American Hospital Association
One North Franklin
Chicago, Illinois 60606
Dear Mr. Davidson:
We are writing to urge you to contact all AHA-affiliated hospitals alerting them to the fact that Montefiore Medical Center in New York City has recently been cited and fined for failure to comply with the Occupational Safety and Health Administration’s (OSHA’s) Bloodborne Pathogens Standard (BPS). Because we believe that conditions similar to those at Montefiore likely exist at most hospitals in the U.S., many AHA members currently risk OSHA sanctions. More importantly, because there are safer alternatives to many of the devices currently in use in U.S. hospitals, nurses, residents, medical students and other hospital staff are placed at unnecessary risk of acquiring potentially fatal infections due to needlestick injuries.
On October 7, 2003, OSHA cited Montefiore Medical Center for violations of workplace health hazard regulations that require the use of syringes, needles and scalpels with engineered sharps injury protections. Altogether, OSHA found 46 instances of unsafe practices under the BPS and fined the institution a total of $9,000.
OSHA’s BPS was initially completed in 1991. It was modified again in 2001 to comply with the Needlestick Safety and Prevention Act passed by Congress in 2001. Even with these revisions, the BPS was not concrete in its requirements for specific devices. However, in this ruling, the agency sheds some light on the minimum standards for engineered devices needed to comply with the standard.
The following are some of the activities cited at Montefiore:
- Needles without engineering controls were used for the administration of intramuscular injections. (Similar violations were noted for subcutaneous and intravenous push delivery of medications.)
- Needles without engineering controls were used for central line blood drawing and flushing.
- Sharps without engineering controls (e.g., scalpels, introducer needles and needles for lidocaine administration) were used for the placement of central venous catheter lines, peripherally inserted central catheter lines, hemodialysis catheter lines, and Swan-Ganz catheter lines. (There were similar citations for thoracentesis, paracentesis, placement of radial arterial lines, umbilical arterial lines, arterial blood gas collection, and umbilical cord blood collection.)
- Suture needles (instead of adhesive materials) were used to secure central venous catheter lines, peripherally inserted central catheter lines, arterial lines, hemodialysis catheter lines and chest tubes.
- Scalpels without engineering controls were used for procedures including incision and drainage, chest tube insertions, perionychium infection, appendectomy, tracheostomy, inguinal hernia repair, and other operating room procedures.
Some of these deficiencies at Montefiore have been addressed since the complaint was filed with OSHA.
These practices are likely to be present in many (if not most) U.S. hospitals. Following a request for comments regarding the bloodborne pathogen transmission problem published in the Federal Register in September 1998, OSHA received submissions from over 300 health care delivery institutions. Among the respondents, 87% used safer medical devices for intravenous (IV) lines. However, only 31% of respondents did so for IV catheter insertion, 17% for intramuscular or subcutaneous injection and 41% for blood drawing. There is enormous potential for response bias in such a survey, with those implementing safer devices presumably more likely to respond, leading to overestimates of safer device use. The Veterans Administration reported that, in 1996, 96% of its facilities used safer medical devices for IV delivery and 53% did so for IV insertion. On the one hand, these statistics demonstrate that it is feasible to implement these systems; on the other, the likely reporting artifact suggests that too many U.S. hospitals still lack these devices, are likely to be out of compliance with the BPS and are thus susceptible to citation.
We ask the American Hospital Association (AHA) to act now by warning U.S. hospitals to limit the continuing spread of serious infectious diseases among health care workers at its member institutions. Each year, health care workers sustain approximately 590,000 needlestick injuries as they care for patients nationwide. As of June 2001, a total of 56 confirmed cases of occupational human immunodeficiency virus (HIV) transmission in the U.S. were reported to the CDC. Another 138 episodes of HIV in health care workers are considered possible occupational HIV transmissions. In addition, an estimated 100-200 health care workers die annually from hepatitis B and hundreds annually contract hepatitis C, although data are scant. Safer practices have been demonstrated to reduce the number of needlestick injuries by as much as 90%. A General Accounting Office report suggests that using needles with safety devices would prevent about 69,000 needlesticks a year, preventing at least 25 cases of hepatitis B per year and at least 16 cases of hepatitis C per year.
While the safer sharps are typically marginally more expensive, the costs of failing to comply with current OSHA guidelines as clarified by this ruling are likely to be higher. Needlestick injuries cost the institution about $500-$1000 per incident.2 These cost estimates do not include the cost of prophylactic HIV medicines for a month beginning immediately after the incident, which are likely to drive the cost-per-incident estimate up considerably. These estimates also do not include the approximate cost of lifetime HIV treatment costs, estimated in 1997 at $195,188 for those who become infected. Most importantly, housestaff, nurses and support staff are unnecessarily and illegally being exposed to bloodborne pathogens such as HIV and hepatitis with the attendant psychological stress of waiting for blood test results to come back.
Multiple reviews and panels have concluded that these devices reduce the incidence of needlestick injuries. The AHA itself has spoken about its commitment to worker safety:
The AHA and its member institutions … have a long-standing commitment to ensuring the safety of patients and health care workers. Our work on this particular issue dates back to the early 80s, when the AHA developed recommendations on managing HIV infection, including adherence to blood and body fluid precautions … We are especially proud of our collaboration with OSHA when the agency developed the 1991 Bloodborne Pathogens Standard. This standard revolutionized safety for the approximately 5.6 million health care workers at risk of exposure to bloodborne pathogens, such as HIV, Hepatitis B and Hepatitis C.
We ask you to facilitate the compliance of your member institutions with current OSHA standards by writing to each of them informing them of this landmark OSHA ruling. In the alternative, medical students and residents stand ready to file institution-by-institution complaints against violating hospitals.
Steve Cha, M.D.
Chief Resident in Internal Medicine
Montefiore Medical Center*
Joseph Ross, M.D.
Resident in Internal Medicine
Montefiore Medical Center*
Peter Lurie, M.D., M.P.H.
Public Citizen’s Health Research Group
Lauren Oshman, M.D., M.P.H.
American Medical Students Association
Sidney M. Wolfe, M.D.
Public Citizen’s Health Research Group
*For identification purposes only
 Occupational Safety and Health Administration. Citation and Notification of Penalty, Montefiore Medical Center, Inspection Number 305769994. September 30, 2003.
 Occupational Safety and Health Administration. Record summary of the request for information on occupational exposure to bloodborne pathogens due to percutaneous injury. Available at: http://www.osha-slc.gov/html/ndlreport052099.html.
 International Health Care Worker Safety Center. Annual number of occupational percutaneous injuries and mucocutaneous exposures to blood or potentially infective biological substances. 1998. Available at: http://www.med.virginia.edu/medcntr/centers/epinet/estimates.html.
 Center for Disease Control and Prevention. Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV and HIV and Recommendations. Morbidity and Mortality Weekly Report 2001;50:RR-11.
 Centers for Disease Control and Prevention. Draft guideline for infection control in health care personnel. Washington, D.C.: Government Printing Office, 1997. Cited in: Occupational Safety and Health Administration. Safer needle devices: protecting health care workers. October 1997. Available at: http://www.osha-slc.gov/SLTC/needlestick/saferneedledevices/saferneedledevices.html.
 Williams I, Centers for Disease Control and Prevention Hepatitis Branch, November 28, 2000, personal communication.
 Gershon RR, Pearse L, Grimes M, Flanagan PA, Vlahov D. The impact of multifocused interventions on sharps injury rates at an acute-care hospital. Infection Control and Hospital Epidemiology 1999;20:806-11.
 General Accounting Office. Occupational Safety: Selected Cost and Benefit Implications of Needlestick Prevention Devices for Hospitals. November 17, 2000. Available at: http://www.gao.gov/new.items/d0160r.pdf
 Holtgrave DR, Pinkerton SD. Updates of cost of illness and quality of life estimates for use in economic evaluations of HIV preventions programs. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 1997;16:54-62.
 The American Medical Association’s Council on Scientific Affairs conducted a review concluding that “scientific data now indicate that the appropriate use of needlestick protection devices, especially in comprehensive prevention programs, significantly reduces the incidence of needlestick injuries. (Tan L, Hawk JC, Sterling ML, Council on Scientific Affairs, American Medical Association. Report of the Council on Scientific Affairs: preventing needlestick injuries in health care settings. Archives of Internal Medicine 2001;161:929-36.) The Cochrane Collaboration reviewed all available randomized trials in 2000 and concluded: “Studies evaluating the effectiveness of engineering control interventions, particularly sheathed and self-capping needles, needleless intravenous systems, blunt suture needles, and needle covers, have shown significant reductions in [needlestick injuries].” (Rogers B, Goodno L. Evaluation of interventions to prevent needlestick injuries in health care occupations. American Journal of Preventive Medicine 2000;18:90-8.)
 Testimony of Tammy Lundstrom on behalf of the American Hospital Association before the Subcommittee on Workforce Protections of the Committee on Education and the Workforce of the United States House of Representatives. June 22, 2000. Available at: http://www.hospitalconnect.com/aha/advocacy-grassroots/advocacy/testimony/2000/60022Needles.html.