Manufacturers of reusable devices with lumens and difficult-to-reach channels should design them so that they can more easily be disassembled for cleaning and subsequently reassembled, according to participants at a recent medical device reprocessing summit.

Device makers also should provide annual updates on instructions for cleaning reusable devices, most participants agreed at the Oct. 11-12 meeting in Silver Spring, Md., sponsored by FDA and the Association for the Advancement of Medical Instrumentation.

Attendees, including regulators, industry and hospital reps, researchers and other subject experts, attempted to reach consensus on top priorities for appropriate reprocessing of reusable devices. Among the top priorities identified are ensuring easy break-apart and reassembly of reusable lumened devices and providing up-to-date instructions, a majority of participants agreed.

Bone reamers are one type of device that can have difficult-to-clean channels, and retain tissue and blood residue after use. (Photo: Spectrum Surgical and Seavey Healthcare Consulting)

Bone reamers are one type of device that can have difficult-to-clean channels, and retain tissue and blood residue after use. (Photo: Spectrum Surgical and Seavey Healthcare Consulting)

The meeting comes as FDA works to complete a final guidance on reprocessing following release of draft guidance in May. (See “ Also see "FDA Reprocessing Guidance Aims To Reduce Hospital Infections" - Medtech Insight, 9 May, 2011. ” – “The Gray Sheet” May 9, 2011.)

The agency previously elaborated on key points the guidance will cover at a June 8-9 meeting. (See “ Also see "Cleaning And Sterilization Needs Require Closer Attention By Reusable Device Makers – FDA" - Medtech Insight, 20 June, 2011. ” – “The Gray Sheet” June 20, 2011.)

In comments on the draft guidance, manufacturers have suggested that FDA emphasize hospitals’ responsibility for accurately following reprocessing instructions. For example, AdvaMed asserted that lapses by health care facilities – not the designs of devices – are “the major cause of infection outbreaks.” (See “ Also see "Manufacturers Tell FDA, Don’t Forget Hospitals’ Role In Device Reprocessing" - Medtech Insight, 15 August, 2011. ” – “The Gray Sheet” Aug. 15, 2011.)

During the Oct. 11-12 meeting, however, CDRH Office of Science and Engineering Lab Microbiologist Victoria Hitchins emphasized that with some current-generation instruments, “we really can’t see if the inside of the device is visibly clean, due to the complex designs, which include long and narrow lumens, junctions with insulating sheaths, and devices that can’t be disassembled.”

She added that devices using combinations of materials, like endoscopes that include both metallic and polymeric plastic parts, can increase the difficulty of reprocessing. In addition to endoscopes, other reusable devices that are notoriously difficult to clean include bone reamers and arthroscopic shavers.

Lumens And Channels Difficult To Clean

A majority of participants at the meeting agreed that reprocessing of devices with narrow lumens is a continuing challenge. “Dead-end lumens and channels create difficulty,” because of “the inability to inspect blind areas along the lumen joints and parts,” said Mark Duro, manager of the central supply division for New England Baptist Hospital.

In some cases, he added, devices have retractable components that must be held apart so that internal parts can be properly cleaned. “Our technicians have to come up with crafty ways to put [some retractable devices] through the wash, like propping it open, so it goes through the wash and stays open,” he said.

Instructions for reprocessing such devices may not warn end users of these issues, Duro asserted. And in some cases, screws within devices that hold disparate parts together will trap bone and debris when the device is being washed, he noted.

“The bone gets stuck inside, because it is screwed down and difficult to open, and the instructions for use don’t tell you that you have to dismantle it. The instructions didn’t give us a whole lot of definition or clarity,” Duro told meeting participants.

Hospitals Cite Need For Updated Instructions

Much of the discussion at the meeting centered on the need for clearer and more readily available instructions for use for reprocessing of new reusable devices.

But hospital users also said they want to receive periodic updates to older cleaning instructions as well, and most meeting participants agreed that annual updates would be helpful. At minimum, hospitals would like to receive updates to cleaning instructions when device makers make changes or add upgrades to the devices.

Most reprocessing instructions “go out with the trash at receiving” instead of being passed along to appropriate hospital staff – Stryker’s Rodney Parker

Some manufacturers at the meeting emphasized that their obligation was to provide reprocessing instructions to the buyer only at the time of the initial sale. This can be problematic, however, if the hospital buyer does not pass along the instructions to reprocessing staff or if there are a number of staff turnovers and instructions are lost or wear out.

In one case, a hospital consultant described the difficulty she had in obtaining a replacement set of cleaning instructions for a flexible reamer. Rose Seavey, CEO of Seavey Healthcare Consulting, said it took her 10 emails and 23 days to track down the right person at a device manufacturer to obtain updated instructions for reprocessing.

The instructions were obtained only after an initial refusal by the company and Seavey’s threat to report the firm to FDA’s Medwatch safety information and adverse event reporting program, she said.

Sales reps can often be the best and only contact for hospital personnel seeking replacement copies of reprocessing instructions, Rodney Parker, senior manager of clinical sciences at Stryker’s Instruments Division, told “The Gray Sheet” at the meeting.

Among the problems posed by reprocessing is that hospitals will sometimes ignore specific reprocessing instructions accompanying an individual device, Parker told meeting attendees.

The instructions “must get through receiving, through transport, to the central sterile supply department, to the central sterile manager, then to the decontamination personnel after training,” Parker said. “Unfortunately, most go out with the trash at receiving,” he asserted.

Manufacturers are asking FDA to spell out in its guidance a definition of “how clean is clean” to help clarify the appropriate extent of reprocessing procedures.

The request stems from tensions between hospital staff and manufacturers, in many instances, about how extensive reprocessing should be and how long it should take. While some hospital staffers seek instructions for cleaning a device in 10 to 20 minutes, manufacturers sometimes outline more time-consuming procedures including 60 or 70 steps, meeting participants said.

Participants also agreed that manufacturers must determine the proper number of reprocessing cycles that a device can undergo before it is worn out and no longer safe to use. Such determinations also should be spelled out in reprocessing instructions, most attendees said.

The group also grappled with the types of soil that should be used to validate the ability to appropriately reprocess a device. CDRH’s Hitchins suggested that the agency will “possibly” ask for “two assays that have two different cleaning endpoints – such as [from] protein, total organic carbon or carbohydrates.”

Also, “please provide proper instructions on how to reassemble your device” once it has been disassembled for cleaning, Hitchins told manufacturers.

By Sue Darcey

Lumened Device Designs Should Facilitate Reprocessing – FDA/AAMI Meeting

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