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How Federal and State Guidelines Can Keep You Healthy During a Hospital Visit

Hospital HealthyOften those preparing for a medical procedure which will require a hospital stay are not concentrating on the risk of catching an additional “bug” but it is more common than the healthcare industry would like us to believe. The risk of infection or injury from the use of a non-sterile reprocessed surgical instrument or the use of a non-disinfected medical device can also cause further damage as well.

A Need for Regulation

It is well known that healthcare facilities are a breeding ground for numerous and often dangerous superbugs, so much so that in 2008, the Centers for Disease Control and Prevention(CDC) published guidelines for disinfection and sterilization procedures for all healthcare facilities. In summary, the CDC guidelines have established a universal protocol for all healthcare professionals in hospital, ambulatory care centers, and home care agencies.

With the concentration of the 2008 guidelines focusing upon the disinfection and sterilization of surgical instruments, the CDC hopes that proper procedures will decrease the number of injuries, infections and possible medical malpractice allegations.

Under the guidelines, sterilization is described as the process that destroys or completely eliminates all forms of microbial life. It is to be observed and carried out by all healthcare facilities and healthcare professionals. The most common uses of sterilization include:

  • Chemical methods;
  • Pressurized steam;
  • Dry heat optimization;
  • Ethylene Oxide or EtO gas process;
  • Hydrogen peroxide gas plasma; and
  • Various other liquid chemical agents.

Disinfection, refers to the process that is designed to eliminate all pathogenic microorganisms. The most common methods of disinfection in a healthcare facility is the use of liquid chemicals or wet pasteurization.

Both of these practices relate to the reuse of medical devices or surgical instruments intended for only a single use. Since 1970, the reuse of these type of devices has increased significantly, so much so that the practice now involves regulatory, ethical, medical, legal and economic factors. The controversy and heightened patient awareness as to the practice was so evident that in August of 2000, the U.S. Food and Drug Administration (FDA) imposed specific guidelines on hospitals or third-party agencies who were reprocessing surgical instruments or medical devices, holding them accountable as a direct manufacturer with the same regulatory guidelines as when the device was first produced.

For healthcare professionals working in California, the importance of understanding the objectives, terminology and classifications of reprocessing surgical instruments and medical devices was made evident when in 2013 the California Department of Public Health (CDPH), the California APIC Coordinating Council (APIC), and the Healthcare-associated Infections (HAI Elimination) offered a two-day course on the subject. Besides the basic information, the course also highlighted the three critical mandates for sterilization and disinfection when reprocessing surgical instruments and medical devices.

Critical Care Items

All critical care items, such as any surgical device that may enter tissue or the vascular system must be sterilized. Specific instruments include:

  • Biopsy forceps;
  • Cardiac and urinary catheters; and
  • Implants and needles.
Semi-Critical Care Items

This area includes high disinfection or sterilization protocol for such surgical instruments or medical devices used in the care of the any mucous membrane areas and includes:

  • Respiratory therapy equipment;
  • Anesthesia devices or instruments;
  • Laryngoscopes;
  • Bronchoscopes; and
  • Vaginal ultrasonic probes.
Non-Critical Items

Although disinfection of non-critical items should be part of the healthcare safety protocol, some items may range from intermediate to low levels of disinfection and include:

  • Blood Pressure or BP cuffs;
  • Stethoscopes; and
  • Durable, mobile patient equipment.
Seek Legal Help

If you recently acquired a non-descriptive infection either from airborne bacteria or the use of a non-sterilized surgical instrument, the experienced San Jose medical malpractice attorneys of Corsiglia, McMahon & Allard, L.L.P. would be interested in speaking with you. To schedule your no-cost initial consultation, contact our team at (408) 289-1417 today.

Client Reviews
My experience with Attorney Brad Corsiglia during my recent medical malpractice case was nothing short of amazing given the very stressful circumstances. I was fortunate to find Brad highly recommended from a mutual contact and from the very beginning of the process, Brad was truly engaged and knowledgeable in understanding my case and providing input on what avenues were available to me. Michelle M.