Making sure medical equipment is in compliance

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George Landauer
George Landauer

All long-term care and other healthcare facilities should have a proper Medical Equipment Management Program in place. With budgetary issues, staff cutbacks and decreasing reimbursements, many facilities choose to avoid this expenditure. But this is a failure to recognize that it is a matter of good risk management, as well as being both a regulatory and accreditation compliance requirement. 

Hospitals today typically have their own in-house biomedical engineers to service, maintain and inspect their equipment. Long-term care facilities do not have, or even need, an entire Biomedical Engineering Department, but they are still required to have their equipment properly maintained and tested. Otherwise, residents can be in danger.

The lack of ongoing preventive maintenance of medical equipment increases the risk of potential injury to patients or staff members caused by defective equipment. Lawyers could easily argue “negligence” lawsuits against facilities, administrators and operators, for not “properly maintaining” their medical equipment. One example was in McKnight's this fall. Most accrediting organizations such as The Joint Commission, AAAASF, HFAP, CHAP, CARF, and even the DOH, to name a few, require proper maintenance as indicated in their accreditation guidelines. While some refer simply to “properly maintaining” equipment, others such as TJC, are quite specific regarding the requirements.

So what is the generally accepted standard? The requirement for equipment maintenance comes from the National Electric Code (NEC), NFPA-99; chapter 10 of the Health Care Facilities Code. Organizations such as AAMI, ECRI and ASHE have helped develop the standards that are in use today.

As part of an Equipment Management Program, a qualified technician or engineer must periodically inspect equipment. Some of the key factors are electrical safety, proper operation, routine maintenance, calibration and performance testing. In addition to the periodic inspections, all equipment must be inspected prior to being placed into service and after any repairs. All of these inspections must be properly documented. A comprehensive program would include the proper documentation of the routine maintenance and repairs and it would include asset control numbers and safety stickers indicating the date of next inspection. It is important to note that all equipment must be tested and documented, regardless of ownership (i.e. facility owned, leased, borrowed, etc.). The burden is on the facility, not the equipment provider.

The cost of having an ongoing program is far less than the costs and risks of not having one. While accidents can happen due to equipment failure; a safety program establishes a reasonable defense against negligence. Why risk the potential of lawsuits, higher insurance premiums, negative press, or regulatory deficiency citations?  An Equipment Management Program helps your facility create a safer environment. Proper management can improve the cost-effectiveness and utilization of your equipment by reducing downtime and minimizing equipment failures.

George H. Landauer is President and CEO of GDC Medical Electronics in Plainview, NY. He is a Certified Clinical Engineer (CCE) and holds a BS in Electrical Engineering and an MS degree in Industrial Management. 

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