By L. Matthew Snyder, Sr. Director of Certification at Intertek
Medical electrical equipment such as MRIs, anesthesia machines, surgical equipment, scanning systems, patient monitors and other types of products are a significant investment for any healthcare organization. Refurbished medical equipment, devices that are reconditioned and made comparable to new products, are becoming a realistic option for the industry given their lower costs. In fact, many original equipment manufacturers are increasingly focused on refurbishing equipment, which in turn is pushing growth of the market.
A potentially more budget-friendly approach, refurbished equipment is an appealing prospect for not only healthcare industries but for others that regularly use electrical devices. Given the increased interest in this type of product, the National Electric Code (NEC) has been updated to better ensure the safety and performance of refurbished (or reconditioned) products. Previously the NEC did not address this type of product directly, but that changed with the more recent version of the code.
The 2020 edition of the NEC, specifically Section 110.21(A)(2), includes requirements for reconditioned or refurbished electrical equipment, defined as “electromechanical systems, equipment, apparatus, or components” that have been reworked and restored to operating conditions. Only certain types of equipment can be reconditioned, and these products must be identified as such.
Along with their new classification, reconditioned/refurbished products must be released with new model and serial numbers. The revised NEC includes a provision to remove the original certification mark (but not the entire equipment label) of the refurbished electrical equipment. The rebuilt product must be re-evaluated and recertified to applicable safety and performance standards. This new certification then applies to the new model and serial numbers given to the product during the refurbishment process.
Reconditioning is different from repair or servicing, which brings a product back to working condition using the same components in the certification report. When a product is serviced or repaired, its original model, serial number, and certification are maintained. This is because the overall composition of the equipment itself has not changed, so its original certification also remains in place and valid. Repairs are also usually done by an authorized facility, and when complete, the product is returned to the original owner. Repaired products are not intended to be resold the way refurbished equipment is. Straightforward repairs or servicing do not require the product’s reassessment or recertification.
Refurbishment, however, often uses alternate components to restore the product. These alternate parts were not included in the original product certification. While alternate components may be recognized or certified themselves, these components were not included in the equipment’s original evaluation, certification, and listing. Using alternative components essentially alters the overall makeup of the certified product. As such, refurbishing has invalidated the original certification, making additional evaluation and new certification necessary.
National Recognized Testing Laboratories (NRTLs) can evaluate and certify reconditioned medical equipment as easily as they test and certify new products. In fact, the process for certifying refurbished equipment is no different than the process for new products. The lab identifies the applicable standard(s) for a product, such as IEC 60601-1 for medical electrical equipment, the CB Scheme, and the EU’s Medical Device Directive and Radio Equipment Directive. Based upon the standards identified and the known conditions of the product’s refurbishment, the lab then establishes a testing plan for the equipment.
Once a test plan is in place, the testing lab evaluates the product to the current version of the identified standard(s). These assessments may include component evaluations, review of qualified staff training records, assessment of instruction manuals and the review of the disassembly/assembly process. Testing might include safety considerations (shock, fire, temperature, etc.), performance requirements, assessments for electromagnetic compatibility (EMC), batteries, and construction considerations.
As with a new product evaluation, once the testing phase is complete, the relevant data is compiled into a test report that is submitted for review along with the original certification report and nameplate, new nameplate, identification of alternative components used in the refurbishment, remanufacturing instructions, information from a staff training and qualification review, and required environmental conditions. All this information is examined during a technical review and, subsequently a certification review. If all needs are met and the product is shown to comply with applicable standards and mark/label review. Successful reviews at all three levels results in certification being issued for the refurbished product(s).
Medical electrical equipment that is reconditioned may also need to be given a new nameplate and unique model name. This should be applied before the equipment is sold or placed in the field, along with an applicable refurbished certification mark. Depending on the NRTL, the language may vary, but refurbished certification marks are typically the NRTL’s customary certification mark accompanied by “refurbished,” “reconditioned,” or something similar. Following certification, factory surveillance along with maintenance activities will occur, just as happens with newly manufactured products.
Many manufacturers are recognizing the potential in refurbishing medical electrical equipment to meet the budgetary demands of the healthcare industry. While these products offer an appealing alternative, it is important to ensure their safety and performance and adhere to codes like the NEC. Recertifying these products may at first seem daunting, but the process can be smooth provided you stay up to date on applicable standards, compile information on your alternative components and parts, and work with a trusted third party to efficiently evaluate and recertify products to get them to market.
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