Contracting for Reprocessing Services

Why Consider Alternatives to Reprocessing?

Reprocessing equipment safely is a complex and exacting process with strict guidelines from the Provincial Infectious Diseases Advisory Council (PIDAC) and the Canadian Standards Authority (CSA).   Because of the challenges of reprocessing, many practice groups have chosen to use either disposable instruments or a contracted reprocessing service.  

Practices that have adopted an alternative to reprocessing onsite have found that the benefits offset the costs. Benefits include: 

  • savings from the costs of pouches, an autoclave printer, chemical indicators, biological indicators, preventative maintenance of the autoclave and administrator time, if administrators are tasked with reprocessing
  • one less demand on stretched midwives, if midwives reprocess or oversee reprocessing
  • no cost and time associated with training staff
  • not having to develop or update written procedures for reprocessing
  • not being responsible for ensuring adherence to pertinent PIDAC and CSA standards for reprocessing, including standards that are especially challenging for practice groups to meet (e.g. ongoing internal audits of reprocessing practices, maintaining a dedicated area with a one-way workflow)
  • avoiding most liability for reprocessing practices and possible investigation of reprocessing practices by regulatory bodies (e.g. Public Health Ontario, College of Midwives of Ontario)

Additionally, outsourced reprocessing minimizes the environmental impact of disposables.

For more information on reprocessing standards, see the AOM’s Midwifery Guide to Reprocessing.

Who Should Midwives Approach about Contracting for Reprocessing Services?

In Ontario, there are two options available for contracted reprocessing services: private service providers and local organizations that already reprocess medical equipment. The AOM is aware of only one private service provider in Ontario, which operates in the Greater Toronto Area (GTA). Because of the challenges of maintaining sterility in transport, they are not able to provide services outside of the GTA at present. 

In terms of local organizations that already reprocess medical equipment, the AOM is only aware of hospitals offering this service to midwives. In hospitals, the Medical Device Reprocessing Department (MDRD), also referred to as the Medical Device Reprocessing Centre (MDRC), Central Sterile Department (CSD), or Sterile Processing Department (SPD), is responsible for reprocessing reusable medical devices.  

How Should a Midwife Approach a Hospital to Contract Reprocessing Services?

When approaching an MDRD to contract reprocessing services, midwives may wish to find out who the MDRD manager reports to – in hospitals, this is usually the director of the surgical program. Writing a letter to the MDRD manager, copying the director, is a good first step. The letter should indicate that the practice would like to contract their facility’s services for reprocessing midwifery equipment (see below). The AOM is currently developing a template letter for practices.

There are several points midwives may wish to include when approaching a hospital to request reprocessing services:

  • The practice has low volumes of instruments to reprocess (e.g. a 20% home birth rate with 400 clients a year is only 80 birth kits a year).
  • It is difficult for the practice to meet CSA standards, and they want to have the equipment reprocessed in a facility where staff are trained to current CSA standards and are audited on an ongoing basis.
  • The practice is interested in the hospital’s MDRD facility because it is accredited and the midwives want to verify that their equipment is being reprocessed safely, following current CSA and Accreditation Canada standards.
  • Midwives and the MDRD are both working to provide the best care for the community of patients, and some of the hospital’s patients are also the midwives’ patients. Midwives can call on the MDRD director’s professionalism, collegiality and commitment to patient safety to help them deliver the same.
  • While midwives are doing their best to ensure adequate sterilization, the practice does not have the dedicated space or expertise to do this.  

Additionally, because of the weight given to Accreditation Canada standards by hospitals, midwives may wish to cite the standard on reprocessing, which reads: 

Preferably, medical device reprocessing (MDR) is done through a centralized system that provides reprocessing services to multiple areas within the organization. From a safety and cost-effectiveness perspective, centralizing reprocessing services is preferred to replicating them in several areas of the organization. If reprocessing services are decentralized, they are held to the same standards as the MDR department. (emphasis added) (1)

While this quotation applies only to hospital services, the idea behind the standard is equally or more applicable to reprocessing in the community. From a safety perspective, centralizing reprocessing services (e.g. in a hospital’s MDRD) is preferable to replicating those services in several areas in the community.

What Barriers Might the Midwife Encounter?

"Certification"

Some hospitals indicate that they cannot reprocess external items for legal reasons, as they are not “certified.” In fact, there is no certification available or required to reprocess on a contractual basis. Hospital administrators are likely confusing the licensing needed to be a third-party reprocessing centre for “single use devices,” which is different from reprocessing reusable items.

Logistics

Some hospitals have concerns about capacity, cost, pre-cleaning and maintaining sterility of equipment in transport. Midwives will need to directly address these concerns with the MDRD. 

  • Instrument volumes are low enough that they will not significantly add to the demands on the MDRD, but centralized reprocessing will significantly help midwives and their clients.
  • The hospital may establish requirements around pre-cleaning in the community (e.g. keeping instruments wet in an enzymatic foam during transport). If so, midwives may wish to discuss the risk of rust if equipment is wet for extended periods of time during delays in transport.
  • Midwives can refer to the AOM’s reprocessing guide for advice on maintaining sterility during transport.
  • Hospital MDRDs may wish to contact other hospitals that have accepted contracts to reprocess midwives’ instruments. The February 2018 issue of Hospital News contains information on the experience of other midwives and hospitals.

Setting Up Instrument Sets

MDRDs often follow a “recipe” when reprocessing and packing instrument kits. For midwives, this means that they may be required to include the same instruments in every home birth kit, rather than each midwife individualizing their own. Midwives can agree to a single birth kit that all midwives in the practice will use, or create a kit with several different options in it (e.g. every birth kit could contain two types of clamps or cord scissors).

If any of the practice’s instruments have rust, pitting or damage, the MDRD may request that they be replaced. The MDRD may also wish to identify the practice’s individual instruments through embossing, not engraving.

Risk Management and Liability

The most challenging issue for midwives to address may be a hospital’s concerns regarding risk management and liability for improperly sterilized instruments. The concern is that the hospital will be held legally responsible for any infections that occur when midwives are using hospital reprocessed equipment.  

Some of this concern can be addressed through quality reprocessing practices and good contracts. Healthcare Insurance Reciprocal of Canada (HIROC) is developing a risk management resource for such situations. Watch the Midwifery Memo for its release.

Although midwives may not be able to completely mitigate this concern, they can put it into context for MDRD administrators. The hospital already strives to maintain robust reprocessing practices. Should there be a reprocessing failure, the hospital is accountable to the large number of patients that receive care at the hospital, including the majority of midwifery clients who have hospital births. The addition of relatively few home birth clients would not substantially increase the hospital’s liability. 

What Should Midwives Consider if Discussions are Fruitful?

Once the midwifery practice is in discussions with a hospital to contract reprocessing services, the contract between the practice and facility should include:

  • the responsibility of each party during the process
  • the turnaround time for equipment reprocessing, which will likely require the practice to purchase additional sets of instruments
  • how dirty instruments are pre-cleaned and transported
  • how sterile instruments are transported
  • what documentation the hospital will maintain regarding reprocessing and verification
  • responsibility and liability coverage, including a directive that the hospital adjusts their insurance policy to cover the midwives’ reprocessing contract.  

Note that HIROC is currently developing resources for midwives and hospitals, and that HIROC can review a contract before midwives sign it. Contact riskmanagement@hiroc.com for details.

How Much does a Reprocessing Contract Cost?

It is very difficult to estimate the cost of contracting reprocessing services, as the cost has varied significantly for midwifery practices in the past. Some practices are charged a nominal amount, while others pay up to $30 per tray of birth instruments in addition to setup costs and the purchase of instrument trays. Despite cost variability, practices that have chosen to contract out reprocessing services have concluded that the expense is worthwhile. For example, after considering the time and costs associated with continuing to autoclave in the clinic, Family Midwifery Care of Guelph concluded that “it made the most financial sense for the practice to outsource the work to the hospital.”

References

  1. Accreditation Canada: Standards: Reprocessing of Reusable Medical Devices. January, 2017, page 2.