Processing proton therapy equipment; automated washer testing; managing loaner trays

by Ray Taurasi

Q At a recent leadership meeting it was announced that our radiology department is going to be opening a new Proton Therapy unit at the first of the year. Support services were advised to gear up to support the center and to plan accordingly in our FY ’13 budget preparations. I have never even heard of proton therapy before and I am not sure what sort of instrumentation or equipment they might expect CSP to handle for them or if there will be special processing requirements. Any information or assistance you could share would be greatly appreciated.

A Proton therapy is an advanced form of radiation therapy which delivers higher doses of radiation directly to a tumor site to effectively destroy cancerous tumors. The power, speed and intensity of the proton beam allows for a more direct hit of a cancerous target and can help avoid contact and damage to surrounding non cancerous tissue. Proton therapy is one of the latest innovations, and is another option for prostate patients instead of more invasive traumatic surgery or conventional radiation therapy. Proton therapy is also used to destroy tumors in the brain, lungs, head and neck. Researchers believe that the unique characteristics of proton therapy will have advantages in the treatment of cancers growths found in close approximation to critical body structures.

Regarding the equipment and medical devices used in this process it is unlikely to have a significant impact on the workload of your CSP. The devices and associated instrumentation will be similar to that which is conventionally used in nuclear medicine and radio therapy units. I would suggest that you plan a meeting with the clinicians involved with the planning of your Proton Therapy Center to learn more about what expectations they may have of your department to learn what services you may be able to provide them. If you find there are some new forms of technology and other devices that you will be required to care for you will need to contact the device manufacturers to obtain the instructions for use including reprocessing, cleaning and sterilization.

Currently there are only about 10 Proton Therapy Centers of this type operating in the USA (several others are under construction or in development). I have listed some of the centers below. You may want to do some networking with your counterparts at these centers to learn from their experience.

• Proton Therapy Center in partnership with Princeton Radiation Oncology Group and CentraState Healthcare System, Somerset, NJ

• James M. Slater, M.D. Proton Treatment and Research Center at Loma Linda University Medical Center

• The University of Florida Proton Therapy Institute

• MD Anderson Cancer Center’s Proton Center, Houston

• ProCure Proton Therapy Center, Oklahoma City

• The Roberts Proton Therapy Center at University of PA Health System

• Hampton University Proton Therapy Institute Hampton, VA

• CDH Proton Center, A ProCure Center, Chicago Area, IL

• Indiana University Health Proton Therapy

• Francis H. Burr Proton Center at Mass. General Hospital Boston, MA

Q Would you please clarify the testing recommendations for cleaning verification? Who or what agency determines the frequency of testing automatic washers? Do the same requirements apply to offsite surgery centers?

A It basically is up to each hospital or healthcare system to determine their policy for monitoring the efficacy of all automated processing equipment. The policy should address all types of automated washers including instrument washers, washer disinfectors, ultrasonic washers, (AER) automated endoscope preprocessors, cart washers and the like. With the ever increasing media attention on growing healthcare associated infection rates and adverse patient care incidents associated with breeches in reprocessing techniques and processing equipment failures the various accrediting bodies such as, the Joint Commission, CMS, Healthcare Facilities Accreditation Program (HFAP), and Det Norske Veritas Healthcare, Inc. (DNV) are really focusing on Quality Assurance of Cleaning processes. They expect hospitals and healthcare systems to implement best practices. Most healthcare facilities do follow AAMI and AORN recommendations. Below are the current AAMI/AORN recommendations related to monitoring the efficacy of automated washers. There is no distinction between offsite surgery centers or hospitals, the same standards of care and recommendations apply.

AAMI ST 79:2009 Section 7.5.3.3

Monitoring and verifying cleaning should be documented.

Mechanical cleaning equipment should be tested upon installation, weekly (preferably daily) during routine use, and after major repairs.

Section 10.2 and ANNEX D

"Health care personnel may perform verification tests as part of the overall quality assurance program. This verification may include the use of test devices that monitor the functionality of the cleaning equipment in cleaning surfaces and that ensure adequate fluid flow in equipment that has adaptors for lumened devices…"

AORN Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Section XXII. A

• A quality management program should be in place to test mechanical cleaning equipment.

• Mechanical instrument washers should be tested for proper functioning before initial use, weekly during service, and after major maintenance.

There is a growing trend amongst hospitals to move toward daily testing of all automated washers.

Q Our facility recently became part of a large hospital network and we have added two new orthopedic surgeons and our case volume has spiked. We are doing many more special procedures that require loaner trays. I would like to develop some polices to manage these sets as we are already encountering problems. Can you provide any samples or an outline?

A The Orthopedic Council of IAHCSMM has published a position paper on the management of loaner instrumentation and a sample policy that you would find very useful as a reference source and guide in developing your policy. You can find these documents at the following websites:

• http://iahcsmm.org/pdfs/IAHCSMMPositionPaperontheManagementof
Loaner1.30.2012%20FINAL.pdf

• http://iahcsmm.org/pdfs/IAHCSMMLoanerInstrumentationSamplePolicy
andProcedureJWEdits.1.30.2012%20FINAL.pdf