Making the Operating Room a Safer Place

November 1, 2002

Making the Operating Room a Safer Place

By Michael Garvin, MHA

OccupationalSafety and Health Administration (OSHA) injury data indicates that outside ofthe patient room, the operating room (OR) is the site of the most employeeinjuries due to needles, scalpels and other sharp, invasive medical devices.Some of the devices are hollow-bore products and others are not. The hollow-boredevice creates more of a concern about transfer of disease from patient to staffsimply due to its ability to carry a certain volume of blood that can beinjected into the injured staff member. Devices such as syringe and needles usedby surgeons and anesthesiologists fall into the category of hollow-bore medicaldevices. IV-insertion devices also fall into this category. Scalpels andsutures, however, are considered to also provide a threat of injury andpotential disease transfer to staff. The OSHA Needlestick Prevention and SafetyAct of 2001 now requires that all ORs, whether located in a hospital or in astand-alone facility, evaluate and use appropriate safety medical devices thatcan reduce sharps injuries.

EVALUATING SAFETY DEVICES AND ESTABLISHING SAFETY POLICIES

There are a number of sharps medical devices that are used in the OR. Thereare also certain policies OSHA wants to see incorporated into the dailyactivities of the OR staff. The regulation stipulates that OR managers mustestablish a system where safety devices are clinically evaluated. There is nevera situation where all safety devices are rejected because they can negativelyimpact the delivery of healthcare services. Many of the safety devices such asthe safety syringes, blood-draw sets and " butterfly" devices are usedroutinely in surgery area. If a device has been clinically trialed and it isfound that the products do not enhance safety or they do create a negativeimpact on the treatment of patients, then it can be rejected. That rejection hasto be document and kept on file. If a surgeon or a group of surgeons refuses touse a device that is accepted by the other surgeon, then an "exceptionform" can be completed. The exception form describes why the device doesnot work for that surgeon. The surgeon needs to sign the form and it can be keptin a file in case the facility is 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, IMinjection devices such as syringes, safety scalpels and blunt sutures.

The OR has traditionally been the most difficult healthcare center to convertto safety devices, therefore, it has not been in full compliance with federaland state safety regulations. The requirements of the OSHA Bloodborne Pathogenregulation state that if you are engaged in healthcare delivery and you haveemployees working in that service, you need to evaluate safety medical devicesand standard procedures that have the potential of reducing employee sharpsinjuries. Oftentimes, surgeons and anesthesiologists working in the operatingroom have not accepted OSHA's inspection authority within the OR. Due to thisgeneral attitude, OSHA inspectors are starting to target surgeons andanesthesiologists because OSHA perceives that they may lag behind in theevaluation and use of safety devices in their work place. The key to compliancewith these safety regulations is to work, in good faith, to introduce safetyprocedures and devices into your surgical work place.

SAFETY PROCEDURES THAT HELP REDUCE INJURIES

Thetwo safety procedures that are commonly associated with the surgical work placeare "safe zone" instrument passing and a ban on recapping of needles.Recently, a large Midwestern teaching hospital was fined by OSHA for allowinghand passing of instruments during a case. OSHA requires that surgical personneluse "safe zone" techniques for passing surgical instrument. Someoperating rooms are using trays or basins where the instrument is place beforebeing picked up by the second person. Sometimes they use a designated area on acart of table.

There is very little an operating room manager can do to defend hand passingof surgical instruments. In some situations, surgeons using microscopes insistthat 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 procedureswhere looking up from the case may have a negative impact on the surgery. OSHAhas not tested the validity of the exception forms.

The procedure to ban recapping is an obvious but sometimes difficult one toenforce, particularly with anesthesiologists. It has been common practice foranesthesiologists to give the patient intermittent injections. The syringe wouldbe recapped between injections. There are two ways to balance the needs of theanesthesiologists and the requirements of the safety regulation. The totalinjection dose can be placed in three or four smaller syringes so that eachsyringe can be placed in a sharps disposal container after the injection. Thesecond method is to purchase safety syringes that allow the needlepoint to becovered but not completely locked over by the safety covering. This way theanesthesiologist can cover the needlepoint after each injection and stilldisengage the safety covering before the next injection. There are both hingedsafety devices and resheathable safety syringes that can accommodate thispractice. After the last injection, the safety feature can be locked permanentlyin place and the syringe can be placed in the sharps disposal container.

There are a few simple steps to follow to ensure compliance with theBloodborne 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 foryour surgery area and established a safer work environment.

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

Michael Garvin, MHA, is a safety consultant for the University of IowaHospital and Clinics.