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Clinical Engineering Services and Human Subjects Research Activities
The Johns Hopkins Hospital (JHH) and the Johns Hopkins Bayview Medical Center (JHBMC) follow JCAHO requirements for environment of care and safety of equipment used at the facilities. In addition, the Hospitals are required to conduct acceptance testing of equipment that comes into contact with patients. In order to meet the JHH and JHBMC policy requirements, JHM established Clinical Engineering Services (CES) at JHH and JHBMC to assure that the appropriate review, safety inspection, testing, reporting, and documentation required for equipment has been met before equipment is used or installed at JHM. The requirement for equipment testing applies to both clinical care and to research related procedures.
CES review is required for equipment/devices/software, with limited exceptions. CES review is not required for: (i) implantable devices, including pacemakers, implantable electrodes, heart valves, shunts, stents, catheters, or other marketed or research investigational devices; (ii) devices already at JHM and used in current, daily clinical applications (devices and equipment used at JHM for daily clinical applications will have a yellow device tag with an HTE control number on the tag); (iii) MRI scanners; (iv) ionizing radiation; (v) low power battery devices that do not make electrical contact or penetrate the body (e.g., phones, tablet computers, video games, laptops, cameras).
All other equipment and devices provided to an investigator by a sponsor or vendor and used in a study must be approved by CES before the IRB issues final approval. The eIRB application contains questions to assist investigators in submitting information regarding equipment/devices that will require CES review.
CES staff prepared the following list of Frequently Asked Questions:
Q. What is the CES definition of a device?
CES uses FDA definitions of a device: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
Q. Why do I have to have this device reviewed when it runs on batteries?
CES is charged with providing a safe environment of care (JCAHO standards of care) within the hospitals and the JHU clinics. This means that all medical devices, including those used for research, are included in the Medical Equipment Management Plan (MEMP) and must be inspected for safety.
Q. Why does CES need to review the device if it is already approved by FDA?
JHH and JHBMC safety policy and JCAHO require that CES acceptance test clinical equipment prior to use on a patient.
Q. Why does CES have to inspect the device again in a year?
For most studies, only an initial inspection is required. If the research study lasts for six months or less, CES does not have to conduct a repeat review. Devices that do not emit energy usually do not require re-inspection. All other devices require re-inspection based on the risk criteria assigned at the initial CES review. For example, a life support device such as an external defibrillator may require inspection every six months, but a suction regulator may only require inspection once.
Q. Why does CES charge for time spent on these reviews?
CES does not have a budget for performing reviews associated with research projects. CES is required by JHH and JHBMC senior management to be self sufficient and charge back for labor.
Q. I don’t have a budget number and I won’t get funding until sometime after the study is approved. How can I pay for the required CES review?
Principal Investigators may use gift accounts, department/division accounts, or other valid JHU account numbers to provide a source to bill for CES services while they await a funding decision by a sponsor.
Q. If a device is to be used at APL, is a safety review required?
A. Yes. The review, however, will be conducted by the Safety staff at APL working in accord with CES when necessary.
CES staff is available to discuss device and equipment issues with investigators. Please contact the following staff members if you have questions about equipment you wish to purchase for a research study, wish to lease for a research study, or which will be provided by a sponsor/vendor for use only in a research study.
Andrew Curie, Biomedical Equipment Technician II, JHH CES: email@example.com
Roy Shipley, Associate Clinical Engineer, JHH CES: firstname.lastname@example.org
Charles Bacon, Director of Clinical Engineering, JHBMC CES: email@example.com