Premier Safety Share
In this edition
Premier Safety Web site
May 2002
Welcome to Safety Share, the online newsletter from the Premier Safety Institute. We invite you to comment.
Also, visit our Safety Web site for more safety resources: disaster readiness, latex allergies, reuse of single-use devices, sharps injury prevention, evidence-based practices (AHRQ report), environmentally preferable purchasing, and mercury pollution prevention.
News
- Frontline workers identify performance characteristics for sharps safety devices
- OSHA releases ergonomic plan and eTools; Nursing homes targeted for initial inspections
- High volume of surgical procedures linked to reduction in surgical mortality risk
- AHA and hospital groups object to new requirements for reuse of single-use devices
- Fifteen-fold increase in medical device adverse event reporting prompts FDA to launch pilot project
- New bioterrorism resources: Clinician training, policy planning, local response, and protective equipment
- Patient education resources on preventing medical errors
Frontline workers identify performance characteristics for sharps safety devices
More than 900 frontline healthcare workers recently evaluated 37,000 safety syringes and phlebotomy devices in field evaluations led by the Premier Safety Institute. The evaluations were intended to determine what frontline workers consider to be the key performance considerations for sharps safety devices, to serve as the basis for designing future devices. (Download report below.)
Overall, workers expressed confidence in the safety of these devices, with almost 80 percent reporting that they believed the devices they tested would protect them against needlesticks. The majority of workers surveyed reported that they "felt comfortable" with phlebotomy devices after using them 10 times or less; with safety syringes, after only five uses. Such information on key performance considerations may also be useful to individuals responsible for selecting, evaluating, and adopting sharps safety devices in their organizations, although the final selection of any sharps safety device will depend on numerous factors including frontline worker preferences and the clinical procedures to be performed.
The Premier Safety Institute offers OSHA compliance tools (download tools below) and resources for implementing a comprehensive sharps injury prevention program.
- Download Sharps safety device field evaluation report
- Premier Safety Web resource: OSHA compliance tools
- Premier Safety Web resource: Sharps injury prevention
OSHA releases ergonomic plan and eTools; Nursing homes targeted for initial inspections
The U.S. Occupational Safety and Health Administration (OSHA) has announced that under a new National Emphasis Program, it will begin inspecting 1,000 nursing or personal care facilities out of 2,500 that have reported high injury and illness rates. The program will focus on specific hazards that account for the majority of nursing home staff injuries and illnesses, including ergonomics (primarily back injuries from patient handling), bloodborne pathogens/tuberculosis, and slips, trips and falls. OSHA indicated it would randomly select 200 workplaces to assess the degree of compliance with OSHA requirements.
The first industry-specific guidelines for reducing ergonomic injuries and illnesses will be developed for nursing homes, according to OSHA. The draft guidelines, expected to be ready for public comment later this year, will be published in the Federal Register.
Ergonomic guidelines for nursing homes represent just one part of OSHA's comprehensive plan to dramatically reduce ergonomic injuries (see April 5 press release). In addition to industry and task-specific guidelines, OSHA's comprehensive plan includes tough enforcement measures, workplace outreach, advanced research, and efforts to protect Hispanic and other immigrant workers. OSHA also announced plans for the formation of a National Advisory Committee on Ergonomics, which will help to identify gaps in existing research (see press release below).
Interactive ergonomic electronic tools are a recent addition to OSHA's educational efforts. Visit OSHA's electronic hospital tour to learn about hazards, controls, and related standards and safe employee practices (see download below).
- Download OSHA ergonomics plan press release (22 KB)
- Download OSHA advisory press release (20 KB)
- Ergonomic eTools
High volume of surgical procedures linked to reduction in surgical mortality risk
A nationwide study has confirmed that patients needing high-risk surgery fare better in hospitals performing a high volume of such procedures. The study, published in the April 11, 2002, issue of the New England Journal of Medicine (NEJM), found that Medicare patients undergoing selected cardiovascular or cancer surgeries can significantly reduce their risk of surgical-related mortality by selecting high-volume hospitals. (Download abstract of study below.)
Previous research on volume and outcome has been questioned, in part because many studies were regional, outdated, or did not take into consideration the recent reduction in overall surgical mortality. This new study attempts to overcome the limitations of previous research by studying 2.5 million Medicare patients, a population which accounts for the majority of all patients in the United States undergoing high-risk surgery and an even larger majority of those dying after surgery.
As part of a broader initiative to improve safety, the Leapfrog Group, a large coalition of private and public purchasers of health insurance, is encouraging patients to seek care at high-volume hospitals. The new study will likely support the Leapfrog Group’s efforts.
- Download
abstract: NEJM: Hospital volume and surgical mortality
(26 KB) - Premier and the Leapfrog Group
AHA and hospital groups object to new requirements for reuse of single-use devices
In a letter to Congress, the American Hospital Association and several other hospital and healthcare groups strongly objected to a Senate proposal that would impose additional requirements on third party reprocessors – maintaining the requirements are so burdensome and costly that they would put an end to the reprocessing of single-use devices.
The proposed language on reuse of items labeled as "single-use" was included in the Bioterrorism Preparedness Act of 2001 (H.R. 3448). The letter -- from AHA, the Association of American Medical Colleges, the American Society for Healthcare Central Services Professionals, the Cleveland Clinic Foundation, the Federation of American Hospitals, and the Henry Ford Health System -- said the proposal would increase the cost of reprocessed devices to hospitals without improving safety or efficiency; moreover, it would mandate additional labeling requirements that could be impossible for reprocessors to meet. The industry groups argue that the FDA -- in a cooperative and open process involving original equipment manufacturers (OEMs), device reprocessing companies, and hospitals -- has already implemented a plan under which all device reprocessors are treated as manufacturers, subject to the same regulatory requirements.
Opponents of reuse, including the Association of Disposable Device Manufacturers (ADDM), contend that reprocessing of single-use devices poses a risk to patients and maintain that third party reprocessors must be subject to the same requirements as OEMs. The Association of Medical Device Reprocessors (AMDR) argues that third party reprocessors are already required to comply with same regulatory requirements. The AMDR has resources on its Web site for hospitals interested in voicing an opinion on the Senate proposal.
The Premier Safety Institute has learned that the FDA has not approved any applications for reuse of Class III devices such as electrophysiology ablative catheters -- essentially ending the reuse of these items at this time. Download a summary of issues below.
- Download AHA letter to Congress on reuse (22 KB)
- Link to AMDR Web site
- Download Premier Safety Institute Summary of Reuse Issues (38 KB)
Fifteen-fold increase in medical device adverse event reporting prompts FDA to launch pilot project
The FDA Center for Devices and Radiological Health (CDRH) has launched the Medical Product Surveillance Network (MedSun) to collect data on adverse events involving medical devices. The pilot project, which got underway in 50 hospitals in March 2002, was based on findings from an initial study by an independent research group that identified a 15-fold increase in the reporting of adverse events.
CDRH’s mission is to protect the public by providing reasonable assurance of the safety and effectiveness of medical devices. In light of evidence that the clinical community significantly under-reports adverse events associated with medical devices, CDRH plans to determine whether the MedSun system is useful in obtaining better data on problems with medical devices. CDRH has selected the CODA research organization to carry out the study.
To overcome the barriers to reporting identified in the initial study, various steps have been taken including protecting the confidentiality of people filing reports, providing a newsletter targeted to those making reports, and providing feedback after reports are filed. The 50 participating hospitals will receive training in reporting deaths, serious injuries, and close calls involving medical devices; a newsletter on the FDA’s use of the data; and copies of CDRH alerts, advisories, and recalls immediately upon release.
Participating in MedSun will fulfill requirements for medical device reporting under the Safe Medical Devices Act. The FDA has provided answers to frequently asked questions as well as additional information (download frequently asked questions below).
In a related matter, the FDA issued a final rule in the February 8, 2002 Federal Register that amends the medical device tracking regulation (download FDA final rule below). One of the amendments adds specific language about patient confidentiality, so that patients receiving devices subject to tracking requirements may refuse to release any information that could be used to identify them.
- MedSun Web site
- CODA Web site
- Download MedSun Frequently Asked Questions (32 KB)
- Download
FDA Medical Device Tracking Amendments: Final Rule
(57 KB)
New bioterrorism resources: Clinician training, policy planning, local response, and protective equipment
A number of new resources on bioterrorism have recently been released – including an evidence report by the Agency on Healthcare Research and Quality (AHRQ) on training clinicians, a summary of a workshop by the Forum on Emerging Infections on strengthening the nation's response capabilities, the results of a survey noting the gaps and resources needed by local public health agencies to respond effectively to bioterrorism, and a report from ECRI on personal protective equipment.
AHRQ report. A new evidence report by AHRQ found that teleconferences on bioterrorism preparedness are as effective as classroom training for large numbers of clinicians in widespread geographic locations (download summary of AHRQ report below). The evidence report, Training of Clinicians for Public Health Events Relevant to Bioterrorism Preparedness (technical report No. 51), was prepared for AHRQ by Johns Hopkins University. The full report will be available online in a few weeks at the AHRQ Web site.
Smallpox vaccination guidelines. The New England Journal of Medicine published several articles on bioterrorism related to smallpox vaccine and smallpox vaccination policy in the April 25, 2002 issue. The editors are making these articles accessible to the general public (free to non-subscribers) because of their public health importance. The articles are available at the NEJM Web site, www.nejm.org.
Proceedings policy workshop. A new book identifies the next steps required to prepare and strengthen bioterrorism response capabilities -- an important priority for policymakers, researchers, public health officials, healthcare institutions, and the private sector. The book, Biological Threats and Terrorism: Assessing the Science and Response Capabilities, summarizes a November 2001 workshop sponsored by the Forum on Emerging Infections. Workshop participants agreed that moving an agenda forward would require prioritizing response measures, evaluating the components of the National Stockpile Inventories, considering the development of a peer-review system for screening new bioterrorism defense research ideas, and considering the role and responsibilities of a civilian biodefense program. The book may be ordered on the National Academy Press Web site.
Local public health survey. Local public health agency response after the September 11 terrorist attack was the subject of a recent survey by the National Association of County and City Officials (NACCHO). More than one-fourth of local public health agencies have a comprehensive, written emergency response plan in place, while more than half have plans that are 80 percent complete. However, gaps continue to be identified. For example, of those agencies with complete plans, only 12 percent have a section specifically devoted to bioterrorism. The survey identified the key role these agencies played in responding to anthrax-related calls as well as the lack of necessary communication and information systems for effective, rapid dissemination of information. (Download a summary of the NACCHO study below).
ECRI report: Protective equipment. ECRI and the Center for Healthcare Environmental Management (CHEM) have developed an advisory on the selection, use, and maintenance of personal protective equipment (PPE) for frontline healthcare workers during emergency responses. When selecting PPE, consider the facility size and location, the likelihood of a disaster as determined by a hazard vulnerability analysis, and local emergency response capabilities and plans. A free copy of the advisory may be downloaded below or from the ECRI Web site at www.ecri.org.
For online education and training courses on bioterrorism – tailored to the needs of healthcare professionals – visit the Premier Safety Institute disaster readiness Web site.
- Download AHRQ: Summary of Report on Training of Clinicians for Bioterrorism (41 KB)
- Download NACCHO Local Public Health Agency Survey summary (18 KB)
- Premier Safety Institute disaster readiness resources
- National Academy Press Web site
- Download ECRI advisory on PPE for chemical and biologic exposures (89 KB)
Patient education resources on preventing medical errors
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Agency for Healthcare Research and Quality (AHRQ) have released patient education resources on preventing medical errors.
These patient and consumer education initiatives are based on research indicating that patients who take an active part in decisions about their healthcare are likely to have better outcomes. The Centers for Medicare and Medicaid Services (CMS) also support efforts to increase consumer awareness and involvement.
The JCAHO Speak Up campaign includes buttons and brochures that can be customized for specific organizations (link to brochure below). AHRQ has developed the consumer brochure How to Protect Yourself and Your Family from Medical Errors. Available in both English and Spanish, the brochure outlines specific steps for preventing medication errors, wrong-site surgery, and infections (ordering information below). Other materials available on the site include a patient fact sheet with 20 tips on preventing medical errors (download 20 tips patient fact sheet below) and a family-oriented brochure, Ways to Help Your Family Prevent Medical Errors (download Ways to Help Your Family below).
- Download JCAHO Speak Up (33 KB)
- Download AHRQ How To Protect Yourself and Your Family; ordering information (19 KB)
- Download AHRQ 20 Tips to Prevent Medical Errors (32 KB)
- Download AHRQ Ways to Help Your Family Prevent Medical Errors (143 KB)
Editorial team
Gina Pugliese, RN, MS editor
Judene Bartley, MS, MPH, associate editor
Donna Bernstein, MPH, marketing consultant
Derek Kleckner, BA, Web master
About Premier
Premier, Inc. is a national strategic alliance of leading hospitals and healthcare systems representing more than 200 not-for-profit owners that own, operate, or are affiliated with approximately 1,600 facilities. Premier members have access to a wealth of resources that support them as they evolve into integrated delivery systems and improve community health across the continuum of care. Premier maintains corporate offices in San Diego, CA; Charlotte, NC; Chicago, IL; and Washington, DC. For information, visit www.premierinc.com.