Reduce Equipment-Related Adverse Events

With the growing number of complex medical devices, equipment-related patient incidents are on the rise. Equipment problems are a frequent cause of untoward events. The causes of medical device accidents fall into four categories: (1) Basic device failures (e.g., design/labeling error, manufacturing error, random component failure, invalid device foundation); (2) External factors (e.g., electrical power supplies; medical gas and vacuum supplies; electromagnetic or radio frequency interference; environmental controls); (3) System errors (e.g., poor incident/recall reporting systems; failure to impound; lack of competent accident investigation; failure to train and credential; poor prepurchase evaluation; use of inappropriate devices; failure to conduct incoming and pre-use inspections); and (4) Operator errors (e.g., device misassembly; inappropriate reliance on an automated feature; accidental misconnections; improper maintenance, testing, repair, or incoming inspection; incorrect clinical use; incorrect control settings; incorrect programming). The materials department can help to alleviate some of the problem areas through an effective equipment procurement, maintenance, and monitoring program.

Accident Prevention Steps

Several steps can be taken to eliminate the error-producing factors in the workplace that may cause undesirable equipment-related events. An important issue is communication. Every health care facility should have a formal process for identifying product hazards and communicating effective safety practices to all relevant healthcare professionals. This means that someone, perhaps in the materials department, is designated to receive and dissemination information about product recalls and device safety alerts. Groups such as the Food and Drug Administration, the Institute for Safe Medication Practices, and the ECRI regularly issue equipment hazard reports that are relevant to many different patient care units. These communications must routinely be distributed to everyone affected by the products in question.

All material and equipment should be briefly inspected for damage in the materials department prior to delivery to patient care units. This inspection involves both the packaging and the equipment/device. Typical steps include the following:
- Conduct a visual through-the-packaging inspection of the equipment/device for obvious defects.
- Check the package integrity. Are the package and seals intact?
- Verify the package label. Does the label accurately identify the equipment/device contained in the package? If the device has an expiration date, has the date passed?
- Is there any debris or unidentified material within the package?
- Is the equipment/device complete and properly assembled?
- Are there any external defects (e.g., broken insulation of disposable electrodes, cracks or splits in catheters)?
- Are all connections and junctions intact and secure?

It may be necessary to involve the engineering department in the inspection of electrical items if staff in the materials department is not qualified to evaluate electrical components.

Identify Risky Products

The materials department can also help in identifying high-risk equipment/devices. High-risk products are those that require repeated repair or replacement. The information found in the log of items sent out of the facility for repair or replacement can be used to evaluate whether the repair rate for a piece of equipment/a device is increasing (a signal that the reliability is decreasing) and determine if repair/replacement rates are higher in a particular unit (a signal of possible misuse or lack of staff knowledge). The materials department staff is often aware of the scope of equipment problems and complaints voiced by physicians and clinical staff. These concerns can be early-warning signs of an impending equipment-related patient incident and should be brought to the attention of the Patient Safety or other relevant committee.

Involve Equipment Users

The materials department is responsible for procuring quality materials, supplies, and equipment use at the lowest total delivered cost. However these decisions should not be made in isolation from those who use the products. Every patient care device should be evaluated by user groups to determine if the equipment:
- Conforms to user expectations.
- Is easy to learn how to operate.
- Contains easily perceived displays and simple controls.
- Provides relevant information to the user thus avoiding reliance on the user's memory.
- Comes with clear and adequately detailed user documentation and technical manuals.

Studies of medical device accidents show that operator error accounts for 50-70 percent of the problems. The goal is to ensure that operators are proficient in critical tasks. Critical tasks are those requiring human performance which, if not accomplished in accordance with product requirements, will most likely have adverse effects on equipment reliability or safety. Before purchasing new patient care supplies, accessories, and equipment the materials department must make clinical departments aware of any training implications. An operational assessment should be conducted prior to purchase to determine if the new equipment will need to be added to the physician credentialing process or if there is a need for training of physicians, nurse and/or support staff.

To Learn More: Patrice L. Spath is available for in-house presentations on this and other health care performance improvement topics. For further details, visit Brown-Spath & Associates on the web at: http://www.brownspath.com or write to: Brown-Spath & Associates, PO Box 721, Forest Grove, OR 97116.

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