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How to Assess a Durable Medical Equipment Facility

by Contributing Writer

Overview

Having durable medical equipment is an essential component of delivering quality health care, whether in a small private clinic or a tertiary care hospital. Uses of medical equipment are varied, ranging from diagnosis of diseases to treatment of patients. In the same way that doctors must adhere to the dictum "primum non nocere" (i.e., first, do no harm), the manufacturers, distributors and operators of medical equipment should ensure patient safety when these devices are put into actual use. Medical equipment should be subjected to standards of safety and efficacy, to give maximum benefit with minimal risk to patient health.

Step 1

Scrutinize the product's conception and development. Identify the rationale for developing the medical equipment. Does it adhere to principles of human anatomy and physiology? If the equipment is for treating diseases, does its mechanism address the cause of the problem? Can it perform better or more efficiently than existing medical devices that have a similar function?
Step 2

Inspect the manufacturing process. It is important that the quality of medical equipment remains consistent throughout. Even if the prototype medical equipment is well designed, lapses in the manufacturing process can lead to faulty end products. Identify areas of possible human- or machine-error.
Step 3

Inspect the labeling. Labels are essential to identify medical equipment and to specify instructions on how to store and use them properly. Labels also warn handlers and operators of the possible risks associated with using the medical equipment.
Step 4

Inspect the packaging. The packaging of the medical equipment ensures that it reaches the health care facility in optimum condition. If packaging is inadequate, the medical equipment may become unsterile or may be damaged when subjected to different stresses during transport.
Step 5

Inspect the advertising materials. The promotional materials for medical equipment should not make fraudulent claims, which may mislead hospital administrators into buying devices that would be of marginal benefit to patients.
Step 6

Check the after-sale service. When vendors sell a piece of medical equipment, they implicitly agree to provide support when a customer encounters problems in operating the medical device. This is even more essential when the manufacturer of the medical equipment is based abroad. The vendors should have trained technicians who can do on-site repairs. Otherwise, the end-users might be forced to use faulty medical equipment.
Step 7

Check the skills of the operators. Before attempting to use the medical equipment, operators should receive appropriate hands-on training and must be familiar with the indications, contraindications and basic troubleshooting procedures of the device.
Step 8

Look for the medical equipment's operating permit and maintenance schedule. Even if the medical equipment seems to be working normally, regular calibration and assessment by qualified technicians will prevent mishaps and costly repairs later on.

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Medical equipment Checklist of safety standards Operating instructions of medical equipment
Medical equipment
Checklist of safety standards
Operating instructions of medical equipment
Look for guidelines on good manufacturing practice (GMP) covering your specific type of medical equipment.
Look for guidelines on good manufacturing practice (GMP) covering your specific type of medical equipment.
Failure to label medical equipment properly may lead to unwanted lawsuits, particularly for devices that emit radiation, exert a strong magnetic force, use high voltage or contain biologic hazards.
Failure to label medical equipment properly may lead to unwanted lawsuits, particularly for devices that emit radiation, exert a strong magnetic force, use high voltage or contain biologic hazards.