (Akron, Ohio) must refund the product's purchase price of $82, and the FDA said that the refunds are the first under the Federal Food, Drug and Cosmetic Act in which a company has been ordered to pay restitution to consumers. The firm's advertising claimed that the igniters could relieve a variety of problems ranging from migraine to carpal tunnel syndrome. Its ads ran in a variety of national publications; TV infomercials featured celebrities promoting their benefits.

The devices are basic gas grill igniters to which the company then added "finger grips," the FDA said in a statement detailing terms of the refunds. "Users were instructed to apply the tip of the Stimulator to so-called accupressure points on the body and press a plunger to send an electric current into the body." The agency has received reports about the devices going back to 1994 – sparked, it said, by complaints from disappointed buyers. It said that although federal marshallsl seized $1.2 million worth of the devices in 1995, the company continued to sell them. That was followed by a 1997 order to halt sales and make refunds, a decision that was upheld on appeal last year. This past June the U.S. Supreme Court refused to hear the case.

In another instance of federal scrutiny, bioengineering firm SMLX (Hallandale, Florida) said the FDA is investigating the Rapid HIV Test Kit, a product which the company no longer manufactures. The agency contends that from December 1995 to July 1998 the Rapid HIV Test Kits were sold in an adulterated form and without the necessary FDA clearances.

SMLX said it stopped making the kit when the FDA began its questioning and that the officers and directors of the company allegedly responsible for the manufacturing and distribution activities have resigned. They also have been served notice of the government's investigation, according to SMLX. Ken Robertson, appointed president of the company this past October, said SMLX "knew there was some kind of problem, but we didn't find out the full scope of it until the third quarter of 2000."