• should be qualified by the Manufacturer prior to authorization;
• should be authorized by the Manufacturer;
• should be controlled by the manufacturer in an appropriate way;
• should be accountable to provide feedback to the manufacturer; and
• there should be a quality assurance agreement regarding post market information between the refurbisher and the manufacturer.
While other requirements in the standard appropriately address important knowledge areas such as sterilization, disinfection and testing, the standard does not identify why those who refurbish must be qualified, approved and accountable to a manufacturer. Parenthetically, I am not aware of manufacturers who would voluntarily approve refurbishers who are not otherwise involved in a manufacturer joint venture or parent/subsidiary business arrangement. Such standard requirements seem inconsistent with appropriate balancing of interests and other requirements for adoption of a national or international standard. We hope that the highly respected IEC would not issue final approval on a standard which apparently requires manufacturers to vet, approve and control the refurbishing process. Perhaps there is another draft in the offing which omits this requirement. Compliance with QMS and safety requirements does not always necessitate that only those approved by the manufacturer may refurbish.

About the author: Robert J. Kerwin is the general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.

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