Making the Operating Room a Safer Place

Making the Operating Room a Safer Place

By Michael Garvin, MHA

Occupational Safety and Health Administration (OSHA) injury data indicates that outside of the patient room, the operating room (OR) is the site of the most employee injuries due to needles, scalpels and other sharp, invasive medical devices. Some of the devices are hollow-bore products and others are not. The hollow-bore device creates more of a concern about transfer of disease from patient to staff simply due to its ability to carry a certain volume of blood that can be injected into the injured staff member. Devices such as syringe and needles used by surgeons and anesthesiologists fall into the category of hollow-bore medical devices. IV-insertion devices also fall into this category. Scalpels and sutures, however, are considered to also provide a threat of injury and potential disease transfer to staff. The OSHA Needlestick Prevention and Safety Act of 2001 now requires that all ORs, whether located in a hospital or in a stand-alone facility, evaluate and use appropriate safety medical devices that can reduce sharps injuries.

Michelle McMurray, of Elliot Hospital in Manchester, NH, has participated in the conversion of safety scalpels. "We have used the BD safety scalpel for a few months now. The surgeons have gotten into the habit of closing the scalpel after using it. The scalpel is easy to use so it did not take a lot of training for people to catch on."

Evaluating Safety Devices and Establishing Safety Policies

There are a number of sharps medical devices that are used in the OR. There are also certain policies OSHA wants to see incorporated into the daily activities of the OR staff. The regulation stipulates that OR managers must establish a system where safety devices are clinically evaluated. There is never a situation where all safety devices are rejected because they can negatively impact the delivery of healthcare services. Many of the safety devices such as the safety syringes, blood-draw sets and " butterfly" devices are used routinely in surgery area. If a device has been clinically trialed and it is found that the products do not enhance safety or they do create a negative impact on the treatment of patients, then it can be rejected. That rejection has to be document and kept on file. If a surgeon or group of surgeons refuse to use a device that is accepted by the other surgeon, then an "exception form" can be completed. The exception form describes why the device does not work for that surgeon. The surgeon needs to sign the form and it can be kept in a file in case the facility is ever inspected by OSHA.

There are a number of different safety medical devices used in the OR, including: IV-insertion devices, blood-draw sets, needleless IV connections, IM injection devices such as syringes, safety scalpels and blunt sutures.

The OR has traditionally been the most difficult healthcare center to convert to safety devices, therefore, it has not been in full compliance with federal and state safety regulations. The requirements of the OSHA Bloodborne Pathogen regulation states that if you are engaged in healthcare delivery and you have employees working in that service, you need to evaluate safety medical devices and standard procedures that have the potential of reducing employee sharps injuries. Oftentimes, surgeons and anesthesiologists working in the operating room have not accepted OSHA's inspection authority within the OR. Due to this general attitude, OSHA inspectors are starting to target surgeons and anesthesiologists because OSHA perceives that they may lag behind in the evaluation and use of safety devices in their work place. The key to compliance with these safety regulations is to work, in good faith, to introduce safety procedures and devices into your surgical work place.

Safety Procedures That Help Reduce Injuries

The two safety procedures that are commonly associated with the surgical work place are "safe zone" instrument passing and a ban on recapping of needles. Recently, a large Midwestern teaching hospital was fined by OSHA for allowing hand passing of instruments during a case. OSHA requires that surgical personnel use "safe zone" techniques for passing surgical instrument. Some operating rooms are using trays or basins where the instrument is place before being picked up by the second person. Sometimes they use a designated area on a cart of table.

There is very little an operating room manager can do to defend hand passing of surgical instruments. In some situations, surgeons using microscopes insist that they do not have the luxury of looking up form the procedure to locate the "safe zone" tray. Exception forms have been used for those procedures where looking up from the case may have a negative impact on the surgery. OSHA has not tested the validity of the exception forms.

The procedure to ban recapping is an obvious but sometimes difficult one to enforce, particularly with anesthesiologists. It has been common practice for anesthesiologists to give the patient intermittent injections. The syringe would be recapped between injections. There are two ways to balance the needs of the anesthesiologists and the requirements of the safety regulation. The total injection dose can be placed in three or four smaller syringes so that each syringe can be placed in a sharps disposal container after the injection. The second method is to purchase safety syringes that allow the needlepoint to be cover but not completely locked over by the safety covering. This way the anesthesiologist can cover the needlepoint after each injection and still disengage the safety covering before the next injection. There are both hinged safety devices and resheathable safety syringes that can accommodate this practice. After the last injection, the safety feature can be locked permanently in place and the syringe can be placed in the sharps disposal container.

There are a few simple steps to follow to ensure compliance with the Bloodborne Pathogen Standard.

  • Gain support from the top of the organization. The hospital or owners and managers of your surgical center will be held responsible if OSHA does conduct an inspection. Management needs to convey to staff that safety is considered very important.
  • Assign a person responsible for the program. Someone has to have the authority to develop and maintain the program.
  • Create or amend your bloodborne pathogen exposure control plan. Make sure that you explain how safety devices are selected, tested and purchased. Sample plans can be obtained from vendors.
  • Involve non-managerial staff. OSHA is insistent on having non-managerial staff involved in the program. Staff input is very important when selecting safety devices.
  • Train staff and document that training. Be sure to see that all staff who are using the new devices are properly trained on clinical use.
  • Conduct clinical trials on safety products. OSHA will be looking for documentation that you have tested products for such procedures as medication injections, blood draw procedures, IV insertion procedures, etc. You do not have to buy a certain device but you do have to document why you do not select tested devices.
  • Review your facility's bloodborne pathogen exposure control plan annually. Document any changes in your safety supplies and document annual training of staff

With these simple steps you will have created compliance documentation for your surgery area and established a safer work environment as well.

Michael Garvin is a safety consultant for the University of Iowa Hospital and Clinics.


For more information, log on to the following Web sites:

1. www.isips.org

2. www.bd.com

3. www.med.virginia.edu/epinet

4. www.osha-slc.gov/SLTC/needlestick

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