October 2002

FDA investigates dialysis patient deaths

On September 12, the Food and Drug Administration (FDA) announced that Baxter Healthcare Corporation had notified dialysis centers that certain blood tubing used with its Meridian dialysis machines may be linked to patient deaths and injuries at several kidney dialysis centers in late August. The FDA is working with Baxter and Medisystems Corporation to identify the exact cause of the problem. To date, it is not clear that the equipment is linked to the deaths. However, Baxter has notified hemodialysis centers that the company is investigating whether the patients hemodialysis treatments all used the same model dialysis machine and bloodline set. On September 6, Baxter told customers to immediately discontinue the use of certain models of Medisystems blood tubing in conjunction with Meridian dialysis machines and to use other Medisystems blood tubing instead.

Additional general information on dialysis surveillance and publications are available from the Centers for Disease Control and Prevention (CDC).

Download the Baxter dialysis letter (20 KB).
For additional dialysis surveillance information and publications, go to http://www.cdc.gov/ncidod/hip/Dialysis/dialysis.htm.

Register now for CleanMed 2002 October conference

Its not too late to register for CleanMed. This years conference will be held in Chicago October 24 26. Environmental and occupational issues of concern to hospitals will include mercury, latex, greener cleaners, polyvinylchloride (PVC) with plasticizer di- (2-ethylhexyl) phthalate (DEHP), and safer needles Conference panels will focus on addressing environmental problems through purchasing and design choices.

The agenda also features content related to green buildings. Renowned architect William McDonough will give the keynote address on October 25, and a daylong seminar on green buildings is planned for October 24.

CleanMed will be held at the Holiday Inn-Mart Plaza. It will feature environmental leaders from major healthcare systems, group purchasing organizations, and hospitals. Co-sponsors include Premier, Inc., Catholic Health Initiatives, and Health Care Without Harm.

Links and information

For more information or to register, visit http://www.cleanmed.org, or call Peter Diamond at 617.524.6018.

List of pharmaceutical products containing mercury now available

Pharmacies now have another source of information to identify products that contain mercury. A list of pharmaceuticals containing mercury is available on the Premier Safety Institute Web site along with resources for mercury pollution prevention. This list, provided free by Premier, Inc., is intended to assist in the identification, management, and/or disposal of pharmaceuticals containing mercury. The list is historical; that is, it identifies products that contained a mercury compound as a preservative at some time in their history. Current formulations of products on this list may or may not contain mercury compounds as preservatives. Although most of the products present minimal risk of mercury exposure during normal use and proper handling, problems may occur if the mercury is exposed to air or improperly discarded. Many products are being reformulated. However, replacements may not be available in all instances. In such cases, the best practice is to have effective procedures in place for handling, recycling, or disposal (the last resort).

Download the mercury-free product list (222 KB).
Review more on mercury pollution prevention, on the Premier Safety Web site.

Device manufacturers propose alternatives to bar codes

A bar-coding requirement for drugs, biologics, and, possibly, medical devices is good idea. That was the consistent message the Food and Drug Administration (FDA) received at a public meeting it held July 26, 2002 to solicit input on the issue. More than 40 stakeholders presented their positions and communicated their willingness to work with one another and the FDA to develop applicable standards. Several stakeholders maintained that a bar-coding requirement was long overdue in light of potential benefits for patient safety, worker satisfaction, and supply chain efficiency, and they urged the agency to move forward with all deliberate speed.

Advocates of bar-coding of drugs maintain that it can minimize errors through the use of a unique numeric code that identifies the specific drug, dosage, lot number, and expiration date. For example, using a scanner to compare the bar code on a drug product to a specific patient's drug regimen, a healthcare professional could verify that the patient is receiving "the right drug, at the right dose, at the right time." In addition, the use of bar codes for pharmaceuticals would facilitate automation of other patient safety initiatives, such as drug prescribing or ordering, monitoring for drug toxicities, ensuring that drugs are not administered past their expiration dates, and developing electronic medical records. When linked to a bar-coding system, automated drug prescribing and ordering systems would not only minimize drug mix-ups, but also ensure that physicians and others have access to crucial information at the time of prescribing.

Numerous details must be resolved before a proposed rule can be issued. In the interest of speed, meeting participants recommended that the FDA initially develop a bar code requirement for drugs.

Medical device manufacturers and the blood banking community advised the FDA to consider alternatives to bar-coding, noting that it may be the current technology of choice but could soon be replaced by superior alternatives. As new technologies such as radiofrequency identification using "smart tags" on embedded chips become more widely available, device manufacturers and blood banks are wary of being locked into a single standard, technology, or coding language. The FDA’s regulatory agenda sets a November 2002 target for publishing a proposed rule, but the agency will not confirm if it will meet that deadline. For the complete summary of issues, see barcoding article below.

Download full article on bar codes ( 34 KB).
Transcript of FDA public meeting – Docket 02N-0204 – 7/26/02.
NOTE: document is 300 pages in length. Go to: http://www.fda.gov/ohrms/dockets/dockets/02n0204/02n0204-tr.htm.
Premier Safety Web site on UPN and bar-coding:
https://premierinc.com/quality-safety/tools-services/safety/topics/bar_coding/index.htm.
Download Journal of American Medical Informatics Association article by Patterson et al. (26 KB).
Abbott Laboratories press release.
National Coordinating Committee for Medication Error Prevention and Reporting recommendations: http://www.nccmerp.org

Premier joins stakeholders in responding to FDA on sharps devices

Premier, Inc. has joined other worker safety advocates in responding to the Food and Drug Administrations (FDAs) request for input on banning, labeling, and establishment of performance standards for sharps or needle-bearing devices. In its comments, Premier, along with organizations such as the American Hospital Association (AHA), supported a ban on sharps devices that pose a significant occupational safety risk as long as sufficient alternative safety devices are readily available in the marketplace. Examples are glass capillary tubes and conventional IV infusion equipment. However, Premier and others cautioned against banning devices when sufficient alternatives, such as IV catheters, are not available for all patient populations. While supportive of the introduction of innovative technology, Premier remains concerned that specific FDA performance criteria may inhibit innovation. Premier also provided the FDA with the results of its field evaluations of performance considerations of syringe and phlebotomy sharps safety devices identified as important by frontline workers, as well as with a scientific publication from the Premier Safety Institute on the challenges of collecting valid data on needlestick injury rates.

In a separate response to the FDAs June 20, 2002 request, the AHA urges consideration of the importance of encouraging and not inadvertently inhibiting, the development and introduction of new technologies. AHA also advocates comprehensive assessment of the likely consequences of banning specific devices, as well as evaluations of potential benefits to healthcare workers. Those include consideration of how a ban on a particular device might impact the use of other safety and conventional devices. Under some circumstances, banning conventional devices would not necessarily permit or allow healthcare workers to use corresponding safety ones. The AHA also points out that before a ban is considered, sufficient alternative devices ought to be readily available and appropriate for all patient populations.

Download Premier’s comment letter (124 KB).
Additional information on Premier sharps safety device field evaluations (18 KB).
Collecting data on needlestick injury rates (1 MB).
The original FDA notice is available in the June 20, 2002 Federal Register or download here (44 KB).
AHA’s comment letter is available at: http://www.hospitalconnect.com/aha/advocacy-grassroots/
advocacy/index.html

FDA publishes guidelines on PVC medical devices

In a recent Federal Register notice, the Food and Drug Administration (FDA) announced publication of draft guidelines that offer suggestions to manufacturers of medical devices made from polyvinylchloride (PVC) using the plasticizer di- (2-ethylhexyl) phthalate (DEHP). The FDA recommends that manufacturers label devices containing DEHP and consider reducing or eliminating its use in certain devices in which it may pose risks to specific patient populations. The FDA draft "Guidance for Industry" document issued September 6, 2002 follows on the heels of the FDAs July 12, 2002 advisory, a safety assessment of PVC devices containing DEHP. The advisory lists the medical devices and procedures posing potential risk to particular patient groups. Comments and suggestions on this latest draft document should be submitted to the FDA by December 5, 2002 and may be forwarded electronically to: http://www.fda.gov/dockets/ecomments

NOTE: The Premier Safety Institute is offering additional information regarding this issue. Go to premierinc.com/safety "Safety topics A-Z" and click on "Environmentally preferable purchasing;" then click on "Polyvinylchloride and DEHP." Members (password required) may download lists of PVC-DEHP-free products.

The Federal Register announcement "Medical Devices; Draft Guidance." (43 KB)
Download the full FDA "Medical Devices; Draft Guidance" document (53 KB).
Download the July 12 FDA advisory letter (29 KB).
Premier Safety Institute: Members may download lists of products on contract that are PVC-DEHP free. Go to Safety topics A-Z and link to the EPP module.

CDC favors smallpox vaccination of healthcare workers and public

For the first time, at an October 4, 2002 news briefing, key public health officials announced their support for offering smallpox vaccine to the public, but only after healthcare workers, including emergency workers and first responders, are immunized and a vaccine is licensed for general use. The final plan awaits approval from President Bush, but possible options were discussed by Julie Gerberding, M.D., director of the Centers for Disease Control and Prevention (CDC); Jerry Hauer, assistant secretary of Health and Human Services (HHS) and director of the Office of Public Health Preparedness; and Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID).

Dr. Gerberding indicated that the number of healthcare and emergency workers to immunize before a case occurs could be as high as 10 million, far higher than previous estimates. (Update: October 16, 2002 the CDC made a final recommendation to immunize 500,000 healthcare workers or approximately 100 per hospital.) Although the plan may call for providing the vaccine to the general public once some healthcare workers have been immunized, Dr. Gerberding cautioned that this did not constitute a recommendation. While Dr. Gerberding said the benefits do not outweigh the risks of adverse side effects, she recognizes that individuals may want to weigh the risk and benefits for themselves. It was also announced during the conference that the military will receive one million doses. (Note: A table depicting possible adverse outcomes of smallpox vaccination is available online from the CDC.)

On September 23, detailed guidelines for vaccinating the entire U.S. population against smallpox within five days of an outbreak were released to all 50 states and the District of Columbia. This vaccination plan would be activated only if an outbreak actually occurred. It is intended as a blueprint for state and local health officials nationwide and reveals a growing belief within the Bush administration that even one case of smallpox in the Western Hemisphere would signify a terrorist assault and should trigger a far more massive response than officials had previously suggested.

The guideline, which is almost 100 pages, was developed in consultation with local health officers, medical societies, the military, and businesses such as UPS and Federal Express. All of these organizations and individuals have logistical expertise and have offered advice on how to operate mass vaccination clinics, from issues such as parking to the medical challenge of treating severe side effects. The guideline is not all-inclusive, however. Omissions include timing, costs, and feasibility. The document does not address the multiple problems of preparing healthcare workers to conduct vaccinations or how to communicate plans to the public. Finally, aside from an assumption that some healthcare workers will be vaccinated before an attack, the document does not resolve the question of when and how healthcare workers would receive vaccination.

Download the guideline (950 KB).
CDC table of possible adverse outcomes of smallpox vaccination: http://www.bt.cdc.gov/agent/smallpox/
vaccine-safety/adverse-events-chart.asp

Safety tools

Assessment tool - Bioterrorism preparedness checklist
Disaster kit - Tools to meet children’s needs
Brochure - Infection prevention information for patients
Video - Patient education on adverse medical events
Video - Four one-hour videotapes: Patient, worker, environment, and medication safety
Assessment tool - Environmentally preferable purchasing checklist

Assessment tool Bioterrorism preparedness checklist

The Agency for Healthcare Research and Quality (AHRQ) has announced a new survey on its Web site that hospitals can download and use as a checklist for assessing their capacity to handle victims of bioterrorist attacks and for evaluating existing emergency plans. The site gives users access to the 42 questions in AHRQ's Bioterrorism Emergency Planning and Preparedness Questionnaire for Healthcare Facilities, which covers such subjects as biological weapons training for personnel, procedures to permit rapid recognition of credentialed staff from other facilities, on-call nursing policies, and designated areas of emergency overflow for patients. The survey also asks hospitals about matters including their supplies of selected antibiotics and the diagnostic capability of their in-hospital laboratories. The checklist is available at http://www.ahrq.gov/about/cpcr/bioterr.pdf or download here (135 KB).

Disaster kit Tools to meet childrens needs

The American Academy of Pediatrics has launched a new area on its Web site to aid pediatricians, community leaders, parents, and others in preparing for and meeting children's needs during a disaster. The site provides a kit that addresses family concerns, as well as clinical questions and concerns of pediatricians and other healthcare providers on issues such as bioterrorism, chemical terrorism, radiological events, and the psychological aspects of terrorism. The project was funded by a grant from the Robert Wood Johnson Foundation. Go to http://www.aap.org/terrorism.

Brochure Infection prevention information for patients

The American Hospital Association (AHA) collaborated with the American Medical Association and the National Patient Safety Foundation (NSPF) to provide hospitals with a brochure for patients entitled "Preventing Infections in the Hospital What You as a Patient Can Do." The brochure, produced by NPSF as part of its "Stand Up for Patient Safety" project, is designed to provide patients with helpful principles for managing their healthcare and becoming an active partner with their healthcare team through infection prevention. A downloadable version of the brochure is available at the NPSF Web site at http://www.npsf.org/download/PreventingInfections.pdf.

Video Patient education on adverse medical events

This month, the National Patient Safety Foundation (NPSF) is releasing a 30-minute video providing instruction and guidance on how to talk with patients and families when an adverse medical event has occurred. The video, "Let's Talk," comes from the 2001 NPSF Patient Safety conference on "Let's Talk: Communicating Risk and Safety in Health Care." Step-by-step instructions on how to disclose medical errors, why disclosure is important, and how open communication can strengthen the patient-provider relationship are some of the subjects on the video. To obtain a copy, contact NPSF at 312.464.5672 or visit the Web site at: http://www.npsf.org/htm/prevent_infections.html.

In Minnesota, contact the Minnesota Alliance for Patient Safety at 651.641.1121.

Video Four one-hour videotapes: Patient, worker, environment and medication safety

Case studies of successful safety programs Order from Premier Safety Institute online Safety Store.