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Clinical Engineering Services and Human Subjects Research Activities

August 2010

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 all 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 only two exceptions.  The first exception is implantable devices.  CES review is not required for pacemakers, implantable electrodes, heart valves, shunts, stents, catheters, or other marketed or research investigational devices.  The second exception is 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 indicating inspection has been conducted by CES.  Such equipment will have an HTE control number on the tag affixed to the equipment.  If a research project will involve a medical device or equipment with an HTE tag and number, additional CES review is not required.

All other equipment and devices provided to an investigator by a sponsor or vendor require CES review before the IRB may issue final approval of a protocol that involves either a marketed or investigational device or equipment.  The eIRB application contains questions to assist investigators in submitting information regarding equipment/devices that will require CES review and subsequent IRB approval. 

Biomedical devices and equipment have CES Classifications as follows:

  1. Investigational device, covered by an Investigational Device Exemption issued by the FDA and fabricated by a JHM entity
  2. Investigational device, covered by an Investigational Device Exemption issued by the FDA and fabricated by an outside manufacturer, laboratory, etc.
  3. Investigational device that the IRB believes represents a non-significant risk device for which an Investigational Device Exemption is not required
  4. FDA approved device that is not owned by JHH, JHBMC, or JHU for which there is an FDA approved indication
  5. FDA approved device that is not owned by JHH, JHBMC, or JHU for which there is an FDA approved indication, but the device is on loan to JHH, JHBMC, or JHU from a vendor for research use only
  6. FDA approved device owned by JHH, JHBMC, or JHU which is to be used in research for an off label application (i.e., different from the intended application)
  7. FDA approved device which will be owned by JHH, JHBMC, or JHU but which will be purchased by Hopkins only for use in a research study

CES staff prepared the following list of Frequently Asked Questions:

Q. What is the CES definition of a device?

A. 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?

A. 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?

(See CES Device Classifications above)

A. Just because a device is FDA approved does not mean it is completely safe or effective.  There are many examples of bad designs that have made it to market and caused patient injury.  In addition, JHH and JHBMC safety policy and JCAHO require that CES acceptance test all clinical equipment prior to use on a patient.

Q. Why does CES have to inspect the device again in a year?

A. 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 have to charge ($63.00/hour) for time spent on these reviews?

A. 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?

A. CES must have a means of receiving payment prior to releasing the approval.  Experience has demonstrated that if CES submits approval without a confirmed budget number, CES does not receive payment for services.  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. What should be done if you need the approval ASAP because your grant proposal is due tomorrow?

A. Waiting until the last minute is never a good idea.  CES clinical engineers are busy with many other projects and we usually require at least three weeks advance notice to schedule the review. The IRBs may approve a project with administrative changes and require the PI to submit CES approval at a later date. Such projects, however, may not begin until the CES review has been completed.

Q. If a device or equipment is purchased for research use only, will be used in laboratory space, and will only be used with normal volunteers, is CES review required?

A. Yes.  Any device or equipment that will be used on research subjects (who may be either patients or normal volunteers) must be reviewed for safety, regardless of the location at which it will be used.  This requirement applies to imaging equipment that emits ionizing radiation or MRI scanners.  Review of imaging equipment is coordinated by the Department of Radiology and CES.

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: acurrie2@jhmi.edu
Roy Shipley, Associate Clinical Engineer, JHH CES: rshiple1@jhmi.edu
Charles Bacon, Director of Clinical Engineering, JHBMC CES: cbacon5@jhmi.edu



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