Sunday, November 21, 2004

The Short End of the Stick

Roy Appleton, Dallas Morning News, has written an interesting profile/update about Retractable Technologies, the manufacturer of retractable syringes which were specifically designed by Texan Thomas Shaw to eliminate needle stick injuries and reduce the spread of HIV and other infectious diseases in the health care setting. Appleton's article details the legal battles and financial struggles that resulted from Shaw's attempt to break into the closed world of medical suppliers.

Interestingly, Appleton makes no mention of current Texas law, which requires public entities whose employees are at risk of exposure to bloodborne pathogens through sharps injuries, including needle stick injuries, to provide safety engineered medical devices for their employees' use. This would be the Health and Safety Code, Chapter 81, Subchapter H: Bloodborne Pathogen Control (paragraphs 81.301-307).

This section of the law has a more or less interesting legislative history. In the 76th Regular Session (1999), Rep. Harryette Ehrhardt (D-Dallas) introduced HB 1646, which successfully passed through the Public Health Committee and was sent to the House floor as part of the Local & Consent Calendar. The companion bill, SB 905, by Sen. David Bernsen (D-Beaumont), moved similarly smoothly through the Senate. Both bills, however, ran up against the end of session crunch. Rather than lose them entirely, the authors decided to append them to another bill (HB 2085), the reauthorization of the Texas Department of Health, which was sure to pass.

As a result of this legislation, the then Texas Department of Health produced its Bloodborne Pathogen Exposure Control Plan, which includes the following procedures:

All publicly owned or financed institutions that provide health services, even if health services are not their primary purpose, shall comply with the state and federal laws concerning bloodborne pathogen exposure. Providers such as public hospitals, school clinics, home health agencies, local agencies (LAs), EMS providers etc are covered by these laws. Under the law, these providers are required to:
A. Use needleless systems and sharps with engineered sharps injury protection for all venous/arterial access, body fluid withdrawal, and all fluid administrations and injections.
B. Develop an Bloodborne Exposure Control Plan, modeled after and equal to the plan mandated by TDH, that monitors employee exposure determinations, addresses training and education, establishes safer work practices and procedures, provides employee vaccination, specifies use of personal protective equipment, and addresses housekeeping and laundry safety, post-exposure evaluation, followup and documentation. The BPECP shall be submitted to the state agency (SA) for approval prior to each fiscal contract period.
C. Record and report employee bloodborne exposure incidents to TDH. Keep a sharps injury log to record date, time, and related incident information as mandated by law. Sharps injuries shall be reported to TDH within 10 working days of the end of the calendar month in which the exposure occurred.
D. Employee medical records regarding vaccination, needlestick exposures, and treatment shall be retained for the term of employment plus 30 years. (Hard copy records may be converted to electronic storage formats.) Additionally, training records shall be retained for 3 years from the date of the training.
E. Review and update the exposure control plan - at least annually, or more frequently if safer work practices or devices are available or if further workplace guidelines, rules or regulations are issued.

Although early analysis of the legislation predicted that up to 25 safety-engineered devices would be registered with the state in any given year, only three are on the current list. Two of them are manufactured by Retractable Technologies.

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